linjc16/ctgov huggingface dataset:
Exploring Folk Health Practices in Latinos With Chronic Medical Conditions

Study Overview
=================
Brief Summary
-----------------
This study will explore how culture influences the use of folk healing practices and medical services in Latinos with chronic medical conditions.

Detailed Description
-----------------
Sociocultural aspects of using ethnomedical health practices in a community-based Latino population will be described using both qualitative and quantitative survey methods. This study will rely heavily on its descriptive section, which will use in-depth, open-ended questions in a semi-structured personal interview format following qualitative research principles. It will also use closed-ended questions in a short survey format to begin to explore some variables that may be associated with using traditional healing practices. These variables include level of acculturation, degree of family social support, degree of adherence to standard medical regimens, perceived health status, presence of depressive symptoms, and severity of co-illnesses. These variables will be examined using common, validated scales.

Official Title
-----------------
Exploring Folk Health Practices in Latinos With Chronic Medical Conditions

Conditions
-----------------
Asthma, Diabetes, Hypertension, Heart Disease, Stroke, Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be self-identified, adult men and women from the community setting. The sample comprise a convenience sample, including persons of Mexican, Puerto Rican, Cuban, Dominican, Central American, South American, or other Spanish speaking culture. Latino men and women over the age of 18 Those self-identifying as having at least one chronic medical condition including:diabetes, hypertension, asthma, history of heart disease or stroke or musculoskeletal disease (arthritis). Those reporting use of complementary or alternative therapies, including ethnomedical healing practices or practitioners. Those who speak English or Spanish. Exclusion Criteria: Individuals who refuse to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| A<br>Participants will be self-identified, adult Latino men and women from the community setting. The sample will comprise of a convenience sample from community-based organizations, including persons of Mexican, Puerto Rican, Cuban, Dominican, Central American, South American, or other Spanish-speaking culture. | |

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
-----------------
Latino patients, Health practices, Culture influences
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups. Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.

Official Title
-----------------
Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.

Conditions
-----------------
Hyperuricemia, Leukemia, Lymphoma

Intervention / Treatment
-----------------
* Drug: Rasburicase (SR29142)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from: acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or lymphoma,Stage ≥ III without regard to uric acid level; or lymphomas, Stage II with bulky disease; or lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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

| Intervention/Treatment |
| --- |
|Drug: Rasburicase (SR29142)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters and anti-SR29142 antibodies |  |  |
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether preload of carbohydrate or water before elective hip replacement improve insulin sensitivity and or beta cell function in human.

Official Title
-----------------
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery: A Randomised Doubled-blinded Control Study

Conditions
-----------------
Insulin Sensitivity

Intervention / Treatment
-----------------
* Dietary Supplement: Experimental: PreOp, NutriciaNordica AB
* Dietary Supplement: Placebo Comparator: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective hip replacement Exclusion Criteria: Known diabetes mellitus Kidney failure (creatinine clearance <40 ml/min Liver failure (aspartate and alanine aminotransferases x 2 above reference) Hb <110 g/l Ongoing severe bacterial or viral infection Malignancies Psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PreOp, NutriciaNordica AB<br>PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started. | Dietary Supplement: Experimental: PreOp, NutriciaNordica AB<br> <br> * Other names: PreOp, serial number 27 62 95, NutriciaNordica AB;|
| Placebo Comparator: Water<br>Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started. | Dietary Supplement: Placebo Comparator: Water<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insulin Sensitivity | Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp | Morning before surgery and up to two days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beta Cell Function | Beta cell function is measured with intravenous glucose tolerance test (IVGTT) | Morning before surgery and up to two days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin sensitivity, Beta cell function, Carbohydrate preload, Elective hip replacement, Double-blind randomized control study
Low-dose Digital Radiographs in the Idiopathic Scoliosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.

Detailed Description
-----------------
The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years). The young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique. The aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.

Official Title
-----------------
Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis

Conditions
-----------------
Idiopathic Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with suspected or known idiopathic scoliosis patients able to maintain orthostasis without medical devices patients from 9 to 20 years old Exclusion Criteria: patients with known congenital, syndromic, neurological scoliosis patients not able to maintain orthostasis obese patients low back pain or known tumor pathology patients with vertebral arthrodesis patients younger than 9 years old, or older than 20 years old

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 20 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 |
| --- | --- | --- |
| Repeatability and reproducibility | Repeatability and reproducibility of the Cobb angle measurement | baseline (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability and reproducibility | Repeatability and reproducibility of kyphosis angle, lordosis angle, lumbosacral angle, Nash-Moe rotation index and Risser index measurement | baseline (day 0) | 
| Radiation exposure | collection of dosimetric data | baseline (day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic scoliosis, radiographs, low dose
Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones

Study Overview
=================
Brief Summary
-----------------
Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT) scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate kidneys for suspected renal stones.

Detailed Description
-----------------
All patients aged 18 years of age and over who are undergoing a renal stone protocol for evaluation of flank pain will be included. Pregnant patients will not be included.

Official Title
-----------------
Evaluation of Twinkling Artifact Compared to Computed Tomography for Evaluation of Kidney Stones

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Other: CT Scan followed by ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, able to consent, flank pain Exclusion Criteria: Pregnant, unable to consent

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 |
| --- | --- |
| suspect kidney stones<br>Patients presenting with flank abdominal pain | Other: CT Scan followed by ultrasound<br>* A limited U/S is performed after the CT scan which is ordered by the Emergency Department physician.<br>* Other names: U/S - ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection of kidney stones on ultrasound compared to CT. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of hydronephrosis, a sign of obstruction of the urinary tract, will also be detected. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal calculi
Develop and Validate a Self-Administered Instrument That Will Screen for Eating Disorder Symptoms in Persons Aged 12 and Older With Type 1 Diabetes.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and validate a survey instrument to be used by persons with type 1 diabetes aged 12 and older to screen for an eating disorder.

Detailed Description
-----------------
Phase 1 - Develop an initial instrument and start to establish content validity. What do dually diagnosed patients believe are the most important, relevant, and significantly contributing constructs that we should measure in order to capture those individuals with type 1 diabetes who may exhibit symptoms of an eating disorder? What individual items will best measure these constructs? Phase 2 - Conduct individual interviews for cognitive testing of our instrument and further examine its content validity. How well do the individual items included in our instrument capture eating disorder symptoms in patients with type 1 diabetes? Do these items accurately capture the information we seek to collect? What symptoms have we not considered? How readable and understandable are our questions? Phase 3 - Explore the internal consistency reliability and construct validity of our instrument. Do the items in our instrument accurately capture the constructs we wish to measure? Do similar items hang together in a manner that is clinically and theoretically meaningful? Phase 4 - Address convergent and discriminant validity as well as test-retest reliability. Does our instrument demonstrate appropriate convergent and divergent validity as well as test-retest reliability? Does our instrument capture eating disorder symptoms among persons with diabetes? Is our instrument more specific to the population of individuals with diabetes than traditional eating disorder instruments (i.e., does our instrument capture more information and give a more accurate presentation than the other instruments)?

Official Title
-----------------
Development of an Instrument to Screen for Eating Disorder Symptoms in Persons With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes, Eating Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eating disorder type 1 diabetes Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns

Study Overview
=================
Brief Summary
-----------------
Parental approval to enroll their sick children in clinical research was studied. However, the motivation of parents to enroll healthy children and/or babies was not yet studied. The importance of clinical research among the healthy population is of extreme value. The aim of this study is to assess the motivation, medical trust and other factors influencing parents' decision to enroll their healthy baby in a clinical study.

Detailed Description
-----------------
Mothers to either healthy full-term babies post delivery or preterms will be asked to anonymously answer a questionnaire. The questionnaire includes demographic data, questions regarding their approach to medical issues, factors that influence her to enroll her baby in a research trial (different research types, different benefits from the research and fears). Finally, the mother will be asked if she will be willing to enroll her baby to on-going studies in the department.

Official Title
-----------------
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns

Conditions
-----------------
Parents Approval to Research

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers to healthy newborns during hospital stay after delivery, and mothers of preterm infants during their hospitalization in NICU. Exclusion Criteria: Mothers of sick newborns (respiratory distress, receiving IV infusion, etc.) who are in the special care for newborns.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parents, newborn, clinical trials
Effect of Feedback and Practice on Probabilistic Decision Making in Attention Deficit and Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how feedback and practice affect decision making in adolescents with attention deficit and hyperactivity disorder. Participants will have to choose between low and certain outcome and a higher but uncertain outcome, with or without serial feedback after each trial. Participants will perform the task twice to examine practice effects.

Official Title
-----------------
Effect of Feedback and Practice on Probabilistic Decision Making in Attention Deficit and Hyperactivity Disorder

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Behavioral: probabilistic choice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD Exclusion Criteria: Current major depression, Psychosis, Autism, Tourette syndrome

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control, no feeback<br>subjects without ADHD, probabilistic choices without feedback | Behavioral: probabilistic choice<br>* subjects should choose between low-certain outcome and high-uncertain outcome<br>|
| Active Comparator: control, feedback<br>subjects without ADHD, probabilistic choices with feedback | Behavioral: probabilistic choice<br>* subjects should choose between low-certain outcome and high-uncertain outcome<br>|
| Experimental: ADHD, no feedback<br>subjects with ADHD, probabilistic choices without feedback | Behavioral: probabilistic choice<br>* subjects should choose between low-certain outcome and high-uncertain outcome<br>|
| Experimental: adhd, feedback<br>subjects with ADHD, probabilistic choices with feedback | Behavioral: probabilistic choice<br>* subjects should choose between low-certain outcome and high-uncertain outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probabilistic choice | The number of risky outcomes a subject chose on a probabilistic choice paradigm | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, probabilistic, choice, feedback, practice
Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

Study Overview
=================
Brief Summary
-----------------
Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.

Detailed Description
-----------------
Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs. This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.

Official Title
-----------------
Zinc Therapy in Zinc Deficient HIV Positive Drug Users

Conditions
-----------------
HIV Infections, Substance-Related Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: zinc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected Drug User Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml Exclusion Criteria: Currently participating in an another clinical trial Blood selenium level less than 85 mcg/L Pregnant or intends to become pregnant

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 |
| --- | --- |
| Active Comparator: Zinc gluconate<br>Zinc supplementation | Dietary Supplement: zinc<br>* supplementation with zinc gluconate<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: zinc<br>* supplementation with zinc gluconate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune failure | CD4 cell count <200 cells/uL | For at least 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | AIDS related morbidity | For at least 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Naive, Treatment Experienced