linjc16/ctgov huggingface dataset:
Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients

Study Overview
=================
Brief Summary
-----------------
Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.

Official Title
-----------------
Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients

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

Intervention / Treatment
-----------------
* Drug: levonorgestrel and ethynilestradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1st or 2nd IVF cycle BMI <30 kg/m2 regular menstrual cycles basal FSH <10 IU and E2 <60 pg/ml Exclusion Criteria: Polycystic ovaries endometriosis previous ovarian surgery previous low ovarian response

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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: OCP+GnRH antagonist<br>Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist | Drug: levonorgestrel and ethynilestradiol<br> <br> |
| Active Comparator: long GnRH agonist<br>daily triptorelin starting day 21st of previous cycle | Drug: levonorgestrel and ethynilestradiol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | 2 weeks after the embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility patients requiring IVF, good prognosis
Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Study Overview
=================
Brief Summary
-----------------
This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of inflammation in the sinus mucosa, to create models that predict improvement in quality of life following treatment.

Official Title
-----------------
Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Conditions
-----------------
Chronic Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>= 18 years) Chronic rhinosinusitis as defined by the 2007 multi-disciplinary adult sinusitis guidelines Able to complete all surveys/questionnaires in English Persistent symptoms following initial medical management Received at least 1 course of broad spectrum antibiotics or culture directed antibiotics for at least a total of 14 days Received at least a 3 week trial of topical steroid sprays OR at least a 5 day trial of systemic corticosteroid therapy. Counseled for subsequent treatment options including either medical management or endoscopic sinus surgery Exclusion Criteria: Children (<18 years) Unable to complete all surveys/questionnaires at baseline

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Endoscopic sinus surgery<br>Patients electing endoscopic sinus surgery for chronic rhinosinusitis | |
| Medical management<br>Continued medical management for symptoms of chronic rhinosinusitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific quality of life |  | 18 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General health-related quality-of-life |  | 18 months post-treatment | 
| Olfaction |  | 18 months post-treatment |
Enoxaparin in Acute Venous Thromboembolic Disease

Study Overview
=================
Brief Summary
-----------------
Study objectives : To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.

Official Title
-----------------
The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial

Conditions
-----------------
Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors Exclusion Criteria: Patients with a history of heparin or warfarin treatment longer than 24 hours, Patients requiring thrombolytic treatment, Patients having thrombophilia diagnosis, Patients with prior deep vein thrombosis or pulmonary emboli evidence, Patients with familial bleeding disorder, Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month Patients with renal failure (serum creatinine concentration > 180 mmol/L or > 2.03 mg/dL), Patients with severe hepatic failure Patients with history of allergy against heparin and protamine, Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment, Patients participating in another clinical study within the last 4 months Patients who are pregnant 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

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: 1<br>enoxaparin | Drug: enoxaparin<br>* All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days. Long-term oral anticoagulation will be started in all patients after 24 hours of initiation of enoxaparin treatment and continued at least for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants. |  | 3 months |
Safety and Performance of the Cardiovalve TR Replacement System

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Detailed Description
-----------------
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System

Official Title
-----------------
Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation

Conditions
-----------------
Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Device: Cardiovalve TR valve replacement System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional TR ≥3+ Symptomatic, NYHA Class II-IVa Patient approved by the Subject Screening Committee Exclusion Criteria: Cardiac anatomy deemed not suitable for the Cardiovalve TR system Hemodynamic instability Severe right ventricular failure Refractory heart failure requiring advanced intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, single arm, open label, multi center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiovalve TR replacement Group<br>Cardiovalve TR valve replacement System | Device: Cardiovalve TR valve replacement System<br>* The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device or procedure-related adverse events | Freedom from device or procedure-related adverse events | 30 days | 
| Reduction in TR grade | Reduction in TR in comparison to baseline | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test | Change in Six minute walk distance from Baseline | 30 days, 6 months, 12 months, annual for five years | 
| KCCQ | Change in health status from Baseline | 30 days, 6 months, 12 months, annual for five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tricuspid valve, Heart valve, Cardiovascular disease
Efficacy Test on Skin Hydration and Skin Barrier Function

Study Overview
=================
Brief Summary
-----------------
The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined. Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation on the other side twice daily (morning and evening) for 28 days. All subjects gave written informed consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S. ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.

Detailed Description
-----------------
It is expected that the long-term application of P-IP increase skin surface water contents and suppress TEWL.

Official Title
-----------------
Human Use Test on Skin Hydration and Skin Barrier Function

Conditions
-----------------
Dry Skin

Intervention / Treatment
-----------------
* Other: Pyridoxine tri-isopalmitate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy skin Exclusion Criteria: don't use any moisturizer

Ages Eligible for Study
-----------------
Minimum Age: 33 Years
Maximum Age: 62 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of P-IP on hydration and barrier function<br>Effects of P-IP on improvement of skin hydration and TEWL were examined. | Other: Pyridoxine tri-isopalmitate<br>* 2% dosage, oil-in-water emulsion, twice a day, 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of skin surface water content and Trans-Epidermal Water Loss (TEWL) | Subjects were treated with P-IP formulation on one side of the face and with a placebo formulation (without P-IP, oil-in-water emulsion type) on the other side twice daily (morning and evening) for 28 days. Skin surface water contents and TEWLs were measured at the time frame described above and the results were analyzed as a change from a value of before-application at each measurement. | Before application, 1 week, 2 week and 4 weeks after application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry skin condition
Tracking Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate an investigational system that may allow doctors to show images of the different parts inside the eye that show greater detail than current equipment can produce.

Detailed Description
-----------------
The purpose of this research study is to evaluate an investigational system that may allow doctors to make images of the parts inside the eye that show greater detail than current equipment can produce.

Official Title
-----------------
Tracking Optical Coherence Tomography

Conditions
-----------------
Macular Degeneration, Glaucoma, Diabetic Retinopathy, Choroidal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals (this includes women of child-bearing potential) who are familiar with vision experiments and ophthalmic equipment, all over 18 years. Subjects will have a retinal screening if they are over 50 years old or have a known risk factor for eye disease, such as family history of age related macular degeneration or cardiovascular disease. Patients with retinal and choroidal disease: age related maculopathy or age related macular degeneration, diabetic retinopathy, glaucoma. Exclusion Criteria: Over 85 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
maculopathy
To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To demonstrate that CT-P16 is similar to US-approved Avastin in terms of efficacy determined by overall response rate (ORR) up to Cycle 6 during the Induction Study Period

Official Title
-----------------
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Conditions
-----------------
Adenocarcinoma of Lung

Intervention / Treatment
-----------------
* Drug: CT-16
* Drug: Avastin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as recurrent disease or stage IV has at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Exclusion Criteria: has predominantly squamous cell histology non-small cell lung cancer had surgery for metastatic nsNSCLC

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: CT-P16<br>Drug: Bevacizumab 15mg/kg IV of CT-16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. | Drug: CT-16<br>* 15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period.<br>|
| Active Comparator: Avastin<br>Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period. | Drug: Avastin<br>* 15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessment: ORR | Objective Response Rate | Primary efficacy endpoint-Induction Study Period (around 21 weeks) |
Bronchopulmonary PK of AT-527 (R07496998)

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)

Official Title
-----------------
A Phase 1, Open-label, Randomized Study in Healthy Subjects to Assess the Bronchopulmonary Pharmacokinetics, Safety and Tolerability of AT-527, a Potential Treatment for COVID-19

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: AT-527


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must agree to use birth control, as required by the protocol. Females must have a negative pregnancy test at Screening and prior to dosing Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2 Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2 Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Concomitant use of prescription medications, or systemic over-the-counter medications Other clinically significant medical conditions or laboratory abnormalities

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527 Group A<br>n=8 | Drug: AT-527<br>* administered twice daily (BID) for 2.5 days (5 doses in total)<br>* Other names: RO7496998;|
| Experimental: AT-527 Group B<br>n=8 | Drug: AT-527<br>* administered twice daily (BID) for 2.5 days (5 doses in total)<br>* Other names: RO7496998;|
| Experimental: AT-527 Group C<br>n=8 | Drug: AT-527<br>* administered twice daily (BID) for 2.5 days (5 doses in total)<br>* Other names: RO7496998;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of AT-527 in epithelial lining fluid |  | 4-5 hours after last dose and 11-12 hours after last dose |
Evaluation of Accuvein in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.

Official Title
-----------------
Evaluation of Accuvein in Obese Patients

Conditions
-----------------
Primary Care

Intervention / Treatment
-----------------
* Device: Accuvein
* Device: Routine technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter Exclusion Criteria: pregnant woman

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: Accuvein<br>Use of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients | Device: Accuvein<br> <br> |
| Active Comparator: Routine technique<br>Routine technique used to insert a peripheral intravenous catheters in obese patients. | Device: Routine technique<br>* Placement of peripheral intravenous catheters using the routine technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of success of the first vein puncture | Successful successful placement of IV catheter | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of evaluation of the device | Evaluation of the device by the operator and the patient | one hour |