linjc16/ctgov huggingface dataset:
Regulation of Intracerebral Pressure During Electroconvulsive Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether electroconvulsive therapy (ECT) has an influence on pressure within the human brain before, during and after ECT.

Detailed Description
-----------------
Aim: Our main objective concerning this study is to determine to what extent ECT does lead to an increase of the Pulsatility Index (as an indicator of intracerebral pressure) measured by a Transcranial Doppler Device (TCD). As a secondary objective we want to compare the PI measurements with simultaneously measured systemic blood pressure. Study design: a.Observational study: cohort study Treatment: a. Treatment as usual, PI and blood pressure measurement at baseline, just before ECT, during and 5 minutes after ECT. Data will be collected during unilateral treatment during 3 consecutive ECT treatments. Endpoints: A minimum of sixteen patients are needed according to the power analysis.

Official Title
-----------------
Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?

Conditions
-----------------
Depression, Intracranial Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Temporal window to measure PI Major depression Psychotic depression Exclusion Criteria: Under 18 years of age

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>All patients in the Rijnstate Hospital with an indication for unilateral ECT treatment and a major depression or psychotic depression according to DSM IV-TR criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulsatility Index before, during and after electroconvulsive therapy |  | before, during and after three consecutive ECT treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodpressure before, during and after ECT. |  | before, during and after three consecutive ECT treatments. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, electroconvulsive therapy, Ultrasonography Doppler Transcranial, intracranial pressure
Gastroparesis Registry

Study Overview
=================
Brief Summary
-----------------
The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

Detailed Description
-----------------
The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.

Official Title
-----------------
Gastroparesis Registry

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, post-prandial fullness, Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study Patients with either or both abnormal 2 hour (>60% retention) and 4 hour (>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp) Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE) Age at least 18 years at initial screening visit Ability and willingness to participate in follow-up Exclusion Criteria: Inability to comply with or complete the gastric emptying scintigraphy Presence of other conditions that could explain the patient's symptoms: Pyloric or intestinal obstruction Active inflammatory bowel disease Eosinophilic gastroenteritis Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions Acute liver failure Advanced liver disease (Child's B or C) Acute renal failure Untreated chronic renal failure (serum creatinine >3 mg/dL) Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy will be eligible for enrollment) Any other plausible structural or metabolic cause Any other condition, which in the opinion of the investigator would interfere with study requirements Inability to obtain informed consent

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
-----------------
gastroparesis
Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients

Study Overview
=================
Brief Summary
-----------------
To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).

Official Title
-----------------
A Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 in Blood and Cerebrospinal Fluid, When Administered Orally to Healthy Young Subjects and Patients With Alzheimer Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: GSI-953
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs. For AD patients: Patients must be generally healthy with the exception of Alzheimer Disease. (same as above)

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: GSI-953<br> <br> |
| Placebo Comparator: B<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will assess the pharmacodynamics (PD) of biomarkers amyloid beta 40 and 42 in CSF, following single oral doses of GSI-953 in healthy young and Alzheimer's Patients. |  | 5 months |
Exercise in Men With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.

Official Title
-----------------
A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy

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

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men aged 50 years or older diagnosed with adenocarcinoma prostate cancer will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment Patients will also consent to participating in the study. Exclusion Criteria: severe cardiac disease (New York Heart Association class III or greater) angina severe osteoporosis uncontrolled hypertension (blood pressure > 160/95mm Hg) orthostatic blood pressure drop > 20mm Hg moderate to severe aortic stenosis acute illness or fever uncontrolled atrial or ventricular dysrhythmias uncontrolled sinus tachycardia (> 120 beats per minute) uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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 |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Exercise<br> | Behavioral: Exercise<br>* Walking exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone health |  | baseline, 12 months |
Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation

Study Overview
=================
Brief Summary
-----------------
The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiated skin.

Detailed Description
-----------------
We will investigate the changes of the epidermal cell proteome after UV irradiation to the forearms of healthy young male volunteers. Knowledge of specific molecular markers may provide knowledge of basic biological systems and possibly targeted therapy of inflammation. By using combined proteomic methodologies we will be able to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins. This study may allow us to obtain fairly comprehensive profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understand of biological responses to UV irradiation.

Official Title
-----------------
Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation

Conditions
-----------------
Proteomics

Intervention / Treatment
-----------------
* Procedure: UV Irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Males age 18-30 Caucasian No neurological disease Exclusion Criteria: Use of any medication that affects skin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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: 1<br>Comparing irradiated skin to non irradiated skin. | Procedure: UV Irradiation<br>* UV irradiation<br>* Other names: UV irradiation.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain a profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understanding of biological responses to UV irradiation. |  | 1 year |
Influence of the COVId-19 Pandemic on STRESS and Eating Habits

Study Overview
=================
Brief Summary
-----------------
The Coronavirus has caused containment of more than a third of the world's population. Containment can drastically change lifestyle habits, including eating habits such as the number of meals, meal times or their composition. However, there is currently no data on the influence of confinement on eating habits.

Detailed Description
-----------------
This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made. The self-administered questionnaire will assess stress, changes in eating habits, and relationships with socio-demographic or lifestyle factors. This questionnaire includes 9 specific questions on nutrition and 40 general questions.

Official Title
-----------------
Influence of the COVId-19 Pandemic on STRESS and Eating Habits

Conditions
-----------------
Nutrition

Intervention / Treatment
-----------------
* Behavioral: Eating habits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All volunteers who are screened Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Eating habits|Questionnary online|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress measures | Attitudes and stress related to screening procedure will be measured via questionnaire | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition | Eating habits will be measured via questionnaire | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, Covid-19, Eating habits, Stress
ctDNA Methylation Sequencing for Myeloma

Study Overview
=================
Brief Summary
-----------------
To carry out research on minimal residual disease (MRD) monitoring in patients with multiple myeloma (MM) based on plasma circulating tumor DNA (ctDNA) methylation sequencing, which aims to explore new MRD detection methods for MM; Carry out ctDNA-based methylation sequencing in newly diagnosed, remission, and, relapsed MM patients, to track the clonal evolution patterns; and explore the in the initial diagnosis-remission-relapse stage of MM, track the clonal evolution characteristics of methylation profiles in MM patients during the disease progression.

Official Title
-----------------
Circulating Tumor DNA Methylation Sequencing for Multiple Myeloma Minimal Residual Disease Detection and Clonal Evolution Monitoring

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: plasma circulation DNA methylation sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - For myeloma patients: i) Age no less than 18 and no more than 75; ii) Diagnosed with symptomatic multiple myeloma according to IMWG consensus; iii) Provide informed consent in accordance with the declaration of Helsinki. - For healthy controls: i) Age no less than 18 and no more than 75; ii) Provide informed consent in accordance with the declaration of Helsinki. Exclusion Criteria: - For myeloma patients: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons. - For healthy controls: i) Insufficient amount of peripheral blood obtained; ii) Methylation sequencing failed due to technical reasons.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Myeloma<br>This study includes a total of 60 multiple myeloma patients, and peripheral blood will be collected at newly diagnosed, remission after 4 cycles of therapy, and, relapse stage. | Other: plasma circulation DNA methylation sequencing<br>* 10 mL of peripheral blood will be drawn from 60 multiple myeloma patients at diagnosis, 4 months post-induction, and at relapse, and cell-free DNA is then extracted and undergo bisulfite methylation sequencing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample Collection Completed | When the peripheral blood samples required for the study have been collected | From Aug 31 2022 to Jun 30 2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circulationg tumor DNA, methylation sequencing, minimal residual disease, clonal evolution
Study of FYU-981 in Hyperuricemia With or Without Gout

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

Official Title
-----------------
Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)

Conditions
-----------------
Hyperuricemia With or Without Gout

Intervention / Treatment
-----------------
* Drug: FYU-981


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperuricemic or gout patients Serum urate level: >= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL Exclusion Criteria: Gouty arthritis within two weeks before start of study treatment Secondary hyperuricemia HbA1c: >= 8.4% Uric acid-overproduction type in the classification of hyperuricemia History of, clinically significant cardiac, hematologic and hepatic disease Kidney calculi or clinically significant urinary calculi eGFR: < 30mL/min/1.73m^2 Systolic blood pressure: >= 180 mmHg Diastolic blood pressure: >= 110 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 20 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: FYU-981<br> | Drug: FYU-981<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction from baseline in serum urate level at the final visit |  | 34 or 58 weeks |
Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females

Study Overview
=================
Brief Summary
-----------------
it is a cross-sectional study conducted in female patients attending outpatient clinc in our university hospital to assess their awareness regarding the symptoms of premenstrual dysphoric disorders.

Detailed Description
-----------------
this study will be conducted on females in the reproductive age attending the gynecological outpatient clinic to assess the prevalence of premenstrual dysphoric disorder(eeiPMDD) and their awareness regarding the symptoms of PMDD and the impact of these symptoms on their quality of life using questionnaire including ( knowledge , attitude and practice) of those Egyptian females.

Official Title
-----------------
Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females.Results of Surveying Two Centers in Delta Region

Conditions
-----------------
Premenstrual Dysphoric Disorder

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females in reproductive age history of regular menstruation Exclusion Criteria: history of any psychological disorders history of chemotherapy in last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire|it is in the form of questionnaire and scoring tool|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire  awareness of participants regarding PMDD symptoms | knowledge , attitude and practice through the time of questionnaire | during the study, an avarege 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire impact of the PMDD symptoms on the participants life | impact on their life questionnaire | 3 months |