linjc16/ctgov huggingface dataset:
Changes in Mitochondrial Uncoupling Protein 2 (UCP2) Messenger RNA(mRNA) in Type 2 Diabetes (T2DM) Patients

Study Overview
=================
Brief Summary
-----------------
Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose levels, high free fatty acids and high oxidative stress. The investigators intend to learn about the changes in UCP2 along the process of reaching glycemic control.

Official Title
-----------------
Changes in UCP2 mRNA in T2DM Patients

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: Blood withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Un balanced diabetic patients. Exclusion Criteria: No current infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Diabetic patients<br>Un balanced diabetic patients | Procedure: Blood withdrawal<br>* This is the only intervention that is part of the study. A family physician or other physician will be responsible of the diabetic treatment (common treatment, e.g Metformin).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of gene expression for UCP2 (RQ) | Checking UCP2 levels compared to HgBA1c | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved metabolic state | Glycemic control (glucose level and HgA1c), levels of free reactive oxygen species (ROS) and non-esterified fatty acids (NEFAs). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycemic control, Metabolic control, Oxidative stress, Diabetes
Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis

Detailed Description
-----------------
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis or meningitis at Vinmec International Hospital, Hanoi, Vietnam

Official Title
-----------------
The Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis at Vinmec International Hospital

Conditions
-----------------
Encephalitis, Meningitis

Intervention / Treatment
-----------------
* Combination Product: Stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurological sequelae due to encephalitis or meningitis Exclusion Criteria: Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell transplantation<br>Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward | Combination Product: Stem cell transplantation<br>* Transplantation of Autologous Bone Marrow Mononuclear Cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMFM-88 | Change in Total Score of Gross Motor Function Measure GMFM-88 | Baseline, 6 months, and 12 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | Baseline, 6 months, and 12 months after transplantation | 
| Number of adverse events | Examples of adverse events to look for: fever, infections, vomit, epilepsy | Through study completion, an average of 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
encephalitis, meningitis, neurological sequelae due
Zoledronic Acid in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis. Low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (CF); they have an increased rate of bone fractures in comparison to the general population. CF patients start to lose bone density in adolescence/early adulthood due to an imbalance in bone breakdown and formation. Predicted survival for patients with CF has increased from 16 years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities associated with increased longevity in CF e.g. decreased bone density. Oral and intravenous bisphophosphonates are known to increase bone density in CF; the current licensed oral preparations require daily or weekly dosing which are difficult to maintain. Zoledronate, which is licensed for use, is administered intravenously once a year which should be easier to administer. The current evidence relates to its use in other disease groups e.g. glucocorticoid induced osteoporosis and oncology. The purpose of this study is to ascertain its efficacy in cystic fibrosis.

Official Title
-----------------
Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Zoledronic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cystic fibrosis Aged at least 18 years Bone mineral density score of -1.5 or less at lumbar spine or total hip Able to give informed consent Exclusion Criteria: Previous solid organ transplant on solid organ transplant waiting list Long trem oral glucocorticosteroids CRP >20mg on day of randomisation Hypocalcaemia Poor dental hygiene

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: Zoledronic acid<br>Active IMP | Drug: Zoledronic acid<br>* Single dose, intravenous solution 5mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density | Bone density measure by DEXA | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of zoledronic acid on the number of bone fractures | Bone fractures | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic fibrosis, Bone density
Evaluation of CNAP During Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the non invasive measurement of arterial pressure (CNAP monitor) with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia

Official Title
-----------------
Evaluation of CNAP During Induction and Maintenance of General Anesthesia

Conditions
-----------------
General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 ASA II, III or IV weight between 40 and 180 kg; BMI < 35 surgical procedure performed in supine position normal Allen's test and hand Doppler examination. Exclusion Criteria: cardiac arrhythmias, history of vascular surgery or vascular implant in the upper limb

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 |
| --- | --- | --- |
| Comparison between both methods of arterial pressure measurement |  | intraoperative |
Hip-Flexion Strength Training: Can Elastic Bands Induce a Relevant Effect?

Study Overview
=================
Brief Summary
-----------------
Strength training of the hip flexors using elastic bands can induce an effect on isometric hip strength of at least 15 %.

Conditions
-----------------
Hip Flexion Strength

Intervention / Treatment
-----------------
* Other: Hip flexion strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically active (more than 2.5 h/week) individuals Exclusion Criteria: Injury in the lower back or legs within the last 6 months. Systematic strength training of the hip flexors more than once a week within the last 6 months before the study was initiated.

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

Allocation: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br> | Other: Hip flexion strength training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric hip flexion strength |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip flexion strength training, elastic bands, external resistance
Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.

Conditions
-----------------
Warm Water, CO2 Colonoscopy, Unsedated Colonoscopy

Intervention / Treatment
-----------------
* Procedure: CO2
* Procedure: Warm water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria adult outpatients willing to undergo colonoscopy without routine initial sedation Exclusion Criteria: refuse to initiate colonoscopy without routine sedation inadequate bowel preparation incapacity to give informed consent

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2<br>CO2 insufflation instead air insufflation in unsedated colonoscopy | Procedure: CO2<br>* CO2 insufflation<br>|
| Experimental: Warm Water irrigation<br>warm water irrigation during the insertion phase of colonoscopy | Procedure: Warm water<br>* warm water irrigation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients undergoing complete unsedated colonoscopy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of pain and tolerability scores |  | 6 months |
Naltrexone Treatment of Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management.

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)
* Behavioral: Compliance Enhancement Tech.
* Behavioral: Cognitive Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for current diagnosis of alcohol dependence. Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days. Successful completion of medical detoxification. Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits. Understands and signs the informed consent. Exclusion Criteria: Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana. Evidence of opiate use in the past 30 days. Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification). History of unstable or serious medical illness, including need for opioid analgesics. Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms. Use of an investigation medication in the past 30 days. Female subjects who are pregnant, nursing, or not using reliable method of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|
|Behavioral: Compliance Enhancement Tech.|nan|
|Behavioral: Cognitive Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Sperm DNA Integrity on In Vitro Cycles

Study Overview
=================
Brief Summary
-----------------
Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.

Official Title
-----------------
Impact of Sperm DNA Integrity on In Vitro Cycles

Conditions
-----------------
Male Infertility, Unexplained Infertility, Abortion, Habitual

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: couple undergoing IVF at the Center for Human Reproduction sperm sample given from partner (not a donor) Exclusion Criteria: low sperm concentration (<5 million/cc) using a donor sample
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVF<br>those individuals undergoing conventional IVF to inseminate their retrieved eggs | |
| ICSI<br>those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sperm DNA integrity, Toluidine blue assay (TBA), IVF outcome
Narrow Band Green Light and Migraine

Study Overview
=================
Brief Summary
-----------------
Study volunteers are asked to use the Allay Lamp routinely during the 6-week study period. A web based survey is provided when the Lamp is purchased for study volunteers to complete. A daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. At the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.

Official Title
-----------------
A Real World Evaluation of the Allay Lamp in Reducing Headache Symptoms and Frequency

Conditions
-----------------
Migraine, Headache

Intervention / Treatment
-----------------
* Device: Allay Lamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with headaches or migraines. Exclusion Criteria: Not having headaches or migraines

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allay lamp (narrow band green light)<br>Subjects who purchased the Allay Lamp are asked to document the effects of spending time in the narrow band of green light it emits, on their headache or any of its associated symptoms. | Device: Allay Lamp<br>* The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10 lux) narrow band (20 nm) green light (peak wavelength 520 nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of headache days per week | Number of days with headache per week without and with using the Allay lamp | Change from baseline at 6 weeks | 
| Change in number of headache days per month | Number of days with headache per month without and with using the Allay lamp | Changes from baseline at weeks 3-6 of using the Allay lamp | 
| Change in frequency of experiencing photophobia | Assessing frequency of photophobia during days with headache as depicted by participants using the following options: (1)never, rarely, (2)less than half, (3)half or more, (4)nearly all the time. | Changes from baseline at 6 weeks of using the Allay Lamp. | 
| Change in headache severity | Assessing headache severity while using the Allay lamp. Improvement is determined by the number of times participants answer Yes or NO in their daily diary. | Changes from baseline at 6 weeks of using the Allay lamp |
TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.

Official Title
-----------------
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: TGR-1202 + Obinutuzumab + Chlorambucil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Chronic Lymphocytic Leukemia (CLL) Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Ability to swallow oral medication Exclusion Criteria: Known hepatitis B virus, hepatitis C virus or HIV infection Primary central nervous system lymphoma or known intracranial involvement Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TGR-1202 + Obinutuzumab + Chlorambucil<br>TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days. | Drug: TGR-1202 + Obinutuzumab + Chlorambucil<br>* TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose<br>* Other names: Chlorambucil: Leukeran;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose acceptable for participants | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 28 days (1 cycle of therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil | Up to 1 year |