linjc16/ctgov huggingface dataset:
Behavioral Therapy Development for Methamphetamine Abusers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is...to assess whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.

Official Title
-----------------
Behavioral Therapy Development for Methamphetamine Abuse

Conditions
-----------------
The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care Settings

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the UCLA CARE clinic, aged 18-65 Willing to give informed consent and comply with study procedures; Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications; Diagnosed with current methamphetamine abuse as determined by MINI; and Interested in seeking treatment for their methamphetamine abuse and in participating in this research project. Exclusion Criteria: Unwilling to give, or withdrawal of, informed consent; Inability to understand nature of study; A psychiatric condition that, in the principal investigator's judgment, warrants additional intervention to ensure participant safety (e.g., meets DSM-IV-TR criteria for current bipolar disorder or a psychotic disorder); Current suicidal ideation or suicide attempt within the past 3 months; and Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Medication compliance |  |  | 
| Addiction severity |  |  | 
| Psychiatric interview |  |  | 
| Sex-risk behavior |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  |  | 
| Quality of Life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavior Therapy, methamphetamine
Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF

Study Overview
=================
Brief Summary
-----------------
This is a monocentric, longitudinal, prospective, observational post-market follow-up study. 30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the cataract procedure, data collection will take place during visits planned by the physician as part of normal follow-up. Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria. The patient will be followed up after one day, one week, one month, six months, one year and three years post-op. An interim analysis will be performed with one-year clinical results. The main objective of the study is to evaluate is to evaluate efficacy and long-term safety for the InFo - Instant Focus © lens.

Official Title
-----------------
Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: InFo - Instant Focus (c) lens implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Suffering from cataract Physician has made the decision to implant on InFo - Instant Focus © lens Age ≥ 18 years, of either sex Having given written informed consent, prior to any procedure Non inclusion criteria: Presenting with an astigmatism of >1.00D Presenting contraindications for the implantation of an intraocular lens Presenting an ophthalmic disorder liable to interfere with study endpoints History of previous intraocular surgery in the study eye in the previous 6 months Refusing or unable to comply with the follow-up schedule Participation in other interventional therapeutic trial at time of inclusion Pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation

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: InFo - Instant Focus (c) lens implantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near best corrected visual acuity |  | Year 1 | 
| Intermediate (80cm) best corrected visual acuity |  | Year 1 | 
| Far best corrected visual acuity |  | Year 1 | 
| Near uncorrected visual acuity |  | Year 1 | 
| Intermediate (80cm) uncorrected visual acuity |  | Year 1 | 
| Far uncorrected visual acuity |  | Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast sensitivity |  | Year 1 | 
| Tilting sensitivity |  | Year 1 | 
| Decentration sensitivity |  | Year 1 | 
| Patient satisfaction | Questionnaire | Year 1 | 
| Adverse events | Including Posterior Capsule Opacification rates | Year 1 |
Effects of Naproxen on Physical Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.

Official Title
-----------------
Effects of Naproxen on Physical Performance

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

Intervention / Treatment
-----------------
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal to or greater than18 years of age No history of allergy or adverse reaction to any NSAID No use of any NSAID in past 2 weeks No history of peptic ulcer disease (PUD), gastroesophageal disease (GERD), or gastritis No major medical history including but not limited to diabetes, hypertension, asthma, kidney disease and coronary artery disease Currently not taking any medication including oral contraceptives Exclusion Criteria: Age < 18 years of age History of allergy or adverse reaction to any NSAID Use of any NSAID in past 2 weeks History of a bleeding disorder History of PUD, GERD, or gastritis Pregnant A medical history of diabetes, hypertension, asthma, kidney disease or coronary artery disease Taking any medication including oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on physical performance in terms of maximum oxygen consumption |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physically fit volunteers
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to treat children with severe, moderate, resistant or relapsing C. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data will be collected throughout the FMT procedure to determine effectiveness and to help standardize this procedure. Stool samples will be collected to look at the different bacteria that are in the intestines before and after FMT.

Official Title
-----------------
Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)

Conditions
-----------------
Clostridium Difficile Infection

Intervention / Treatment
-----------------
* Other: Fecal microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Recipient Inclusion Criteria Older than 18 months of age FMT procedure has been decided by the treating gastroenterologist and was based on: Recurrent or relapsing CDI and: Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for <18years and insurance authorization may not be possible). At least 2 episodes of CDI requiring hospitalization Moderate CDI not responding to vancomycin for at least a week. Severe CDI with no response to vancomycin after 4 hours. English speaking Recipient Exclusion Criteria Lack of informed consent/assent. Not eligible for FMT procedure

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatrics, C. Diff.<br>Fecal Microbiota Transplantation in children with c. difficile infection | Other: Fecal microbiota<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT) |  | 3 years |
Management of Albuminuria in Hypertensive Diabetics

Study Overview
=================
Brief Summary
-----------------
Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.

Official Title
-----------------
A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice

Conditions
-----------------
Microalbuminuria, Hypertension, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years and older and able to visit the study sites every 3 months T2D patients with ongoing anti-diabetic therapy for at least 5 years Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP> 130/80 mmHg) Able and agreeing to provide informed consent. Exclusion Criteria: Type 1 diabetes patients Ongoing therapy with perindopril, Known hypersensitivity or allergies to ACEI or sulfonamide derivatives, A history of angioedema related or not to previous treatment with ACEI, Impaired renal function defined as serum creatinine levels > 177 µmol/L, eGFR <30 mL/min, Hyperkalemia or hypokalemia, Severe hepatic impairment, Use of non-antiarrhythmic agents causing torsade de pointes, Pregnant or lactating women, or who are planning to become pregnant, Any conditions which may impact on participation according to treating physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Stabilisation or improvement of urine albumin excretion status by at least one stage |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microalbuminuria (or further stages of CKD) after 12 months |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microalbuminuria, Hypertensive, Diabetics, urine albumin
Ankle Instability Treatment in Patients With Chronic Ankle Instability

Study Overview
=================
Brief Summary
-----------------
Ankle joint self mobilization.

Detailed Description
-----------------
The intervention would consist in the administration of self mobilization with movement techniques in patients with chronic ankle instability in addition to an exercise program

Official Title
-----------------
Mobilization With Movement Treatment in Patients With Chronic Ankle Instability

Conditions
-----------------
Ankle Injuries

Intervention / Treatment
-----------------
* Other: mobilization with movement techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ankle range of motion limitation respect the contralateral ankle. At least two episodes of giving way on the affected ankle. Scores of at least 24 in the cumberland ankle instability tool. Exclusion Criteria: recent fractures of the involved limb. Vestibular or balance dysfunction. Acute ankle sprain.

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
Interventional Model Description: randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobilization group<br>this group will receive mobilization with movement techniques. | Other: mobilization with movement techniques<br>* patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion<br>* Other names: Joint mobilizations;|
| No Intervention: Control group<br>The control group will receive no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion | the ankle range of motion will be measured by goniometry. | from baseline prior to the beginning of the intervention to the completion of the study at four weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dynamic balance | Dynamic balance will be determined by the star excursion balance test | from baseline prior to the beginning of the intervention to the completion of the study at four weeks. | 
| Self reported instability | Self reported instability will be assessed by the Cumberland ankle instability tool | from baseline prior to the beginning of the intervention to the completion of the study at four weeks. |
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Study Overview
=================
Brief Summary
-----------------
Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells through intrahepatic arterial catheterization.

Detailed Description
-----------------
The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will undergo intrahepatic arterial administration of autologous adipose tissue derived stromal cells through catheter.

Official Title
-----------------
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Biological: adipose tissue derived stromal cells dosage


Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria defined in the implementation protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: adipose tissue derived stromal cells<br> | Biological: adipose tissue derived stromal cells dosage<br>* single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause harmful events |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Cirrhosis
Effect of Acute Exercise on Exosome Associated Biomarkers

Study Overview
=================
Brief Summary
-----------------
This research study is being done to understand the underlying mechanism by which exercise affects the body on the cellular level, in an acute aerobic endurance setting. This may help to better understand the overall benefits of endurance exercise.

Official Title
-----------------
Effect of Acute Exercise on Exosome Associated Biomarkers

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages: 18 to 45 years Exclusion Criteria: BMI >32 kg/m2. Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease. Orthopedic problems that would keep them from being able to perform an exercise. - -- Medications that are known to affect mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta-blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist). Smoking. Pregnancy.

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

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 |
| --- | --- | --- |
| List of biomarkers | Exosome proteomes and MiRNA from blood samples | Baseline |
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.

Detailed Description
-----------------
butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.

Official Title
-----------------
Butyrate Therapy in Hispanic Children With Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Butyrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7-21 years, mild to moderate ulcerative colitis Exclusion Criteria: UC therapy within 4 weeks of study medication initiation infectious colitis, -pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 21 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: open label intervention arm<br>Butyrate enemas will be administered once daily for twelve weeks. | Drug: Butyrate<br>* Butyrate enemas will be administered once a day for 12 weeks<br>* Other names: Butyrate enemas;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission of clinical disease | pediatric ulcerative colitis activity index, remission is <10, mild disease 10-34, moderate 35-64, severe 65 or greater | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of inflammatory markers including ESR, CRP, Calprotectin | normalization or at least improvement of inflammatory markers described above | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulcerative colitis