linjc16/ctgov huggingface dataset:
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: DFD01 Spray
* Drug: Comp01 Lotion
* Drug: Vehicle Lotion
* Drug: Vehicle Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis. Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas. Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit Exclusion Criteria: Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis). Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters. History of psoriasis unresponsive to topical treatments. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

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 |
| --- | --- |
| Experimental: DFD01 Spray<br>DFD01 Spray twice daily for 28 days | Drug: DFD01 Spray<br> <br> * Other names: Topical corticosteroid spray;|
| Placebo Comparator: Vehicle Spray<br>Vehicle Spray twice daily for 28 days | Drug: Vehicle Spray<br> <br> |
| Active Comparator: Comp01 Lotion<br>Comp01 Lotion twice daily for 14 days | Drug: Comp01 Lotion<br> <br> * Other names: Topical corticosteroid lotion;|
| Placebo Comparator: Vehicle Lotion<br>Vehicle Lotion twice daily for 28 days | Drug: Vehicle Lotion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Success According to the Investigator Global Assessment (IGA) | IGA of clear or almost clear | Day 15 |
Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.

Official Title
-----------------
Effects of Leucine and Branched-chain Amino Acids (BCAA) Supplementation on Resistance Exercise-induced Muscle Damage and Inflammation: a Randomized, Double-blind, and Placebo-controlled Study

Conditions
-----------------
Muscle Damage, Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: BCAA
* Dietary Supplement: Leucine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary; No muscle disorders; Must be able to swallow tablets

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Exercise and BCAA<br> | Dietary Supplement: BCAA<br>* 7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days<br>|
| Experimental: Exercise and Leucine<br> | Dietary Supplement: Leucine<br>* 7 g of leucine + 7 g of alanine per day during 9 days<br>|
| Placebo Comparator: Exercise and Placebo<br> | Dietary Supplement: Placebo<br>* 14 g of alanine per day during 9 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle maximal strength |  | 4 days | 
| Muscle edema |  | 4 days | 
| Muscle soreness |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle inflammation | Immunohistochemistry, protein expression. | 4 days | 
| Muscle damage | Serum creatine kinase | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Branched-chain amino acids, Leucine, Muscle damage, Inflammation, supplementation, resistance exercise-induced
Dental Pain (Following Third Molar Tooth Extraction) Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.

Detailed Description
-----------------
A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg, and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Official Title
-----------------
A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects With Pain Following Third Molar Tooth Extraction

Conditions
-----------------
Dental Pain, Surgery, Dental

Intervention / Treatment
-----------------
* Drug: GW406381


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Scheduled for outpatient surgical removal of at least two third molar teeth. Exclusion criteria: Subjects who do not achieve moderate to severe pain. Subjects who do not use acceptable contraception. Additional medical criteria will be assessed by the investigator.

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

| Intervention/Treatment |
| --- |
|Drug: GW406381|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between treatments over time based on pain intensity and pain relief scores. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between treatments based on changes in onset, duration of activity, overall effectiveness, and patient based assessments. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cox-2 inhibitor, Dental Pain, Dental Surgery
Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk prostate cancer. The goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131. Patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI. The study is a phase II study. Patients will be followed prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every three months in year one and every six months from year two through year five. Urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.

Official Title
-----------------
Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Focal prostate brachytherapy with Cesium-131


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1c-T2aN0M0 Gleason score <= 3+3=6 prostate specific antigen (PSA) <10 ng/ml <= 2 cores positive out of a minimum of 12 cores sampled
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Brachytherapy, using Cesium 131
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focal Therapy<br> | Radiation: Focal prostate brachytherapy with Cesium-131<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical disease free survival |  | five years |
Physical Activity and Motor Memory in Pedal Dexterity

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study was to investigate if a six months period of physical exercise, could improve motor memory consolidation in elderly people on pedal dexterity

Detailed Description
-----------------
34 subjects of both genders, with a mean age of 71 years old participated in the study. Subjects were divided in two groups: a control group and an experimental one. Before the intervention of physical exercise program, subjects performed a Tapping Pedal Test to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.

Official Title
-----------------
Physical Activity and Motor Memory in Pedal Dexterity

Conditions
-----------------
Elderly

Intervention / Treatment
-----------------
* Other: Regular physical activity in Motor memory consolidation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals not engaged in physical activity; persons aged from 65 years. Exclusion Criteria: sensory abnormalities; mental abnormalities; motor abnormalities; other atypical health problems.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 73 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor memory consolidation<br>Subjects were divided in two groups: a control group and an experimental one. Before the intervention of physical exercise program, subjects performed a Tapping Pedal Test to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training. | Other: Regular physical activity in Motor memory consolidation<br>* After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training. For the analysis of the results, descriptive and inferential statistics were used.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects performed a Tapping Pedal Test to measure a performance in motor memory consolidation. | investigate if a six months period of physical exercise could improve motor memory consolidation in elderly people | 6 months |
Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.

Detailed Description
-----------------
Chronic acute liver failure (ACLF) is a systemic multi-organ failure driven by acute liver injury in the basis of chronic liver disease. The main cause of chronic acute liver failure in China is hepatitis b virus infection.Previous studies on the prognosis of acute on-chronic liver failure mainly focused on the short-term survival rate and the follow-up time was relatively short, while the study on the long-term prognosis of patients with spontaneous recovery of chronic acute liver failure was still lack-ing. Thus,this study mainly retrospectively analyzed the clinical data of patients with chronic hepatitis b related acute liver failure admitted to the department of infectious diseases, the third affiliated hospital of sun yat-sen university, and con-ducted telephone follow-up survey to analyze the long-term prognosis of patients with chronic hepatitis b related acute on-chronic liver failure.

Official Title
-----------------
The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure

Conditions
-----------------
Hepatitis B, Acute-On-Chronic Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 to 65 years old; The diagnosis consistent with hepatitis b associated chronic acute liver failure； After hospitalization, the survival time > 90 days； The inpatient clinical data are complete. Exclusion Criteria: Human immunodeficiency virus infection or congenital immune deficiency diseases; Liver cancer and other tumors, autoimmune liver disease, genetic and metabolic liver disease, or other serious diseases that significantly affect patient survival; Other conditions that the researchers judged not appropriate for inclusion.

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 |
| --- | --- |
| HBV-ACLF<br>To investigate the clinical events and prognosis of patients with hepatitis b associated acute on-chronic liver failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Adverse events included decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Acute-On-Chronic Liver Failure, Prognosis
Plasma Profile of Exclusively Breastfed Infants

Study Overview
=================
Brief Summary
-----------------
To characterize nutrient levels in breastfeeding infants and their mothers.

Detailed Description
-----------------
The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Official Title
-----------------
Plasma Profile of Exclusively Breastfed Infants

Conditions
-----------------
Breast Fed Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant is judged to be in good health. Infant is a singleton from a full term birth. Infant's birth weight was > 2490 g. Infant is between 6 weeks and 16 weeks (42 to 112 days). Infant must have been exclusively breastfed at enrollment. Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day. Mother is a non-smoker. Mother is in good health. Mother confirms her intention to continue breastfeeding. Exclusion Criteria: An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development. Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment. Infants who have consumed any solid or liquid foods or juices prior to enrollment. Infants who have received any supplements containing carotenoids prior to enrollment. Mother who is consuming dietary supplements containing carotenoids. Participation in another study that has not been approved as a concomitant study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 16 Weeks

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 |
| --- | --- | --- |
| Plasma carotenoids in breastfed infants |  | At visit 1 (enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma carotenoids in mothers of breastfed infants |  | At visit 1 (enrollment) | 
| Dietary carotenoid intake of mothers of breastfed infants |  | At visit 1 (enrollment) and visit 2 (14 days) | 
| Carotenoid levels in breastmilk |  | At visit 1 (enrollment) and visit 2 (14 days) |
Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.

Detailed Description
-----------------
Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria: The age of the selected children ranged from 3 To 6 years old. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program. Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.

Official Title
-----------------
Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Procedure: Core stability exercises program
* Procedure: Traditional physical therapy program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age of the selected children ranged from 3 To 6 years old. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987). Children with hemiparetic cerebral palsy Exclusion Criteria: 1. Fructures and fixed deformities

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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
Interventional Model Description: study group and control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Children in study group treated using core stability exercises program in addition to traditional program | Procedure: Core stability exercises program<br>* Strengthening to the trunk muscles<br>Procedure: Traditional physical therapy program<br>* Neurodevelopmental training excercises<br>|
| Active Comparator: control group<br>Children in the control group treated using traditional physical therapy program. | Procedure: Traditional physical therapy program<br>* Neurodevelopmental training excercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric reach test | Reaching score | assessment after 6 weeks of intervention |