linjc16/ctgov huggingface dataset:
Role of Activin A (ActA) in the Human Cancer Cachexia

Study Overview
=================
Brief Summary
-----------------
The goal of the investigators study is to investigate the role of a hormone named Activin A (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy gene program. To answer this question, the investigators plan first to compare circulating levels of ActA in cancer patients with and without cachexia. In a second step, the investigators would like to assess whether ActA circulating levels are predictive for the development of cachexia and short survival.

Official Title
-----------------
Role of Activin A (ActA) in the Human Cancer Cachexia

Conditions
-----------------
Colorectal Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Other: blood tests and muscular biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-year-old or older Colorectal or lung cancer demonstrated by histology or cytology New diagnosis or new recurrence Expected survival more than 3 months No previous history of other cancer in the last 5 years No pregnancy or lactation Signed informed consent Exclusion Criteria: Non-caucasian Major digestive malabsorption Major depression Artificial nutrition Height doses of steroids (>1 mg/kg hydrocortisone equivalent) Hyperthyroidism Other causes of malnutrition Expected survival less than 3 months Severely impaired walking Anticoagulants or antiplatelet therapy Disability or medical condition which might prevent the compliance to the protocol Any conditions which may prevent the compliance to the protocol Performance status ECOG > ou = 4 Participation to other clinical studies

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cachectic versus no cachectic patients<br>blood tests, muscular biopsies | Other: blood tests and muscular biopsies<br>* blood tests and muscular biopsies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating Activin A level |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary assessment measured by SNAQ score and 3-Day intake |  | 2 years | 
| Body mass index |  | 2 years | 
| Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference |  | 2 years | 
| Body composition measured by bioimpedance |  | 2 years | 
| Muscle strength as measured by grip strength |  | 2 years | 
| Quality of life as assessed using the QLQ-C30 |  | 2 years |
The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis

Study Overview
=================
Brief Summary
-----------------
Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive Periodontitis patients.

Conditions
-----------------
Aggressive Periodontitis

Intervention / Treatment
-----------------
* Procedure: orthodontic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with aggressive periodontitis in maintenance that had completed orthodontic treatment age 13-40 with full records of periodontal treatment with full records of orthodontic treatment Exclusion Criteria: smoking over 10 cigarets/day non controlled diabetes pregnancy alcohol consumption

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 40 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 |
| --- | --- |
| aggressive Periodontitis<br>Aggressive Periodontitis during maintenance | Procedure: orthodontic treatment<br>* Patients with Aggressive Periodontitis which are in the maintenance phase, had been treated for malocclusion.<br>|
| aggressive periodontitis<br>aggressive periodontitis patients during maintenance | Procedure: orthodontic treatment<br>* Patients with Aggressive Periodontitis which are in the maintenance phase, had been treated for malocclusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periodontal pocket depth |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAR index | index for measuring the stability of orthodontic treatment results. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aggressive periodontitis orthodontic stability
Union Rate of Transverse Tibia Fracture

Study Overview
=================
Brief Summary
-----------------
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.

Official Title
-----------------
Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking

Conditions
-----------------
Closed Transverse Fracture of Shaft of Tibia

Intervention / Treatment
-----------------
* Device: Conventional Compression
* Device: Standard Backslapping
* Device: Dynamic Locking with Backslapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Closed Tibia Shaft Fracture Treated with an IMN Exclusion Criteria: Unable to consent due to language Unlikely to follow-up for one year

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Compression<br>Nail will be seated using conventional compression technique | Device: Conventional Compression<br>* Method of Nail fitting<br>|
| Active Comparator: Standard Backslapping<br>Nail will be seated using standard backslapping technique | Device: Standard Backslapping<br>* Method of Nail fitting<br>|
| Active Comparator: Dynamic Locking with Backslapping<br>Nail will be seated using backslapping with dynamic locking | Device: Dynamic Locking with Backslapping<br>* Method of Nail fitting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of Tibia Fracture by radiographic exam | Healing of Tibia Fracture by radiographic exam | One Year |
Evaluation of Transperineal US in Stress Incontinence

Study Overview
=================
Brief Summary
-----------------
Stress urinary incontinence (SUI) has an observed prevalence of between 4%and 35%.Identified risk factors are aging, obesity and repeated pregnancies and deliveries. Urodynamic remains the gold standard for diagnosis in the past years. Trans labial ultrasound appears to have a good role in diagnosing stress incontinence

Detailed Description
-----------------
A comparative observational cross sectional study will be conducted . The symptom, or subjective indicator of disease, of SUI is described as the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing. 1 Stress urinary incontinence (SUI) has an observed prevalence of between 4% and 35%. It's a social problem that causes hygienic problem that s distressing for females. Urodynamic study is the gold standard for diagnosis of most types of urinary incontinence with some limitations as it's not done routinely in all cases of urinary incontinence according to the NICE guidelines 2 Translabial ultrasound is a simple, noninvasive, available, and reproducible method for qualitative and quantitative evaluation of the lower urinary tract in females.

Official Title
-----------------
Evaluation of Role of Transperineal US in Differentiating Degrees of Genuine Stress Incontinence in Females Diagnosed by Urodynamics

Conditions
-----------------
Stress Incontinence, Female

Intervention / Treatment
-----------------
* Diagnostic Test: Transperineal Ultrasound -


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females between 20-75 years old -Women diagnosed to have genuine stress urinary incontinence diagnosed by history taking, voiding diary and confirmed by urodynamic. Exclusion Criteria: -Known to be Diabetic Urge incontinence or mixed type Voiding dysfunction Neurological problems open suprapubic wound Previous surgery for POP(pelvic organ prolapse) or incontinence suspicion of pelvic malignancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transperineal Ultrasound -|Every women with stress incontinence witll be subjected to urodynamics to confirm genuine stress incontinence then will be subjected Transperineal US|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who will be properly diagnosed to have genuine stress incontinence To determine the role of transperineal ultrasound in diagnosing stress incontinence | the outcome describes how much the transperineal us have a power to diagnose stress incontinence in comparison to urodynamic study | within a week |
Drug Intervention in Chronic Fatigue Syndrome

Study Overview
=================
Brief Summary
-----------------
Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy. The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.

Official Title
-----------------
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.

Conditions
-----------------
Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: Saline (NaCl 0,9 %) (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: verified chronic fatigue syndrome (CDC-criteria) age >18 and <60 years informed consent Exclusion Criteria: pregnancy or lactation previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ previous long-term use of immunosuppressive drugs previous exposure to rituximab endogenous depression multi-allergy with risk of serious drug reaction reduced renal function (creatinin > 1.2 x UNL) reduced liver function (bilirubin or transaminases > 1.5 x UNL) known HIV infection signs of active viral infection by pretreatment investigations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: 1<br>Rituximab | Drug: Rituximab<br>* Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart<br>|
| Placebo Comparator: 2<br>Placebo (saline) | Drug: Saline (NaCl 0,9 %) (placebo)<br>* Two infusions of saline (NaCl 0,9 %) given two weeks apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. |  | 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes |  | 2, 4, 6, 8, 10, 12 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Fatigue Syndrome, CFS, Myalgic Encephalomyelitis, Rituximab, B-lymphocyte depletion, B-cell depletion
Treatment for HBV-MN Patients in Chinese: An Open Parallel Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Lamivudine treatment for HBV-DNA negative HBV-GN patients.

Detailed Description
-----------------
lamivudine and predinisone treatment for HBV-DNA negative HBV-GN patients.

Official Title
-----------------
an Open Parallel Clinical Trial in HBV-GN Patients

Conditions
-----------------
Proteinuria, HBVe-antigen

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult HBV-GN patients with biopsy-proven MN, heavy protinuria, HBsAg or HBeAg positive, HBV-DNA negative Exclusion Criteria: Primary MN patients, HBV-DNA positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| prednisone<br> | |
| prednisone and anti-virus<br> | |

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
-----------------
remission of proteinuria, HBVe-antigen
Diabetes Scorecard Educational Intervention Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.

Official Title
-----------------
Use of a Card to Improve Risk Factor Control in Patients With Type II Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Scorecard
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncontrolled Type II diabetes (HbA1c ≥ 8%) Exclusion Criteria: Type I Diabetes HbA1c < 8% Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier Pregnancy Planning to move within the next year

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scorecard<br>Score of points for variables. | Behavioral: Scorecard<br>* Points were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level.<br>Behavioral: Control<br>* Standard of care for diabetes subjects<br>|
| No Intervention: Control<br>Standard of care for diabetes subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total score | The total score was calculated by points assigned to variables (systolic blood pressure, diastolic blood pressure, HbA1c, aspirin usage and daily exercise). The maximal score of 100 corresponds to all variables at target. Fewer points were assigned to higher blood pressure, worse HbA1c levels, less exercise, etc. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol |  | 9 months | 
| HbA1c | Measure of glycemic control | 9 months |
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Study Overview
=================
Brief Summary
-----------------
This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.

Official Title
-----------------
TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Intravenous Treprostinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1) Exclusion Criteria: Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Treprostinil<br>Intravenous treprostinil was supplied as 1 mg/mL. | Drug: Intravenous Treprostinil<br>* Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.<br>* Other names: Remodulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD) | The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living. | The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit | 
| Effect of Long-term Remodulin Therapy on the NYHA Functional Classification | The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment). | The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remodulin, 6-Minute Walk Test
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.

Official Title
-----------------
A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection

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

Intervention / Treatment
-----------------
* Drug: Harvoni


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis Patients who are prescribed Harvoni Key Exclusion Criteria: None Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 |
| --- | --- |
| Harvoni<br>Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital. | Drug: Harvoni<br>* Harvoni (90/400 mg) FDC tablet administered orally once daily<br>* Other names: GS-5885/GS-7977;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reaction (ADR) under real world settings |  | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24) | SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 12 and 24 | 
| Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks |  | Approximately 12 weeks after treatment completion or discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C virus, observational, post-marketing, ledipasvir/sofosbuvir, Japan