pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
NCT Number: NCT06498167
Acronym: LOOK-UP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Inflammatory Disease|Drug Side Effect|Drug Use|Adverse Drug Event|Adverse Drug Reaction|Safety Issues
Interventions: DRUG: Upadacitinib
Sponsor: Universidade do Porto
Collaborators: INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.|Unidade de Farmacovigilância do Porto|Unidade Local de Saúde de São João, E.P.E.|Unidade Local de Saúde de Santo António, E.P.E.|Unidade Local de Saúde de Gaia/Espinho, E.P.E.|RISE Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Unidade Local de Saúde de Santo António, E.P.E., Porto, 4050-366, Portugal|Unidade Local de Saúde de São João, E.P.E., Porto, 4200-319, Portugal|Unidade Local de Saúde de Gaia/Espinho, E.P.E., Porto, 4434-502, Portugal

Summary:
The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. The Marketing Authorisation Holder is AbbVie Deutschland GmbH \& Co. KG.

Primary Outcome Measures: Incidence of adverse events, Incidence of adverse events occurring during the established follow-up period, coded according to MedDRA terminology.

The outcome will be assessed through an ad-hoc questionnaire. The occurrence of adverse events will be queried in an open-ended, non-directed manner. Patients will be encouraged to report any undesired events they experience during the treatment, without being limited to predefined specific adverse events., For the prospective cohort, the follow-up includes contacts at baseline (t=0), 2 weeks (t=1), 1 month (t=2), 2 months (t=3), and 3 months (t=4) after starting treatment.
Secondary Outcome Measures: Rate of non-compliance with PRAC recommendations, Rate at which patients identified with risk factors are prescribed Rinvoq™ despite the availability of viable therapeutic alternatives. Patients considered to have risk factors include: (i) individuals aged 65 or older; (ii) current smokers or those with a long history of smoking; (iii) individuals at high risk of serious cardiovascular problems, such as heart attacks or strokes, or those more likely to develop cancer.

The outcome will be assessed through direct contact with clinical specialists (prescribers) to confirm the availability of therapeutic alternatives. A case is non-compliant if a patient with risk factors is prescribed Rinvoq™ despite an available alternative., This outcome will be assessed at any time during the three-month monitoring period of each patient.
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
NCT Number: NCT06498154
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: RADIATION: Neoadjuvant Chemotherapy combined with Neoadjuvant Radiotherapy
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Collaborators: The First Affiliated Hospital of Zhengzhou University|The First Affiliated Hospital of Hainan Medical University|Shandong Cancer Hospital and Institute|First Affiliated Hospital of Kunming Medical University|Chongqing University Cancer Hospital|Tangshan People's Hospital|Taizhou Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2032-06-30
Locations: Tianjin medical university cancer institute and hospital, Tianjin, China

Summary:
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy.

Primary Outcome Measures: 5-year EFS, 5 years event-free survival after neoadjuvant chemoradiotherapy, 60 weeks
Secondary Outcome Measures: b-pCR, Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate (bpCR: ypT0), 18 weeks|OS, overall survival after completing of neoadjuvant chemoradiotherapy, 60 weeks
MucinB5 Gene Polymorphism and Leucocytes Telomere Length in Interstitial Lung Diseases
NCT Number: NCT06498141
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mucin B5 rs (35705950) Gene Polymorphism in Interstitial Lung Diseases
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2024-12-31
Locations: Sohag university hosoital, Sohag, Egypt

Summary:
This is an observertional study aimed at Study the association between Mucin B5 rs (35705950) gene polymorphism and Leucocytes telomere length in relation to interstitial lung diseases.

Primary Outcome Measures: MucinB5 rs (35705950) gene polymorphism, whether homogenetic or heterogenetic, 6 Months|Leucocytes telomere length, Measurement of the relative length of WBCs telomere in patints with interstitial pulmonary fibrosis, 6 months
Norepinephrine on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia
NCT Number: NCT06498115
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Maternal Hypotension
Interventions: DRUG: Norepinephrine
Sponsor: The Third People's Hospital of Bengbu
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2024-12
Locations: The Third People's Hospital of Bengbu, Bengbu, Anhui, 233000, China

Summary:
Norepinephrine has emerged as a potential alternative for stabilizing blood pressure during spinal anesthesia for cesarean section, purportedly maintaining maternal heart rate and cardiac output more effectively than phenylephrine. However, its application as an intravenous bolus for treating hypotension remains underexplored. Consequently, this current investigation aimed to determine the ED50 and ED95 of norepinephrine for managing maternal hypotension during cesarean section. A prospective trial enrolled 100 patients undergoing elective delivery under spinal anesthesia, with norepinephrine dosage determined using the upper and lower sequential distribution method (UDM).

Primary Outcome Measures: Intravenous norepinephrine to maintain maternal systolic blood pressure 80% above baseline before fetal delivery., Intravenous norepinephrine pumped to maintain maternal systolic blood pressure 80% above its basal value prior to delivery of the foetus, From the initiation of anesthesia to the delivery of the fetus.
Secondary Outcome Measures: Intraoperative adverse reactions, Dizziness, chest tightness, nausea, vomiting, bradycardia, secondary hypertension and other adverse reactions, Perioperative period|Number of remedial drugs, Includes incidence of remedial use of atropine, incidence of remedial use of norepinephrine., Perioperative period|Neonatal Apgar score, Neonatal 1-min and 5-min Apgar scores, Immediately After delivery of the foetus
The Underlying Mechanisms Regarding the Effect of Glucagon on the Kidneys Will be Investigated in Healthy Males.
NCT Number: NCT06498063
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Diseases
Interventions: OTHER: Glucagon|OTHER: Placebo|OTHER: Glucagon and exendin 9-39
Sponsor: Ali Asmar
Collaborators: University of Copenhagen|The Augustinus Foundation, Denmark.|The Novo Nordic Foundation
Sex: MALE
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-02-20
Completion Date: 2025-07-31
Locations: Physiological laboratory, Bispebjerg Hospital, Research Unit, Clinical Physiology / Nuclear Medicine Department, Copenhagen, 2400, Denmark

Summary:
The goal of this crossover study is to investigate to what extend glucagon affects the kidneys. The main questions it aims to answer are:

Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? Does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? Does glucagon regulate kidney function by increasing renal salt excretion?

Primary Outcome Measures: Natriuresis, From urine samples, unit mmol/L, Analyzed from urine samples at -60, 0, 60 and 120 minutes|Glucagon extraction, From blood samples, unit pmol/L, Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes
Secondary Outcome Measures: Glomerular filtration rate, Unit mL/min, Measured via Fick's principle during steady state using [99mTc]Tc-DTPA (diethylene-triamine-pentaacetate) as a tracer given as a constant infusion from -210 to 180 min.|Diuresis, from urine samples, unit mL/min, Analyzed from urine samples at -60, 0, 60 and 120 minutes|Renal Blood Flow, Unit mL/min, Measured via Fick's principle during steady state using [99mTc]Tc-DTPA (diethylene-triamine-pentaacetate) as a tracer given as a constant infusion from -210 to 180 min.|Urea, Unit mg/dL, Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
NCT Number: NCT06498037
Acronym: FERRARI
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Cancer Pain
Interventions: DRUG: Fentanyl
Sponsor: Erasmus Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-23
Completion Date: 2025-12-02
Locations: Erasmus Medical Center, Rotterdam, Zuid-Holland, 3015 GD, Netherlands

Summary:
The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer. The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient.

Patients will be treated with additional loading boluses and plasma-PK samples will be obtained.

Primary Outcome Measures: Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach, Using a paired t-test the geometric mean of the ratio of the two fentanyl plasma concentrations will be compared. The 90% confidence interval of the geomteric mean should fall within the range of 80 - 125%., 48 hours after dose increase
Secondary Outcome Measures: Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses., This will be performed as a descriptive analysis, up to 48 hours after dose increase|Describe the course of patient reported pain intensity in the 48 hours following the loading boluses., This will be performed as a descriptive analysis, up to 48 hours after dose increase|Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus., The pharmacokinetic data will be imputed into a population pharmacokinetic model that allows to simulate other situations and dosing regimens which will be used to further optimize dosing of subcutaneously administered fentanyl, up to 48 hours after dose increase
Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 2)
NCT Number: NCT06498024
Acronym: ABWE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Glucose
Interventions: OTHER: Kellogg's - rice krispies (control)|OTHER: Kellogg's - rice krispies (control) + 125ml milk|OTHER: Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk|OTHER: Novel cereal (40% Canadian wild rice, 60% fava bean blend)|OTHER: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)|OTHER: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milk
Sponsor: University of Manitoba
Collaborators: Protein Industries Canada|Mitacs
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2025-05-01
Locations: Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, Manitoba, R2V 3M3, Canada

Summary:
The goal of this acute double-blind cross over trial to test the effects of different wild rice cereal products compared to products currently on the market on glycaemic control. The main questions it aims to answer are:

1. What is the effect compared to products currently on the market on glycaemic control?
2. Is the wild rice product palatable?

Participants will:

* consent to attend 6 study visits being 2.5 hours each
* come to each visit fasted for at least 10-12 hours.
* complete a Motivation to Eat VAS following each blood measure

Primary Outcome Measures: The effects of different wild rice products compared to products currently on the market on glycaemic control., Finger stick blood glucose will be measured throughout each session., Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.
Secondary Outcome Measures: To measure the palatability of the wild rice products following consumption., Visual Analogue Scale (VAS)., VAS measuring palatability will be completed right after the consumption of the treatments.
Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 1)
NCT Number: NCT06497972
Acronym: ABWE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Glucose
Interventions: OTHER: White bread (control)|OTHER: Brown rice cake|OTHER: Wild rice (25%) and brown rice (75%) cake
Sponsor: University of Manitoba
Collaborators: Protein Industries Canada|Mitacs
Sex: ALL
Age: ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-10
Completion Date: 2024-12-30
Locations: Chronic Disease Innovation Centre, Seven Oaks Hospital, Winnipeg, Manitoba, R2V 3M3, Canada

Summary:
The goal of this acute double-blind cross over trial is to test the effects of a wild rice cake product compared to products currently on the market on glycaemic control. The main questions it aims to answer are:

1. What is the effect compared to products currently on the market on glycaemic control?
2. Is the wild rice product palatable?

Participants will:

* consent to attend 4 study visits being 2.5 hours each
* come to each visit fasted for at least 10-12 hours.
* complete a Motivation to Eat VAS following each blood measure

Primary Outcome Measures: The effects of different wild rice products compared to products currently on the market on glycaemic control., Finger stick blood glucose will be measured throughout each session., Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.
Secondary Outcome Measures: To measure the palatability of the wild rice products following consumption., Visual Analogue Scale (VAS)., VAS measuring palatability will be completed right after the consumption of the treatments.
Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter
NCT Number: NCT06497933
Acronym: FRANCE-PFA
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Atrial Fibrillation
Interventions: PROCEDURE: Atrial fibrillation ablation
Sponsor: University Hospital, Rouen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5223
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-01
Completion Date: 2026-03-01
Locations: University Hospital of Rouen, Rouen, 76000, France

Summary:
Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.

Primary Outcome Measures: long-term efficacy (AA), freedom from all types of atrial arrhythmia recurrences, within 1-year period post-procedure|very long-term efficacy (AA), freedom from all types of atrial arrhythmia recurrences, Within 2 years period post-procedure
Secondary Outcome Measures: long term efficacy (AF), freedom from atrial fibrillation recurrences, within 1-year period post-procedure|very long-term efficacy (AF), freedom from atrial fibrillation recurrences, Within 2 years period post-procedure|Safety outcomes, the composite of major adverse events, including esophageal complications, symptomatic PV stenosis, cardiac tamponade requiring intervention, stroke or systemic thromboembolism, persistent phrenic nerve injury, vascular access complications requiring surgery, coronary artery spasm, and death, within 1-month post-procedure
rTMS to Improve Motor Function in Autism
NCT Number: NCT06497920
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autism Spectrum Disorder|Motor Activity
Interventions: DEVICE: Active rTMS to the motor cortex|DEVICE: Sham rTMS to the motor cortex
Sponsor: Centre for Addiction and Mental Health
Sex: ALL
Age: ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-24
Completion Date: 2029-06-30
Locations: Center for Addiction and Mental Health (CAMH), Toronto, Ontario, M6J 1H4, Canada

Summary:
In the current project, investigators have two main goals: i) Testing whether an excessive plasticity, i.e. hyperplasticity in the motor cortex underlies motor function difficulties in autistic adults, and ii) Using repetitive Transcranial Magnetic Stimulation (rTMS) with autistic adults to examine whether resulting reduced hyperplasticity in the motor cortex will be associated with clinical improvements in the motor function.

Primary Outcome Measures: Changes in motor cortical plasticity using motor evoked potentials (MEPs) in autistic adults following rTMS., Plasticity will be indexed by the duration of facilitation of motor evoked potentials (MEPs) amplitude, i.e. the time for the MEP amplitude to return to baseline values following iTBS., Plasticity in the motor cortex will be evaluated at baseline, immediately after rTMS, and 1 and 4 weeks after the last rTMS session.|Changes in motor function in autistic adults following rTMS., Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) will be used to assess motor function. The total motor composite score will be used as the primary measure of motor function. A higher score on BOT-2 indicates better motor performance., Motor function will be assessed at baseline, immediately after rTMS, and 1 and 4 weeks after the last rTMS session.
Secondary Outcome Measures: Changes in motor cortical plasticity using cortical evoked activity (CEA) in autistic adults following rTMS., A secondary measure of plasticity will be indexed by the maximum post-iTBS/pre-iTBS cortical evoked activity (CEA) ratio. CEA will be defined as the area under rectified curve for averaged electroencephalography (EEG) recordings in the electrode over motor cortex between 50-275 millisecond post-stimulus., Plasticity in the motor cortex will be evaluated at baseline, immediately after rTMS, and 1 and 4 weeks after the last rTMS session.|Changes in the adaptive daily living skills in autistic adults following rTMS., The daily living skills domain of Adaptive Behavior Assessment System-3rd edition will be used to assess adaptive daily living skills. A higher score represents better adaptive skills., Adaptive daily living skills will be assessed at baseline, immediately after rTMS, and 1 and 4 weeks after the last rTMS session.
Environmental Enteropathy Among Infants and Children With Growth Faltering
NCT Number: NCT06497907
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Growth Failure|Enteropathy
Interventions: DIETARY_SUPPLEMENT: polymeric formula|DIETARY_SUPPLEMENT: peptide based formula
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-04-30
Completion Date: 2024-06-25
Locations: Faculty of Medicine-Ain Shams University, Cairo, Abbasia, 1181, Egypt

Summary:
The study was conducted on 200 patients with growth faltering on 2 phases. In the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 SD for age and sex on the WHO scores were defined as non responders and entered the second phase. In the second phase Upper Gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.

Primary Outcome Measures: Assessment of the prevalence of environmental enteropathy among children with faltering growth., Assess the number of patients whose weight still below -2SD and upper gastrointestinal endoscopy showed the criteria of environmental enteropathy., 12 weeks of nutritional rehabilitation with polymeric formula.
Secondary Outcome Measures: Determine the increase in weight of children with growth faltering and environmental enteropathy after nutritional rehabilitation with peptide-based formula., Weight z- score, 8 weeks of nutritional rehabilitation with peptide-based formula.
No More Sleepless Nights in Perimenopause
NCT Number: NCT06497894
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Insomnia|Menopause
Interventions: BEHAVIORAL: Cognitive Behavioural Therapy for Insomnia (CBT-I)|DRUG: Hormone Replacement Therapy (HRT)|BEHAVIORAL: Sleep Hygiene
Sponsor: Insel Gruppe AG, University Hospital Bern
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-09-30
Locations: University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine, Bern, 3010, Switzerland

Summary:
The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are:

* Are HRT and CBT-I effective in reducing insomnia in menopausal women?
* Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population?

Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions.

Participants will:

* Complete a screening and baseline assessment
* Receive Hormone Replacement Therapy (as prescribed), Cognitive Behavioral Therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks.
* Keep a daily diary (sleep e-diary), to assess sleep-quality.
* Wear an electroencephalogram (EEG) during 6 nights (3 at baseline \& 3 post-intervention), to assess deep sleep cycles and waking episodes.
* Receive a phone call for intervention compliance
* Complete a post-intervention assessment.

Primary Outcome Measures: Reduction of Insomnia Severity, Change from baseline in Insomnia Severity Index (ISI), Week 10
Secondary Outcome Measures: Improvement in Climacteric Syndrome, Change from baseline in Menopause Rating Scale (MRS-II), Week 10|Changes in bio-functional age, Change from baseline in biofunctional status (i.e. differences between chronological age and biofunctional age)., Week 10|Changes in maladaptive sleep-related cognitions, Change from baseline in Dysfunctional Attitudes and Beliefs about Sleep Scale (DBAS)., Week 10
Self-compassion and Bipolar Disorder
NCT Number: NCT06497868
Acronym: COMPASS-TB
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bipolar Disorder
Sponsor: University Hospital, Strasbourg, France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-20
Completion Date: 2025-06-20
Locations: Service de Psychiatrie - CHU de Strasbourg - France, Strasbourg, Les Hôpitaux Universitaires De Strasbourg, 67091, France

Summary:
Currently, pharmacotherapy is central in the management of bipolar disorder (BD), but does not guarantee satisfactory results for many patients. Existing psychotherapies, notably cognitive-behavioral therapy (CBT), show some effectiveness, but do not target the mechanisms that maintain the disorder. Indeed, people with BD present a low level of self-compassion, suffer from comorbidities (e.g. anxiety, depression), and have a high level of emotional dysregulation, which can contribute to increasing the risk of relapse and mood instability.

In this context, it has been suggested that interventions targeting self-compassion could reduce BD psychopathology and strengthen emotional regulation skills.

Two psychological therapies targeting self-compassion could be promising in the treatment of BD: Compassion-Based Therapy (CBT) and Cognitive Therapy focused on Mental Imagery (mTCI). These approaches partly emphasize compassionate mental imagery to promote self-soothing and emotion management skills.

Studies on the feasibility and effectiveness of CBT and mTCI in the context of BD are few in number, and do not focus on their impact on emotional regulation abilities. Evaluating these therapies could lead to the development of more specific and effective interventions for people with TB.

Primary Outcome Measures: Evaluation of the effectiveness of the Compassion-Based Therapy (CBT) and the Cognitive Therapy focused on Mental Imagery (mTCI)., For the evaluation of these two psychological therapies targeting self-compassion, the Self Compassion Scale (SCS; Neff, 2003) will be used :

* The SCS is a 26-question self-assessment questionnaire with a response format of 5-point Likert type (from 1= almost never to 5= almost always).
* The score between :

  * 1.0-2.49 is considered to be low,
  * 2.5-3.5 is considered to be moderate,
  * 3.51-5.0 is considered to be high., Up to 1 year
Impact of Estimated Concentration of Propofol on Implicit Memory Formation
NCT Number: NCT06497855
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: General Anaesthesia|Implicit Memory
Sponsor: University of Padova
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-11-15

Summary:
Implicit memory formation and learning during general anaesthesia is a still debated question and no anesthetic regimen (ie intravenous anaesthesia vs inhalatory one) nor analgesic regimen (i.e. low or high opioids usage) has been identified for prevention.

With this study the investigators aim to investigate if, during Total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) different concentrations of Propofol at loss of responsiveness, maintenance and return of responsiveness can have a role in implicit memory formation.

Primary Outcome Measures: The role of Propofol Concentration at the loss of responsiveness on Implicit Memory formation, CeP at LOR will be compared between patients who exhibit or not implicit memory formation., CeP will be recorded at Loss of responsiveness. Word Steam recognition, Free recall and Forced Choice Recognition Task will be performed within 12-24 hours after surgery. These 3 tests are analysed togheter to check for implicit memory formation.|The role of Propofol Concentration at the maintenance of anaesthesia on Implicit Memory formation, CeP at anaesthesia maintenance will be compared between patients who exhibit or not implicit memory formation., CeP will be recorded during anaesthesia maintenance. Word Steam recognition, Free recall and Forced Choice Recognition Task will be performed within 12-24 hours after surgery. These 3 tests are analysed togheter to check for implicit memory formation.|The role of Propofol Concentration at the return of responsiveness on Implicit Memory formation, CeP at ROR will be compared between patients who exhibit or not implicit memory formation., CeP will be recorded at Return of responsiveness. Word Steam recognition, Free recall and Forced Choice Recognition Task will be performed within 12-24 hours after surgery. These 3 tests are analysed togheter to check for implicit memory formation.
Effort During Resistance Training in Type 2 Diabetes
NCT Number: NCT06497842
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type2 Diabetes Mellitus
Interventions: BEHAVIORAL: High-effort resistance exercise training|BEHAVIORAL: Low-effort resistance exercise training
Sponsor: University of New Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-02-01
Locations: UNM Exercise Physiology Lab, Albuquerque, New Mexico, 87131-0001, United States

Summary:
In this study the primary aims are to investigate the effect of resistance exercise training with different degrees of effort on glycemic control and psychological variables in individuals living with type 2 diabetes mellitus. As a secondary aim, investigate adherence and dropout rates and reasons for dropping out and adhering or not to the protocols.

Primary Outcome Measures: Glucose concentration, Average glucose concentration (measured in milligrams per deciliter of blood, with a continuous glucose monitoring device), For 60 hours before the first training session and for 60 hours after the last (32nd) training session
Secondary Outcome Measures: Adherence to the resistance training protocols, Adherence rate assessed using the Kaplan-Meier method, From date of randomization until the date of first documented dropout from any cause, assessed up to 16 weeks (the end of the training period)
Geranylgeraniol Supplementation in Patients With Mevalonate Kinase Deficiency
NCT Number: NCT06497829
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mevalonate Kinase Deficiency
Interventions: DIETARY_SUPPLEMENT: geranylgeraniol
Sponsor: University Hospital, Motol
Collaborators: Washington University School of Medicine
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2022-01-25
Completion Date: 2025-12-31
Locations: University Hospital, Motol, Prague, 15006, Czechia

Summary:
Mevalonate kinase deficiency (HyperIgD syndrome, HIDS) is an inborn error of immunity caused by a block in the mevalonate pathway. The subsequent lack of isoprenoids with antiinflammatory properties might contribute to the autoinflammatory nature of the disease.

A pilot study aims to verify the safety and efficacy of the dietary supplement Geranylgeraniol, aiming at a mitigation of isoprenoids deficiency caused by the above-mentioned block in the MVK pathway.

Primary Outcome Measures: Change in inflammatory parameters, Monitoring inflammatory markers before and after intervention - CRP (C reactive protein) and SAA (serum amyloid A) levels will be measured before and after the intervention (time 0 and time 3 months of GG use).

These values tend to be elevated in patients with MVK deficiency due to their inflammatory status compared to normal values defined in clinical laboratories (UHMotol CRP \< 8 mg/l, SAA \< 10 mg/l).

The expected outcome would result in a decrease in inflammatory markers., 3 monhts of intervention
Secondary Outcome Measures: Change in the clinical status of patients, Monitoring of general clinical status and defined parameters - general condition, fatigue, fever, skin manifestations, abdominal pain, and headache using a questionnaire. The questionnaire is designed for daily monitoring of the parameters mentioned above. The scale of the questionnaire is from 1 to 10, with 1 being the best, normal condition, and 10 being the worst degree of disability., 3 months
The Effect of Nurse-Led Body Protection Education in Students With Visual Impairments
NCT Number: NCT06497803
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Child Sexual Abuse|Disability, Vision
Interventions: OTHER: Nurse-Led Body Protection Education|OTHER: Reminder Education Brochure
Sponsor: Marmara University
Sex: ALL
Age: CHILD
Enrollment: 53
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-10-08
Completion Date: 2022-01-07
Locations: Marmara University, Istanbul, Turkey

Summary:
In the study, it was aimed to examine the effect of nurse-led body protection education on the sexual abuse knowledge levels of students with visual impairments.

Primary Outcome Measures: The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale, The Good Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale was applied in the pre-test, post-test and follow-up test. The scale was developed by Tutty in 1992 and finalized by revising in 1995 (Tutty, 1997). The Turkish adaptation study of the scale was conducted by Yilmaz and Cenkseven-Onder (2020). Eight items on the scale (1, 3, 8, 17, 20, 25, 27 and 30) are under the Good Touch subdimension. The responses to the items are in the form of Correct, Incorrect, and Don't Know. In the analysis of the scale, "correct" answers are scored as 1 point, and "incorrect" and "Don't Know" responses are scored as 0 point., Change in knowledge level within two months|The Bad Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale, The Bad Touch subscale of the Children's Knowledge of Abuse Questionnaire-Revised scale was applied in the pre-test, post-test and follow-up test. The scale was developed by Tutty in 1992 and finalized by revising in 1995 (Tutty, 1997). The Turkish adaptation study of the scale was conducted by Yilmaz and Cenkseven-Onder (2020). 22 items are under the Bad Touch subdimension. The responses to the items are in the form of Correct, Incorrect, and Don't Know. In the analysis of the scale, "correct" answers are scored as 1 point, and "incorrect" and "Don't Know" responses are scored as 0 point., Change in knowledge level within two months
BJH-SDS Validation of the German Translation
NCT Number: NCT06497790
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Dysphagia|Stroke, Acute
Interventions: DIAGNOSTIC_TEST: BJH-SDS Screenint Test|DIAGNOSTIC_TEST: Flexible Endoscopic Evaluation of Swallowing
Sponsor: University of Giessen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 570
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-15
Completion Date: 2026-05-01
Locations: University Hospital Giessen and Marburg, Campus Giessen, Giesen, Hessen, 35392, Germany

Summary:
The first object of the study is the validation of a translation of the Barnes-Jewish Hospital Stroke Dysphagia Screen with determination of sensitivity, specificity, interrater reliability (especially between different professional groups) and criterion validity.

If the German translation proves to be suitable, it will also be validated on general neurological patients, i.e. patients on a neurological ward without a stroke.

Primary Outcome Measures: Penetration-Aspiration Score, Penetration-Aspiration-Score, minimum value 1, maximum value 8; higher scores mean worse outcome, Immediately after the intervention|Barthel-Index, Barthel-Index; minimal value 0, maximum value 100; lower values mean worse outcome, Immediately before the intervention|MRS, Modified Rankin Scale; minimal value 0, maximum value 6; higher values mean worse score, Immediately before the intervention
The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer. Diagnosis of Pancreatic Cancer
NCT Number: NCT06497777
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pancreas Adenocarcinoma|MicroRNA
Interventions: GENETIC: MicroRNA (mir-642b-3p)
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-06
Completion Date: 2026-06-01
Locations: National Taiwan University Hospital, Taipei, 100225, Taiwan

Summary:
Previous research has shown that microRNAs in the blood can serve as biomarkers for early pancreatic cancer, with potential applications including detection, differential diagnosis, and prognosis prediction of pancreatic cancer. The current primary method for detecting microRNAs is RT-qPCR, but this process requires repeated temperature cycling, which demands high precision from the equipment. As an alternative, isothermal nucleic acid amplification technology does not require expensive temperature control instruments. Our research team has developed various isothermal nucleic acid amplification strategies for microRNA sensing platforms, applied to biological sample detection. This study combines the circular strand displacement amplification strategy with DNA nanomachines to develop a fluorescence sensing platform that performs dual signal amplification at a constant temperature. It is designed to detect pancreatic cancer-related microRNAs, exploring its role and potential applications in the diagnosis of pancreatic cancer patients.

Primary Outcome Measures: Ratio of the target microRNA in patients with and without pancreatic adenocarcinoma., 24 hours
Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)
NCT Number: NCT06497764
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alopecia
Interventions: DEVICE: Vibrational Anesthesia (VA) Device|PROCEDURE: PRP Treatment
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2025-07-01
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.

Primary Outcome Measures: Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure, At the end of the 10-minute PRP procedure, participants will rate their pain on: 1) The side of the scalp with no VA, and 2) the side of the scalp with VA. Participants will rate pain using a VAS, where pain is rated on a 0-10 scale; larger values indicate greater pain levels., End of procedure (About 10 minutes, Day 1)
Secondary Outcome Measures: Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm, Day 1
Teleguidance-facilitated Airway Management
NCT Number: NCT06497725
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Telemedicine|Intubation; Difficult or Failed|Emergencies
Interventions: DEVICE: Teleguidance-facilitated Airway Management
Sponsor: Kocaeli University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-05-01
Completion Date: 2024-08-01
Locations: Kocaeli University Medical Faculty Emergency Medicine Department, Kocaeli, 41730, Turkey

Summary:
The advent of telemedicine has introduced teleguidance as a promising support to enhance endotracheal intubation skills among inexperienced operators. Several studies showed the effectiveness of supervisor assisted ETI using the various VL devices and commercial videoconferencing softwares. However, recent developments in VL technologies introduced the VL integrated videoconferencing features for this purpose. Scoper VL device (Technomedicare Inc, Turkiye) developed a real-time teleconsultation feature for difficult airway scenarios to be assisted by experts during the procedure. However, the literature is very limited about the effectiveness and feasibility of teleguidance-facilitated airway management.

This high-fidelity simulation study aims to assess impact of teleguidance-facilitated airway management on the success of ETI performed by inexperienced operators in a mobile ambulance.

Primary Outcome Measures: Rate of first attempt success (n,%), Visualization of the endotracheal tube passing between the vocal cords within the first 60 seconds of the procedure., Measured at the 60-second mark.
Secondary Outcome Measures: Intubation duration (seconds), Duration between the passage of the endotracheal tube through the lips and its pass between the vocal cords, procedure (Measured at the confirmation of the tube passed between vocal cords.)|Operator confidence assessed by Likert Scale., Self-evaluation of procedure confidence using 7-point Likert Scale, At the end of the procedure|Feasibility of intubation assessed by Likert Scale., Self-evaluation of methods feasibility using 7-point Likert Scale, At the end of the procedure
The Application of Rapid Fresh Digital Pathology on the Diagnosis and Biomarker Testing of Lung Cancer
NCT Number: NCT06497686
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer|Intraoperative Pathology|3D Pathology|Immunochemistry Staining
Interventions: DIAGNOSTIC_TEST: mesoscale nonlinear optical gigascope|DIAGNOSTIC_TEST: Fluorescence microscope
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2025-12-31

Summary:
Through this project, the rapid staining process will be optimized for ex-vivo human lung specimens and integrate advanced ex-vivo mesoscale nonlinear optical gigascope. Initially, this will provide rapid digital pathological diagnosis during lung cancer surgeries. This will help achieve the dual goals of precise and efficient complete resection of lung cancer tissues while preserving tissue functionality. The application of this technology aims to provide higher-quality medical services for patients suffered from lung cancers.

Primary Outcome Measures: Evaluate the feasibility of replacing frozen section pathology with rapid digital pathology diagnosis., Obtain a portion of specimens and directly perform rapid H\&E staining. Then, place the edge of the cut surface of the specimen flat on the microscope objective for observation. The same specimen will then undergo the standard histological staining process in the pathology department for comparative analysis. Another portion of the specimen will be processed using the pathology department's standard frozen section procedure for comparative analysis. In this study, the investigators will acquire the pathological tissue images (with multiple distinct structures like nuclear atypia, vessels, vesicles, and so on) in those images via rapid-fresh-pathology, frozen pathology and formalin-fixed embedded pathology. And the analysis of the number of abnormal cells, irregular vesicles and tumor structures will be conducted to provide pathologists information to compare and distinguish whether it is normal or not., 1 years
Secondary Outcome Measures: Utilize rapid digital pathology for biomarker detection and 3D pathology in lung cancer., Obtain specimens for testing with rapid immunohistochemical (IHC) staining process and used for the three-dimensional reconstruction of lung tissue structure. First, label and stain the specimen using antibodies, then observe it under the mesoscale optical microscope or the fluorescence microscope. The same specimen will then undergo the standard histological staining process in the pathology department for comparative analysis. In this study, the image data will be reconstructed using 3D reconstruction technology to present the three-dimensional structure (for example: vessels, vesicles and so on) of the lung tissue specimen. This will be used for three-dimensional digital pathology research on tumor grading and growth patterns.(including low-grade or high-grade patterns, invasive or in situ lesions, and STAS) and three-dimensional pathology will also be evaluated., 1 year
Sanger Human Cell Atlasing Project
NCT Number: NCT06497673
Acronym: HCA
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Human Development|Genetic Disease
Interventions: OTHER: sample collection
Sponsor: The Wellcome Sanger Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-12-16
Completion Date: 2029-11-07
Locations: Wellcome Sanger Institute, Cambridge, United Kingdom

Summary:
"Cell Atlasing" refers to a novel strategy to characterise cells in tissues at the molecular level in a quantitative manner. The international Human Cell Atlas consortium brings together a community of biologists, clinicians, technologists, physicists, computational scientists, software engineers, and mathematicians to capitalise on drawing together leaders with various biological, technical and computational expertise. The project is based on the aim to define all human cell types in terms of their distinctive patterns of gene expression, physiological states, developmental trajectories, and location. This will pave the way to create a reference map of all human cells as a basis for understanding human health and diagnosing, monitoring, and treating disease.

Primary Outcome Measures: This project aims to scale up the single cell genomics and high-throughput highly multiplex spatial gene expression profiling approaches., Coupled with powerful computational methods, this strategy will produce a comprehensive and systematic reference map of human cells, providing a fundamental blueprint of cell states for both basic biological research and clinical practice., 10 years