linjc16/ctgov huggingface dataset:
Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.

Study Overview
=================
Brief Summary
-----------------
This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Official Title
-----------------
Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

Conditions
-----------------
Adhesion Prevention

Intervention / Treatment
-----------------
* Device: Sepraspray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old and over that require laparoscopic abdominal surgery Exclusion Criteria: Patients who are pregnant or have an ongoing infectious complications from a previous surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sepraspray<br>Receive Sepraspray | Device: Sepraspray<br>* Max. 10g of Sepraspray<br>|
| No Intervention: Control<br>No Treatment, No Placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 30 days |
Sentinel Surveillance of Malnutrition, Niger

Study Overview
=================
Brief Summary
-----------------
Malnutrition is a critical public health problem in developing countries. Malnutrition may be linked to more than one half of the deaths in children under 5 years old. In July 2001, after an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a nutritional program in Maradi, in the South of Niger. The introduction of ready to use therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the treatment of the majority of children at their homes using ambulatory treatment. Children with complicated cases were cared for in an inpatient center. With ambulatory treatment the number of children cared for in the MSF program reached close to 70000 in 2006. This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a preventative supplementary feeding program. The primary hypotheses were that short-term RUTF supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.

Official Title
-----------------
Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: PlumpyNut
* Dietary Supplement: PlumpyDoz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children resident in randomized villages 6-59 months Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: PlumpyNut|nan|
|Dietary Supplement: PlumpyDoz|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight-for-height in children 6 to 60 mo of age |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, ready to use food, Niger
Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies

Study Overview
=================
Brief Summary
-----------------
To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Detailed Description
-----------------
To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.

Official Title
-----------------
Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Persistent infection with mild hepatitis that is non-progressive.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV Antibody Library
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis of Restasis® benefits in dry eye contact lens patients.

Detailed Description
-----------------
Charts of contact lens wearers with diagnosed dry eye who are being treated with Restasis will be evaluated to determine success in treatment by retrospectively looking at various outcome measures including but not limited to schirmer, staining and osmolarity levels

Official Title
-----------------
A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients

Conditions
-----------------
Dry Eye Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, > or = 18 years of age Subject was previously diagnosed (prior to Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); or Subject was newly diagnosed (at Baseline Visit) with mild to severe dry eye disease (ITF level 1, 2 or 3) which required continuous medical therapy with Restasis® for a minimum duration of 6 months post-Baseline (Visit 1); Subject was prescribed Restasis® therapy at Baseline Visit (Visit 1) and commenced dosing immediately after Baseline Visit (Visit 1) Baseline Visit occured between 01 July 2012 and 01 January 2014; Subject had corneal staining and at least one dry eye sign (i.e., Schirmer's Test score <10 mm, decreased tear lake, TBUT <10 seconds, conjunctival staining, tear osmolarity >310 mOsmol/L Subject had charted tolerability and efficacy data reflecting at least one follow-up visit following Restasis® treatment initiation; and Subject wore contact lens(es) concurrently while receiving Restasis® treatment for a minimum duration of 6 months post-Baseline (Visit 1) Exclusion Criteria: -

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 |
| --- |
|Other: No Intervention|No drug is administered in this study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Schirmer's Test score |  | 6 months | 
| Increased contact lens wear time |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition

Study Overview
=================
Brief Summary
-----------------
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.

Detailed Description
-----------------
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck & Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.

Official Title
-----------------
A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co., Inc.,USA Under Fed Condition

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

Intervention / Treatment
-----------------
* Drug: Omeprazole
* Device: Prilosec® 40 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who provided written informed consent. Subjects who were healthy within 18-45 years of age, weighing at least 50 kg. Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg. Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I). Subjects with normal ECG, chest X-ray (PA view) and vital signs. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omeprazole<br>Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited | Drug: Omeprazole<br>* Omeprazole Delayed Release Capsules 40 mg<br>* Other names: Prelosec 40 mg;|
| Active Comparator: Prilosec<br>Prilosec® 40 mg Merck & Co. Inc | Device: Prilosec® 40 mg<br>* Prilosec® 40 mg<br>* Other names: Omeprazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on Cmax and AUC parameters |  | 4 months |
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.

Detailed Description
-----------------
The specific aims of the study are to: Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus. Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus. Determine the therapeutic time course of improvement in tinnitus. Determine the long-term improvement in tinnitus derived from TRT.

Official Title
-----------------
The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Behavioral: Tinnitus retraining therapy
* Device: Sound therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic non-pulsatile tinnitus Exclusion Criteria: Hyperacusis Subjective hearing loss Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL) Evidence of significant depression or suicidal ideation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tinnitus retraining therapy|Sound therapy and counseling|
|Device: Sound therapy|sound therapy and counselling|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective measure of tinnitus loudness using psychoacoustic matching task |  | 18 months | 
| Change in subjective handicap rating of tinnitus using a standardized questionnaire |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective ratings of tinnitus loudness, annoyance and awareness |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus
Genetic and Histopathologic Characteristics of Interstitial Cystitis

Study Overview
=================
Brief Summary
-----------------
Genetic and Histopathologic Characteristics of Interstitial Cystitis

Official Title
-----------------
Genetic and Histopathologic Characteristics of Interstitial Cystitis

Conditions
-----------------
Interstitial Cystitis

Intervention / Treatment
-----------------
* Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female aged 19 yrs or greater Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy Exclusion Criteria: Male and female under aged 20 yrs A person whose area of bladder cancer is larger than that of the normal area A person who is going to have a cystectomy after chemotherapy on bladder cancer

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Interstitial Cystitis<br> | Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue<br>* Obtain the bladder tissue of Interstitial Cystitis and normal during the operation<br>|
| normal<br> | Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue<br>* Obtain the bladder tissue of Interstitial Cystitis and normal during the operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis |  | 30days | 
| Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue |  | 30days |
The Effect of Maximum Body Weight in Lifetime on the Development of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Hypothesis : The maximum body weight in lifetime is associated with the onset of development of type 2 diabetes.

Detailed Description
-----------------
Obesity is well recognized risk factor for type 2 diabetes. Recent studies reported that weight change, especially severe weight gain was associated with an increased risk of type 2 diabetes. The aim of this study is to investigate whether the maximum body weight of lifetime is associated with the early onset of type 2 diabetes or an increased risk of type 2 diabetes in Korean.

Official Title
-----------------
Study of MAXimum Weight in Lifetime on Glucose Homeostasis (MAXWEL)

Conditions
-----------------
Diabetes, Prediabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean with type 2 diabetes Korean with confirmed IFG or IGT Korean with NGT Exclusion Criteria: Malignancy except thyroid cancer Active tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| type 2 diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of diabetes |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DM complication |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, prediabetes, impaired fasting glucose (IFG), impaired glucose tolerance (IGT), body weight
Characteristics of Critically Ill COVID 19 Patients

Study Overview
=================
Brief Summary
-----------------
COVID19 is n outbreak with unpredictable outcome

Official Title
-----------------
Clinical Characteristics and Outcome in Critically Ill COVID 19 Patients

Conditions
-----------------
COVID19

Intervention / Treatment
-----------------
* Other: COVID19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID 19 patients need oxygen therapy Exclusion Criteria: patients does not need oxygen therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: COVID19|viral infection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical characteristics | measurements of arterial blood gas | 48 hours |
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of progressive strength training after rotator cuff and labrum operation of the shoulder joint.

Official Title
-----------------
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture: Randomized Controlled Trial

Conditions
-----------------
Rotator Cuff Disease, Shoulder Joint

Intervention / Treatment
-----------------
* Behavioral: Progressive exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rupture of rotator cuff rupture of anterior labrum age 18 to 65 years motivated to continue in work life motivated for rehabilitation Exclusion Criteria: former operation in the same joint major arthrosis in the same joint cervical disk herniation concised spinal cord conditions after cervical spine operations rheumatic diseases fibromyalgia pregnancy severe depression alcoholism misusing of drugs disease that prevents progressive exercise eg. back pain, heart disease

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Behavioral: Progressive exercise<br>* home-based exercise program, 2 to 3 exercise sessions per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength and mobility |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder joint, recovery of function, effectiveness of rehabilitation, rehabilitation