linjc16/ctgov huggingface dataset:
A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

Detailed Description
-----------------
Minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (MR) imaging and tissues samplings. Because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem MR imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.

Official Title
-----------------
A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

Conditions
-----------------
Stillbirth and Fetal Death, Termination of Pregnancy, Neonatal Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stillbirth and fetal deaths over 21 weeks of gestation termination of pregnancy over 21 weeks of gestation neonatal death patient having read the letter of information and signed the consent. Exclusion Criteria: legal incapacity limited ability to consent lack of parental consent

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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 virtopsy made completely | Number of virtopsy made completely (from death until clinical report). | month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post mortem Magnetic Resonance Imaging, stillbirth, fetal death, neonatal death, Minimally Invasive Autopsy, Tissue samplings
Clinical Evaluation of QFlu Combo Test

Study Overview
=================
Brief Summary
-----------------
Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.

Detailed Description
-----------------
The study design is to collect samples from participants. A portion of the sample is used for drug resistance detection using the test (QFlu Combo Test) under investigation. The remaining portion of the sample is used for culture. The culture positive samples are used for determination of IC50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu test will be calculated by comparing to the gold standard test.

Official Title
-----------------
Clinical Evaluation of QFlu Combo Test

Conditions
-----------------
Cough, Myalgia, Nasal Obstruction, Sore Throat, Headache, Fatigue, Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General population<br>This group of participants is primarily an out-patient population. | |
| In-patient population<br>This group of participants is primarily an in-patient population. | |
| Pediatric Group<br>Participants in this group are children 18 years or younger. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity for drug resistance detection | Interim results may be assessed after the first year study. | approximately 12 months after the study is completed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the Test for Influenza Diagnosis | Results may be assessed after the first year study. | 12 months after the study is completed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cough, myalgia, nasal obstruction, sore throat, headache, fatigue, feverishness, Patients who exhibit flu-like symptoms during a flu season, including cough, myalgia, nasal obstruction, sore throat, headache, fatigue, and/or feverishness.
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Official Title
-----------------
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Diclofenac Topical Sodium Gel 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion criteria Osteoarthritis of the knee Key Exclusion criteria Other rheumatic disease, such as rheumatoid arthritis Active gastrointestinal ulcer during the last year Known allergy to analgesic drugs

Ages Eligible for Study
-----------------
Minimum Age: 35 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

| Intervention/Treatment |
| --- |
|Drug: Diclofenac Topical Sodium Gel 1%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain score in target knee at Week 12 |  |  | 
| WOMAC physical function score in target knee at Week 12 |  |  | 
| Global rating of disease activity by patient at Week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8 |  |  | 
| WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12 |  |  | 
| Pain on movement in target knee and use of rescue medication recorded in diary |  |  | 
| Global evaluation of treatment at final visit |  |  | 
| Treatment responder rate according to OARSI criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children

Study Overview
=================
Brief Summary
-----------------
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:

Detailed Description
-----------------
Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group

Official Title
-----------------
Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study

Conditions
-----------------
Rectal Prolapse

Intervention / Treatment
-----------------
* Device: Laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with persistant complete Rectal Prolapse. Failure of conservative treatment. more than 2 attacks of prolapse requiring manual reduction. Exclusion Criteria: Sever constipation Previous abdominal or pelvic surgery with extensive adhesions. Cases older than 12ys, Patients with rectal polyp

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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
Interventional Model Description: The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesh Rectopexy<br>Using Laparoscopy | Device: Laparoscopy<br>* Laparoscopic Procedures for Rectopexy<br>|
| Active Comparator: Suture Rectopexy<br>Using Laparoscopy | Device: Laparoscopy<br>* Laparoscopic Procedures for Rectopexy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of improvement | No recurrence of Rectal Prolapse | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of improvement | Improvement of Fecal Incontinence score(Rintala score) | 30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal Prolapse, Laparoscopy, Mesh, Rectopexy, pediatrics
REBEAT Resynchronisation and Beta-Blocker European Trial

Study Overview
=================
Brief Summary
-----------------
This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

Detailed Description
-----------------
The purpose of this investigation is to evaluate the effect of CRT combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up-titrated to optimal doses before CRT.

Official Title
-----------------
Resynchronisation and Beta-Blocker European Trial

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Contak Renewal (CRT-D)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (<25% of optimal dosage). Exclusion Criteria: chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Contak Renewal (CRT-D)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF changes between baseline and 6 months measured by Echocardiography |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase % of patients with successful uptitration for Betablockers, reduce all cause hospitalizations and all cause mortality, reduce all cause mortality and heart failure hospitalizations, reduce all cause mortality and cardiovascular hospitalizations |  |  |
Safety of NNC 0123-0000-0338 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.

Official Title
-----------------
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: NNC 0123-0000-0338
* Drug: placebo
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subject Body mass index (BMI) between 18 and 28 kg/m^2 (both inclusive) Exclusion Criteria: Known or suspected hypersensitivity to trial products or related products Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose levels 1-7<br> | Drug: NNC 0123-0000-0338<br>* Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.<br>Drug: placebo<br>* Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.<br>Drug: insulin glargine<br>* As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | from trial product administration and until completion of the dosing visit (Day 0 to Day 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve |  | from 0 to 120 hours after a single dose | 
| Area under the glucose infusion rate-time curve |  | from 0 to 24 hours after a single dose |
Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

Study Overview
=================
Brief Summary
-----------------
Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

Detailed Description
-----------------
Inclusion criteria ER positive breast cancer Postmenopause women Older than 60yr S/P bilateral salphingo-oophorectomy No menstruation history within 1yr and FSH>30mIU/mL Ipsilateral invasive breast cancer Undergone curative resection No evidence of distant metastasis Capable of breast MRI

Official Title
-----------------
Prospective Study Analyzing Value of Breast Density Change Predicting ENdocrine Therapy Response in Postmenopausal Women Taking Adjuvant ARomatase Inhibitor

Conditions
-----------------
Invasive Breast Cancer, Estrogen Receptor Positive Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ER positive invasive breast cancer Postmenopause women age 60yrs or older s/p bilateral salphingo-oophorectomy No history of menstruation and FSH>30mIU Planned for aromatase inhibitor Unilateral breast cancer Curative resection No evidence of distant metastasis Exclusion Criteria: Bilateral breast cancer Male breast cancer Acceptable for breast MRI Pregnancy or lactation

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

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

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 |
| --- | --- | --- |
| disease free survival | recurrence locoregional distant metastasis Confirmed by clinical imaging or pathology | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast density change | breast density change measured by cumulus(mammogram) and MRI(bilateral breast MRI) imagings taken after 6mos, 1yr, 2yr after endocrine therapy initiation | 6mos, 1yr, 2yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast density change, endocrine therapy response, aromatase inhibitor
Glowing and Expecting Follow Up

Study Overview
=================
Brief Summary
-----------------
This study will help us learn more about how a mother's health during pregnancy may influence her child's growth and development later in life.

Detailed Description
-----------------
This study will follow participants who participated in the Glowing and Expecting study. 514 people who are 5 to 14 years of age who agreed to be contacted for future studies will be part of this study.

Official Title
-----------------
Glowing and Expecting Follow Up

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Former Glowing and Expecting study participants aged 5 to 14 years of age Exclusion Criteria: Participants who were dropped from the Glowing and Expecting studies.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lean mothers<br>Participants that were in Glowing born from Lean mothers. | |
| Overweight mothers<br>Participants that were in Glowing born from Overweight mothers. | |
| Obese mothers<br>Participants that were in Glowing born from Obese mothers. | |
| Exercise group mothers<br>Participants that were in Expecting born from mothers that were in the exercise group. | |
| Non Exercise group mothers<br>Participants that were in Expecting born from mothers that were in the non- exercise group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's growth and development | Will be determined with body composition equipment (DXA and NMR) | up to age 14 | 
| Child's metabolism and physical activity | Will be determined with metabolic cart and fitness test equipment | up to age 14 |
Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain. The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Behavioral: Self-hypnosis
* Procedure: Lung transplantation
* Other: Standard post-operative pain management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 15 years of age indication of lung transplantation Exclusion Criteria: patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 90 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: Self-hypnosis<br>Patients trained to self-hypnosis before surgery | Behavioral: Self-hypnosis<br>* Patients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery<br>Procedure: Lung transplantation<br> <br> Other: Standard post-operative pain management<br>* Post-operative pain management treatments as per usual protocols in the hospital<br>|
| Active Comparator: Usual pain management<br>Patients receiving the usual post-operative pain management protocols | Procedure: Lung transplantation<br> <br> Other: Standard post-operative pain management<br>* Post-operative pain management treatments as per usual protocols in the hospital<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Score (Visual Analog Scale) One Month After Surgery | Average level of pain (scored by the patient on a visual analog scale), during the 48 hours preceding the scheduled consultation at one month post-surgery | one month after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
All terminal, leading, indication, lung transplantation