linjc16/ctgov huggingface dataset:
Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.

Official Title
-----------------
Treatment of Pulmonary Disease Caused by MAIS, M.Xenopi or M.Malmoense: A Comparison of Two Triple Drug Regimens and an Assessment of the Value of Immunotherapy With M.Vaccae

Conditions
-----------------
Pulmonary Diseases

Intervention / Treatment
-----------------
* Drug: Addition of clarithromycin to rifampicin and ethambutol
* Drug: Addition of Ciprofloxacin to rifampicin and ethambutol
* Biological: Vaccination with M.vaccae


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions. Exclusion Criteria: Pregnant women and women of childbearing age not taking adequate contraceptive precautions. Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis. Patients who have AIDS or who are known to be HIV positive

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Addition of clarithromycin to rifampicin and ethambutol|nan|
|Drug: Addition of Ciprofloxacin to rifampicin and ethambutol|nan|
|Biological: Vaccination with M.vaccae|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rates |  |  | 
| Cure rates |  |  | 
| Relapse rates |  |  | 
| Unwanted effects of therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit or not of immunotherapy with M.vaccae |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Opportunist Mycobacteria, pulmonary disease, Clarithromycin, Ciprofloxacin, M.vaccae, Pulmonary diseases caused by Opportunist Mycobacteria
Functional Role of RUNX1 Mutations in the Etiology of Acute Myeloid Leukemia (AML)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the role of RUNX1 in Acute Myeloid Leukemia (AML), in particular, the transcriptional regulation of genes by mutated forms of this protein. This research will study the effect of mutations found in AML patients

Detailed Description
-----------------
The RUNX1 gene, located at chromosomal band 21q22, is a transcription factor, crucial for hematopoiesis and the generation of hematopoietic stem cells in the embryo. RUNX1 is the most frequent target for chromosomal translocation in leukemia. In addition, point mutations in the RUNX1 gene have been found to constitute an important mode of genetic alteration in development of leukemia. Recent publications stressing the clinical need for implementing RUNX1 point mutations as both a diagnostic and unfavorable prognostic marker of AML, have aroused particular interest in the functional role of RUNX1 in this disease. In order to pinpoint specific RUNX1 target genes involved in pre-leukemic transformation or exacerbation of existing leukemia, the investigators plan to compare expression profiles from human hematopoietic progenitors overexpressing a mutated form of RUNX1with controls (RUNX1 wild-type and knocked-down). In this study the investigators intend to collect blood, after receiving informed consent, from umbilical cords of neonates born vaginally, in order to isolate CD34+ hematopoietic progenitors. Human umbilical cord blood contains relatively high numbers of CD34+ cells, which may be frozen directly after collection and used as a source of progenitor cells for further culture or direct analysis.

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting women who have had full-term birth Exclusion Criteria: Systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Umbilical cord blood<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of expression arrays on transfected CD34+ cells | Performance of expression arrays on transfected CD34+ cells (derived from human cord blood), expecting differential gene expression between the wild type RUNX1-transfected cells and mutated RUNX1-transfected cells. | One year |
Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles

Study Overview
=================
Brief Summary
-----------------
This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.

Detailed Description
-----------------
This study will be a non-blind, prospective, double-armed, randomized clinical trial. The study will be conducted at five centers, the Educational Hospital Fertility Unit of Tanta University, the fertility center of Cairo University, the fertility center of Assiut University, the Egyptian Consultants Fertility Center in Tanta, and MRC fertility center in Cairo from May 1st 2019 till the end of the objected number. The study will be conducted in accordance with the Declaration of Helsinki, and all participants should sign a written informed consent before inclusion in the study.

Official Title
-----------------
Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles is it Going to Make the Difference?

Conditions
-----------------
Infertility, IVF, ICSI, Cryopreservation

Intervention / Treatment
-----------------
* Procedure: Priority to freeze
* Procedure: Fresh embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for IVF/ICSI Presence of good number of embryos > 5 Exclusion Criteria: Low quality embryos Low ovarian reserve Low number of embryos

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Study group<br>Will be subjected to priority to freeze | Procedure: Priority to freeze<br>* Priority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone.<br>|
| Active Comparator: Control group<br>Will receive fresh embryo transfere | Procedure: Fresh embryo transfer<br>* usual strategy of giving the priority for fresh embryo transfer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative pregnancy rates | The number of pregnant women in both groups after 3 cycles | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of pregnancy | Failed ICSI | 3 months |
Vascular and Metabolic Effects of Omega-3 Fatty Acids

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that omega does-dependently improves vascular and insulin resistance.

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: omega


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertriglyceridemia Exclusion Criteria: overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br> <br> |
| Active Comparator: omega 1<br>omega 1 gm | Drug: omega<br> <br> |
| Active Comparator: omega 2<br>omega 2 gm | Drug: omega<br> <br> |
| Active Comparator: omega 4<br>omega 4 gm | Drug: omega<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance
Undislocated Distal Both-Bone Forearm Fractures in Children

Study Overview
=================
Brief Summary
-----------------
We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.

Detailed Description
-----------------
children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial. After informed consent, a randomization between 2 kinds of cast will be done. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Official Title
-----------------
Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.

Conditions
-----------------
Fracture, Forearm, Distal, Child, Treatment

Intervention / Treatment
-----------------
* Procedure: above- or under elbow cast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both-bone forearm fracture distal undislocated age < 16 years Exclusion Criteria: fracture older than 1 week no informed consent refracture open fracture (Gustillo 2 and 3) both fractures type torus

Ages Eligible for Study
-----------------
Maximum Age: 15 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: above- or under elbow cast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pronation and supination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications, function, esthetics, complains in daily living, X-rays |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Forearm, Fracture, Distal, Child, Treatment
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Study Overview
=================
Brief Summary
-----------------
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Official Title
-----------------
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric

Conditions
-----------------
Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Intervention / Treatment
-----------------
* Procedure: endoscopic management, surgery and follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old Chinese; Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors; Patients voluntarily signed informed consent and have been orally informed of the specific trial plan. Exclusion Criteria: Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery; Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease; gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life; The investigator considers that it is not suitable for this test.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: endoscopic management<br> | Procedure: endoscopic management, surgery and follow up<br>* endoscopic management, surgery and follow up<br>|
| Other: follow up<br> | Procedure: endoscopic management, surgery and follow up<br>* endoscopic management, surgery and follow up<br>|
| Other: surgery<br> | Procedure: endoscopic management, surgery and follow up<br>* endoscopic management, surgery and follow up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recur or not in 2 years after endoscopic surgical procedure or surgery | Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography. | 2 years after endoscopic surgical procedure or surgery |
The Injury and Its Consequences in the Sports Lower Limb Amputee

Study Overview
=================
Brief Summary
-----------------
This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact. It aims to study sports-related injuries in lower limb amputees. Its objective is to determine the prevalence, but also to describe the injuries (type, location, duration, type of management) and their repercussions in terms of after-effects, and repercussions on sports, professional and personal practice. It also aims to begin a correlation between injury and sports load, type of sport (discipline, practice modality), technical aids used

Official Title
-----------------
The Injury and Its Consequences in the Sports Lower Limb Amputee

Conditions
-----------------
Leg Lower Amputation, Traumatic Amputation

Intervention / Treatment
-----------------
* Other: completion of a questionnaire on the practice of sports and possible injuries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lower limb amputee or lower limb agenes Amputee before 55 years old Amputee for more than 2 years Willing to participate in the study Practicing a regular physical activity (at least 1x/week) Patient affiliated or beneficiary of a health insurance plan. Patient aged 18-65 years Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| lower limb amputee<br>No intervention, pure observational study | Other: completion of a questionnaire on the practice of sports and possible injuries<br>* completion of a questionnaire on the practice of sports and possible injuries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of injuries | presence of injuries (Yes/No, if yes, Nb) | in the 5 years preceding the completion of the questionnaire | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sport, lower limb amputation
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

Study Overview
=================
Brief Summary
-----------------
The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.

Official Title
-----------------
A Positron Emission Tomography Study to Assess the Level and Duration of Occupancy of Serotonin-1A Receptors Produced by Single Oral Doses of SRA-444 in Healthy Elderly Subjects and in Subjects With Alzheimer Disease

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

Intervention / Treatment
-----------------
* Drug: SRA-444


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men or women from 60 years of age at screening. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG). Exclusion criteria: History of drug abuse within 1 year before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRA-444 + Placebo<br>Experimental; Placebo | Drug: SRA-444<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease |  | after each dose group completion | 
| To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET |  | 1 month |
PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients

Study Overview
=================
Brief Summary
-----------------
The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve Replacement/Repair patients) Study aims to evaluate those preoperative factors which can predict the early postoperative right ventricular failure or determine the functional shift seen in right ventricular function after mitral valve replacement/repair. The PREPARE-MVR study focuses mainly on echocardiographic (both conventional and advanced) parameters and includes right heart catheterization intraoperatively and in the early postoperative period as gold standard method.

Official Title
-----------------
The PREPARE-MVR Study: PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients

Conditions
-----------------
Right Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure, Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: Mitral valve replacement/repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted for mitral valve replacement/repair severe mitral valve insufficiency Exclusion Criteria: preoperative right ventricular dysfunction cardiac surgery in medical history infective endocarditis primary cardiomyopathies congenital heart disease decreased left ventricular ejection fraction pulmonary embolism in medical history severe chronic obstructive pulmonary disease primary pulmonary hypertension any malignancy affecting right heart

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mitral valve replacement/repair|Mitral valve replacement/repair: standard of care operation of the mitral valve due to severe insufficiency|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right ventricular failure | Early postoperative right ventricular failure is defined as right ventricular stroke work index <300 mmHg/mL/m2 measured by right heart catheterization. Late right ventricular failure is defined as >10% decrease in right ventricular ejection fraction compared to preoperative value measured by 3D echocardiography. | From date of operation until the date of first documented right ventricular failure assessed up to 6 months |