louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04167111: Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
Official title: Pilot Study- Treat to Target Vitamin D in End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects will be started on Vitamin D3 4000 per day or 2400 IU per day at baseline and based on 3 month 25(OH)D levels, will be adjusted to a different vitamin D dose if needed
Primary purpose: OTHER

Brief summary: Feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin D level of 35-50 ng/ml in end stage renal disease patients

Detailed description: Pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(OH)D level of 35-50 ng/ml in end stage renal disease patients.

Eligibility criteria: Inclusion Criteria:

* likely be able to complete the study, \>3 months on hemodialysis, receiving standard of care through their nephrologist.

Exclusion Criteria:

* on peritoneal dialysis, allergy to vitamin D, liver disease, intestinal disorders that interfere with vitamin D absorption, taking vitamin D \>800 IU per day, 25(OH)D level \>30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.

Primary outcomes:
measure: 25(OH)D level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Laura Graeff-Armas, MD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06596811: Research on the Risk Warning Model and Prevention Strategies for Acute Kidney Injury Associated With Cyclosporine Based on Explainable Deep Neural Networks and Therapeutic Drug Monitoring
Official title: Research on the Risk Warning Model and Prevention Strategies for Acute Kidney Injury Associated With Cyclosporine Based on Explainable Deep Neural Networks and Therapeutic Drug Monitoring
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: AKI
Therapeutic Drug Monitoring (TDM)
Keywords: deep learning
AKI
ADM
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients treated with tacrolimus or cyclosporine and monitored for therapeutic drug concentrations at three medical centers from January 2020 to December 2023, including Shandong First Medical University Affiliated Hospital, Binzhou Medical University Affiliated Hospital, and Jinan First People's Hospital.

Brief summary: In this study, the investigators will focus on hospitalized patients using cyclosporine and develop an acute kidney injury risk prediction model through in-depth analysis of electronic medical record data, employing interpretable deep learning methods. This model aims to provide timely decision-making support for clinicians regarding prevention and treatment. Compared to traditional machine learning models, deep neural network models can extract deeper features from complex medical data and perform more precise pattern recognition, thereby improving the accuracy and reliability of predictions. By developing a prediction tool based on interpretable deep learning models, the investigators will be able to better assess the association between the use of CNI-class immunosuppressants and acute kidney injury, explore targeted prevention strategies, and offer more accurate prediction and intervention guidance for clinicians. Additionally, this study has significant socioeconomic benefits and promising prospects for application and promotion.


Eligibility criteria: Inclusion Criteria:

1. During hospitalization, tacrolimus or cyclosporine was used, and therapeutic drug monitoring was conducted according to standard procedures.
2. Aged 18 years or older at the time of admission.
3. Length of hospital stay \&gt; 48 hours.
4. At least 2 serum creatinine tests were conducted during hospitalization.

Exclusion Criteria:

1. Chronic kidney disease stage 5 was achieved before admission.
2. Incomplete clinical data.
3. Serum creatinine levels were consistently below 40 mmol/L during hospitalization.

Primary outcomes:
measure: AKI
timeFrame: From January 2020 to December 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University &amp; Shandong Provincial Qianfoshan Hospital
Study officials:
affiliation: Qianfoshan Hospital
name: Xiao Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566911: Voice Analysis for Monitoring Patients With Heart Failure
Official title: A Pilot Study on AI-Based Voice Analysis for Monitoring Patients Hospitalized With Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Noah Labs
Sponsor class: INDUSTRY
Collaborators: name: Charite University, Berlin, Germany
name: Mayo Clinic
First posted: 2024-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes adult patients, aged 18 and older, hospitalized with acutely decompensated heart failure, irrespective of left ventricular ejection fraction.

Brief summary: This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with Acutely Decompensated Heart Failure.
* At least 18 years of age.

Exclusion criteria:

* Disabling mental diseases (e.g., Alzheimer's disease)
* Clinically diagnosed chronic obstructive pulmonary disease (COPD)
* Treatment in ICU or IMU
* Dialysis treatment
* Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
* Neurodegenerative diseases
* Pregnancy
* Inability to provide consent

Primary outcomes:
measure: Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
timeFrame: Hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
Study officials:
affiliation: German Heart Institute
name: Gerhard Hindricks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05686811: Tension Type Headache, Myofascial Release Therapy , Post Isometric Relaxation Technique
Official title: Comparative Effect of Myofascial Release Therapy and Post Isometric Relaxation Technique on Pain and Functional Disability in Patients With Tension Type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Myofascial release therapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To compare the effects of myofascial release therapy and post isometric relaxation technique on pain and functional disability in patients with tension type headache
Primary purpose: TREATMENT

Brief summary: COMPARATIVE EFFECTS OF MYOFASCIAL RELEASE THERAPY AND POST ISOMETRIC RELAXATION TECHNIQUE ON PAIN AND FUNCTIONAL DISABILITY IN PATIENTS WITH TENSION-TYPE HEADACHE

Detailed description: Tension-type headache (TTH) is the most common type of primary headache, typically presenting as a bilateral, non-throbbing headache with mild to moderate intensity. Patients with tension-type headache often report band-like tightness and increased tenderness of the pericranial muscles. Use of myofascial release technique and post isometric relaxation technique is believed to reduce the pain and improve the functional disability.

Eligibility criteria: Inclusion Criteria:

* • Age range 25-45years14

  * Both male and females
  * Suffer from tension type headache more than three months
  * Head pain on bilateral location
  * may suffer from photophobia, phonophobia
  * Pericranial tiredness
  * not getting enough exercise or sleep

Exclusion Criteria:

* • History of teeth clenching or grinding

  * Cardiovascular disease
  * Pregnancy
  * arthritis in the neck
  * being overweight

Primary outcomes:
measure: Numerical pain rating scale
timeFrame: at the end of 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Abdul Mateen
state: Punjab
Study officials:
affiliation: University of Lahore
name: Abdul Mateen, MS(msk)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02939911: Residual Neuromuscular Blockade in Pediatric Anesthesia
Official title: Residual Neuromuscular Blockade in Paediatric Patients Before Extubation and in Postanesthetic Care Unit:Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Residual Neuromuscular Blockade
Keywords: Residual neuromuscular blockade
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 291
Sex: ALL
Minimum age (years): 29
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients undergoing surgery with neuromuscular blocking agents were administered

Brief summary: Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not known. The aim of this prospective observational cohort study is to evaluate the early RNB just before extubation and late RNB at the time of arrival to postanesthetic care unit (PACU).

Detailed description: Residual neuromuscular blockade (RNB) is frequent and it is associated with negative impact on postoperative morbidity and mortality. The incidence of the RNB in adult is well described, however in pediatric subpopulation it is currently not known. The aim of this prospective observational cohort study is to evaluate the early RNB just before extubation and late RNB at the time of arrival to postanesthetic care unit (PACU). In the trial will be enrolled all pediatric patients (28 weeks of age and older - 19 years old) whom will be administered neuromuscular blocking agent during anesthesia. The demographic data will be collected including: age, weight, type of surgery, ASA status. The anesthesia management will be described including: airway management, type and cumulative dose of neuromuscular blocking agent (NMBA) and time and dose of the last administered bolus of NMBA. The residual neuromuscular blockade will be measured according to the standards: TOF Watch accelerometry at the moment prior to extubation (two measurements) in TOF mode and at the arrival to postanesthetic care unit (PACU) (two measurements) in TOF mode.

Eligibility criteria: Inclusion Criteria:

* Paediatric patients undergoing surgery with neuromuscular blocking agents were administered with the age limits

Exclusion Criteria:

* weight under 3000 grams
* neuromuscular disease
* haemodynamic impairment (vasopressor need)
* planned postoperative mechanical ventilation

Primary outcomes:
measure: Early residual neuromuscular blockade
timeFrame: before extubation
Secondary outcomes:
measure: Late neuromuscular blockade
timeFrame: at arrival to PACU
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
Study officials:
References:
Clinical trial NCT03931811: Effects of Short Wave Diathermy Added on Dextrose Prolotherapy Injections in Osteoarthritis of the Knee
Official title: Effects of Short Wave Diathermy Added on Dextrose Prolotherapy Injections in Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Prolotherapy
Hypertonic dextrose solution injections
Short-wave diathermy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 63
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Goal: To show the effects of short wave diathermy added on prolotherapy injections in osteoarthritis of the knee on pain, physical functioning and quality of life.

Material and Methods: 63 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study. Patients were randomized to two grous, first being dextrose prolotherapy+ short wave diathermy(SWD), and second being dextrose prolotherapy with sham SWD. Patients were injected with dextrose prolotherapy solutions in the beginning, 3rd and 6th week of the study, for a total of 3 times, and took 20 minutes of SWD after injection(true or sham). Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogous Scale for pain(VAS) and Short Form Health Survey (SF-36)were applied before, after(6th week) and at the 3rd month of treatment.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were being between 45 and 75 years old, knee pain of 3 months or longer duration, and having OA of the knee compatible with Kellgren-Lawrance class 2 or 3

Exclusion Criteria:

* Patients using analgesics other than acetaminophen, having pregnancy, diabetes mellitus, infectious or inflammatory arthritis, hemophilia, knee prosthesis, history of knee injections in last 3 months or anticoagulant use, allergy to ingredients of the solutions, having cardiac pacemaker or other device, or metallic implants were exluded from the study.

Primary outcomes:
measure: Visual Analogous Scale(for the intensity of pain)(VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 3 months
measure: Short Form-36 (SF-36)
timeFrame: 3 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege university school of medicine
Study officials:
References:
Clinical trial NCT00875511: Effects of a Computer Game on Activity Choices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Keywords: peer rejection
obesity
amount of food chosen
amount of social time chosen
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between the ages of 18-50

Brief summary: The study seeks to discover whether peer rejection increases the value of food relative to peer interaction in overweight individuals. After playing a computer game that randomly simulates peer rejection or peer acceptance, participants will play another computer game that will assess the value of food and social interactions.

Overweight individuals may be more likely to resort to food in moments of distress and less likely to choose to interact with a peer to reestablish their sense of belongingness.


Eligibility criteria: Inclusion Criteria:

* Adults ages 18-50
* Adults with a BMI greater than or equal to 18.5
* Adults must report at least a moderate liking of study foods used

Exclusion Criteria:

* Adults should have no psychopathology
* Adults should have no developmental disabilities
* Adults should have no cold or upper respiratory distress that could influence their activities
* Adults should have not be taking medications that could affect their food intake
* Adults should have no dietary restrictions
* Adults should have no food allergies

Primary outcomes:
measure: amount of food chosen amount of social time chosen
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Division of Behavioral Medicine
state: New York
Study officials:
affiliation: University at Buffalo
name: Sarah J Salvy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00298311: Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression
Official title: An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Canadian Research Institute for Social Policy
Sponsor class: OTHER
Collaborators: name: Women's Health Research Unit
name: Social Support Research Program
name: University Health Network, Toronto
name: Edmonton Mental Health Services
name: Canadian Mental Health Association
name: Pediatric Rehabilitation Services
name: Department of Health and Wellness, NB
First posted: 2006-03-02
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to examine the impact of a home-based peer support intervention for mothers affected by postpartum depression (PPD) and for their infants.

Detailed description: This controlled study will help establish the link between support for maternal caregiving, maternal-infant interaction, infant neuroendocrinology and infant cognitive and social development. The primary hypothesis predicts that home-based peer support will improve maternal-infant interactions. Secondary hypotheses predict that home-based peer support will: improve infants' cognitive development; improve infants' social development; decrease average daily salivary cortisol levels in infants; reduce maternal depressive symptomatology; and improve maternal perceptions of social support.

Eligibility criteria: Inclusion Criteria:

* Eligible mothers will be identified as experiencing symptoms of PPD and scores \>12 on the Edinburgh Postnatal Depression Scale.
* Mothers must speak English or French.
* Mothers will not be excluded for taking anti-depressant or anti-psychotic medication, using other interventions for PPD, or reporting a history of mental illness;
* The infant must be full-term, in the care of the mother and between 3 to 6 months of age at initial enrollment.

Exclusion Criteria:

* Infants who have been admitted to the NICU
* Infants will be excluded if medicated with corticosteroids

Primary outcomes:
measure: maternal-infant interaction
timeFrame: 12 months
Secondary outcomes:
measure: cognitive development
timeFrame: 12 months
measure: social development
timeFrame: 12 months
measure: salivary cortisol
timeFrame: 12 months
measure: depressive symptomatology
timeFrame: 12 months
measure: social support
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Nicole Letourneau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
Clinical trial NCT05122611: Post Lumbar Radiofrequency Neurotomy Imaging
Official title: Post Lumbar Radiofrequency Neurotomy Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facet Joint Pain
Lead sponsor: FUSMobile Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients volunteering to receive an MRI scan with and without contrast following radiofrequency neurotomy treatment for chronic lumbar pain

Brief summary: MRI imaging post radio frequency ablation procedure for facet arthritis

Detailed description: This study is an imaging study. Following a radio frequency ablation procedure for facet arthritis low back pain the patient can join the imaging study.

During the study the patient undergo contrast enhanced MRI imaging of the lumbar spine Once the imaging is done the patient finishes the study

Eligibility criteria: Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study
2. Able and willing to complete the research questionnaires and communicate with the investigator and research team
3. Patients who are scheduled to have bilateral or unilateral treatment by radiofrequency neurotomy for chronic lumbar pain.

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18
3. Patients unable to understand and complete the research questionnaires in English
4. Patient with any contraindication for MRI contrast agents - Patients with known intolerance or allergies to the MRI contrast agent (e.g., Gadovist) including advanced kidney disease
5. Patients with a pacemaker, implanted defibrillator or internal pacing wires.
6. Patient with mechanical heart valve
7. Patient with an aneurysm clip
8. Patient with eye surgery or injury involving a metallic object
9. Patient with ear surgery or implanted device to the ear
10. Patient with any implanted electrical, metallic or magnetic device such as implanted neurostimulator, implanted drug infusion pump or bone growth stimulator
11. Patient with any kind of prosthesis (Eye, Ear, Penile, limb), or any other metal in your body from surgery or injury
12. Patient with vascular clamp, filter, coil or stent
13. Pregnant or breast-feeding patient
14. Patient with anemia, liver disease or history of MRI contrast reaction
15. Patient with any known kidney disease, prior kidney surgery or on dialysis
16. Patient with hypertension or diabetes that requires medication
17. Patient with any metal in or on their body (example: shrapnel, BB's, Tattoos, permanent makeup)
18. Patients who are claustrophobic or known adverse psychological reactions with previous MRI

Primary outcomes:
measure: MRI imaging of the lumbar spine
timeFrame: Up to 5 days after the RFA procedure (which was done before the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Silver Medical Group
state: Ontario
Study officials:
References: