louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03217305: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation After Cardiac Surgery
Official title: NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventilator Lung
Keywords: EIT. NAVA. Endexpiratory Lung Impedance.
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Control-Intervention-Control
Primary purpose: TREATMENT

Brief summary: The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation.

Detailed description: The aim of the study is to compare two different ventilation modes in complicated postcardiac surgery patients, who need ventilatory support during weaning phase, in the Cardiothoracic Intensive Care Unit. The two different ventilation modes are Neuronally Adjusted Ventilatory Assist (NAVA) and Pressure Support ventilation. NAVA ventilation mode have been introduced a couple of years ago as an alternative to pressure support. The advantage of NAVA mode compared to pressure support is a better synchrony between patient and ventilator in the inspired and expired phases. Maybe there are also physiological advantages of the NAVA mode, which we want to study in the present study.

All patients have three measurement periods. 1) Pressure support during 20 min, NAVA equilibration period of 30 min, followed by 2) NAVA ventilation for 20 min, pressure support equilibration period of 30 min and 3) pressure support for 20 min. Blood gases and cardiac output measurements is performed before and after each measurement period. Regional ventilation is measured by Electric Impedance Tomography (EIT).

Eligibility criteria: Inclusion Criteria:

* Complicated Post Cardiac surgery patients in the ventilator weaning phase.
* Patients requiring assisted ventilation
* Respiratory and circulatory stable patients
* Sedated patients, RASS -2 to -3

Exclusion Criteria:

* Transplanted patients
* Pleural effusion.

Primary outcomes:
measure: Ventilation distribution
timeFrame: Through study completion, within approximately 18 months
measure: Alveolar dead space
timeFrame: Through study completion, within approximately 18 months
measure: End expiratory lung impedance
timeFrame: Through study completion, within approximately 18 months
measure: PaO2/FiO2
timeFrame: Through study completion, within approximately 18 months
measure: Alveolar shunt
timeFrame: Through study completion, within approximately 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: University of Goteborg
name: Anders Thoren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165005: Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
Official title: Mindfulness-based Short Intervention for Seniors - Decentering Effects on Cognitive Functions and Psychological Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age; Debility
Psychological Distress
Cognitive Change
Keywords: elderly
MBSR
cognitive functions
psychological status
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
Collaborators: name: Ruppin Acdemic Center
First posted: 2019-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study examined the effect of a short Mindfulness-based intervention emphasizing a 'decentering' component on elderly seniors. Methods: 30 community seniors (Mage= 74.7) performed either 'decentering' intervention, guided imagery intervention, or control care as usual. The 8-week interventions included weekly 20-minute sessions and daily 10-minute home practice. Participants underwent a cognitive and emotional assessment before and after the interventions, which included filling out questionnaires and performing the Simon task. Trial registration: The study follows the principles of the Declaration of Helsinki, approved by the committee in Beer-Yaacov Hospital, Israel (number 579) on 24 Oct. 2017.


Eligibility criteria: Inclusion Criteria:

* age 65 and above
* membership in the study's specific enrollment community centers
* scoring 24 and above in the Mini-Mental State Examination (MMSE).

Exclusion Criteria:

* age under 65
* not being a member in the study's specific enrollment community centers
* scoring under 24 in the Mini-Mental State Examination (MMSE).

Primary outcomes:
measure: Simon task- change from baseline to after intervention
timeFrame: at baseline and through intervention's completion, 10 weeks.
Secondary outcomes:
measure: FFMQ- change from baseline to after intervention
timeFrame: at baseline and through intervention's completion, 10 weeks.
measure: PWB questionnaire- change from baseline to after intervention
timeFrame: at baseline and through intervention's completion, 10 weeks.
measure: MMSE- change from baseline to after intervention
timeFrame: at baseline and through intervention's completion, 10 weeks.
measure: PHQ-9- change from baseline to after intervention
timeFrame: at baseline and through intervention's completion, 10 weeks.
measure: BDI-II- change from baseline to after intervention
timeFrame: at baseline and through intervention's completion, 10 weeks.
Other outcomes:
Locations:
city: Emek-Hefer
country: Israel
facility: Ruppin Academic Center
Study officials:
References:
citation: Aisenberg-Shafran D, Shturm L. The effects of mindfulness meditation versus CBT for anxiety on emotional distress and attitudes toward seeking mental health treatment: a semi-randomized trial. Sci Rep. 2022 Nov 16;12(1):19711. doi: 10.1038/s41598-022-24256-9.
Clinical trial NCT02376205: Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
Official title: The Effectiveness of Postoperative Local Retropharyngeal Space Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Anterior Cervical Discectomy and Fusion
Dysphagia
Lead sponsor: Justin Parker Neurological Institute
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to analyze the effects of local anesthetic application into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence rates in patients undergoing anterior cervical discectomy and fusion.

Detailed description: The patients will be randomly assigned into one of the two groups to receive either bupivacaine hydrochloride 0.5% solution if they are randomized to the treatment group or 0.9% NaCl solution if they are randomized to the control group. These solutions will be poured into the retropharyngeal space intraoperatively before wound closure.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 y.o.
* Patients undergoing one- or two-level anterior cervical discectomy and fusion surgery for radiculopathy or myelopathy symptoms
* Patients are wiling and able to sign informed consent and complete questionnaires

Exclusion Criteria:

* More than 2-level ACDF surgeries
* Previous cervical spine surgery
* Surgeries for trauma, infection or tumor
* Known hypersensitivity reactions to bupivacaine hydrochloride or other amino-amide anesthetics (e.g. lidocaine)
* Known history of swallowing issues (e.g. dysphagia, odynophagia)
* Pregnant or breastfeeding

Primary outcomes:
measure: Reduction in dysphagia scores
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
Study officials:
affiliation: Boulder Neurosurgical Associates
name: Alexander Mason, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063998: A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma
Official title: A Urinary Tumor Marker (Kidney Injury Molecule-1) for the Detection of Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Cell Carcinoma
Keywords: Renal cell
Carcinoma
Biomarkers
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2010-02-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having nephrectomy.

Brief summary: The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

Detailed description: In the United States there were 38,900 cases and 12,840 deaths from renal cell carcinoma in 2006. Renal cell carcinoma represents 2% of all cancers worldwide. The majority of kidney tumors are discovered incidentally during investigation of unrelated complaints. However, nearly 30% of patients present with metastatic disease at the time of diagnosis and 30-40% of patients with clinically localized kidney cancer will have a recurrence. The diagnosis and monitoring of kidney cancer requires expensive and frequent imaging examinations. There is a significant need to find diagnostic and prognostic biomarkers to screen, diagnose, and monitor renal cancers.

A reliable urinary assay for kidney cancer would have major implications for tumor screening in high risk patients, in selection of patients for adjuvant therapy, in surveillance and prognosis and possibly as a surrogate marker for response to therapy. Human kidney injury molecule-1 (KIM-1) has been found to be a sensitive and specific biomarker in identifying kidney injury. The urine levels of KIM-1 are increased in the patients with kidney failure and major types of kidney tumors. The purpose of the study is investigate how urine KIM-1 and a routine blood marker for renal failure (creatinine) can distinguish kidney tumors from non-tumor kidney injury. The ultimate goal of this project is to develop a simple non-invasive method to screen patients for potential kidney tumors.

Eligibility criteria: Inclusion Criteria:

* Patients demonstrate normal serum creatinine and no radiological evidence of a renal tumor.

OR

* Patients diagnosed with renal cancer and normal creatinine.

Exclusion Criteria:

* None.

Primary outcomes:
measure: To test the sensitivity and specificity of KIM-1 urine excretion in a group of patients with kidney cancer.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospitals
state: Michigan
Study officials:
affiliation: Beaumont Hospitals
name: Jason Hafron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05470998: L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of L-Arginine in Children Having Sickle Cell Disease With Increased Tricuspid Regurgitant Jet Velocity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sickle Cell Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the possible efficacy and safety of L-Arginine in children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity


Eligibility criteria: Inclusion Criteria:

* children having Sickle Cell Disease with increased Tricuspid Regurgitant Jet Velocity
* age 5-18 years

Exclusion Criteria:

* Another chronic hemolytic anemia.
* Patients with documented causes of pulmonary hypertension other than SCD.
* Allergy to L-arginine.
* Patients with Asthma.
* Hepatic dysfunction: serum Alanine Aminotransferase (ALT) \> 3X upper value.
* Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.

Primary outcomes:
measure: change in tricuspid regurgitant jet velocity (TRJV) detected by Color Doppler Echocardiography
timeFrame: 3 months
Secondary outcomes:
measure: change in serum level of N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
timeFrame: 3 months
measure: change in serum level of L-Arginine
timeFrame: 3 months
measure: change in serum level of Asymmetric Dimethyl Arginine (ADMA)
timeFrame: 3 months
measure: change in serum level of Nitric Oxide
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: Other (Non U.s.)
Study officials:
affiliation: Tanta University
name: dalia A gomaa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067698: Alpha Lipoic Acid in Ulcerative Colitis
Official title: Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Ulcerative Colitis (UC)
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating the efficacy and safety of alpha-lipoic acid as adjuvant therapy to mesalamine in patients with mild to moderate ulcerative colitis due to its effect as anti-oxidant and anti-inflammatory drug which can help to improve disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old.
* Both male and female sex.
* Newly diagnosed patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline for diagnosing Ulcerative Colitis in Adults.26
* Patients treated with 5-aminosalisylic acid (mesalamine).

Exclusion Criteria:

* Patients with severe ulcerative colitis.
* Patients with colorectal cancer.
* Patients on rectal or systemic steroids.
* Patients on immunosuppressants or biological therapies.
* Patients with previously failed treatment with sulphasalazine.
* Patients with known allergy to study medications.
* History of complete or partial colectomy.
* Patients with significant liver disease (fibrosis, cirrhosis, NASH, NAFLD).
* Patients with other inflammatory diseases.
* Patients with thyroid diseases.
* Patients with arrhythmia, ischemic heart disease, and heart failure.
* Patients with diabetes.
* Patients on antioxidants supplement (vitamin A, C, E), selenium, co-enzyme Q.
* Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).

Primary outcomes:
measure: Change in both health related quality of life
timeFrame: 3 months from start of treatment
measure: Change in disease severity
timeFrame: 3 months from start of treatment
Secondary outcomes:
measure: Change in "fecal calprotectin" as biological parameters
timeFrame: 3 months from start of treatment
measure: Change in "reduced glutathione" as biological parameters
timeFrame: 3 months from start of treatment
measure: Change in "interleukin-6" as biological parameters
timeFrame: 3 months from start of treatment
measure: Change in "Transforming growth factor - beta 1" as biological parameters
timeFrame: 3 months from start of treatment
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanat university hospital
Study officials:
References:
Clinical trial NCT06800898: Orexin Gene in Anorexia Nervosa
Official title: The Methylation Level of the Orexin Gene in Anorexia Nervosa: Relationship With Eating Disorder, Depressive State, and Sleep Quality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: Orexins
Methylation
Epigenetics
Psychiatric comorbidities
Eating disorder
Quality of sleep
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 young women (\> 18 years old), hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), for each of whom a diagnosis of AN will be formulated based on the DSM-criteria 5 (Diagnostic and Statistical Manual of Mental Disorders 5; American Psychiatric Association, 2013).

For each patient, a woman of comparable age, with a BMI between 18.5 and 24.9 kg/m2, is enrolled in the control group.

Brief summary: The objectives of this study will be to determine the methylation of the promoter of the Orexin A (OX-A) and B (OX-B) genes in young women (\> 18 years) with Anorexia Nervosa (AN), compared with a control group; and to evaluate the relationship of promoter methylation of the genes for OX-A and OX-B with the severity of the eating disorder, psychiatric comorbidities (in particular, depression), and sleep quality.


Eligibility criteria: Patients with Anorexia Nervosa:

Inclusion Criteria:

* Female sex
* Age 18 years and older
* Anorexia Nervosa
* Hospitalized at the Division of Eating and Nutrition Disorders, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

Exclusion Criteria:

* Absence of signed informed consent

Control group:

Inclusion Criteria:

* Female sex
* Age 18 years and older
* Body Mass Index between 18.5 and 24.9 kg/m2

Exclusion Criteria:

* Absence of signed informed consent
* Presence of any physical and mental pathology

Primary outcomes:
measure: Orexin A promoter methylation
timeFrame: Baseline
measure: Orexin B promoter methylation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS, Site Piancavallo
state: Verbania
Study officials:
References:
Clinical trial NCT05383898: Study to Evaluate D-1553 in Subjects With Lung Cancer
Official title: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: NSCLC
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-20
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1/2, open label study of D-1553 single agent treatment to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic NSCLC with KRasG12C mutation


Eligibility criteria: Inclusion Criteria:

* Subject with histologically proven, locally advanced, unresectable and/or metastatic NSCLC for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
* Subject has KRasG12C mutation in tumor tissue or other biospecimens containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used for Phase 1 subjects. Phase 2 subjects must be tested for KRasG12C mutation by a central laboratory.
* Subject has measurable disease according to RECIST, v1.1

Exclusion Criteria:

* Subject with unstable or progressive central nervous system (CNS) metastases.
* Subjects with clinically significant cardiovascular disease
* Subject with interstitial lung disease (ILD) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
* Subject has impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption or metabolism of oral medications.
* Subject is pregnant or lactating.

Primary outcomes:
measure: Subject incidence of Dose-limiting toxicities (DLT)
timeFrame: through out the DLT period, approximately 21 days
measure: Number of subjects participants with adverse events
timeFrame: Through study completion, approximately 3 years
measure: antitumor activity of D-1553 in subjects with advanced or metastatic NSCLC with KRASG12C mutation
timeFrame: Through study completion, approximately 3 years
Secondary outcomes:
measure: Plasma concentration of D-1553
timeFrame: approximately 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
state: Zhejiang
Study officials:
affiliation: Shanghai Chest Hospital
name: Shun Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: