linjc16/ctgov huggingface dataset:
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the effects of adding supervised exercise in supplement to an educational self-management program, and to determine which subgroups would gain effects of the treatment.

Detailed Description
-----------------
164 patients with fibromyalgia and chronic widespread pain were randomized to an exercise-education group or to education-only group. The study period was 20 week. The primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact Questionnaire. Several other self-administered instruments were included.

Official Title
-----------------
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Behavioral: Exercise and education
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with Fibromyalgia or Chronic widespread pain, aged from 18 to 60 years. Exclusion Criteria: Other somatic or psychiatric disorders, inability to understand Swedish, allergy to chlorine, ongoing treatments or plans to start other treatments during the study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: 1<br>Exercise and education | Behavioral: Exercise and education<br> <br> |
| Active Comparator: 2<br>Education only | Behavioral: Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body function (he six-minute walk test) and health status (the Fibromyalgia Impact Questionnaire) |  | 2004-2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-administered questionnaires assessing distress, stress, quality of life, physical activity, fatigue |  | 2004-2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, chronic pain, physical, exercise, activity, education
Asthma in the Delta Region of Arkansas (ADRA): Prevalence and Morbidity

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence and morbidity in a predominately minority, low-income population in rural Arkansas.

Detailed Description
-----------------
Asthma is the leading chronic disease of childhood in the United States and an important public health concern in Arkansas. Arkansas, a predominately rural state, has one of the leading mortality rates in the nation for African Americans. The specific aims of the study will examine asthma prevalence in children age 4-17 years old in public schools in Eudora and Marvell Arkansas. The study will also examine asthma morbidity among identified asthmatics by characterizing activity limitation, days missed from school, daytime and nocturnal symptoms, healthcare utilization and medication use. The specific aims of the current study will provide novel data on an understudied population of asthmatics and will test our working hypotheses that pediatric asthma prevalence in the Delta region of Arkansas is higher than national estimates; and asthma diagnosis is related to significant morbidity among rural asthmatics.

Official Title
-----------------
Asthma in the Delta Region of Arkansas (ADRA): Prevalence and Morbidity

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 4-17 years, enrolled in the public schools in Eudora and Marvell Arkansas. Exclusion Criteria: Children aged 18 or older enrolled in the public schools in Eudora and Marvell Arkansas were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2000,3000,4000<br>Children at risk for asthma were identified using a cross-sectional asthma screening survey. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The findings suggest that asthma diagnosis and active symptoms are prevalent among this predominately minority and low-income rural population in the Arkansas region of the Mississippi Delta. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High rates of inadequately controlled asthma are evidenced by activity limitation, medication use and increased healthcare utilization. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma; minority; low-income; African American; Arkansas
R(+)PPX High Dose Treatment of ALS

Study Overview
=================
Brief Summary
-----------------
R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.

Official Title
-----------------
Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: R(+) pramipexole dihydrochloride monohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: definite ALS no prior exposure to R(+)PPX Exclusion Criteria: ALSFRS at baseline <40 FVC at baseline <70%

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients with early ALS | Drug: R(+) pramipexole dihydrochloride monohydrate<br>* 100 mg tid orally daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decline in ALSFRS score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma PPX levels |  | 6 months | 
| CSF PPX levels |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroprotection, oxidative stress
Navigated Abdominal Lymph Node Dissections

Study Overview
=================
Brief Summary
-----------------
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. In this study we will randomize patients which will undergo an abdominal lymph node dissection in order to evaluate the actual technical and clinical benefit of navigation

Detailed Description
-----------------
In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.

Official Title
-----------------
Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)

Conditions
-----------------
Image-guide Surgery, Lymph Node Metastasis

Intervention / Treatment
-----------------
* Procedure: Surgical navigation
* Procedure: Conventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan Exclusion Criteria: Metal implants in the pelvic area Contra-indication for contrast enhanced CT scanning

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation<br>Patients will get the standard of care in the Netherlands with the addition of surgical navigation | Procedure: Surgical navigation<br>* Patients will be operated with assistance of a navigation system<br>|
| Other: Conventional<br>Patients will get the standard of care in the Netherlands | Procedure: Conventional<br>* Patients will be operated using the conventional technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of failed procedures | Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time to remove lymph node | time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time, | After surgery | 
| LN success | individual LN retrieval rate | 3 months |
Biochemical Alterations of Stored Erythrocyte Membranes

Study Overview
=================
Brief Summary
-----------------
The investigators will define procoagulant properties of packed red blood cells and investigate whether packed red blood cells from certain donor populations are prone to induce procoagulant states.

Official Title
-----------------
Biochemical Alterations of Stored Erythrocyte Membranes

Conditions
-----------------
Coagulation

Intervention / Treatment
-----------------
* Other: protein expression pattern of packed red blood cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group 1: healthy female volunteers 18-35 y.o. group 2: healthy male volunteers 18-35 y.o. group 3: healthy female volunteers 36-60 y.o. group 4: healthy male volunteers 36-60 y.o. group 5: female volunteers 36-60 y.o., BMI 26-45 group 6: male volunteers 36-60 y.o., BMI 26-45 Exclusion Criteria: age below 18 years age above 60 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy young female<br> | Other: protein expression pattern of packed red blood cells<br>* the proteome of packed red blood cells will be assessed at predefined time points<br>|
| healthy young male<br> | Other: protein expression pattern of packed red blood cells<br>* the proteome of packed red blood cells will be assessed at predefined time points<br>|
| healthy older female<br> | Other: protein expression pattern of packed red blood cells<br>* the proteome of packed red blood cells will be assessed at predefined time points<br>|
| healthy older male<br> | Other: protein expression pattern of packed red blood cells<br>* the proteome of packed red blood cells will be assessed at predefined time points<br>|
| obese older female<br> | Other: protein expression pattern of packed red blood cells<br>* the proteome of packed red blood cells will be assessed at predefined time points<br>|
| obese older male<br> | Other: protein expression pattern of packed red blood cells<br>* the proteome of packed red blood cells will be assessed at predefined time points<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protein expression pattern |  | week 0 | 
| protein expression pattern |  | week 2 | 
| protein expression pattern |  | week 4 | 
| protein expression pattern |  | week 6 |
A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

Study Overview
=================
Brief Summary
-----------------
This study evaluates patients infected with both HIV and Hepatitis C virus (HCV) who are receiving anti-HIV drugs. The purpose of this study is to learn more about HCV infection in patients whose HIV blood level decreases to less than 500 copies/ml.

Detailed Description
-----------------
Sixty naive patients with HIV and confirmed hepatitis C who are co-enrolled in another AACTG antiretroviral study that involves the testing of HAART (Highly Active Antiretroviral Therapy) are entered on this prospective study. Patients who are defined as naive have never received specific, active antiretroviral agents that sustain viral suppression below the limit of detection (500 copies/ml) or have received those agents for only a very limited time. HAART is defined as therapy which is likely to result in HIV-1 RNA plasma levels less than 500 copies/ml for at least 16 weeks. Plasma is collected and evaluated during the study for additional quantitative measurements: Hepatitis C virus (HCV) by HCV RNA PCR and HIV-1 RNA levels. All evaluations for HIV-1 RNA are obtained from the co-enrolled study at the following time points: Pre-entry, entry, at least 2 measurements before Week 16, Week 16, and at least 1 measurement after Week 16.

Official Title
-----------------
Dynamics of Hepatitis C Infection in Subjects With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Receiving Highly Active Antiretroviral Therapy (HAART)

Conditions
-----------------
HIV Infections, Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive and have Hepatitis C. Have an HIV blood level of at least 2,500 copies/ml 30 days before study entry. Are co-enrolled in an active adult AIDS clinical trial using anti-HIV treatment. Are at least 13 years of age (parent or guardian consent required if under 18). Exclusion Criteria Patients will not be eligible for this study if they: Have liver disease. Have cancer requiring chemotherapy. Have Hepatitis B. Abuse alcohol and/or drugs. Have received certain antiretroviral (anti-HIV) drugs in the past.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, Drug Therapy, Combination, Hepatitis C, RNA, Viral, Anti-HIV Agents
Cardiometabolic Care-team Integration Improves Outcomes in Diabetes

Study Overview
=================
Brief Summary
-----------------
A pragmatic, quasi-experimental (non-randomized) design was used to evaluate clinical and cost outcomes among patients with type 1 or 2 diabetes (T1D or T2D) at two primary care clinics (n=1 intervention, n=1 usual care) between March 2012 and September 2014. At the intervention clinic, the 12-month Cardio-metabolic Care-Team Intervention (CMC-TI) was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months, and a process evaluation gauged CMC-TI feasibility and satisfaction.

Official Title
-----------------
Cardiometabolic Care-team Integration in Primary Care Improves Outcomes in Diabetes: a Pragmatic, Case-controlled Study

Conditions
-----------------
Cardio-metabolic Care-Team Intervention (CMC-TI)

Intervention / Treatment
-----------------
* Behavioral: Cardometabolic Team Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with type 1 and type 2 diabetes Exclusion Criteria: None

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 |
| --- | --- |
| CMC-TI<br>Cardiometabolic Care Team Intervention | Behavioral: Cardometabolic Team Intervention<br>* The CMC-TI team included a registered nurse/certified diabetes educator (RN/CDE) Care Manager, medical assistant (MA) Health Coach, and RN Depression Care Manager. Decision support tools guided therapy for glucose, BP, low-density lipoprotein cholesterol (LDL-c), and depression. At the intervention clinic, the 12-month CMC-TI was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months.<br>|
| Non-Intervention Comparator site<br>Non intervention comparator site with usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c between Intervention and Comparator sites | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital/ER costs |  | 12 months | 
| LDL | Change in LDL between Intervention and Comparator sites | 12 months | 
| Blood pressure | Change in blood pressure between Intervention and Comparator sites | 12 months |
Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine the effects of fatty fish and white (lean) fish on cardiovascular disease risk factor levels in subjects with established coronary heart disease using multiple medications. The main end points are blood pressure, serum lipids, inflammatory markers, arrhythmias and gene expression in peripheral mononuclear cells. The study design was a controlled, parallel study lasting 8 weeks with three diet groups: fatty fish, white fish and control group (lean pork, beef or chicken).

Official Title
-----------------
Effects of Fatty and Lean Fish Intake on Cardiovascular Risk Factors in Subjects With Coronary Heart Disease

Conditions
-----------------
Blood Pressure, Arrhythmia, Inflammation

Intervention / Treatment
-----------------
* Other: Dietary intervention
* Other: Dietary intervention
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: myocardial infarction or unstable ischemic attack use of beta blockers normal sinus rhythm fasting serum triglyceride less or equal to 3.5 mmol/l fasting serum cholesterol less or equal to 8 mmol/l BMI 18.5-30 kg/m2 fasting plasma glucose less or equal to 7 mmol/l Exclusion Criteria: diabetes use of other antiarrhythmic medications than beta blockers atrial fibrillation use of psychotropic medications abnormal liver, thyroid or kidney function inflammatory bowel disease excessive use of alcohol use of fish oil supplements or high habitual intake of fish

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Fatty fish<br> | Other: Dietary intervention<br>* Fatty fish at least 4 meals per week.<br>|
| Experimental: Lean Fish<br> | Other: Dietary intervention<br>* Lean fish at least 4 meals per week.<br>|
| Placebo Comparator: Control diet<br> | Other: Dietary intervention<br>* Control diet with lean meat and chicken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression in peripheral mononuclear blood cells, risk of arrhythmias, serum lipids and blood pressure |  | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers |  | 8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary heart disease