linjc16/ctgov huggingface dataset:
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

Detailed Description
-----------------
We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

Official Title
-----------------
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Conditions
-----------------
Abnormal Uterine Bleeding

Intervention / Treatment
-----------------
* Procedure: Endometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication to carry out diagnostic hysteroscopy Agrees and is suitable for outpatient/office hysteroscopy Exclusion Criteria: Failed outpatient/office hysteroscopy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H Pipelle<br>Endometrial sample obtained using the H Pipelle | Procedure: Endometrial biopsy<br>* Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy<br>* Other names: H Pipelle;|
| Active Comparator: Pipelle<br>Endometrial sample obtained with standard Pipelle | Procedure: Endometrial biopsy<br>* Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy<br>* Other names: H Pipelle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort |  | End of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time, biopsy adequacy |  | End of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menorrhagia, Uterine fibroids, Endometrial polyps, Endometrial cancer
Rehabilitation by Effort for Patients With Advanced Bronchial Cancer

Study Overview
=================
Brief Summary
-----------------
Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life. Investigators want to ensured the feasibility of rehabilitation by effort for these patients.

Official Title
-----------------
Rehabilitation by Effort for Patients With Advanced Bronchial Cancer

Conditions
-----------------
Bronchial Cancer, Malignant Mesothelioma

Intervention / Treatment
-----------------
* Behavioral: rehabilitation by effort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General condition according to World Health Organisation 0-1 Age between 18 and 70 years old Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment Autonomous patient Voluntary written informed consent signed Patients with social security insurance Exclusion Criteria: Bone metastasis with fracture risk Significant cardiovascular pathology Cardiac, vascular, rheumatologic or neurologic contraindication Patients living far 60 kms from Toulouse Patients under juridical protection guardianship, or tutelage measure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rehabilitation by effort<br>8 sessions of rehabilitation by effort in sports medicine | Behavioral: rehabilitation by effort<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients who completed at least 6 sessions of rehabilitation | number of patients who completed at least 6 sessions of rehabilitation by effort | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchial cancer, rehabilitation
Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved. If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19. However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

Official Title
-----------------
Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

Conditions
-----------------
SARS-CoV Infection, Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: Electrical Impedance tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the intensive care unit for SARS-CoV-2 ARDS Under controlled invasive ventilation for less than 7 days Exclusion Criteria: Pneumothorax Deformation of the rib cage Contraindication to Electrical Impedance Tomography Pregnant or breastfeeding woman

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electrical Impedance tomography|Electrical Impedance tomography recording during 5 minutes every day during 7 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of correlation between the percentage of derecruitment of dependent areas (measured with Electrical Impedance Tomography) and the response to prone position | The percentage of derecruitment of dependent areas will be measured every day with Electrical Impedance Tomography. The response to prone position will be assessed every day. | Up to 7 days |
Multistimulation Group Therapy for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Our previous findings support the notion that group activity program, based on cognitive stimulation, recreational-occupational activities and physical-psychomotor exercises, can lead to an improvement in behavioral aspects for people with Alzheimer's Disease (AD). The purpose of this study is to clarify the efficacy of a rehabilitation program in outpatients affected by AD in mild to moderate stages.

Official Title
-----------------
Multistimulation Group Therapy in Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Other: Multidimensional stimulation group therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of possible/probable AD mild to moderate stage of AD (MMSE score of 15 - 24)and CDR score of 1-2 range years in age (65-85) and in school attendance (5-17) right handed Exclusion Criteria: severe aphasia (Token test score < 20) severe auditory and/or visual loss overt severe behavioral disturbances (delusions, hallucinations, agitation) recent (three month before the MST) introduction or dose modification of the following pharmacological treatments: cholinesterase inhibitor, memantine, antidepressant or antipsychotic drugs.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rehabilitation (MST) program<br>The Multidimensional Stimulation group therapy (MST) involved three levels of treatment. The first level was focused on PWA, the second level involved the caregiver, while the third one the dyad PWA-caregiver. | Other: Multidimensional stimulation group therapy<br>* The MST program involved three levels of treatment. The first level was focused on PWA, the second level involved the caregiver, while the third one the dyad PWA-caregiver.<br>|
| No Intervention: Usual care program<br>Usual care PWA program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in behavioral level | Neuropsychiatric Inventory scale | Baseline, 10ws, 22ws | 
| Change from baseline in cognitive level | ADAS cog scale | Baseline, 10ws, 22 ws | 
| Change from baseline in quality of life | SF36 questionaire | baseline, 10ws,22 ws |
Comparison of Refraction Measurments in Children Under General Anesthesia, With and Without Cycloplegic Drops

Study Overview
=================
Brief Summary
-----------------
Assessment of refraction measurements in children under general anesthesia, with or without cyclopelgic eye-drops

Detailed Description
-----------------
Comparing to adults, children have high ability to preform accommodation of the intraocular lens, that is due to the Ciliary muscle. In order to measure children's refraction in an accurate way the Ciliary muscle must be paralyzed and that is usually done be cycloplegic eye-drops .In case a child is undergoing a medical procedure under general anesthesia the assumption that the Ciliary muscle is paralyzed (complete or partially) due to anesthetic medications. In this study we would like to compare the refraction measurements in children under who undergo general anesthesia before and after applying cycloplegic eye-drops. In this way we can learn about the effect of anesthetic medication on the Ciliary muscle.

Official Title
-----------------
Methodes of Meausring Refraction in Children Under General Anesthesia

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Other: instulling cyclopentolate drops in the eye


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 - 12 years old Eyes that didn't underwent surgical procedure Exclusion Criteria: 1. eye operation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>The measurement will be done at all the participants. the results will the divides in the following way: Refraction measurements under general anesthesia without cycloplegic eye drops. Refraction measurements under general anesthesia with cycloplegic eye drops. | Other: instulling cyclopentolate drops in the eye<br>* measuring refraction with and wirthout cyclopentolate drops under general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in refraction results with and without cyclopentolate drops under general anesthesia |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye surgery, Children
Military Women's Health and Illness Behaviors in Deployed Settings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain better understanding of how recently deployed military women managed urinary and vaginal symptoms while deployed. Participants in this study will be asked to take part in a 45-60 minute interview.

Official Title
-----------------
Military Women's Health and Illness Behaviors in Deployed Settings

Conditions
-----------------
Genitourinary Symptoms

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deployment within the last 12 months Managed genitourinary symptoms while deployed (does not have to be diagnosed by a medical provider) Exclusion Criteria: Women who are assigned to a medical group/hospital

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women in the military who have returned from deployment within the past 12 months. | Other: No intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of deployed experience using qualitative methods | interview data analysis | 2008 to 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Military Women, Women's Health, Genitourinary Symptoms, Illness Behaviors, To determine how women manage genitourinary symptoms while deployed.
Multicenter AIDS Cohort Study (MACS)

Study Overview
=================
Brief Summary
-----------------
This is a comprehensive observational study of HIV infection in homosexual and bisexual men.

Detailed Description
-----------------
The Multicenter AIDS Cohort Study (MACS) provides important information about the changing nature of HIV-mediated disease progression, the impact of antiretroviral treatment, the nature of HIV pathogenesis, and viral and host genetic factors. This study will also assess the long-term patterns of therapy use and risk-taking behaviors. Patients will have study visits every 6 months. The visits will include interviews, specimen collection, and a physical examination.

Official Title
-----------------
Multicenter AIDS Cohort Study (MACS)

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV negative, or HIV positive and no history or current use of highly active antiretroviral therapy (HAART), or HIV positive HAART recipient with documentation of HAART initiation, no AIDS diagnosis prior to HAART initiation, and a CD4 cell count and HIV-1 RNA measurement within 6 months prior to first HAART use. Sexual intercourse with men or at least 5 male or female partners in the 5 years prior to enrollment. Exclusion Criteria: Injection drug use within 1 year of enrollment. Perinatally acquired HIV infection.

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)

Conditions
-----------------
Hyperlipidemia, Dyslipidemia, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eligible for statin treatment for LDL cholesterol by NCEP guidelines Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors. Subjects with significant liver or kidney disease or significant heart failure.

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

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in LDL-C and HDL-C from baseline, after six weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in other lipid parameters and other biomarkers. |  |  |
A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.

Official Title
-----------------
A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension

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

Intervention / Treatment
-----------------
* Drug: ADX415
* Drug: ADX415
* Drug: ADX415
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate hypertension Age 18-75 years, inclusive Exclusion Criteria: Clinically significant illnesses or abnormalities upon evaluation Current treatment with 3 or more antihypertensive meds Presence of Type I or uncontrolled Type II diabetes Presence of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX415 (high dose)<br>A high dose of ADX415 | Drug: ADX415<br>* ADX415 taken three times a day to achieve a high total daily dose<br>|
| Experimental: ADX415 (mid level dose)<br>A mid level dose of ADX415 | Drug: ADX415<br>* ADX415 taken three times a day to achieve a mid level total daily dose<br>|
| Experimental: ADX415 (low dose)<br>A low dose of ADX415 | Drug: ADX415<br>* ADX415 taken three times a day to achieve a low total daily dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo taken three times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ABPM measures |  | Baseline to Day 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events, lab tests, vitals signs, and ECGs |  | Throughout treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, High blood pressure, Htn, Addrenex