linjc16/ctgov huggingface dataset:
Treatment for Nonspecific Low Back Pain in Primary Care: a Trial on Different Health Education Booklets

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the effectiveness on the disability of low back pain patients of The Back Book, The Back Guide, and a control intervention (generic recommendations on general health). Patients are divided into 3 groups:those who receive The Back Book (classic education), those who receive The Back Guide (cognitive behavioral education) and the control group). They are patients who consult a physician at the primary care consults of 14 different Health Centers in Spain. The sample size is 240 subjects.

Official Title
-----------------
Treatment for Nonspecific Low Back Pain in Primary Care With Standardized Health Education Booklets: A Randomized Controlled Clinical Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: The Back Book
* Behavioral: The Back Guide
* Behavioral: General health book


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain patients, with or without referred or radiated pain; without red flags for systemic disease or criteria for surgery. Exclusion Criteria: Inability to read the handout or to fill out the questionnaires; habitually in a prostrate position; diagnosis of inflammatory rheumatologic disease, cancer or fibromyalgia; suspicion of fibromyalgia.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The Back Book | Behavioral: The Back Book<br>* A book on how to prevent back pain<br>Behavioral: The Back Guide<br>* A guide for the prevention of back pain.<br>Behavioral: General health book<br>* A book on general health<br>|
| Active Comparator: 2<br>The Back Guide | Behavioral: The Back Guide<br>* A guide for the prevention of back pain.<br>Behavioral: General health book<br>* A book on general health<br>|
| Active Comparator: 3<br>General health book | Behavioral: General health book<br>* A book on general health<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of disability at 180 days of follow-up. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catastrophizing and days on sick leave at 180 days of follow-up. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, disability, health education, primary care
Relation Between Polymorphism in Genes Related to Kidney Disease and Renal Manifistations in Fabry Disease

Study Overview
=================
Brief Summary
-----------------
The rational of the study is to try to predict which of the patients who suffer from Fabry disease will have End Stage Renal Disease. We hope to find correlation between certain modifier genes, previously related to renal disease, to renal disease in Fabry.

Conditions
-----------------
Fabry, Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Fabry disease - Exclusion Criteria:none -
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study to Evaluate MET642 in Patients With NASH

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.

Official Title
-----------------
Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: MET642
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan) Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Exclusion Criteria: History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant. Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis). Excessive consumption of alcohol.

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: MET642 high dose<br> | Drug: MET642<br>* MET642 active treatment<br>|
| Experimental: MET642 low dose<br> | Drug: MET642<br>* MET642 active treatment<br>|
| Placebo Comparator: MET642 Placebo<br> | Drug: Placebo<br>* Placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidences of treatment-emergent adverse events | Up to 28 days after last dose | 
| Vital Signs | Incidences of clinically significant changes in vital signs | Up to 28 days after last dose | 
| Laboratory tests | Incidences of clinically significant changes in laboratory tests | Up to 28 days after last dose | 
| ECG | Incidences of clinically significant changes in ECGs | Up to 28 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profile of MET642 | Cmax | 16 weeks | 
| Pharmacodynamic Profile of MET642 | C4 concentrations | 16 weeks | 
| Pharmacological Activity of MET642 | Measure of changes in liver fat using MRI-PDFF | 20 weeks | 
| Pharmacokinetic Profile of MET642 | Tmax | 16 weeks | 
| Pharmacokinetic Profile of MET642 | T1/2 | 16 weeks | 
| Pharmacokinetic Profile of MET642 | AUC0-inf | 16 weeks | 
| Pharmacodynamic Profile of MET642 | FGF19 concentrations | 16 weeks | 
| Pharmacodynamic Profile of MET642 | Bile Acids concentrations | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH, Fatty Liver
Regional Observation of the Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a regional basis, defined according to National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPIII) guidelines criteria.

Official Title
-----------------
Regional Observation of the Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Laboratory analysis (lipidic profile and glycemia) performed in the last year Exclusion Criteria: Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study Pregnancy or breast feeding Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 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 |
| --- | --- | --- |
| Prevalence of metabolic syndrome in primary care population |  | At visit | 
| Concomitant presence of other cardiovascular (CV) risk factors. |  | At visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, Lipids, Waist Circumference, HDL, hypertension
Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in advanced gastric cancer patients.

Official Title
-----------------
Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Conditions
-----------------
Gastric Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach) patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred measurable or evaluable disease according to RECIST age, 18 years or older ECOG performance status 0 - 2 adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 3.0 mg/dL signed written informed consent Exclusion Criteria: severe co-morbid illness and/or active infections pregnant or lactating women active CNS metastases not controllable with radiotherapy or corticosteroids active and uncontrollable bleeding from gastrointestinal tract known history of hypersensitivity to study drugs patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year interval from the last statin dose, the patient is eligible for study entry)

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: XP/simvastatin<br>Capecitabine/cisplatin + simvastatin | Drug: Simvastatin<br>* simvastatin 40 mg qd daily<br>|
| Placebo Comparator: XP/placebo<br>Capecitabine/cisplatin + placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival of XP ± simvastatin |  | 1-year PFS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, unresectable/metastatic
no Antibiotics for Elective Cesarean With Low Risk of Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.

Official Title
-----------------
A Randomized Controlled Trial on Antibiotics Application For Low Infection-risked Elective Cesarean

Conditions
-----------------
Antibiotics , Elective Cesarean, China

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cesarean With normal temperature; No signs of infection; Normal degree of cleanliness in vaginal; .Normal amniotic fluid. Exclusion Criteria: Failure of vaginal delivery and emergency cesarean; Premature rupture of membranes; Antibiotics having been applied to 3 days before cesarean; Having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis; Having infections in respiratory or urinary system before cesarean; Placenta previa or placental abruption; With medical and surgical complications; BMI ≥ 30kg/m2; Total blood loss more than 1000ml within 2 hours after cesarean

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| Temperature |  | 3days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum hemorrhage volume estimates and Routine blood test. |  | 3days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotics, cesarean
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDOTIXN® in Subject With Benign Masseteric Hypertrophy

Conditions
-----------------
Masseter Muscle Hypertrophy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject who aged 20 to less than 65 years subject with benign masseteric hypertrophy Exclusion Criteria: subject not appropriate for participating in this study according to the investigator's opinion subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDITOXIN<br> | Drug: Meditoxin<br>* Meditoxin (Botulinum toxin type A)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo (Normal saline)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline |  | 12 week follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline |  | 12 week follow-up visit |
National Tunisian Registry of Cardiac Implantable Electronic Devices

Study Overview
=================
Brief Summary
-----------------
The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic Devices in Tunisia. Cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. Data is captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.

Official Title
-----------------
National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)

Conditions
-----------------
Cardiac Implantable Electronic Devices

Intervention / Treatment
-----------------
* Device: Cardiac Implantable Electronic Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients originated from Tunisia Signed informed consent Patients undergoing a cardiac implantable electronic device procedure Exclusion Criteria: Informed Consent not given

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 |
| --- |
|Device: Cardiac Implantable Electronic Devices|Description of Cardiac Implantable Electronic Devices|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients undergoing cardiac implantable electronic devices in Tunisia | Number of subjects with heart disease (heart failure, rythm disorder) and willing to participate at the study and who are eligible for cardiac implantable electronic devices procedures | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart complication | Number of patients with cardiovascular event, including death, tamponade, pericarditis, heart failure, worsening of valvular disease, moving the right ventricular lead, compartment infection, phrenic stimulation, conductor breakage, or any other cardiovascular complication related to the cardiac implantable electronic device | at 12 months of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Implantable Electronic Devices, Heart, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Loop Recorders, Biventricular Pacemakers, Heart rhythm disorder
Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.

Conditions
-----------------
Drug Usage

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 Speak Arabic or English Exclusion Criteria: History of cervical surgery Known hypersensitivity to topical analgesics First trimester abortion or miscarriage in the previous six weeks Second trimester abortion or miscarriage in the previous 12 weeks

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine spray 10%<br> | Drug: Lidocaine<br> <br> |
| Placebo Comparator: Saline<br> | Drug: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score of Pain |  | 5 minutes from lidocaine spraying ( after application of tenaculum) |
Vitamin A for BPD Prevention

Study Overview
=================
Brief Summary
-----------------
Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.

Official Title
-----------------
Vitamin A Oral Supplementation as a Preventive Treatment for Chronic Lung Disease Among Infants Born Before 29 Weeks of Gestation.

Conditions
-----------------
The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Vitamin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature babies under 29 weeks, at any birth weight A preterm baby is less than 4 days to life Exclusion Criteria: Major congenital malformations Known chromosomal disorders

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 5 Days

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Dietary Supplement: Oral Vitamin A<br>* Oral administration of 5000 EU of Vitamin A during first 28 days of life<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of BPD at 28 days | Chronic pulmonary desease of prematue babies | 28 days of life | 
| Incidence of mortality at 28 days | Death before 28 days of life | 28 days of life |