linjc16/ctgov huggingface dataset:
Lived Experience of Overweight/Obese Patients Who Have Benefited From a Mindful Eating Program.

Study Overview
=================
Brief Summary
-----------------
The main objective is to understand the lived experience of overweight/obese patients who have followed the mindful eating program at Montpellier University Hospital. Semi-structured face-to-face interviews will be conducted in the Nutrition-Diabetes service by using a questionnaire.

Official Title
-----------------
Evaluation of the Lived Experience of Overweight/Obese Patients Who Have Benefited From a Mindful Eating Program at Montpellier University Hospital by Semi-structured Face-to-face Interviews.

Conditions
-----------------
Overweight or Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - People who have attended at least 6 out of 8 sessions of the mindful program Exclusion criteria: People who have attended less than 6 sessions of the program. Declining participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of participants with the lived experience | the experience of overweight/obese patients who have followed the current mindful eating program at Montpellier University Hospital. | day 1 |
Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates.

Study Overview
=================
Brief Summary
-----------------
Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen). The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.

Official Title
-----------------
Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: serum progesterone measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years planned embryo transfer signed informed consent Exclusion Criteria: patients falsely included, major inclusion criteria not respected lack of social insurance refusal to participate in the research

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| serum progesterone measurement<br> | Other: serum progesterone measurement<br>* progesterone levels measurement on the day of the embryo transfer on all AMP cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum progesterone levels on the day of embryo transfer | µg/L | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | Post-embryo transfer βHCG levels (UI/l). | 1 month after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum progesterone, embryo transfer, pregnancy rate
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALN-TTRSC04 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single ascending doses of ALN-TTRSC04.

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneously Administered ALN-TTRSC04 in Healthy Subjects

Conditions
-----------------
Transthyretin-Mediated Amyloidosis

Intervention / Treatment
-----------------
* Drug: ALN-TTRSC04
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≥18.0 kg/m^2 and ≤30 kg/m^2 assessed at Screening. Exclusion Criteria: Has an estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m^2 at screening. Has alanine aminotransferase (ALT), aspartate aminotransferase (AST) or direct bilirubin above the upper limit of normal (ULN).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALN-TTRSC04<br>Participants will be administered a single dose of ALN-TTRSC04. | Drug: ALN-TTRSC04<br>* ALN-TTRSC04 will be administered by subcutaneous (SC) injection.<br>|
| Placebo Comparator: Placebo<br>Participants will be administered a single dose of placebo. | Drug: Placebo<br>* Placebo will be administered by SC injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Serum Transthyretin (TTR) Levels Over Time |  | Up to 12 months | 
| Maximum Observed Plasma Concentration (Cmax) of ALN-TTRSC04 |  | Up to 12 months | 
| Time to Maximum Observed Plasma Concentration (Tmax) of ALN-TTRSC04 |  | Up to 12 months | 
| Area Under the Concentration-time Curve (AUC) of ALN-TTRSC04 |  | Up to 12 months | 
| Fraction of ALN-TTRSC04 Excreted in the Urine (fe) |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
siRNA, ATTR amyloidosis
The Analgesic Efficacy of Wound Infiltration With Tramadol

Study Overview
=================
Brief Summary
-----------------
This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.

Official Title
-----------------
A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparity Gestation age between 37-40 weeks CS under general anesthesia Exclusion Criteria: Pre-eclampsia Cardiovascular problems Allergy to any of the study medications Chronic preoperative pain Regular analgesic use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the tramadol group<br>A preprepared 20 ml solution (tramadol 2 mgkg-1 within a 0.9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia. | Drug: Tramadol<br>* A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.<br>* Other names: Placebo (0,9% saline solution);|
| Placebo Comparator: the placebo group<br>A preprepared 20 ml solution (0,9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure in this study was cumulative morphine consumption. | The measure of need for analgesics in the immediate postoperative period in this study was cumulative morphine consumption. | postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tramadol, Postoperative analgesia, Infiltration, Cesarean section
Apple Heart & Movement Study

Study Overview
=================
Brief Summary
-----------------
This study will look for factors that affect heart health and potentially cause deterioration in mobility or heart function. Participant's Apple Watch and iPhone can help researchers gain a better understanding of potential early warning signs. This can lead to new interventions and products that will help millions lead longer, healthier, and more active lives.

Official Title
-----------------
Apple Heart & Movement Study

Conditions
-----------------
Prevention

Intervention / Treatment
-----------------
* Diagnostic Test: Predictors of events


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico); Live in the United States of America; Have an iPhone; Have an Apple Watch (Series 1 or later) at the time of enrollment; Have the Apple Research app installed on your iPhone; Be comfortable communicating in written and spoken English; Not share your iCloud account, iPhone, or Apple Watch with anyone else; Be willing and able to provide informed consent to participate in the study.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with events<br>Individuals who have experienced any of the listed outcomes | Diagnostic Test: Predictors of events<br>* Apple Heart & Movement Study in Apple Research app<br>|
| Participants without events<br>Individuals who have not experienced any of the listed outcomes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Chronic Disease Events | Change in number of participants with incident cardiovascular disease events (including myocardial infarction, coronary revascularization, heart failure hospitalization, stroke/TIA hospitalization, atrial fibrillation, and atrial fibrillation hospitalization), fall events, and other hospitalizations, assessed by patient report. | quarterly (every 90 days) through study completion (up to 5 years) |
Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system

Detailed Description
-----------------
A randomized, comparative study of the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid metabolism in the hypertensive patients with the accumulation of visceral fat by the central registration system

Official Title
-----------------
A Randomized, Comparative Study of the Effects of Candesartan and Telmisartan on the Home Blood Pressure, Glucose and Lipid Metabolism in the Hypertensive Patients With the Accumulation of Visceral Fat by the Central Registration System

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Candesartan
* Drug: Telmisartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Circumference at waist: male ≧85 cm, female ≧90 cm Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg Exclusion Criteria: Significant hypertensive patient with diastolic blood pressure ≧120 mmHg Malignant hypertensive patient Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman) Patient with urinary protein (qualitative) ＋～＋＋ Patient with familial hyperlipidemia Other patients judged as ineligible for the study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Candesartan|nan|
|Drug: Telmisartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home blood pressure in the early morning |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home blood pressure at bedtime |  |  | 
| M/E ratio |  |  | 
| Casual blood pressure |  |  | 
| Body fat percentage |  |  | 
| Body weight |  |  | 
| Height |  |  | 
| BMI |  |  | 
| Blood potassium |  |  | 
| Total cholesterol |  |  | 
| HDL cholesterol |  |  | 
| LDL cholesterol |  |  | 
| Triglyceride |  |  | 
| Blood glucose |  |  | 
| IRI |  |  | 
| HbAlc* |  |  | 
| HOMA-IR |  |  | 
| Urinary trace albumin |  |  | 
| Creatinine |  |  |
Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

Study Overview
=================
Brief Summary
-----------------
Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.

Official Title
-----------------
Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

Conditions
-----------------
Neuromuscular Blockade

Intervention / Treatment
-----------------
* Drug: Normal saline
* Drug: IV dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures Exclusion Criteria: contraindication to dexamethasone administration contraindication to sugammadex administration contraindication to rocuronium administration

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No IV dexamethasone<br>Patients will receive an equivalent volume of normal saline. | Drug: Normal saline<br> <br> |
| Experimental: IV dexamethasone<br>Patients will receive 0.1 mg/kg of dexamethasone. | Drug: IV dexamethasone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean recovery time for T4/T1 ratio > 90% after sugammadex administration |  | surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean recovery time for T4/T1 ratio > 80% after sugammadex administration |  | surgical procedure | 
| Mean recovery time for T4/T1 ratio > 70% after sugammadex administration |  | surgical procedure |
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for 3 weeks. There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and Treatment period (Day 1/ Baseline, Day 15 and Day 22).

Official Title
-----------------
Pharmacokinetic and Pharmacodynamic Study of CD 2027 3µg/g Oily Spray Applied Twice Daily for 3 Weeks Under Conditions of Maximized Use in Adults With Plaque-type Psoriasis

Conditions
-----------------
Plaque-type Psoriasis

Intervention / Treatment
-----------------
* Drug: CD 2027


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (BSA), with a Global Severity Score of at least 3 (moderate) Exclusion Criteria: Other type of psoriasis (other than plaque) Significant abnormal lab findings Secondary hyperparathyroidism Vit D deficiency Hypercalcemia

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD 2027<br> | Drug: CD 2027<br>* 3µg/g Oily Spray<br>* Other names: Calcitriol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD 2027 plasma concentrations |  | 0, 1, 2, 3, 4, 6, 9, 12 hour time points | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium homeostasis |  | Screening, Day -8, -1 and prior to the morning application on Day 1, 15 and 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, PK, calcitriol
Peripheral Primitive Fibromatosis

Study Overview
=================
Brief Summary
-----------------
It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.

Official Title
-----------------
Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression

Conditions
-----------------
Peripheral Primitive Fibromatosis

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peripheral primitive fibromatosis Adults patients Peripheral primitive fibromatosis proved by biopsy Peripheral primitive fibromatosis R2 resected for which monitoring is decided MRI realized before inclusion Patient information and informed consent signed Exclusion Criteria: Local recur Head and neck topography Primitive fibromatosis R0 or R1 resected Specific medical treatment of fibromatosis Patient already included in an other clinical trial with an experimental molecule Persons deprived of liberty Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons Previous history of cancer Counter indication to the realization of an MRI

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial monitoring group<br> | Other: MRI<br>* MRI every 3 months during the first year and then every 6 months during the second year and then one MRI up to 36 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional result | Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proved by biopsy