linjc16/ctgov huggingface dataset:
The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of two different types of health education programs on the disability, beliefs related to low back pain and duration of sick leave in patients seen at a workers' health care organization

Official Title
-----------------
Study of the Effect of Two Short Education Programs for the Treatment of Nonspecific Low Back Pain in Patients Seen at a Workers' Health Care Organization

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Classic back pain prevention education, and cognitive behavioral management.
* Behavioral: General health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low back pain patients, with or without referred or radiated pain no systemic disease or criteria for referral to surgery Exclusion Criteria: inability to fill out the questionnaires and scales bedridden rheumatologic inflammatory disease, cancer or fibromyalgia suspicion of fibromyalgia spinal fracture

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Classic back pain prevention education, and cognitive behavioral management.|Classic education: postural hygiene, Back Guide. Cognitive behavioral management: active management, Back Book.|
|Behavioral: General health education|General health education: a booklet describing general norms for maintaining good health|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A reduction in low back pain related disability and sick leave. |  | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A reduction in catastrophizing beliefs related to low back pain. |  | 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nonspecific low back pain, disability, sick leave, catastrophizing, workers
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients. The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively. Pruritus score and satisfaction will be monitor along the entire course of cast retention.

Official Title
-----------------
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial

Conditions
-----------------
Fracture Distal Radius

Intervention / Treatment
-----------------
* Drug: Baby talcum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fracture distal end radius treated conservatively Exclusion Criteria: open fracture skin disease and wound under cast area Fracture distal end radius needed surgical management Allergy to baby talcum

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No application of baby talcum<br>control | Drug: Baby talcum<br>* 50 grams apply locally prior cast application<br>* Other names: Care brand of baby talcum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus score |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction score |  | 2 years | 
| Complication rate |  | 2 years | 
| Number of antihistamine drugs used |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
baby talcum, pruritus, cast
ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)

Study Overview
=================
Brief Summary
-----------------
The ELECtrode configuraTION CRT Study (ELECTION)

Detailed Description
-----------------
Cardiac resynchronization therapy (CRT) is an accepted treatment for selected heart failure patients. This therapy is delivered using a device (pacemaker (PM) +/- defibrillator (ICD) ) and leads placed in the right atrium (RA), right ventricle (RV) and left ventricle (LV). Rates of LV lead implantation failure and post operative lead related have decreased dramatically over the years, however, the incidence of lead dislodgement and phrenic nerve stimulation is still high. This study is a prospective evaluation of the benefits of having various pace/sense electrode configurations available in a CRT system.

Official Title
-----------------
The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients selected for a Guidant system, symptomatic heart failure, LV dysfunction, QRS width > 120 ms, > or = 18 yrs, able to understand the procedure, available for follow-up. Exclusion Criteria: < 18 years, life expectancy < 6 months, expectation of heart transplantation during the study period, patients who have or are likely to receive a mechanical tricuspid valve, documented aortic stenosis, hypertrophic obstructive cardiomyopathy, inability or refusal to complete the follow-up at an approved centre, enrollment in another cardiovascular clinical investigation unless approved by the Manager of Clinical Studies, Guidant Canada, inability or refusal to sign 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

| Intervention/Treatment |
| --- |
|Device: CRT device|market approved CRT device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to test and compare all available LV pacing and sensing configurations |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to track all programming changes made to the LV pacing/sensing configurations |  | 6 months |
Viral Excretion Among COVID-19 Omicron Recurrence Patients

Study Overview
=================
Brief Summary
-----------------
The study analyzes the viral nucleic acid excretion and its influencing factors of SARS-COV-2 Omicron recurrence patients.

Official Title
-----------------
Viral Excretion and Its Influencing Factors Among COVID-19 Omicron Recurrence Patients

Conditions
-----------------
COVID-19 Recurrence, Surface Contamination

Intervention / Treatment
-----------------
* Other: COVID-19 Omicron Recurrence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with nucleic acid detection N gene and ORF gene Ct value < 40 after discharge from hospital Being able to provide basic information, living habits, vaccination information, admission information Exclusion Criteria: Single gene target positive Patients with incomplete baseline data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: COVID-19 Omicron Recurrence|COVID-19 Omicron Recurrence|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Omicron Recurrence | COVID-19 Omicron Recurrence | Six months |
Hemodynamic and Respiratory Function in Healthy Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This study looks at hemodynamic and respiratory function in healthy pregnant women; it is a longitudinal study.

Official Title
-----------------
Hemodynamic and Respiratory Function in Healthy Pregnant Women - A Longitudinal Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women

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
-----------------
Hemodynamic and respiratory changes and pregnancy, Healthy pregnant women
Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Study Overview
=================
Brief Summary
-----------------
Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a semisynthetic camptothecin derivative introduced in the 1980's. Irinotecan is a prodrug metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and DNA. These complexes collide with replication forks and cause breaks in DNA. Studies substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of grade 3/4 diarrhea remains high at 28 to 40%.

Official Title
-----------------
Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Glutamine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metastatic colorectal cancer to be treated with FOLFIAT chemo Exclusion Criteria: severely abnormal liver and kidney function

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: 1<br>Irinotecan, 5FU, Glutamine | Drug: Glutamine<br>* Glutamine 10 g four times daily starting two days before treatment for six days in total<br>|
| Placebo Comparator: 2<br>Irinotecan, 5FU, Placebo | Other: Placebo<br>* Glutamine placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in diarrhea. |  | Study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
irinotecan, 5FU, amino acids, heat shock protein
Clinical and Genetic Markers of Bone Metabolism in Children Under One Year

Study Overview
=================
Brief Summary
-----------------
The study of children under one year of age for molecular genetic testing-VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) with the study of the frequency distribution of alleles and genotypes by polymorphisms, analysis of the relationship of molecular genetic markers with indicators of bone metabolism.

Detailed Description
-----------------
Children under the age of one year of Kazakh nationality born in Aktobe will be examined. Each child included in the study will have an individual registration card, where information about the health status of the child and the health status of the mother during pregnancy will be filled in. A biochemical analysis will be determined for the level of calcium, phosphorus, calcitonin, parathyroid hormone, osteocalcin, vitamin D in blood serum and deoxypyridinoline in urine. Blood will be taken to determine the genetic polymorphism of VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759). The state of bone tissue remodeling (osteocalcin, vitamin D, Ca, P, calcitonin, deoxypyridinoline) will be revealed The frequencies of allelic variants of the VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) genes in children under the age of one year in the population of Kazakhstan were determined.

Official Title
-----------------
Clinical and Genetic Markers of Bone Metabolism in Children Under One Year of Age in the Kazakh Population

Conditions
-----------------
Genetic Change, Bone Remodeling Disorder, Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Children 0 -12 months old Exclusion Criteria: Musculoskeletal system diseases; Severe chronic somatic diseases; Supplementation of vitamin D in a therapeutic dose; Lack of consent of the parents or legal representatives to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of the method for diagnosing bone metabolism disorders in children under one year old in the Kazakh population | The state of bone metabolism was assessed using the quantitative content of calcium, phosphorus, vitamin D, osteocalcin, and parathyroid hormone. | 2 years |
The Treatment of Acne Vulgaris With Radiofrequency Device

Study Overview
=================
Brief Summary
-----------------
Radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild to moderate acne patients faces. The aim of the study is to check whether RF heating of subcutaneous and dermis will improve acne in needed patients.

Official Title
-----------------
The Treatment of Acne Vulgaris With Radiofrequency Device

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: Radio Frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild-moderate Acne age over 18 otherwise healthy Exclusion Criteria: age under 18 pregnancy systemic acne treatment in the last month local acne treatment in the last month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- |
|Device: Radio Frequency|nan|

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
-----------------
Acne, RadioFrequency
Assessment of the Nutritional Status of Pregnant Women and Optimization of Prenatal Care Services

Study Overview
=================
Brief Summary
-----------------
A national survey in Niger found that women and children are at risk of undernutrition and that many pregnant women don't visit health centers during pregnancy as often as is recommended. The aim is to assess the nutritional and health status of pregnant women in the Zinder region and to understand their knowledge, attitudes and practices related to health and nutrition during pregnancy. In collaboration with the Medical District of Zinder the prenatal care services will be optimized and the programmatic impact on gestational weight gain and anemia prevalence will be assessed.

Official Title
-----------------
Assessment of the Nutritional Status of Pregnant Women in Zinder, Niger and Optimization of Prenatal Care Services

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Programmatic prenatal care optimization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Exclusion Criteria: Pregnant women, who have severe illness warranting immediate hospital referral
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Baseline cohort<br>The baseline survey will be implemented among pregnant women in randomly selected villages using a continuous enrollment schedule over the period of 18 months | |
| Optimization cohort<br>The programmatic impact of optimized prenatal care services on women's health and behavior will be assessed among pregnant women in randomly selected villages (Programmatic prenatal care optimization) | Other: Programmatic prenatal care optimization<br>* To further integrate and improve nutrition-related services and messages in the prenatal care package.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of inadequate gestational weight gain |  | 6 months | 
| Anemia prevalence |  | 6 months | 
| Access and adherence to prenatal iron and folic acid supplements |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of inadequate dietary diversity scores |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron and folic acid supplements, anemia, gestational weight gain
A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

Study Overview
=================
Brief Summary
-----------------
This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Official Title
-----------------
Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

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

Intervention / Treatment
-----------------
* Drug: aleglitazar
* Drug: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >/= 18 years of age Diabetes mellitus, Type 2 Moderately impaired kidney function Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening BMI 25-35 Exclusion Criteria: Current or previous treatment with a thiazolidinedione Current or previous treatment with insulin Treatment with fibrates <3 months prior to screening History of renal disease other than diabetic nephropathy

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 |
| --- | --- |
| Experimental: aleglitazar<br> | Drug: aleglitazar<br>* Aleglitazar 150 mcg po daily for 52 weeks<br>|
| Active Comparator: pioglitazone<br> | Drug: pioglitazone<br>* Pioglitazone 45 mg po daily for 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function: estimated glomerular filtration rate |  | Week 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Tolerability: Adverse events (AEs), laboratory parameters |  | AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 | 
| Renal function: estimated glomerular filtration rate |  | Week 52 | 
| Effect on blood hemoglobin |  | Week 52 |