linjc16/ctgov huggingface dataset:
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease

Study Overview
=================
Brief Summary
-----------------
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

Detailed Description
-----------------
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

Official Title
-----------------
Intravenous Omega-3 Fatty Acid (Omegaven) for Pediatric Patients With Total Parenteral Nutrition Associated Liver Dysfunction

Conditions
-----------------
Cholestasis, Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Omegaven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PN dependence due to congenital or acquired gastrointestinal disease Predicted PN requirement for at least an additional 30 days Parenteral nutrition associated liver disease (PNALD), defined as two conjugated bilirubin levels >= 2 mg/dL at least one week apart, must be obtained to demonstrate persistence of PNALD Failure to respond to standard therapies which may include cycling PN, reduction in the dose of soybean derived IFE, attempts to advance enteral feeds, ursodiol, metronidazole, and avoidance of excessive caloric provision signed parent or legal guardian informed consent Exclusion Criteria: Acute treatable infection (e.g. urinary tract infection, sepsis) Known allergy to egg or fish protein Contraindications to Omegaven Pregnancy Serum triglyceride level greater than 400 mg/dL at baseline History of severe hemolytic disorders or INR greater than 1.5 at baseline (INR cutoff of greater than 2 for infants less than 1 week of age)

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Omegaven|10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.|

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
-----------------
parenteral nutrition associated liver disease, cholestasis, short bowel syndrome, Omegaven
Causes and Characteristics of Occupational Eye Injuries in Western Turkey

Study Overview
=================
Brief Summary
-----------------
Patients with work-related eye injuries (WREI) admitted to the center in the four-year period were enrolled in this prospective study. Institutional Review Board approval was obtained before commencement of the study. A special data recording system was developed for the study. The study sample comprised only the casualties occurred at workplace and while working de facto. The data were abstracted via face to face contact in the emergency department (ED). The data sheets comprised sociodemographic and injury-related information brought together in 15-item questionnaire. Causes of occupational injuries as reported by the victims were assigned to either of two groups: Worker-related causes and workplace-related causes. Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated room in the ED was used for this purpose in order to prevent bias and the patients were not accompanied by any person other than the medical personnel in charge of due medical care. The patients were also assured that the information obtained by the survey are to be used for research purposes only and no feedback is to be given to employers or related persons. Patients who did not give consent for the study, fatal accidents and patients younger than 15 years of age were excluded from the analysis.

Detailed Description
-----------------
All data obtained in the study were recorded in and analyzed using the Statistical Package for Social Sciences for Windows, Version 17. Numerical variables were given as mean and standard deviation (SD), while categorical variables were given as frequencies (n) and percentages.

Official Title
-----------------
Causes and Characteristics of Occupational Eye Injuries in Western Turkey

Conditions
-----------------
Other and Unspecified Superficial Injuries of Eye

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study sample comprised only the casualties occurred at workplace and while working de facto Exclusion Criteria: Other

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
An effective treatment adherence was a key to make the treatment success, some reports had shown that psychologicl factors impact patients adherence seriously,however, in China, the researches were only limited to depression and diabetes,diabetes distress was neglected. Some western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we hypothesized that: 1.perhaps our present depression-oriented health education was inadequate to promote patients' adherence, diabetes distress might played a more important part than depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and depresion was conducted. Objectives: to explore the relationship of diabetes-related distress and depression，and to compare the influence of diabetes distress and depression on treatment adherence in Chinese type 2 diabetes . Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.

Conditions
-----------------
Compare Diabetes Distress and Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1)aged between 18-80 years, 2)diagnosed with diabetes for at least 6 month, 3) having the ability to communicate fluently and clearly, Exclusion Criteria: patients who had the diagnosis of dementia or psychosis and severe diabetes complications (e.g., on dialysis)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of diabetes distress on treatment sdherence |  | 6 month |
Vertical Stability Training Effects on the Eye-Hand Coordination of Female Volleyball Players

Study Overview
=================
Brief Summary
-----------------
Purpose: Optimal eye-hand coordination is important for volleyball players. Neck disorder may affect neck function and subsequently eye-hand coordination. The purpose of this study is to explore the vertical stability training effects on coordination of the upper extremities of female volleyball players. Methods: This study surveyed 25 players of a volleyball team, randomly assigned into the group A (training 1st) and group B (training 2nd). The group A includes 13 volleyball players and the group B includes 12. Eye-hand coordination was tested by a self-developed hand-stroking table device and stay time and motion time of upper extremities were determined. There are two testing modes, regular and random. Motion time for the electric probe moving between target sensor and stay time for the electric probe staying on a target sensors were collected for each mode, before each session of training and after the end of the 2nd session. In the 1st session of training, group A started vertical stability training and group B did control training for six weeks. In the 2nd session of training, the training programs were shifted between group A and B for another six weeks.

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

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Volleyball Players Exclusion Criteria: can't party in training

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 21 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: exercise training|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
-----------------
volleyball, neck vertical stability training, eye-hand coordination
Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum

Study Overview
=================
Brief Summary
-----------------
In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free fraction that is biologically active. Polymorphisms in DBP are related to the serum level of 25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound) 25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as to the RNA expression in peripheral blood to evaluate the biological importance of the free versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D supplementation study to participate in the study which will be one visit only and include collection of blood samples.

Official Title
-----------------
Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum

Conditions
-----------------
Impaired Glucose Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired glucose tolerance living in the Tromsø area Exclusion Criteria pregnancy serious illness

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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 |
| --- | --- |
| Subjects with impaired glucose tolerance<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free fraction of 25(OH)D |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DBP polymorphisms |  | 1 day |
Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.

Conditions
-----------------
Idiopathic Hypogonadotropic Hypogonadism

Intervention / Treatment
-----------------
* Drug: Sustanon 250 mg ampule (Testosterone esters)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: decreased serum testosterone concentration below the normal range (serum T < 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes Exclusion Criteria: previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded. -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 26 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypogonadotropic hypogonadism patients<br>Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism | Drug: Sustanon 250 mg ampule (Testosterone esters)<br>* Drug used for treatment of hypogonadism<br>* Other names: No name;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism |  | 2008-2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism |  | 2008-2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypogonadism, Retinol binding globulin 4, Testosterone treatment
Dawn Simulation and Postural Hypotension

Study Overview
=================
Brief Summary
-----------------
One of the most physiologically demanding things that older people do every day is to get up in the morning. After spending a night laying flat, where the blood distributes evenly across the body, when they stand in the morning (and the blood rushes to their feet), their cardiovascular system may not be able to compensate and maintain blood flow to the brain. This phenomenon is known as orthostatic or postural hypotension. The investigators have found in a group of young individuals that use of a dawn-simulation light that gradually wakes the brain is able to increase cardiovascular tone prior to arising. The goal of this experiment is to determine whether this dawn simulation light is able to increase cardiovascular tone in older adults such that they would have reduced or absent postural hypotension when they awaken in the morning. This would greatly reduce the risks of falls and their associated morbidities in older adults.

Official Title
-----------------
Dawn Simulation as a Passive Countermeasure to Postural Hypotension in Healthy Older Adults

Conditions
-----------------
Orthostatic Hypotension

Intervention / Treatment
-----------------
* Device: Light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of falls or dizziness at exit from bed in the morning (at least two incidents in the past year) At least 20/200 corrected visual acuity Stable health Normal hearing Exclusion Criteria: Regular cigarette smoker Alcohol abuse Drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light<br>Dawn simulation for 30 minutes prior to habitual wake time | Device: Light<br>* 30 minutes of dawn simulation<br>|
| No Intervention: No light<br>Darkness for 30 minutes prior to habitual wake time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sympathovagal balance derived from blood pressure measurement | measure of sympathovagal balance derived from blood pressure measurement at wake time | 30 minutes |
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

Study Overview
=================
Brief Summary
-----------------
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.

Official Title
-----------------
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

Conditions
-----------------
Patients Implanted With a Pacemaker

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sinus Node Disease Brady-Tachy Syndrome Suspected or documented paroxysmal AVB Exclusion Criteria: Permanent high degree AVB Contra indication to the SafeR pacing mode PR higher than 350 ms

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High degree AV blocks |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AV block, SND, BTS, AAIsafeR, SafeR, PM implanted
Amino Acid Therapy for Hot Flashes in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.

Detailed Description
-----------------
Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future. Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.

Official Title
-----------------
Amino Acid Therapy for Hot Flashes/Postmenopausal Women

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: L-norleucine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Experience over 5 hot flashes per day Exclusion Criteria: Hormone Replacement Therapy (HRT) in the past 2 months
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-norleucine|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
-----------------
Postmenopause
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Official Title
-----------------
A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Lanthanum carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females of childbearing potential agree to take adequate precautions to prevent contraception Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study Patient requires treatment for hyperphosphataemia Exclusion Criteria: Pregnant or lactating women Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma Patients who are HIV+ Patients with any significant gastrointestinal surgery or disorders

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lanthanum carbonate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5 |  | Week 3 and Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events |  | Throughout the study period of approximately 20 months. |