linjc16/ctgov huggingface dataset:
Dermacyd Silver Frutal (Lactic Acid) - Acceptability.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To prove the safety of the gynecological formulation in normal conditions of use.

Official Title
-----------------
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow-up (Dermacyd Silver Frutal (Lactic Acid)).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral vaginal mucosa in the product analysis region Use the same category cosmetics products Willingness in following the study procedures and to be present in the clinic at the days and scheduled time Exclusion criteria: Use of Anti-inflammatory, immunossupression or antihistaminics drugs Allergic or atopic history to cosmetics products Cutaneous active disease (local and/or general) in the evaluated area Disease which can cause immunosuppresion, such as diabetes, HIV Endocrinology pathology such as thyroid gland, ovary and adrenal gland Intensive solar exposure until 15 days before evaluation Gynecological treatment until four weeks before the study Other reason considered by the investigator as a reason for not being included. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Silver Frutal (Lactic Acid)<br>Application of Lactic acid during 21 consecutive days | Drug: LACTIC ACID(ND)<br>* Treatment duration: 21 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study (treatment period 21 consecutive days) |
To Motivate Elderly to Move

Study Overview
=================
Brief Summary
-----------------
This study examines the short- and long-term-effects of different repeated frames in which an exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e., autonomous/controlled) in older people (65+). The frames are manipulated experimentally as either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain better health) or neutral (control condition).

Official Title
-----------------
To Motivate Elderly to Move: Focus on Prevention or Promotion?

Conditions
-----------------
Geriatric Disorder

Intervention / Treatment
-----------------
* Behavioral: Regulatory frame: prevention
* Behavioral: Regulatory frame: promotion
* Behavioral: Regulatory frame: not implied


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years of age Exclusion Criteria: severe mental/physical problems

Ages Eligible for Study
-----------------
Minimum 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention<br>Regulatory frame: prevention | Behavioral: Regulatory frame: prevention<br>* Exercise program presented as preventing deterioration.<br>|
| Experimental: Promotion<br>Regulatory frame: promotion | Behavioral: Regulatory frame: promotion<br>* Exercise program presented as promoting improvement.<br>|
| Sham Comparator: Neutral<br>Regulatory frame: not implied | Behavioral: Regulatory frame: not implied<br>* Exercise program presented without implied consequences.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior at long term: exercise frequency during third week | self-reported no exercise sessions | third week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in controlled motivation over long term: end week 3 - baseline | baseline, end week 3 (BREQ-2 questionnaire) | 3 weeks | 
| Change in autonomous motivation over long term: end week 3 - baseline | baseline, end week 3 (BREQ-2 questionnaire) | 3 weeks | 
| Change in controlled motivation over short term: end week 1 - baseline | baseline, end week 1 (BREQ-2 questionnaire) | 1 week | 
| Change in autonomous motivation over short term: end week 1 - baseline | baseline, end week 1 (BREQ-2 questionnaire) | 1 week | 
| Behavior at short term: exercise frequency during first week | self-reported no exercise sessions | first week |
Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.

Official Title
-----------------
Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

Conditions
-----------------
Nonalcoholic Fatty Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years outpatients followed at specialty clinics in HUS and at risk of NAFLD: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on US. endocrinology cohort : type 2 diabetes patients infectious disease cohort : HIV positive patients rheumatology cohort : patients with psoriasis, gout or rheumatoid arthritis nephrology cohort : patients with chronic kidney disease such as diabetic nephropathy or hypertensive nephropathy, including those receiving hemodialysis. cardiology cohorts: patients with history of angina, myocardial infarction, stroke or arteritis of lower limbs. internal medicine cohort: patients with auto immune systemic diseases such as lupus, sclerosis or rheumatoid arthritis. subjects who have given their informed consent Subjects affiliated to a social security system Exclusion Criteria: alcohol consumption > 30g/d in male or > 20g/d in female in the past 6 months history of chronic viral hepatitis history of liver auto immune disease, genetic hemochromatosis, Wilson disease biliary disease, bile duct obstruction drug-induced liver injury secondary liver cancer or other active cancer organ graft use of medications associated with secondary NAFLD (corticosteroids, tamoxifen, amiodarone, methotrexate). congestive heart failure AIDS pregnancy, breastfeeding no information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.) patient under guardianship patients under judicial protection

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 |
| --- | --- | --- |
| Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics | To assess the estimated prevalence of NASH , calcul of the FIB4 | 3 months |
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program

Study Overview
=================
Brief Summary
-----------------
The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility. The main objectives are: Functional capacity measures (VO2 max). Cardiac risk factors Quality of life assessments. Study hypothesis: Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.

Official Title
-----------------
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program - Nine Months Follow up

Conditions
-----------------
Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Interval exercise training
* Other: Continuous exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergone: Myocardial infarction Percutaneous transluminal coronary angioplasty Coronary artery bypass graft Exclusion Criteria: Patients with: Severe ischemia or angina Implantable cardioverter-defibrillator Pacemakers transplants Severe left ventricular dysfunctions Uncontrolled arrhythmias

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interval exercise<br>Exercise bouts in low and high intensities | Other: Interval exercise training<br>* Exercise bouts in low and high intensities<br>|
| Experimental: Continuous exercise<br>Exercise continuously with moderate intensity | Other: Continuous exercise training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal functional capacity | Outcome is assessed at baseline, after 3 months and at nine months | 9 months |
Velcade in MALT Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
Bortezomib for treatment of disseminated MALT lymphoma or at relapse following HP -eradication,or chemotherapy or radiation.

Detailed Description
-----------------
The objectives of this study are to evaluate the effectivity and the safety of bortezomib in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation. It is a phase II prospective single arm study with a target sample of 16 patients. 1.5mg/m2 Bortezomib is given intravenously on day 1,4,8,11 every three week, for a maximum of 8cycles.

Official Title
-----------------
Phase II Trial pf Bortezomib in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

Conditions
-----------------
MALT Lymphoma

Intervention / Treatment
-----------------
* Drug: Bortezomib (Velcade)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histologically confirmed MALT lymphoma with measurable disease (stage I-IV) with first or greater relapse after HP-eradication, radiation or chemotherapy , age > 18 years must be able to tolerate therapy and have adequate cardiac, renal and hepatic function ECOG status of <_ 2 must be capable of understanding the purpose of the study and given written informed consent

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

| Intervention/Treatment |
| --- |
|Drug: Bortezomib (Velcade)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the clinical potential of bortezomib |  |  | 
| to induce objective/histologic responses in patients with MALT-Lymphoma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the impact of bortezomib on progression free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MALT Lymphoma, Bortezomib
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

Study Overview
=================
Brief Summary
-----------------
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Official Title
-----------------
A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease

Conditions
-----------------
Anemia, Iron-Deficiency, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Sodium Ferric Gluconate Complex in Sucrose Injection
* Drug: Ferrous sulfate tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease Exclusion Criteria: Receiving dialysis Known sensitivity to Ferrlecit® or any of its components Receiving therapy with erythropoietic agent Clinically unstable

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV iron<br>Sodium ferric gluconate | Drug: Sodium Ferric Gluconate Complex in Sucrose Injection<br>* Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks<br>|
| Active Comparator: oral iron<br>ferrous sulfate | Drug: Ferrous sulfate tablets<br>* ferrous sulfate, 325 mg oral, three times daily for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin (Hgb) | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. | Baseline to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Ferritin | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. | Baseline to 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency, Anemia, Chronic kidney disease, Sodium Ferric Gluconate, Anemia, Iron-Deficiency/drug therapy/etiology, Kidney Failure, Chronic/blood/complications/therapy
Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the work load caused by weaning was below the patient's AT, oxygen uptake will be constant. Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase. Patient: who have tracheostomy tubes and with prolonged mechanical ventilation Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous breathing trials Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome 2.Specific aims: to investigate the prognostic value of oxygen uptake in weaning patients from prolonged mechanical ventilation Subgroup analysis may suggest which weaning protocol potentially benefit the most for each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular disease, cerebrovascular disease)

Official Title
-----------------
To Investigate the Prognostic Value of Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation

Conditions
-----------------
Ventilator Weaning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult >20 y/o Total duration of mechanical ventilation ≥ 10 days Received tracheostomy Defervescence Meeting the criteria of weaning phase (see supplementary protocols) Exclusion criteria FiO2 >50 % Unstable hemodynamics Fever with active infection No spontaneous respiratory drive Dynamic airway collapse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- |
| 1/patients with tracheostomy tubes and prolonged MV use<br>Patients who have tracheostomy tubes and with prolonged mechanical ventilation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of oxygen uptake (V̇O2) | oxygen uptake during the spontaneous breathing trial | up to 12 hours during the spontaneous breathing trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxygen uptake, prolonged mechanical ventilation, weaning
Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study to compare postoperative pain intensity in patients going laparoscopic colorectal surgery with Enhanced Recovery after Surgery (ERAS), without ERAS and open colorectal surgery.

Detailed Description
-----------------
This study is a matched case-control study. Control patients will be matched to ERAS cases in a 1:1:1 ratio (laparoscopic surgery with ERAS protocol : laparoscopic surgery without ERAS protocol : open surgery).

Official Title
-----------------
Comparison of Postoperative Pain Management in Patients Undergoing Laparoscopic Colorectal Surgery Under Enhanced Recovery After Surgery (ERAS) Program, Laparoscopic Colorectal Surgery Without ERAS and Open Colorectal Surgery

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

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing colorectal surgery under ERAS program and those with the same sort of laparoscopic surgery without ERAS program as well as those with open colorectal surgery with complete required recorded data. Exclusion Criteria: 1. Patients with incomplete required data on record. 2. Those with any major intraoperative or postoperative complications.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERAS<br>Patients undergoing laparoscopic colorectal surgery with ERAS | Drug: Celecoxib<br>* Patients in ERAS group received celecoxib<br>|
| Non ERAS<br>Patients undergoing laparoscopic colorectal surgery without ERAS | |
| Open<br>Patients undergoing open colorectal surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain score (Verbal Numerical Rating Scale: VNRS) after surgery, VNRS consists of 0-10, where 0 means no pain and 10 means worst pain imaginable | Until discharge (5-7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid | Amount of postoperative opioid consumption | Until discharge (5-7 days) |