linjc16/ctgov huggingface dataset:
Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans

Study Overview
=================
Brief Summary
-----------------
We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will increase insulin sensitivity and normalise insulin secretion in overweight and obese individuals through reduction of chronic low grade inflammation. We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and intravenous glucose tolerance test before and after low AGE diet and normal Australian diet in a cross-over design. This study will provide information relevant to the development and prevention of type 2 diabetes.

Official Title
-----------------
Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans

Conditions
-----------------
Type 2 Diabetes, Insulin Resistance, Obesity

Intervention / Treatment
-----------------
* Behavioral: dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: weight stable overweight and obese (BMI ≥ 25kg/m2) non-diabetic individuals, aged 18-50 years and healthy according to medical history, blood biochemistry and physical examination. Exclusion Criteria: Participants will be excluded if they: are aged <18 years or > 50 years; currently smoke, have high alcohol use; or a positive urine drug screening test; have a history of: diabetes, cardiovascular and hematological disease, respiratory, gastrointestinal, endocrine, renal or central nervous system disease, psychosis or psychiatric disorder, active cancer within last 5 years. are actively seeking to lose weight, or if their weight has changed by more than 10 kilograms in the previous 12 months. have been taking medication within one month prior to commencing the study; have acute inflammation (by history, physical or laboratory examination) are on hormonal contraceptives, or pregnant (by HCG urine pregnancy screening test) or lactating have highly unusual dietary habits or follow vegan diets (because of the difficulty in complying with the assigned diet). have current diabetes (determined by history and/or 75g glucose OGTT) are unable to provide informed consent

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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: dietary intervention|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
-----------------
insulin resistance, insulin secretion, advanced glycation end-products
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

Study Overview
=================
Brief Summary
-----------------
Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning and quality of life. Although insomnia is most often treated with medication, a growing number of studies have demonstrated the efficiency of a variety of relaxation techniques, cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims to restore and maintain health through the stimulation of specific points on the body. Previous studies have demonstrated that acupuncture has a positive influence on a number of diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the aim of the present study is to examine the effects of acupuncture as a treatment for insomnia in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period, followes by an 8-week experimental period. During the experimental period, subjects receive acupuncture treatments twice a week. During the first week of the study (no-treatment period) and the last week of the experimental period, subjects' sleep is monitored with a wrist actigraph, and subjects complete a wide spectrum of questionnaires.

Official Title
-----------------
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

Conditions
-----------------
Schizophrenia, Schizoaffective

Intervention / Treatment
-----------------
* Device: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: schizophrenia or schizoaffective disorder - diagnosed according DSM-4. capability to sign inform consent. Exclusion Criteria: unstable physical illness drug or alchohol abuse or dependence

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture needles<br>Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD. | Device: acupuncture<br>* 16 sessions of acupuncture treatment, twice a week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep efficiency |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety and depression levels |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, schizophrenia, insomnia
Inhibiting COMT in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The overall aim of this observational study is to investigate the impact of COMT inhibition on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or computer-based.

Official Title
-----------------
Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60 - 75 years, Caucasian ethnicity, diagnosed PD by UK brain bank criteria, Hoehn & Yahr scale 2 - 3, fertile females have to use contraception Group 1: medication with Stalevo® (L-DOPA/DDI + Entacapone) Group 2: medication with Madopar® or Sinemet® (L-DOPA/DDI) Exclusion Criteria: methotrexate therapy during the last 12 months, treatment with Tolcapone vitamin B6, B12 and/or folic acid supplementation during last 6 months, pregnancy, intention to become pregnant during the course of the study, breast feeding, other clinically relevant concomitant disease states by discretion of the investigator known or suspected non-compliance, drug or alcohol abuse, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, participation in another study with investigational drug within the 30 days preceding and during the present study, enrolment of the investigator, his/her family members, employees and other dependent persons.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Entacapone<br> | |
| No Entacapone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of homocysteine |  | 1 year |
Internet-Based Interventions for MDD

Study Overview
=================
Brief Summary
-----------------
The acute and remission depression patients of 18-65 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological and medication adherence data was collected. After the completion of the baseline assessment and examination, the patients were given antidepressant treatment or antidepressant treatment combined with Internet-based interventions. Clinical evaluation was performed at 1, 3 months (acute patients) and 6, 12 months (remission patients) after treatment, including the medication adherence, therapeutic efficacy, recurrence rate and functional rehabilitation. Through above work, this research is expected to provide clinicians with a set of Internet generalized technologies to improve the compliance and clinical outcomes of patients with depression, and to provide patients with treatment and management of the entire disease cycle.

Official Title
-----------------
Effectiveness of Internet-Based Interventions for Treatment Compliance and Outcomes of Major Depressive Disorder

Conditions
-----------------
Depression, Medication Adherence

Intervention / Treatment
-----------------
* Drug: antidepressant treatment
* Other: antidepressant treatment combined with Internet-based interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 years old, acute (HAMD17 > 17) and remission (HAMD17 < 8) depression Exclusion Criteria: other mental illnesses, serious somatic illnesses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antidepressant treatment<br>recieve antidepressant treatment | Drug: antidepressant treatment<br>* depression recieve antidepressant treatment<br>|
| Experimental: antidepressant treatment combined with Internet-based interventions<br>recieve antidepressant treatment combined with Internet-based interventions | Other: antidepressant treatment combined with Internet-based interventions<br>* depression recieve antidepressant treatment combined with Internet-based interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD17 reduction ratio | The difference of HAMD17 reduction ratio between the two groups was compared | 3 months | 
| recurrence rate | The difference of recurrence rate between the two groups was compared | 12 months |
The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care

Study Overview
=================
Brief Summary
-----------------
The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids, weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24 months follow-up.

Official Title
-----------------
The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care

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

Intervention / Treatment
-----------------
* Other: Enhanced Diabetes Education
* Other: Standard Diabetes Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a clinical diagnosis of Type 2 Diabetes Age 18-85 years English or Spanish speaking Most recent A1C ≥ 7.5% Patient agrees to participate in the study for the full two years duration. Exclusion Criteria: Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener) -- Significant dementia or psychosis (by health provider report or chart review) Terminal illness with anticipated life expectancy < 2 years (per health provider or patient report).

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Diabetes Education<br>Standard Diabetes Education | Other: Standard Diabetes Education<br>* Provide Standard Diabetes Education<br>|
| Other: Enhanced Diabetes Education<br>Enhanced Diabetes Education | Other: Enhanced Diabetes Education<br>* Provide enhanced diabetes education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in A1C at 12 months | The primary outcome will be the improvement in A1C at 12 months between Intervention group patients and Control group patients. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Bag Valve Mask vs Non-rebreather at Flush Rate

Study Overview
=================
Brief Summary
-----------------
Healthy volunteers will participate in a crossover trial comparing preoxygenation with a non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush rate of oxygen (fully opening standard oxygen flowmeter).

Official Title
-----------------
Preoxygenation With a Bag Valve Mask vs Non-rebreather at Flush Rate

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >17 Exclusion Criteria: Pregnant Any facial hair more than stubble that might impede a mask seal

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: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non rebreather<br> | Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.<br>* A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.<br>|
| Active Comparator: Bag valve mask without leak<br> | Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.<br>* A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.<br>|
| Active Comparator: Bag valve mask with simulated mask leak<br> | Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.<br>* A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of expired oxygen | The fraction of expired oxygen will be measured after three minutes of preoxygenation | 3 minutes |
Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.

Official Title
-----------------
Evaluation of Macular and Retinal Nerve Fiber Layer Thickness Measurements for Detection of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Optical Coherence Tomography.

Conditions
-----------------
Multiple Sclerosis, Neuromyelitis Optica

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of multiple sclerosis or neuromyelitis optica age between 15 and 60 years BCVA better than 20/400 no optic neuritis crisis in the last 6 months Exclusion Criteria: diagnosis of glaucoma, opacities or disc anomalies diagnosis of macular disease disc swelling at fundoscopy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 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 |
| --- | --- |
| multiple sclerosis<br> | |
| neuromyelitis optica<br> | |
| controls<br> | |

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
-----------------
optic neuritis, longitudinally extensive transverse myelitis, retinal nerve fiber layer, macular thickness
A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.

Official Title
-----------------
A Phase I/II Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics (Efficacy) of Chronic Twice-Daily Topical Monocular Application of INO-8875 Ophthalmic Formulation in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: INO-8875
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG). Aged 18 to 75 years. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg. Exclusion Criteria: No significant visual field loss or any new field loss within the past year. Cup-to-disc ratio ≥0.8 Central corneal thickness <500 µm or >600 µm History of adult asthma or chronic obstructive pulmonary disease A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Matched vehicle-control | Drug: Placebo<br>* Matched vehicle-control<br>|
| Experimental: INO-8875<br>Adenosine agonist eye drop | Drug: INO-8875<br>* eye drops for 14 days in one eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with decreased Intra-ocular pressure |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, ocular hypertension, adenosine agonist, eye drop, primary open angle glaucoma
Pilot Study of NASHA/Dx Gel for Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

Official Title
-----------------
A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Device: Solesta (Nasha/Dx)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fecal incontinence with at least 2 episodes/week Symptom duration at least one year Failed attempt of conservative therapy Age 18-80 Written informed consent Available for follow-up Fully compliant with protocol Exclusion Criteria: Active inflammatory bowel disease Total external sphincter defect at ultrasound and clinical examination Bleeding diathesis or anticoagulant therapy Rectal prolapse or intussusceptions Present anal sepsis Anorectal implants Recent anorectal surgery (within 6 months) Rectal anastomosis Pregnancy, postpartum (one year) or breast feeding

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Solesta (Nasha/Dx)|Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal incontinence episodes |  | Follow up during a four week period and after 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects related to treatment |  | 12 months |