linjc16/ctgov huggingface dataset:
The Effect of Melatonin and Vitamin C on COVID-19

Study Overview
=================
Brief Summary
-----------------
This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.

Official Title
-----------------
The Effect of Melatonin and Vitamin C on COVID-19

Conditions
-----------------
Covid19, SARS-CoV Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin C
* Dietary Supplement: melatonin
* Dietary Supplement: Placebo
* Other: Symptom Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria COVID-19 positive test (outpatient testing), Age >50 (chosen based greater risk for older patients to be vitamin deficient, age >65 not used so as not to be too restrictive in the inclusion criteria) Experiencing symptoms for <5 days prior to enrollment Able to read and write in English or Spanish Able to access REDCap daily Valid email address Current has a Lancaster General Health primary care physician Exclusion Criteria COVID-19 test ordered pre-procedure for asymptomatic screening Currently taking vitamin C supplements Currently taking melatonin supplements Currently hospitalized Deceased Currently pregnant Currently incarcerated

Ages Eligible for Study
-----------------
Minimum 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental- Melatonin<br>Patients will receive melatonin | Dietary Supplement: melatonin<br>* 10mg melatonin, at bedtime<br>Other: Symptom Survey<br>* Daily symptom survey to be completed by patient electronically<br>|
| Experimental: Experimental- Vit C<br>Patients will receive vitamin C | Dietary Supplement: Vitamin C<br>* 1000mg Vitamin C, at bedtime<br>* Other names: ascorbic acid;Other: Symptom Survey<br>* Daily symptom survey to be completed by patient electronically<br>|
| Placebo Comparator: Control<br>Patients will receive placebo | Dietary Supplement: Placebo<br>* Placebo at bedtime<br>Other: Symptom Survey<br>* Daily symptom survey to be completed by patient electronically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Severity | Symptom severity will be tracked electronically | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom progression | Determine symptom course of those with moderate or severe symptoms | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin c, melatonin
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

Study Overview
=================
Brief Summary
-----------------
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug. The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.

Official Title
-----------------
A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.

Conditions
-----------------
Kidney de Novo Transplant

Intervention / Treatment
-----------------
* Drug: Enteric-coated Mycophenolate sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female patients undergoing first kidney transplant. Patients aged 18 -70 years. Patients receiving an ABO identical or compatible graft. Exclusion Criteria Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney. Positive HBsAg test Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-coated Mycophenolate sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biopsy proven acute rejection incidence at 1 year post-transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection episodes at 6 months |  |  | 
| Incidence of treated rejection episodes at 6 months and 1 year |  |  | 
| Incidence of steroid-resistant episodes at 6 months and 1 year |  |  | 
| Patient and graft survival at 1 year |  |  | 
| Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA) |  |  | 
| Percentage of patients free from steroids at 6 months and 1 year |  |  | 
| Treatment safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine
Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.

Conditions
-----------------
Postpartum Hemorrhage， Cesarean Section

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational week more than 37; to delivery by cesarean section; informed consent form signed Exclusion Criteria: Any known renal or liver disorders History of venous or arterial thrombosis Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker. Do cesarean section because of active bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: placebo<br>NS 10ml IV in 2 minutes after the baby delivered during ceasarean section | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum hemorrhage |  | 24h after the cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of postpartum bleeding |  | 24h after the cesarean section | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum hemorrhage， cesarean section， tranexamic acid
Impact of tDCS on Cerebral Autoregulation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether there is a polarity-specific influence of tDCS on cerebral vasomotor reactivity monitored by transcranial doppler sonography.

Conditions
-----------------
Cerebral Microangiopathy, CADASIL, Migraine With Aura, ICA Stenosis

Intervention / Treatment
-----------------
* Device: Anodal tDCS
* Device: Cathodal tDCS
* Device: sham tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe cerebral Microangiopathy NOTCH3 carrier Migraine with aura (IHS Classification ICHD-II) Stenosis >80%, ECST-Criteria Exclusion Criteria: seizure disorder history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity dementia (1+2) history of stroke in past 3 months (3) migraine prophylaxis (4) contralateral stenosis >50%,

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal tDCS<br>anaodal transcranial direct current stimulation | Device: Anodal tDCS<br> <br> |
| Active Comparator: Cathodal tDCS<br>cathodal transcranial direct current stimulation | Device: Cathodal tDCS<br> <br> |
| Sham Comparator: Sham tDCS<br>no stimulation | Device: sham tDCS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral vasomotor reactivity assessed by transcranial Dopplersonography | comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation | on 3 days within 12 weeks |
Urinary miRNA in Endometrial Cancer Study

Study Overview
=================
Brief Summary
-----------------
This study is a prospective feasibility study with the addition of a retrospective cohort study on the the expression of microRNA in urine in endometrial cancer patients.

Official Title
-----------------
Urinary microRNA Expression in Endometrial Cancer Patients - a Feasibility Study

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Urinary miRNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of endometrial cancer Age: 18 years or older Exclusion Criteria: Prior or coexisting other malignancies Autoimmune disorders (other than diabetes mellitus)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometrial cancer patients<br> | Diagnostic Test: Urinary miRNA<br>* MiRNA detection in urine<br>|
| Control group<br>Patients without cancer | Diagnostic Test: Urinary miRNA<br>* MiRNA detection in urine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of predictive value of miRNA test in detecting endometrial cancer | To determine if miRNA can distinguish endometrial cancer patients from healthy patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation to final histology | To determine how well miRNA correlates with final histology, i.e. can miRNA determine the subtype of endometrial cancer | 6 months |
CATS Tonometer IOP Reduction Latanoprost Verses Timolol

Study Overview
=================
Brief Summary
-----------------
Topical Prostaglandin Analog vs Betablocker - Corneal Biomechanical Evaluation using CATS Tonometer Prism

Detailed Description
-----------------
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative site in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after institution of topical prostaglandin analogs (PGA) for glaucoma treatment. Fifty percent of patients will be randomly placed on topical beta blockers as a control. The difference PGAs and beta blockers would be a measurement of the amount of corneal biomechanical changes made due to the PGA controlled for the effect of IOP lowering by the beta -blocker group.

Official Title
-----------------
Efficacy of Topical Latanoprost 0.005% Verses Timolol 0.5% Demonstrated by Corneal Biomechanical Correcting Modified Goldmann Prism

Conditions
-----------------
Glaucoma; Drugs

Intervention / Treatment
-----------------
* Device: CATS Tonometer
* Drug: Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Male and female patients, at least 18 years of age Subject has a clear understanding and agrees to all the conditions of the informed consent form Exclusion Criteria: Subjects shall be selected in accordance with the following exclusion criteria Subject has undergone ocular surgery within the last 3 months Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk Pregnant or nursing women Those who have had corneal surgery including corneal laser surgery Microphthalmos Buphthalmos Severe Dry eyes Lid squeezers - blepharospasm Nystagmus corneal or conjunctival infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 101 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lataprost<br>latanoprost use | Device: CATS Tonometer<br>* latanoprost vs. timolol<br>* Other names: latanoprost v. timolol;|
| Active Comparator: timolol<br>timolol group | Device: CATS Tonometer<br>* latanoprost vs. timolol<br>* Other names: latanoprost v. timolol;Drug: Latanoprost<br>* latanoprost IOP reduction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP reduction |  | 1 month |
Heart Failure Self-care With the Aid of a Smartphone Application

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with individuals with HF living at home. For the purpose of this study, smart phone communication was utilized. Smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. Using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. This study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.

Official Title
-----------------
Heart Failure Self-care With the Aid of a Smartphone Application

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

Intervention / Treatment
-----------------
* Other: Heart failure application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living in a non-nursing home setting primary providers of own self-care established diagnosis of heart failure cognitively intact able to speak/write English Exclusion Criteria: not willing to use a smartphone not exhibiting acute decompensated heart failure symptoms

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Failure Application<br>A mobile application that allowed for input of physiologic data, qualitative questions about symptoms and education | Other: Heart failure application<br>* A mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care of Heart Failure Index (SCHFI) | Measures how well a person monitors their symptoms, adhere to medication/diet and how confident they are in performing self-care. | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Somatic Awareness Scale | It determines the extent of distress associated with heart failure symptoms. | two weeks |
Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.

Detailed Description
-----------------
To evaluate the hemodynamic impact of different pacing MSLV configurations.

Official Title
-----------------
Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead

Conditions
-----------------
Multi-site Left Ventricular Pacing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system. Patients have signed an informed consent form indicating their willingness to participate to this study. Exclusion Criteria: Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason. Patients with second or third degree AV Block Patients with intrinsic atrial rhythm < 40 bpm Patients with a previously implanted left ventricular pacing lead. Patients who are pregnant. Patients currently participating in a clinical investigation that includes an active treatment arm. Patients under 18 years of age. Patients with a life expectancy of less then 6 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?
-----------------
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
-----------------
CRT-D
Treatment of Parkinson's Disease With Eliprodil

Study Overview
=================
Brief Summary
-----------------
Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. Patients with the disease experience, rigid muscles, stooped posture, and a shuffling-type walk (gait). In this study researchers plan to evaluate the effectiveness of the drug eliprodil for the treatment of Parkinson's Disease. Eliprodil works by blocking special receptors (NMDA) that are associated with the symptoms of Parkinson's Disease.

Detailed Description
-----------------
The objectives of this study are to evaluate the acute effects of the NR2B subtype-selective NMDA antagonist eliprodil on levodopa-associated motor response complications in patients with advanced Parkinson's Disease (PD).

Official Title
-----------------
NMDA-Receptor Blockade With Eliprodil in Parkinson's Disease

Conditions
-----------------
Movement Disorders, Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Eliprodil


Participation Criteria
=================
Eligibility Criteria
-----------------
All patients will carry a diagnosis of idiopathic Parkinson's Disease based on the presence of a characteristic clinical history and neurologic findings. Most will have relatively advanced disease with associated motor response complications. Males and females between the ages of 18-75. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. No patients with baseline QTc prolongation (greater than 440 msec). No pregnant women nor those not practicing effective means of birth control.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Eliprodil|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
-----------------
Dyskinesias, Glutamate Antagonist, Levodopa