linjc16/ctgov huggingface dataset:
Gypenosides Treatment for Optic Neuritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.

Official Title
-----------------
Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Optic Neuritis

Intervention / Treatment
-----------------
* Drug: Gypenosides
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Male and female Chinese patients aged ≥18 to ≤60 years Patients with a first episode of optic neuritis in the eye of interest First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product Best corrected visual acuity in the eye of interest ≤0.8 Exclusion criteria Pre-existing multiple sclerosis MS or NMO Refractive media opacity Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc) Existing other retina or optic nerve diseases Pregnant or females who plan to be pregnant during study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Gypenosides<br> | Drug: Gypenosides<br>* Participants will receive gypenosides 360 mg/day (120 mg three times a day) for 10 days.<br>* Other names: Jiaogulan Zongdai;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Participants will receive placebo three times a day for 10 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean retinal nerve fibre layer thickness |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total macular volume |  | 6 months | 
| Best corrected visual acuity |  | 6 months | 
| Latency and amplitude of visual evoked potentials |  | 6 months | 
| Mean visual field defect |  | 6 months | 
| Number of participants with Adverse events |  | Screening until end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuroprotection, Clinical trial, Traditional Chinese medicine, Axonal loss, Jiaogulan, Gynostemma pentaphyllum, Optical coherence tomography
Pilot Study of Myocardial Effects Following an Endurance Race

Study Overview
=================
Brief Summary
-----------------
Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests for myocardial injury and inflammation. The same data are collected <24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow.

Detailed Description
-----------------
Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests (troponin T, hs-CRP, CK-mb etc) for myocardial injury and inflammation. The same data are collected <24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging (MRI) is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow. The CT of the heart includes contrast injection and blood flow will be determined by a recently developed based on very powerful computers using machine learning.

Official Title
-----------------
A Pilot Study of the Myocardial Effects of an Endurance Race as Evaluated by Computer Tomography

Conditions
-----------------
Myocardial Blood Flow

Intervention / Treatment
-----------------
* Behavioral: Endurance Race


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, experienced in long distance running Exclusion Criteria: Significant renal, kidney, heart, liver or musculoskeletal disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endurance race<br>baseline investigations with CT and lab tests the same CT and lab tests < 24h after an endurance race CT and lab tests again about 1-2weeks after the race | Behavioral: Endurance Race<br>* 1 CT and lab tests, 2 CT and lab tests within 24h of a race, 3 follow up investigations 1-2 weeks after the race with CT and lab tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in myocardial blood flow by the race? | Detection of potential differences in blood flow between occasion 1 and 2 and 3 | All investigations are performed < 2 months |
Missed Serious Medical Illness in Psychiatric Patients Seen in an Academic Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence, etiology, and timing of missed Serious Medical Illness (SMI) in patients referred to adult psychiatry by emergency physicians, as well as to determine admission rates for SMI soon after discharge from an inpatient psychiatry admission.

Official Title
-----------------
Missed Serious Medical Illness in Psychiatric Patients Seen in an Academic Emergency Department

Conditions
-----------------
Psychiatric Patients, Serious Medical Illness

Intervention / Treatment
-----------------
* Other: admission to non-psychiatric service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients greater than or equal to 18 years of age presenting to London Health Sciences Centre, Victoria Hospital emergency department between October 1, 2014 - July 31, 2015 who were referred to adult psychiatry by the emergency physician. Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: admission to non-psychiatric service|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of referrals to medical/surgical consult services within 14 days of psychiatric referral |  | 10 months |
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin 50 mg bid
* Drug: Vildagliptin 50 mg qd
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 Agreement to maintain the same dose of metformin from randomization to the end of the study Age in the range of 18-78 years inclusive Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1 HbA1c in the range of > 7.0 to ≤10% at Visit 1 Agreement to maintain prior diet and exercise habits during the full course of the study Ability to comply with all study requirements Exclusion Criteria: Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1 Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- |
| Experimental: Vildagliptin Dose 1<br> | Drug: Vildagliptin 50 mg bid<br> <br> |
| Experimental: Vildagliptin Dose 2<br> | Drug: Vildagliptin 50 mg qd<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c after 24 weeks |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with HbA1c < 7% after 24 weeks |  | 24 weeks | 
| Adverse event profile after 24 weeks of treatment |  | 24 weeks | 
| Change from baseline in fasting plasma glucose at 24 weeks |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, HbA1c reduction, vildagliptin, add-on to metformin, Chinese patients
Perioperative Melatonin in Lumbar Laminectomy

Study Overview
=================
Brief Summary
-----------------
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.

Official Title
-----------------
Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy

Conditions
-----------------
Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.

Intervention / Treatment
-----------------
* Dietary Supplement: 5 mg melatonin
* Dietary Supplement: 10 mg melatonin
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 65 years old ASA status 1-3 having lumbar laminectomy 2 to 3 levels with or without fusion Exclusion Criteria: receiving emergent procedure surgery for neoplastic spine lesion allergy to melatonin or its non-medicinal ingredients allergy or contraindication BMI over 35 or or less than 20 kg/m2 pregnancy or breastfeeding failure to provide informed consent

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin 5 mg<br>Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. | Dietary Supplement: 5 mg melatonin<br>* Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.<br>|
| Experimental: Melatonin 10 mg<br>Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. | Dietary Supplement: 10 mg melatonin<br>* Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.<br>|
| Placebo Comparator: Placebo<br>Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery. | Dietary Supplement: Placebo<br>* Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be assessed over a 24 hour period following surgery using a visual analogue scale | 24 hours | 
| Anxiety | Anxiety will be assessed over a 24 hour following surgery using visual analogue scale | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score
Effect of Stimulant Drugs on Social Perception

Study Overview
=================
Brief Summary
-----------------
The study will improve our understanding of the prosocial effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the uniquely social effects of MDMA.

Official Title
-----------------
Effect of Stimulant Drugs on Social Perception

Conditions
-----------------
Effects of MDMA on Healthy Human Volunteers

Intervention / Treatment
-----------------
* Drug: 3,4-Methylenedioxymethamphetamine
* Drug: methamphetamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High school degree English fluency Healthy Has used MDMA Exclusion Criteria: Pregnant or trying to become pregnant Any medical or psychiatry condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will attend one session during which they will receive a placebo capsule. | Drug: 3,4-Methylenedioxymethamphetamine<br>* Participants will be given 0.75mg/kg of 1.5mg/kg MDMA<br>Drug: methamphetamine<br>* Please see above.<br>|
| Experimental: Low dose MDMA<br>Subjects will attend one session during which they will receive 0.75mg/kg MDMA. | Drug: 3,4-Methylenedioxymethamphetamine<br>* Participants will be given 0.75mg/kg of 1.5mg/kg MDMA<br>Drug: methamphetamine<br>* Please see above.<br>|
| Experimental: High dose MDMA<br>Subjects will attend one session during which they will receive 1.5mg/kg MDMA. | Drug: 3,4-Methylenedioxymethamphetamine<br>* Participants will be given 0.75mg/kg of 1.5mg/kg MDMA<br>Drug: methamphetamine<br>* Please see above.<br>|
| Experimental: Methamphetamine<br>Subjects will attend one session during which they will receive 20mg methamphetamine. | Drug: 3,4-Methylenedioxymethamphetamine<br>* Participants will be given 0.75mg/kg of 1.5mg/kg MDMA<br>Drug: methamphetamine<br>* Please see above.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to affective touch | Participants will complete an affective touch task during which time they will rate pleasantness of touch | End of study (time 0 and approximately six weeks later) |
Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.

Detailed Description
-----------------
The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease. Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults, even in the absence of antiretroviral treatments. In studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. This study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in HIV infected children in the Dominican Republic. Children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.

Official Title
-----------------
Massage to Enhance Well-Being in HIV-Positive Dominican Children

Conditions
-----------------
HIV Infections, AIDS

Intervention / Treatment
-----------------
* Procedure: Massage therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Parent/caregiver signature on consent form Exclusion criteria: Unknown HIV status Fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry Massage therapy within 30 days prior to study entry Unable to have massage (e.g., extensive skin lesions) Symptoms of child abuse Child born drug-addicted

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Massage therapy|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
-----------------
Complementary Therapies
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.

Official Title
-----------------
A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

Conditions
-----------------
Huntington's Disease

Intervention / Treatment
-----------------
* Other: Placebo
* Drug: Dimebon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD; Able to take medication (capsules) by mouth. Exclusion Criteria: Clinical evidence of unstable medical illness; Females who are pregnant or lactating or who intend to become pregnant during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 29 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: 1<br>Placebo | Other: Placebo<br>* Placebo TID x 90 days<br>|
| Experimental: 2<br>Dimebon | Drug: Dimebon<br>* Dimebon 20 mg TID x 90 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease. |  | 90 days | 
| To assess the pharmacokinetics of Dimebon. |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.