linjc16/ctgov huggingface dataset:
Use of Fetoscopy in Missed Abortion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.

Official Title
-----------------
Use of Fetoscopy in Missed Abortion

Conditions
-----------------
Abortion, Missed

Intervention / Treatment
-----------------
* Procedure: Fetoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with missed abortion during the first trimester of pregnancy Exclusion Criteria: Women diagnosed with missed abortion after the first trimester of pregnancy Any contraindication for hysteroscopy

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fetoscopy in missed abortion<br>Women who have decided to undergo fetoscopy in missed abortion | Procedure: Fetoscopy<br>* Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macroscopic anatomic malformations in missed abortions | The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimize intrauterine adhesions through observation | To minimize intrauterine adhesions that might occur after curettage through the ability to visualize the womb and pregnancy site through a hysteroscope before the surgical procedure so that inadvertent intrauterine adhesions are minimized. After one year, if pregnancy is not achieved (due to intrauterine adhesions that cause infertility), a follow-up hysteroscopy will be performed and intrauterine adhesions can be visualized if they have occurred. | Two years | 
| Prevention of retained conception products | Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb | Two years |
Virtual Reality-Based Exercise in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in cancer patients. The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in cancer patients compared to a control group receiving usual care only.

Official Title
-----------------
Virtual Reality-Based Exercise in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy

Conditions
-----------------
Distorted; Balance, Motor Deficit

Intervention / Treatment
-----------------
* Other: Balance Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to ambulate without assistance willingness to provide informed consent cancer neuropathy related to chemotherapy Exclusion Criteria: severe neurologic, cardiovascular, metabolic, or psychiatric disorders severe visual impairment cognitive impairment
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balance Training<br>Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as ankle reaching and obstacle crossing using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes. | Other: Balance Training<br>* Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as ankle reaching and obstacle crossing using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.<br>|
| No Intervention: Control<br>The control group will keep their normal activity without receiving any intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Balance | Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technologies (BalanSens™) | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait performance | Gait performance will be measured using validated wearable sensor technology (LEGSys™) | 4 weeks |
Retrieval of Patient Information After Discontinuation

Study Overview
=================
Brief Summary
-----------------
A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.

Official Title
-----------------
A Phase 3b Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN15727-301 and 302 But Did Not Enroll in Study ELN115727-351

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

Intervention / Treatment
-----------------
* Drug: Bapineuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Signed, dated, and written informed consent obtained from the subject and/or the subject's legally acceptable representative (LAR, if applicable) in accordance with local regulations. Signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations. Subject must have participated in the Study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo). Subject must have been off treatment for at least 12 months prior to Visit 1. Subjects must have a primary caregiver for the duration of the study. Subject's caregiver must have the ability to assess the subject and answer questions over the phone.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Observational<br>Long term follow-up | Drug: Bapineuzumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dependence Scale | Caregiver's assessment of a patient's need for assistance | 4 years |
CT Assessment of BMI in Endometrial Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective study to investigate the association between body fat distribution and sarcopenia on CT-scan and oncological outcomes in endometrial cancer patients

Official Title
-----------------
Computed Tomography Assessment of Body Fat Distribution in Endometrial Cancer Patients

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of endometrial cancer Age: 18 years or older Abdominal CT-scan as part of pre-operative or post-operative staging work-up (<1 month after surgery) Exclusion Criteria: Women with concurrent cancer Women with unknown body mass index

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Investigation of Patients with High BMI and Survival Rates | To investigate the association between body fat distribution and sarcopenia on CT-scan and survival in endometrial cancer patients | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial Cancer, CT-scan, Fat distribution, Obesity, Sarcopenia
Perioperative Heart Rate Variability Analysis in Realtime

Study Overview
=================
Brief Summary
-----------------
This study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.

Official Title
-----------------
Perioperative Heart Rate Variability Analysis in Realtime: Detection of Cardiovascular and Autonomic Dysfunction

Conditions
-----------------
Individuality, Perioperative/Postoperative Complications, Heart Rate and Rhythm Disorders, Surgical Complications From General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing non-cardiac surgery under general anesthesia Patients aged 18-80 years Patients who are capable of giving informed consent Exclusion Criteria: Patients <18 or >80 years of age Patients with an active cardiac pace maker Patients with an absent sinus rhythm in ECG Patients presenting with a preexisting arrhythmia Patients requiring postoperative ICU therapy Patients with pheochromocytoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Heart rate variability | The analysis of heart rate variability (HRV) has been used to assess autonomic nervous system responses to therapeutic interventions, and to quantify risk in a wide variety of both cardiac and non-cardiac disorders when combined with other diagnostic tests - though HRV analysis has seen its greatest cardiologic use in post-myocardial infarction risk stratification and in assessing risk for arrhythmic events. HRV analysis has become widespread and relatively simple to perform - however, until now, these analyses have not been performed in detail in the perioperative period. | During and immediately subsequent to surgery performed under general anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart rate variability, Electrocardiography, Observational study, Non-interventional study, Risk assessment, Perioperative
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether thyroid hormone levels are predictive of cardiac remodeling following myocardial infarction and the prognosis in patients with STEMI receiving primary percutaneous coronary intervention.

Official Title
-----------------
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients

Conditions
-----------------
Thyroid, Cardiac Remodeling, Ventricular, STEMI

Intervention / Treatment
-----------------
* Other: Thyroid hormone levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention (presenting <12h after symptom onset) patients agreed and provided informed consent Exclusion Criteria: past history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass graft past history of heart failure (LVEF<40%) or myocardiopathy or atrial fibrillation past history of thyroid diseases, or were treated with amiodarone, dopamine, or corticosteroids before hospital admission contraindicating to cardiac magnetic resonance imaging
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Euthyroid<br> | Other: Thyroid hormone levels<br>* This is an observational study. Exposure: Different thyroid hormone levels.<br>|
| Low T3<br>low triiodothyronine syndrome | Other: Thyroid hormone levels<br>* This is an observational study. Exposure: Different thyroid hormone levels.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (major adverse cardiovascular events) | cardiovascular death, re-infarction, revascularization, and stroke | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse cardiac remodeling | a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans | 6 months | 
| all-cause death | death caused by all reason | 12 months |
Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.

Official Title
-----------------
A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ADHD Exclusion Criteria: Patients who weigh less than 20kg at visit 1 Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures Judged to be at suicidal risk Taking psychotropic medication on a regular basis Hypertension

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 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: Atomoxetine Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHIP-CE total mean score after 4 weeks of treatment. |  |  | 
| The domains of the CHIP-CE after 4 and 10 weeks of treatment. |  |  | 
| The following are measured after both 4 and 10 weeks of treatment: |  |  | 
| Family Buden of Illness |  |  | 
| Harter Self Perception Profile |  |  | 
| ADHD-RS |  |  | 
| Clinical Global Impression- Severity |  |  | 
| Clinical Global Impression -Improvement |  |  | 
| To assess whether changes to the above scales are maintained over long term |  |  | 
| Long-term safety of atomoxetine |  |  |
Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Detailed Description
-----------------
The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Official Title
-----------------
Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: intravenous diclofenac sodium (DIC075V)
* Drug: ketorolac
* Drug: oral diclofenac (Cataflam)
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects. Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge. Exclusion Criteria: Bleeding abnormalities or cardiovascular events. Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>intravenous diclofenac sodium | Drug: intravenous diclofenac sodium (DIC075V)<br>* intravenous diclofenac sodium<br>|
| Active Comparator: B<br>intravenous ketorolac | Drug: ketorolac<br>* intravenous ketorolac<br>|
| Active Comparator: C<br>oral diclofenac (Cataflam) | Drug: oral diclofenac (Cataflam)<br>* oral diclofenac (Cataflam)<br>|
| Active Comparator: D<br>oral aspirin | Drug: aspirin<br>* oral aspirin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100. |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100. |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diclofenac, platelet aggregation, ketorolac, aspirin
TAP-Block in Abdominal Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.

Official Title
-----------------
Transversus Abdominis Plane (TAP) Block in Open Abdominal Aortic Surgery : Randomized Controlled Doubled-blind Trial Comparing Ropivacaine 0.2% Versus Placebo

Conditions
-----------------
Aortic Aneurysm, Abdominal

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open abdominal aortic surgery (aneurysm or aortobifemoral bypass) Person who has given his written consent Exclusion Criteria: Emergency surgery Patient with infection Use of opioids in the long term History of chronic pain Higher functions incompatible with the functioning of the PCA Patients under guardianship

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Conventional PCA morphine +TAP-block ropivacaine 0.2% | Drug: Ropivacaine<br>* TAP-block Ropivacaine 0.2% during 48 hours<br>|
| Placebo Comparator: TAP-block with placebo<br>Conventional PCA morphine treatment with TAP-block with placebo | Drug: Placebo<br>* TAP-block with placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of morphine consumption at 24 postoperative hours | Morphine consumption (Patient Controlled Analgesia) statement during the first 24 postoperative hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Visual Analogue Scale scores at 24 postoperative hours | Visual Analogue Scale scores statement during the first 24 postoperative hours (minimum pain 0 - maximum pain 10) | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, TAP-block