linjc16/ctgov huggingface dataset:
Electrophysiological Changes With Diet.

Study Overview
=================
Brief Summary
-----------------
Dietary habits may affect our body by certain mechanisms, visual sense is one of the most vital human senses that needs special attention in our daily habits.

Detailed Description
-----------------
Retinal function directly related to our quality of vision, different drugs can affect our vision in certain ways, however, out unhealthy dietary habits can indirectly affect our quality of life and vision.

Official Title
-----------------
Retinal Functional Changes With Different Dietary Habits.

Conditions
-----------------
Fasting, Intermittent, Fasting Hypoglycemia, Fasting, Obesity, Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: Retinal electrophysiology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects with intermittent fasting. obese subjects with body mass index more than 30. Exclusion Criteria: patients with any retinal diseases that may ter retinal functional test. patients on systemic drugs that may alter retinal function.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intermittent fasting healthy group<br>Healthy participants with intermittent fasting dietary habit. | Diagnostic Test: Retinal electrophysiology<br>* Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.<br>|
| Active Comparator: Obesity group<br>Subjects with body mass index more than 30. | Diagnostic Test: Retinal electrophysiology<br>* Retinal electrophysiology to assess retinal function before and with fasting during ramadan in both groups.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal function amplitude | Changes in amplitude of retinal electrophysiology in both groups measured in nano volt/degree. | Baseline and one month after fasting in both groups. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal function latency. | Changes in latency of retinal electrophysiology in both groups measured in milliseconds. | Baseline and one month after fasting in both groups. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fasting, Ramadan, Diet, Retina, Electroretinogram
Popliteal Block for Lower Limb Angioplasty

Study Overview
=================
Brief Summary
-----------------
Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.

Official Title
-----------------
The Benefit of Popliteal Sciatic Nerve Block for Lower Limb Angioplasty in Critical Limb Ischemia: a Randomised Controlled Trial

Conditions
-----------------
Angioplasty, Anaesthesia and Analgesia

Intervention / Treatment
-----------------
* Procedure: Popliteal block
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 20 year-old with chronic ischemic limb pain Scheduled for peripheral angioplasty under monitor anaesthesia care Expected timing of procedure not more than 3 hours Exclusion Criteria: Age less than 21 Cannot cooperate with the staff Having pain in other areas or both legs Contraindicate for nerve block Allergy to local anesthetic drugs or sedative drugs

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Popliteal block group<br> | Procedure: Popliteal block<br>* Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.<br>|
| Active Comparator: Control group<br> | Other: Control<br>* Sciatic nerve at popliteal fossa would be scanned with the ultrasound. The toothpick would be applied to simulate the procedure of nerve block.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of general anaesthesia |  | Five hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical pain rating scale during procedure |  | Five hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
popliteal block, chronic limb ischemia
Peripheral Blood Biomarkers Associated With CIPN

Study Overview
=================
Brief Summary
-----------------
The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.

Detailed Description
-----------------
The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.

Official Title
-----------------
Investigation of Peripheral Blood Biomarkers Associated With CIPN

Conditions
-----------------
Peripheral Neuropathy, Secondary to Drugs or Chemicals

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN) Age ≥ 18 years Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. Exclusion Criteria: Inability to give consent Inability to tolerate venipuncture for any reason Age < 18 years Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician Consent Refusal by patient

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 |
| --- | --- | --- |
| Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers). | Variant S1P/S1PR related biomarkers; CIPN Questionnaire for Blood Collection Protocol (non-standardized questionnaire, 0-4 rating scales, 0 = no symptoms, 4 = very severe symptoms, symptoms: neuropathic pain severity/unpleasantness, sharpness, depth, tingling, numbness) | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CIPN
Iron Long-Term Labelling Study Malawi

Study Overview
=================
Brief Summary
-----------------
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.

Official Title
-----------------
The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study

Conditions
-----------------
Iron Absorption

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have participated in the original absorption study and the two follow-up samplings Signed written informed consent from the guardian to participate in the study Exclusion Criteria: Long-term medication Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet)) Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start. Residence too far away (> 2 hours by motorbike) from study location (Zomba)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron isotope composition in blood | the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days | 2 years |
Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol.

Official Title
-----------------
Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Acyl ghrelin
* Drug: Placebo (Ringer acetate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male age 18-65 years (included) Body mass index 20-25 (included) Exclusion Criteria: alcohol abuse malignant disease use of any medicine except otc painkillers any disease recognized participation in a trial using radioactive isotopes within the last 6 months

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

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ghrelin<br>Ghrelin | Drug: Acyl ghrelin<br>* Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes<br>* Other names: Ghrelin;|
| Placebo Comparator: Placebo<br>Ringer acetate is used for placebo. | Drug: Placebo (Ringer acetate)<br>* Ringer acetate 2 microliter/min for 300 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial concentrations of glycerol |  | Interstitial concentrations of glycerol at t=120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial concentrations of lactate |  | Interstitial concentrations of lactate at t=120 minutes | 
| Interstitial concentrations of glucose |  | Interstitial concentrations of glucose at t=120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ghrelin, Microdialysis, Controls, Metabolic effects of ghrelin
Follow-Up Study for Men Diagnosed With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program

Study Overview
=================
Brief Summary
-----------------
There is controversy concerning the preferred treatment for men with localized prostate cancer with regard to the relative effectiveness of different treatments in controlling the cancer and how different treatments affect the patient's quality of life. The purpose of this research is to describe the disease course of prostate cancer and to determine the effectiveness, potential complications, and quality of life after different treatments in men with prostate cancer detected via screening with prostate-specific antigen (PSA) and/or digital rectal examination

Official Title
-----------------
Follow-Up Study for Men Diagnoses With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Men with prostate cancer diagnosed through the PSA screening study

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

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

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 |
| --- | --- | --- |
Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h after surgery was assessed and compared using a visual analog scale.

Detailed Description
-----------------
Patients scheduled for elective phacoemulsification and intraocular lens implantation with the Infiniti Vision System (Alcon, Fort Worth, USA) were included. All operations were performed in Kyungpook National University Hospital by the same surgeon between March and August 2016.

Official Title
-----------------
Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification

Conditions
-----------------
Phacoemulsification

Intervention / Treatment
-----------------
* Device: Phacoemulsification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent phacoemulsification with topical anesthesia Exclusion Criteria: Patients who needed general anesthesia or were taking medications capable of affecting perceived pain Patients who had traumatic cataract and/or conditions likely to require vitrectomy and trans-scleral fixation of posterior chamber intraocular lens
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 |
| --- | --- |
| Enrolled group<br>Patients who had senile cataract and underwent phacoemulsification with topical anesthesia. | Device: Phacoemulsification<br>* The device device used to provide and perform small profile entry for cataract extraction with or without option of insertion of a specified intraocular lens implant<br>* Other names: INFINITI® Vision System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score assessed with Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. A third person assessed subjective pain using a pain visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable) after surgery. | 1 hour after the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, axial length, anterior chamber depth, intraocular pressure
Maintenance Transcranial Electrical Stimulation for Depression

Study Overview
=================
Brief Summary
-----------------
Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.

Official Title
-----------------
A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression

Conditions
-----------------
Major Depressive Disorder, Bipolar Disorder

Intervention / Treatment
-----------------
* Device: Transcranial electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants will be ≥ 18 years old. Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS). Exclusion Criteria: Inadequate response to acute trial of TES. Suicidality. Clinically defined neurological disorder or insult. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. Pregnancy (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study). Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication. Treatment for depression is changed during months 3-9 of the trial.

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: Transcranial electrical stimulation<br> | Device: Transcranial electrical stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Treatment, Transcranial electrical stimulation, Maintenance
Open-label Study of Safety and Tolerability of Memantine in Children With Autism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.

Detailed Description
-----------------
This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period. In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats. The weight-based dose limits in these studies were as follows: Group A: ≥ 60 kg; max 15 mg/day Group B: 40-59 kg; max 9 mg/day Group C: 20-39 kg; max 6 mg/day Group D: < 20 kg; max 3 mg/day

Official Title
-----------------
An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism

Conditions
-----------------
Autism, Pediatric Autism

Intervention / Treatment
-----------------
* Drug: Memantine HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed lead-in study MEM-MD-57A (NCT00872898) A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient Exclusion Criteria: Patients with a concurrent medical condition that might interfere with the conduct of the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Memantine<br>Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period. | Drug: Memantine HCl<br>* Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.<br>* Other names: Namenda XR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) | Number of patients who experienced one or more TEAEs during the study | From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Namenda, Autism, Memantine, Pediatric, Forest Laboratories