linjc16/ctgov huggingface dataset:
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Blunt Soft Tissue Injuries/Contusions of the Limbs

Conditions
-----------------
Acute Blunt Soft Tissue Injuries/Contusions

Intervention / Treatment
-----------------
* Drug: Diclofenac sodium
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years and over. Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours. Exclusion Criteria: Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.

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: Diclofenac sodium topical gel 1%<br> | Drug: Diclofenac sodium<br>* Topical gel 1%- 4 times daily<br>|
| Placebo Comparator: placebo<br> | Other: Placebo<br>* Topical gel - 4 times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement | Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain | VAS Score at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Pain Relief | Onset of perceptible pain relief. | From randomization to end of day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blunt soft tissue injury/contusion
Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developmental function, or slowing neurological or developmental deterioration in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, cross over study. Patients are randomized to start with one of two different doses of sodium dichloroacetate (DCA). Patients receive one of two doses of oral DCA for 6 months, then switch to the alternate dose for 6 months. This course is repeated once. Patients are followed for up to 2 years. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Lactic Acidosis

Intervention / Treatment
-----------------
* Drug: sodium dichloroacetate


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of stable, persistent lactic acidemia Venous lactate at least 3 mM under basal conditions defined as: At least 4 hours postprandial No concurrent illness OR Diagnosis of cerebral lactic acidemia with elevated lactic acid in CSF but not in the blood No organic acidemias or defective gluconeogenesis --Patient Characteristics-- Hematopoietic: Hemoglobin at least 7 mg/dL Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST, ALT, or GGT no greater than 10 times ULN Renal: Creatinine no greater than 2 mg/dL Cardiovascular: Ejection fraction at least 25% Other: No hypoglycemia (blood sugar less than 50 mg/dL at no greater than 12 hours fasting) No severe peripheral neuropathy interfering with normal activities of living

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sodium dichloroacetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inborn errors of metabolism, lactic acidosis, rare disease
Relationships Between Toddlers With Feeding Disorder and SPD and Their Parents

Study Overview
=================
Brief Summary
-----------------
The researched attends to observe the relationships between toddlers that were diagnosed as SPD and as having feeding disorder (by DSM-R-IV)and their parents.

Official Title
-----------------
The System of Relationships Between Parents and Their Toddlers, With Eating Disorders and Sensory Processing Disorders Within Meal and Play Situations

Conditions
-----------------
Feeding and Eating Disorders of Childhood, Developmental Disabilities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Toddlers aged between one year to two and a half years Toddlers diagnosed as SPD by occupational therapist Toddlers diagnosed as having feeding disorder by psychiatric physician according to DSM-R-IV Toddlers that are normally developed as reported by pediatrician Exclusion Criteria: Compliant families Toddlers with poor health

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 30 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Families with toddlers that having feeding disorders and SPD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toddlers that having feeding disorders and SPD
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

Study Overview
=================
Brief Summary
-----------------
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

Official Title
-----------------
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

Conditions
-----------------
Scoliosis Idiopathic

Intervention / Treatment
-----------------
* Device: scoliosis brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray Exclusion Criteria: Patients who underwent spinal surgery Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities Patients observed with Cobb's angle less than 20 degrees, over 45 degrees Patients complaining of acute low back pain Patients with cognitive impairment, severe mental illness, and inability to communicate

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: scoliosis patients<br>scoliosis patients who have cobb angle over 20 degree wear scoliosis brace for six months | Device: scoliosis brace<br>* Wear at least 18 hours a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cobb angle | measure lateral curve of vertebra on spine x-ray AP view | through study completion, an average of 6 months |
Impact of COVID-19 Infection During Pregnancy

Study Overview
=================
Brief Summary
-----------------
To asses impact of the COVID-19 infection during Pregnancy on maternal and fetal outcome in relation to gestational age.

Detailed Description
-----------------
COVID-19, caused by SARS-COV-2, was first reported in the city of Wuhan, Hubei province, China, at the end of December 2019. The exact origin of human infection has not yet been clearly identified.SARS-CoV-2 is a member of the Coronavirus family, and other pathogens from this family have inflicted a range of viral infections, including Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The incubation period varies from 2 days to 2 weeks following exposure to the virus.The global pandemic caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2) has been growing at an accelerating rate. The increasing mortality rate warrants identification and protection of the vulnerable populations in society.It is well known that pregnancy-related immune suppression makes mothers more vulnerable than non-pregnant women to several viral infections, including SARS-COV, hepatitis E virus, influenza, and herpes simplex virus. Furthermore, changes in pulmonary function during pregnancy, including decreased total lung capacity and functional residual capacity, may cause susceptibility to viral pneumonia. Data on clinical outcomes of pregnant women suffering from COVID-19 are therefore relatively scarce. Recently a meta-analysis of 13 publications reported preterm births, neonatal pneumonia, and respiratory distress syndrome in infants born of COVID-19-positive mothers. The rates of cesarean deliveries and adverse pregnancy outcomes were substantially higher

Official Title
-----------------
Impact of COVID-19 Infection During Pregnancy on Maternal and Fetal Outcome

Conditions
-----------------
Covid-19 in Pregnancy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All medical records of the pregnant women admitted to EL Bagour Quarantine hospital, Menoufia governorate due to SARS-CoV-2 infection, as confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens. Exclusion Criteria: Patients who had equivocal or negative testing results were excluded from the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Studying impact of COVID-19 on pregnancy | understanding of the impact of COVID-19 on pregnancy will provide critical data about the course of the disease in pregnant women and their infants . | baseline |
Hemodynamic Performance in Stentless Heart Valves

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters. The study will investigate turbulence, flow and aortic root movement in a stentless bioprosthesis and compare it to a stented bioprosthesis.

Official Title
-----------------
Hemodynamic Performance in Stentless Heart Valves

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Device: biological heart valve prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 65 years old Submitted for aortic valve surgery No coronary surgery other than LIMA to LAD Exclusion Criteria: Stentless valve implantation not possible Contraindications for MRI scan

Ages Eligible for Study
-----------------
Minimum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Valve design 1 | Device: biological heart valve prosthesis<br>* Two heart valve designs<br>|
| Active Comparator: 2<br>Valve design 2 | Device: biological heart valve prosthesis<br>* Two heart valve designs<br>|
| No Intervention: Control<br>Healthy control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| turbulence |  | jan 2010 | 
| flow dynamics |  | jan 2010 | 
| aortic root dynamics |  | jan 2010 | 
| Effective orifice area |  | 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stentless, Biological, aortic, heart, valve, prosthesis, artificial
Pharmacotherapy for Schizophrenic Drug Users - 6

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate maintenance neuroleptics for Schizophrenic patients who are cocaine abusers.

Official Title
-----------------
Pharmacotherapy for Schizophrenic Drug Users

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders, Shcizophrenia

Intervention / Treatment
-----------------
* Behavioral: Amantadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Amantadine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Psychological symptoms |  |  | 
| Schizophrenic symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti psychotic agents
The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.

Official Title
-----------------
The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women

Conditions
-----------------
Diabetes, Cardiovascular Risk

Intervention / Treatment
-----------------
* Dietary Supplement: soy protein
* Dietary Supplement: isoflavones
* Dietary Supplement: milk protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes Exclusion Criteria: Women with breast, ovary or other cancers in recent 5-year Severe renal or liver dysfunction Women with androgen excess Smokers Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.

Ages Eligible for Study
-----------------
Minimum Age: 46 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: soy protein and isoflavones<br> | Dietary Supplement: soy protein<br> <br> Dietary Supplement: isoflavones<br> <br> |
| Experimental: milk protein and isoflavones<br> | Dietary Supplement: isoflavones<br> <br> Dietary Supplement: milk protein<br> <br> |
| Placebo Comparator: milk protein only<br> | Dietary Supplement: milk protein<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Ovarian Reserve on Sexual Satisfaction

Study Overview
=================
Brief Summary
-----------------
This is a survey study. The primary aim of the study is to investigate the relationship between the ovarian reserve and sexual satisfaction. All the patients who underwent ovarian reserve assessment for any reason will fill a questionnaire about sexual satisfaction. And the survey results will be compared with patients' ovarian reserve.

Official Title
-----------------
Effects of Ovarian Reserve on Sexual Satisfaction

Conditions
-----------------
Sex Behavior, Ovarian Failure

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who admitted to the gynecology clinic for any reason Patients with ovarian reserve tests 18-45 years Exclusion Criteria: Mental disorders Anatomic genital malformations Patient' Decline to fill the survey Presence of malignancy Without any sexual activity

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Survey Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Group<br>All patients will be enrolled in one arm | Behavioral: Survey<br>* Patients will fill a questionary with 8 questions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Satisfaction Score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Reserve, Sexual Satisfaction
The Role of Routine Bacterial Culture Including Tuberculosis During Bronchoscopy: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined.

Detailed Description
-----------------
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined. Unnecessary bronchial cultures of bacteria may lead to over treatment in patients without clinical evidence of infections and may increase the drug resistant strains. In areas with a high prevalence of TB, routine bronchial cultures may detect clinically unsuspected TB in an appreciable proportion of cases. However, in population with a low prevalence of TB, routine culture of bronchial aspirates may incur an unnecessary expanse and may lead to over diagnosis and over treatment of patients with non pathogenic atypical mycobacteria detected by acid-fast bacillus strains.

Official Title
-----------------
The Role of Routine Bacterial Culture Including Tuberculosis During

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who will undergo a bronchoscopy examination at pulmonary department in Meir Medical Center patients who will sign on informed consent. - Exclusion Criteria: 1)age under 18 years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bronchoscopy patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of positive tuberculosis culture |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, culture, bronchoscopy