linjc16/ctgov huggingface dataset:
Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the safety and tolerability of single escalating doses of Peptide YY3-36 and to determine effects on food intake and serum hormones when administered by intravenous infusion to otherwise healthy overweight adult subjects.

Official Title
-----------------
A Phase 1, Randomized, Placebo- And Positive Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Doses Of Intravenous Peptide YY3-36 In Otherwise Healthy Overweight Adult Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Peptide YY3-36


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 27-35 kg/m2 Exclusion Criteria: Women of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Peptide YY3-36|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma biomarkers, safety, toleration |  |  |
Efficacy and Safety of SPARC0921 in Subjects With Spasticity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether SPARC0921 demonstrate efficacy and safety in the treatment of spasticity.

Conditions
-----------------
Spasticity

Intervention / Treatment
-----------------
* Drug: SPARC0921
* Drug: Placebo0921


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age 18 years and older Able and willing to comply with the protocol, including availability for a scheduled clinic visits Willingness and giving of written informed consent Exclusion Criteria: In relapse or history of unstable course over the prior 30 days prior to the Screening Visit Concomitant neurologic conditions causing spasticity Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit Unable to comply with study procedures in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC0921<br> | Drug: SPARC0921<br> <br> |
| Placebo Comparator: Placebo0921<br> | Drug: Placebo0921<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failure Rate | Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline. The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension. The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse | Week 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Spasticity Assessed by Subject Global Impression Severity Scale | The subject was asked Overall, how would you rate the severity of your spasticity over the past 24 hours? The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable | Week 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity
Vasoplegic Syndrome in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Vasoplasmic syndrome in cardiac surgery is one of the major postoperative complications.This syndrome is characterized by persistent low blood pressure despite an optimization of preload and inotropism.

Official Title
-----------------
Le Syndrome vasoplégique en Post-opératoire de Chirurgie Cardiaque: étude de Construction et de Validation d'un Score prédictif (Etude ISYVACC).

Conditions
-----------------
Vasoplegic Syndrome of Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing cardiac surgery with extracorporeal circulation Patients covered by a social insurance system. Patients who have given oral consent to participate after full information Exclusion Criteria: Cardiac graft. Preoperative ECMO / ECLS. Cardiac assistance. Minor, Patient deprived of liberty, or under safeguard of justice.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasoplegic syndrome | Patients suffering of vasoplegic syndrom defined by persitent arterial hypotension (MAP below70 mmHg) despite fluid rescucitation, normal or high cardiac output, and treated more than 4 hours with norepinephrine | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative organ failure | every post opertaive organ failure: brain, digestive, renal, cardiac... | 30 days | 
| Arrythmia | atrial fibrillation, ventricular tachycardia, ventricular flutter | 30 days | 
| Inotropic use | dobutamine, levosimendan, phosphodiesterase | 30 days | 
| cardiac damage | troponine I release | 1 day | 
| Post operative Sepsis | postoperative sepsis: pneumonae, blood stream, mediastinis, urinary track, other | 30 days | 
| Hemorrhage | postopertaive blood loss defined by the Universal definition of perioperative bleeding | 30 days | 
| Blood transfusion | red blood cell transfusion, plaquette, plasma | 30 days | 
| ICU stays | Stay at ICU until patient discharge | 30 days | 
| Hospital stays | hospital stays until patient discharge | 30 days | 
| Death | Death of any cause | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasoplegicsyndrome, cardiac surgery, predictive risk score
Vitamine D in Post-COVID Patients

Study Overview
=================
Brief Summary
-----------------
In this study routineously collected vitamine D values will compared to healthy cohorts from this year and previous years.

Official Title
-----------------
Vitamine D in Post-COVID Patients

Conditions
-----------------
Post COVID

Intervention / Treatment
-----------------
* Diagnostic Test: Vitamine D in blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with or without post-COVID-Syndrome Exclusion Criteria: substitution of vitamine D diseases influencing vitamine D level
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy subjects 2019<br>subjects with diseases not influencing vitamine D values without substitution nor post-COVID | Diagnostic Test: Vitamine D in blood samples<br>* vitamine D values<br>|
| healthy subjects 2020<br>subjects with diseases not influencing vitamine D values without substitution nor post-COVID | Diagnostic Test: Vitamine D in blood samples<br>* vitamine D values<br>|
| healthy subjects 2021<br>subjects with diseases not influencing vitamine D values without substitution nor post-COVID | Diagnostic Test: Vitamine D in blood samples<br>* vitamine D values<br>|
| post-COVID subjects 2021<br>subjects with diseases not influencing vitamine D values without substitution with diagnosed post-COVID syndrome | Diagnostic Test: Vitamine D in blood samples<br>* vitamine D values<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D values between the groups |  | 6 months |
Prediction of Mortality After CIED Implantation (PM-CIED)

Study Overview
=================
Brief Summary
-----------------
The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation.

Detailed Description
-----------------
The study aims to develop and validate predictive models for the mortality of patients receiving cardiovascular implantable electronic devices (CIED) [including cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD)] implantation, with traditional statistical analysis and machine learning algorithms.

Official Title
-----------------
Development and Validation of Predictive Models for Mortality After CIED Implantation

Conditions
-----------------
Heart Failure, Systolic, Sudden Cardiac Death

Intervention / Treatment
-----------------
* Device: CRT/ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients who received implantation of CRT/ICD Exclusion Criteria: patients who received generator placement of CRT/ICD
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Zhongshan Hospital cohort<br>Patients receiving CIED implantation at Zhongshan Hospital | Device: CRT/ICD<br>* The patients received implantation of CRT/ICD.<br>|
| Fuwai Hospital cohort<br>Patients receiving CIED implantation at Fuwai Hospital | Device: CRT/ICD<br>* The patients received implantation of CRT/ICD.<br>|
| Shanghai Chest Hospital cohort<br>Patients receiving CIED implantation at Shanghai Chest Hospital | Device: CRT/ICD<br>* The patients received implantation of CRT/ICD.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause death | 3 years |
Examining the Long-Term Risks of Oophorectomy

Study Overview
=================
Brief Summary
-----------------
At the time of hysterectomy for benign disease, the overall health benefits of preserving ovarian function in a large population of women have not been established.

Detailed Description
-----------------
We are conducting a prospective, observational study of 32,175 women participants of the Nurse's Health Study who had a hysterectomy with or without removal of both ovaries. We are evaluating mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.

Official Title
-----------------
Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.

Conditions
-----------------
Coronary Heart Disease, Stroke, Breast Cancer, Ovarian Cancer, Cancer, Hip Fracture, Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed. Exclusion Criteria: Evidence of cancer, coronary heart disease (MI or Angina Pectoris), stroke, or hip fracture before entering the study were excluded. Cancer as an indication for hysterectomy also excluded. Women reporting unilateral oophorectomy, unknown oophorectomy status, unknown age of hysterectomy, or those who had oophorectomy before hysterectomy were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>all women having a hysterectomy with oophorectomy | |
| 2<br>all women having a hysterectomy without removal of ovaries | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes. |  | 28 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of postmenopausal hormone use on mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes. |  | 28 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oophorectomy, ovarian conservation, stroke, breast cancer, ovarian cancer, other cancer, hip fracture
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.

Official Title
-----------------
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study

Conditions
-----------------
Irritable Bowel Syndrome, Wheat Sensitivity

Intervention / Treatment
-----------------
* Other: Sourdough wheat bread
* Other: Regular yeast baked toast bread
* Other: Gluten-free diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS & subjective sensitivity to wheat Exclusion Criteria: celiac disease, pregnancy, lactation, IBD, major GI operations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fermented wheat bread for 7 days<br>Long sourdough fermentation | Other: Sourdough wheat bread<br> <br> Other: Gluten-free diet<br>* Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains<br>|
| Placebo Comparator: Yeast baked wheat bread for 7 days<br>Regular toast bread | Other: Regular yeast baked toast bread<br> <br> Other: Gluten-free diet<br>* Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains<br>|
| Other: Run-in<br>Gluten-free diet for 7 days before entering either bread period | Other: Gluten-free diet<br>* Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptoms using visual analog scale (VAS) daily | Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wheat, IBS, gluten, ATI
sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?

Study Overview
=================
Brief Summary
-----------------
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

Detailed Description
-----------------
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters) The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.

Official Title
-----------------
sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?

Conditions
-----------------
CORONAVIRUS INFECTIONS

Intervention / Treatment
-----------------
* Other: measurement of circulating sFlt1 concentration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with documented COVID-19 (positive PCR) Hospitalized in University Hospital of Reims Patient or family who have previously consented Exclusion Criteria: Patient <18 yo Patient not insured under the French social security

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with COVID-19 infection<br>patients with COVID-19 infection | Other: measurement of circulating sFlt1 concentration<br>* blood circulating sFlt1 concentration will be determined<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between concentration of circulating sFlt1 and use of vasopressor |  | 14 days |
OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Official Title
-----------------
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Conditions
-----------------
Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Procedure: Placebo Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteria: Any intraocular inflammation in the study eye present during the screening slit lamp examination Score greater than 0 on the Ocular Pain Assessment in the study eye at Screening Any intraocular inflammation in the study eye present during the screening slit lamp examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-DP<br>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: PV<br>PV (placebo drug delivery vehicle) | Procedure: Placebo Vehicle<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Absence of Anterior Chamber Inflammation | Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14 | Day 14 | 
| Number of Participants With an Absence of Ocular Pain | Absence of pain (i.e., score of '0') in the study eye at Day 8 | Day 8 |