linjc16/ctgov huggingface dataset:
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls. Regardless the treatment status, we collect the same neuroendocrine-immune data on the participants after 2 months.

Detailed Description
-----------------
This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls. Regardless the treatment status, we collect the same neuroendocrine-immune on the participants (patients and controls) after 2 months. Thus, our study does not control treatment. Patients take treatment in consultation with their physician. Some of them even decide not to take any medications. At the 2nd visit, we do ask them about the the medications they are taking if any.

Official Title
-----------------
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Delusional Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychotic disorder as per DSM-IV criteria of the American Psychiatric Association Exclusion Criteria: Diabetes, type 1 or 2 Prominent substance abuse (i.e. psychotic symptoms attributable entirely to substance use) Age above 50 or age below 14

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, psychosis, type 2 diabetes mellitus
The Influence of Central and Peripheral Fatigue on Sports Performance and Prevention of Sports Injury

Study Overview
=================
Brief Summary
-----------------
This is an observational study that assess the baseball pitchers' fatigue status. The purpose of this study is to find the pitching mechanic change and the fatigue point to provide guidance for coaches to schedule training items . It is expected that earlier detect the pitchers' fatigue point could be able to prevent overuse injury caused by compensatory actions.

Detailed Description
-----------------
The expected outcomes of this study include providing more reliable scientific evidence of the effects of fatigue on baseball players' performance and movement control, which can help to improve muscle endurance and the quality of movement control. Moreover, fatigue that resulted from the prolonged practice can be reduced and recovered faster after exercise, as well as more understanding on the ideal pitching posture and compensatory action that caused by fatigue, providing a guideline for exercise training. This will not only help to prevent fatigue and reduce risk of injury, but also strengthen weak muscle groups and improve movement strategies before matches, as well as lengthen the time of being a baseball player.

Official Title
-----------------
Cooperation Between NTU and NTUS: Integrated Precision Approach to Improve Baseball Skills, Tactics and Competition Performance-The Influence of Central and Peripheral Fatigue on Sports Performance and Prevention of Sports Injury

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Behavioral: Central fatigue group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy baseball pitchers age between 18 35 years old Exclusion Criteria: surgery history in pitching arm Musculoskeletal disease Neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Central fatigue group|a fatigue protocol that pitchers need to pitch 80 trials in a simulated game|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability (HRV) | test HRV during pitches | 8 weeks |
The Sinonasal Outcome Test - 22, Validated for Danish Patients

Study Overview
=================
Brief Summary
-----------------
Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both incidence and prevalence. It calls into attention consensus about diagnosing, assessing symptoms and treatment of patients with CRS. Therefore a validated Danish measure of health-related quality of life in sinonasal disease is needed. Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22. Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation between the initial scores and the retests scores. Kappa was calculated for each item with a mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant difference in the subscales. Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and nasal polyposis.

Official Title
-----------------
The Sinonasal Outcome Test - 22, Validated for Danish Patients

Conditions
-----------------
Chronic Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons diagnosed with Chronic Rhinosinusitis - Exclusion Criteria: Change of treatment or acute change of symptoms due to common cold/influenza in the time between completing the test and the retest. If SNOT-score was very low. Persons who left before offered test or declined testing. -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients with chronic rhinosinusitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility of Sinonasal Outcome test 22 |  | From the time of fullfilling the first SNOT-22 to fullfilling the second SNOT-22 after 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Rhinosinusitis, Sinonasal Outcome test 22
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.

Official Title
-----------------
An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population

Conditions
-----------------
Psoriasis, Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Pandel Cream 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area Good health with the exception of psoriasis or atopic dermatitis Exclusion Criteria: Any disease affecting the HPA-axis Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pandel Cream 0.1%<br>Pandel Cream 0.1% | Drug: Pandel Cream 0.1%<br>* A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-injection Serum Cortisol Level | The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22. | 22 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-injection Serum Cortisol Levels | The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22. | 22 Days | 
| and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL. |  | 22 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Atopic Dermatitis
Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

Study Overview
=================
Brief Summary
-----------------
Lead survivability will be summarized.

Detailed Description
-----------------
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Official Title
-----------------
Attain Ability® Family Left Ventricular Lead Chronic Performance Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive an Attain Ability Model 4396 LV lead Patient within 30 day post implant enrollment window Exclusion Criteria Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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 |
| --- | --- | --- |
| Model 4396 LV Lead-related complication rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of lead-related adverse device effects |  | 5 years | 
| Percent of subjects with changes in electrode programming |  | 5 years | 
| Number of fractures with and without loss of function |  | 5 years | 
| Bipolar electrical performance at 1 year |  | 1 year | 
| Bipolar pacing impedance |  | 1 year | 
| Bipolar pacing capture threshold |  | 1 year |
Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling

Study Overview
=================
Brief Summary
-----------------
Congenital epileptic encephalopathies (EE) are predominantly genetic in origin. Their diagnosis is hampered by the large number of genes involved and their low recurrence. Genetic study in routine diagnosis is limited by the existing techniques and the development costs. The routine diagnostic implementation of high throughput sequencing pushes these limits. High throughput exome sequencing (ES) showed superior diagnostic performance in all diagnostic settings studied. This pilot study is dedicated to evaluating the diagnostic performance of high throughput ES in EE, with an implementation and analysis strategy allowing for a direct transfer to routine diagnostics. This novel approach should improve the diagnostic rate while reducing the diagnostic cost per patient.

Official Title
-----------------
Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling

Conditions
-----------------
Epileptic Encephalopathy of Unindentified Genetic Origin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of epileptic encephalopathy, defined by the clinical association of epilepsy and a significant delay in acquisition Family case with recurrence in siblings, suggesting autosomal recessive transmission or X-linked inheritance (with or without parental consanguinity), or sporadic case resulting from inbreeding. Lack of etiologic orientation based on clinical examination. Normal routine diagnostic genetic examinations including a metabolic check-up, array CGH analysis. Brain imaging which does not suggest an acquired cause. Exclusion Criteria: Unavailable parental samples Diagnostic orientation from one of the tests mentioned above Brain imaging suggesting anoxia sequelae
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 |
| --- | --- | --- |
| Number of diagnoses performed with high throughput ES |  | Through study completion, an average of 1 year. |
Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
A Pressure Release Technique will be test in patient with low back pain compared to a sham

Official Title
-----------------
Effectiveness of Pressure Release Technique in Patients With Chronic Low Back Pain

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

Intervention / Treatment
-----------------
* Other: Pressure Release Technique (PRT)
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic low back pain at least 6 months Exclusion Criteria: hernia, neurologic pain

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: PRT group<br>pressure Release Technique and exercises | Other: Pressure Release Technique (PRT)<br>* A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises<br>Other: Control<br>* exercises<br>|
| Active Comparator: Exercises group<br>Only exercises | Other: Pressure Release Technique (PRT)<br>* A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises<br>Other: Control<br>* exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | self reported pain | immediately after treatment | 
| VAS | self reported pain | at 6 months |
Cardiometabolic Risk of Shiftwork

Study Overview
=================
Brief Summary
-----------------
The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.

Official Title
-----------------
Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption

Conditions
-----------------
Sleep Deprivation, Circadian Dysregulation, Shift-Work Sleep Disorder

Intervention / Treatment
-----------------
* Behavioral: sleep extension & circadian alignment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months. Individuals who have been shift workers for less than 10 years; body mass index <40 kg/m2; No major illness No history of psychiatric, endocrine, cardiac or sleep disorders Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment. Women taking oral contraceptive or hormonal replacement therapy will be included only if they plan to stay on a stable regimen throughout the study. Age must be between 18 and 50 years Exclusion Criteria: Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months. Individuals who have been shift workers for more than 10 years BMI>40 kg/m2 Individuals with a major illness (e.g. diabetes, sleep disorder)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Shift Workers<br> | Behavioral: sleep extension & circadian alignment<br>* Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system<br>* Other names: SWI intervention;|
| Day Workers<br> | Behavioral: sleep extension & circadian alignment<br>* Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system<br>* Other names: SWI intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.

Detailed Description
-----------------
This study is parallel groups' randomized clinical trial with a pre and post test design. The study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. All subjects received a low calorie diet for 4 weeks from registered dietitian. Treatment group received the low- calorie diet including (30g/day) rice bran oil.

Official Title
-----------------
Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Dietary Supplement: rice bran oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hyperlipidemia Exclusion Criteria: pregnancy and lactation cardiovascular disease diabetes

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment, control<br> | Dietary Supplement: rice bran oil<br>* Treatment group received the low - calorie diet with(30g/day) rice bran oil<br>* Other names: King rice bran oil, Bangkok, Thailand);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL, HDL, Cholesterol,Triglyceride(mg/dl) | enzymatic reagents | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (Kg/m2) | weight/(height)2 | Baseline and 4 weeks after intervention | 
| WHR (Ratio) | Waist(Cm)/Hip(Cm) | Baseline and 4 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rice bran oil, diet, cardiovascular disease, low density lipoprotein, total cholesterol