linjc16/ctgov huggingface dataset:
Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning Hemodialysis (HD)

Study Overview
=================
Brief Summary
-----------------
High recombinant human erythropoietin requirement and elevated serum adiponectin were significant determinants of long-term mortality in patients who started hemodialysis therapy.

Detailed Description
-----------------
Background: Responsiveness of recombinant human erythropoietin (rHuEPO) is known to be related with body fatness in hemodialysis (HD) patients. Adiponectin (ADPN) is inversely associated with body fat mass, and in healthy subjects, low ADPN is a predictor of mortality. Recently, higher rHuEPO dose itself is demonstrated to be associated with poor prognosis. So, in this study, we prospectively examined the relationship between rHuEPO dose, serum ADPN, and mortality in patients beginning HD. Methods: We selected 85 patients (51 men/34 women, age; 64±15 years) who survived for more than 3 months after the start of HD. After determining initial rHuEPO dosage, we followed the patients for 3 years, and examined an association between rHuEPO dose, serum ADPN, and all-cause mortality. Results: We could follow totally 74 out of 85 patients for 3 years; 59 patients were survived, but 15 patients expired. Dosage of rHuEPO was significantly and negatively correlated with body mass index (BMI) (r=-0.44, p<0.01) and positively with serum ADPN (r=0.29, p<0.02), but not with leptin. Cox-hazards regression analysis adjusted by age, sex and underlying kidney disease revealed that rHuEPO dose and serum ADPN, as well as nutritional parameter such as protein catabolic rate became significant determinants of 3-year mortality. There was a 12.7% risk increase for 10U/kg/week increase in rHuEPO dose and 1.3% increase for 1µg/ml increment of serum ADPN for the 3-year of follow-up. Conclusion: High rHuEPO requirement and elevated serum ADPN were significant determinants of long-term mortality in patients who started HD therapy.

Official Title
-----------------
Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Conditions
-----------------
Renal Dialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had first started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in Shizuoka prefecture area. Exclusion Criteria: nothing particular

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
recombinant human erythropoietin, adiponectin, mortality
Metabolic Fate Modifications of Saturated Fats After an Overfeeding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).

Detailed Description
-----------------
Healthy overweight and lean young men are subjected to an overfeeding during 56 days which corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et after : D56 overfeeding) they have ingested a breakfast with tracer (d31_palmitic acid, d31_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry (GC-OMS) in palmitic acid pool of lipid fractions.

Official Title
-----------------
Metabolic Fate Modifications of Saturated Fats After an Overfeeding

Conditions
-----------------
Obesity, Lipid Metabolism, Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: Hyperlipidic overfeeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 55 years old BMI 18 to 30 kg/m² Stable physical activity Safety subject during medical consultation Exclusion Criteria: Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflammatory diseases) Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones) Eating disorder Intensive sportive activity Subjects who Smoke Claustrophobic subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Hyperlipidic overfeeding|100g per day of cheese + 40g per day of almonds + 20g per day of butter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post prandial partitioning of exogenous lipids |  | Before and after overfeeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genes expression in adipose and muscle tissues |  | Before and after overfeeding | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overfeeding, stable isotopes, lipoprotein metabolism, lipid oxidation, fat distribution, gene expression, mass spectrometry/gas chromatography, endotoxemia
ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

Study Overview
=================
Brief Summary
-----------------
It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).

Detailed Description
-----------------
Up to now there are no data concerning the prevalence of ASS-Nonresponse following surgical coronary revascularization procedures as assessed with the Multiple Electrode Aggregometry. Results of the present observational study are needed to assess the prevalence of ASS-Nonresponse in order to perform a sample size analysis for a prospective interventional study in a second step.

Official Title
-----------------
ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

Conditions
-----------------
ASS-Nonresponse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years after cardiac surgery Antiaggregatory therapy with aspirin postoperatively Exclusion Criteria: known allergy to aspirin need for an antiaggregatory therapy other than aspirin pregnancy

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 |
| --- | --- |
| CABG Patients<br>Patients undergoing surgery for coronary revascularization. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASPItest | Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA) | at day 3 and 5 after the first dose of aspirin following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRAPtest | Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6 | at day 3 and 5 after the first dose of aspirin following surgery | 
| Platelet Count | Platelet count taken from the daily standard laboratory results. | at day 3 and 5 after the first dose of aspirin following surgery | 
| Mortality | Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study | 12 month | 
| Myocardial infarction | Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview. | 12 month | 
| Readmission to hospital | Did a readmission to hospital due to cardiac or pulmonary reasons take place in the 12 month following enrollment into the study? Assessed by a telephonic follow up interview. | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASS-Nonresponse, cardiac, surgery
Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of nitazoxanide tablets in treating diarrhea caused by Entamoeba histolytica in adults and adolescents.

Official Title
-----------------
Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Tablets in the Treatment of Diarrhea Caused by Entamoeba Histolytica in Adults and Adolescents

Conditions
-----------------
Amebiasis

Intervention / Treatment
-----------------
* Drug: Nitazoxanide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥12 years. Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon. Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment. Exclusion Criteria: Patients with identified causes of diarrhea other than E. histolytica. Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity. Females who are pregnant, suspected of being pregnant or breastfeeding. Serious systemic disorders incompatible with the study. History of hypersensitivity to nitazoxanide. Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness. Patients with amebic liver abscess. Patients known to have or suspected of having AIDS. Patient with immune deficiencies.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of clinical symptoms of amebiasis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of cyst or trophozoites of E. histolytica from post-treatment stool samples |  |  | 
| Time from initiation of treatment to passage of last unformed stool |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amebiasis, Entamoeba histolytica
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

Study Overview
=================
Brief Summary
-----------------
Study to demonstrate the safety and effectiveness of a new oral enhanced airway device to treat simple snoring.

Detailed Description
-----------------
The Keepasleep airway device is a novel and unique buccopharyngeal airway device to enhance breathing during sleep. This method has not been described in the medical literature and has been successful in limited testing. This clinical trial is to determine the safety and effectiveness of the KEEPASLEEP device utilizing 30 subjects with simple snoring. Each subject will serve as his/her own control. The device augments airflow into the posterior pharynx to minimize airway collapse,tissue vibration, and consequent snoring.The device passes through the retromaxillary space and requires that the subject be absent their wisdom teeth.

Official Title
-----------------
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.

Conditions
-----------------
Snoring, Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Device: KEEPASLEEP enhanced breathing device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- 18 yrs. of age or greater generally good health Intact dentition / ABSENT upper and lower wisdom teeth ( by extraction or lack of development ) Simple snoring( documented by observer) or mild sleep apnea RDI < 15 ( documented by polysomnogram) Subject must have a concerned observer to assess of sleep and snoring behavior during trial period Exclusion Criteria:- Presence of Wisdom teeth (third molars) active oral disease acute illness BMI (body mass index) > 30

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: KEEPASLEEP enhanced breathing device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction/Elimination of snoring behavior |  |  |
Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.

Detailed Description
-----------------
Subjects enrolled into the study will be randomly assigned to one of 2 groups. The first group will receive one hour of conventional gait training, consisting of lower extremity strengthening exercises, stretching, and full weight bearing walking as tolerated, with appropriate physical assistance from a therapist. The second group will receive walking therapy using a Lokomat, which is a special treadmill that works in conjunction with 2 light-weight robotic arms that assists the subject to move their legs while they try to walk on the treadmill. Some of the subject's body-weight will be supported using a harness. During Lokomat training sessions, subjects will receive feedback of their walking performance on a computer monitor to help them walk. Both groups will be trained for 8-10 weeks, 3 times per week, for 1 hour training sessions (24 total sessions). Resources for transportation to the National Rehabilitation Hospital will be provided to all study participants.

Official Title
-----------------
Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training

Conditions
-----------------
Hemiparesis, Stroke

Intervention / Treatment
-----------------
* Device: Lokomat (Robotic Orthosis) combined with slat belt treadmill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Unilateral brain lesion. Within 6 months post-stroke. Receiving no other therapy targeting function of lower limb. Demonstration of hemiparesis (motor dysfunction in lower limb). Able to walk 5 meters without therapist assistance (walking device only). Able to follow commands and protocol. Exclusion: Significant cognitive or communication impairments. Uncontrolled hypertension. Uncontrolled diabetes. Clinical depression.

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

| Intervention/Treatment |
| --- |
|Device: Lokomat (Robotic Orthosis) combined with slat belt treadmill|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
-----------------
Physical Therapy, Locomotion therapy, Gait training, Stroke, Robotics, Rehabilitation, Treadmill, Hemiparetic stroke, Unilateral brain lesion
Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)

Study Overview
=================
Brief Summary
-----------------
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment

Official Title
-----------------
ALNA® - AWB in Pre-treated Patients With BPS

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: ALNA®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suffering from BPS symptoms Preceding treating with Terazosin for at least one month IPSS sum score >= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month Exclusion Criteria: Patients fulfilling one of the general or specific contraindications listed in the ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with symptomatic BPS<br> | Drug: ALNA®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire |  | Baseline, after 1 month | 
| Change of Quality of Life (QoL) Index by means on patient questionnaire |  | Baseline, after 1 month | 
| Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale |  | after 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in maximum urinary flow rate (Qmax) |  | Baseline, after 1 month | 
| Change from Baseline in residual urinary volume |  | Baseline, after 1 month | 
| Change from Baseline in blood pressure |  | Baseline, after 1 month | 
| Change from Baseline in Pulse rate (bpm) |  | Baseline, after 1 month | 
| Change in complications due to low blood pressure | Patient is asked for complications (weakness, dizziness, nausea) | Baseline, after 1 month | 
| Global assessment of efficacy by investigator on 4-point scale |  | after 1 month | 
| Global assessment of tolerability by investigator on 4-point scale |  | after 1 month | 
| Global assessment with BPS- treatment by investigator on a 4-point scale | Switch from Terazosin therapy to ALNA® | Baseline, after 1 month |
Turkish Version of LIFE Habits Assessment

Study Overview
=================
Brief Summary
-----------------
Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.

Official Title
-----------------
Validity and Reliability of Turkish Version of LIFE Habits (Life-H) Assessment for Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Other: Assessment via questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be diagnosed as cerebral palsy Exclusion Criteria: Children whose family didn't accept to participate to study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 |
| --- | --- |
| Children with cerebral palsy<br>Children who diagnosed as cerebral palsy by a pediatric neurologist | Other: Assessment via questionnaire<br>* All the children will be assessed via assessment questionnaires.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Habits Questionnaire (LIFE-H) | Assessing of the participation level of children | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Classification System (GMFCS) | Assessing severity of the disability of children | At baseline | 
| Pediatric Outcomes Date Collection (PODCI) (Questionnaire) | Assessing health-related quality of life of children by parent proxy questionnaire | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Participation, LIFE Habits (life-H), Validity, Reliability