linjc16/ctgov huggingface dataset:
Biotin Sample Collection Study

Study Overview
=================
Brief Summary
-----------------
This protocol has been designed for a collection of urine samples from volunteers who will be given high dose biotin supplements over a period of 5 days, in order to provide a research sample bank to examine for biotin excretion rates

Detailed Description
-----------------
This is a sample collection study from a minimum of 10 volunteers who will be required to take a Biotin supplement daily for a period of 5 days. Each volunteer will be asked to read the volunteer information sheet and if they wish to participate in the study, the study admission form will be completed and the volunteer will be asked to sign a consent form. After informed consent each volunteer will be assigned a unique volunteer number for the duration of the trial to provide anonymity. The volunteer will be provided with a daily diary, urine collection material and a full set of volunteer instructions. The daily diary will collect the following information; Date Whether or not supplement was taken and time taken sample collection times during the day Volunteers will be requested to: Day 1: Collect a urine sample from every void during the day. Days 2-6: Take biotin supplements with their evening meal and collect a urine sample from every void during the day Day 7: Collect a urine sample from every void during the day All samples will be stored in the SPD Bio-bank until required for analysis.

Official Title
-----------------
Biotin Urine Collection Study

Conditions
-----------------
Healthy Volunteers, Biotin Excretion

Intervention / Treatment
-----------------
* Dietary Supplement: Biotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to take biotin supplements and collect urine samples Has regular menstrual periods SPD employee or partner of SPD employee Exclusion Criteria: Taking any other supplements or medication (other than contraceptive pill) Taken Antibiotics in the last 4 weeks Diagnosed with metabolic disorder, kidney or liver disease Known Pregnancy or seeking to conceive Breast feeding Undergoing medical investigation for hormone imbalance Condition that contra-indicates pregnancy Condition that contra-indicates use of biotin supplements

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biotin<br>Volunteers to take biotin suppliment | Dietary Supplement: Biotin<br>* Biotin supplements (2) to be taken daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biotin excretion | rate of biotin excretion in urine | 2 months |
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective on HBV Carrier With Abnormal Liver Function.

Detailed Description
-----------------
% change HBV DNA title and liver function.

Official Title
-----------------
The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function: a Randomized Controlled Trial

Conditions
-----------------
Liver Dysfunction

Intervention / Treatment
-----------------
* Other: Compound Herbal Formula (RHD-1)
* Other: dilute RHD-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 < GPT <200 HBV carrier Age: 18-65 yrs old Exclusion: Creatinine >2.0 mg/dL Total bilirubin > 2.0mg/dL Not suitable patients diagnosis by physician in charge.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A foumula<br>Compound Herbal Formula (RHD-1) | Other: Compound Herbal Formula (RHD-1)<br>* 100 ml/per day<br>* Other names: Chinese herbal medicine;|
| Placebo Comparator: B formula<br>dilute Compound Herbal Formula | Other: dilute RHD-1<br>* 100 ml/per day<br>* Other names: Chinese herbal medicine dilute;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the % change of HBV DNA title |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the % change of GPT |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV carrier, HBV DNA title, Chinese Medicine, Liver function, RHD-1
Evaluating Pancreatic Tumors in Patients With Zollinger-Ellison Syndrome

Study Overview
=================
Brief Summary
-----------------
This protocol concerns the approach to the localization, diagnosis of MEN1 and management of the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the subsequent management of the tumor and tissue samples for research.

Detailed Description
-----------------
This protocol concerns the approach to the localization and management of the tumor in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor and the subsequent management of the tumor.

Official Title
-----------------
Evaluation of the Gastrinoma in Patients With Zollinger-Ellison Syndrome

Conditions
-----------------
Zollinger Ellison Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: New patients will be evaluated initially as described in the protocol entitled, Diagnostic evaluation of patients with suspected abnormalities of gastric secretion (89-DK-0005). Only those patients that are being treated under the protocol entitled, Medical Therapy of Zollinger-Ellison Syndrome (protocol # 89-DK-0015) will be entered into this tumor localization and management protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients<br>Patients will Zollinger-Ellison Syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine an approach to the localization and management of tumor in patients with ZES. | localization of tumor | Yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zollinger-Ellison Syndrome, Natural History
Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.

Official Title
-----------------
Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Colchicine Tablets
* Procedure: Cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation Candidate for cardioversion Exclusion Criteria: Colchicine allergy Hepatic or renal failure

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Cardioversion without treatment with Colchicine | |
| Active Comparator: Treatment group<br>This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months | Drug: Colchicine Tablets<br>* Administration of Colchicine at a dose of 0.5mg 2x a day for six months.<br>Procedure: Cardioversion<br>* Electrical or pharmacologic restoration of sinus rhythm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation | Atrial fibrillation recurrence rates over the next 12 months will be determined based on medical records and ECG documentation between treatment group (Colchicine) and control group. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha Defensin levels in patients with recurrence of atrial fibrillation | Alpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence. | 12 months |
Clinical Utility of a Low-Cost Hand-Held Breast Scanner

Study Overview
=================
Brief Summary
-----------------
Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.

Official Title
-----------------
Clinical Utility of a Low-Cost Hand-Held Breast Scanner

Conditions
-----------------
Symptomatic Breast Lump

Intervention / Treatment
-----------------
* Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Women and men with symptomatic breast lump (either by palpation or imaging) OR Asymptomatic women presenting to the imaging center for a screening mammogram. Signed Informed Consent Exclusion Criteria: Patients under 18 years of age Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests

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: Diagnostic
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breast scanner<br> | Device: PEFS system (Product Name: Intelligent Breast Exam™ or iBE™<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Quadrants With Detected Breast Lesions | The iBE results were evaluated by definitive quadrants. The definitive quadrants break down the superimposed clock into 4 equal sectors (e.g. 12-3, 3-6, 6-9, 9-12). | 3 months | 
| Sensitivity of iBE Breast Lesion Detection | the number of quadrants with positive breast lesion detected by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant. 77 quadrants were labeled positive for breast lesion by iBE, 66 were confirmed positive by mammogram or ultrasound allowing calculation of sensitivity of the the iBE breast lesion detection | 1 day | 
| Specificity of iBE Breast Lesion Detection | the number of quadrants characterized normal breast by iBE confirmed by mammogram and ultrasound, 4 quadrants per breast per participant | 1 day |
Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in HIV-1 infected asymptomatic individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative drug naїve subjects (secondary endpoint) in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in asymptomatic subjects.

Official Title
-----------------
Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be clinically asymptomatic HIV-1 infected individuals with CD4+ T cell counts ≥400/μL To be naïve for antiretroviral therapy Levels of plasma viremia ≤100,000 copies/ml at baseline Age ≥ 18 years Signed informed consent Exclusion Criteria: Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders Concomitant treatment for HBV or HCV infection

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 |
| --- | --- | --- |
| Specific humoral and cellular immune responses to Tat will be monitored by assessing anti-Tat specific antibodies in sera, proliferative response (CFSE) and production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decline of CD4+ T cells count, the increase of the HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine the progression to disease |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Therapeutic Vaccine
A Real Life Evaluation of the Performance of a Large Volume Nebulizer

Study Overview
=================
Brief Summary
-----------------
Continuous albuterol has become the standard of care for patients in status asthmaticus. We have previously performed an in-vitro study comparing 4 different brands of continuous nebulizers. We now want to compare the in-vitro with the in-vivo performance of the brand we use. we hypothesize that there will be no difference between in-vivo and in-vitro results.

Detailed Description
-----------------
There will be no intervention to the patients. Nebulizers will be used as per current policies and procedures. They will only be marked on the outside at the water level every 2 hours for the first 6 hours. Once ready to be discarded will be collected for laboratory testing Once in the laboratory, nebulizers will be weight on a precision scale without liquid, then they will be filled with normal saline to the first mark (6th hour) and re-weight. The nebulizers will be filled to next mark and re-weight until 200 mls. of total volume are achieved. Solution output will be calculated as the weight difference between the 2 hour periods.

Official Title
-----------------
A Real Life Evaluation of the Performance of a Large Volume Nebulizer

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients admitted to Pediatric Intensive Care Unit due to status asthmaticus, requiring continuous albuterol nebulization. Exclusion Criteria: Patients requiring invasive or non-invasive ventilation.

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |
| Nebulizer solution output |  | every 2 hours for first 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
large volume nebulizer
The Effect of Continuous, Various Doses of Furosemide Drip on Hearing as Measured by Acoustic Emission

Study Overview
=================
Brief Summary
-----------------
Pediatric patients, during their illness often treated with furosemide (Lasix) continuous drip, often, with dosages above 4-6mg/kg/day (the recommended dose). This study will monitor hearing status of these children prior to their therapy with furosemide, during this therapy and after.

Detailed Description
-----------------
This study will record hearing status, by acoustic emission, of critically ill children, treated with different dosages of furosemide drip. Acoustic emission test will be done prior to therapy and q48 hours during their course of treatment with furosemide drip. Dosage of furosemide drip, boluses and other relevant medications (i.e - vancomycin, muscular relaxants, aminoglycosides etc) will be recorded.

Official Title
-----------------
The Effect of Continuous, Various Dosages of Furosemide Drip on Hearing as Measured by Acoustic Emission

Conditions
-----------------
Hearing Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children admitted to Pediatric ICU who are treated with furosemide continuous drip. Exclusion Criteria: Children with known hearing abnormalities prior to treatment.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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
-----------------
children, critically ill, furosemide, acoustic emission
Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.

Official Title
-----------------
Phase3, Open-Label, Long-Term, NSAID-Add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea Associated With Endometriosis.

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: NPC-01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dysmenorrhea associated with endometriosis Exclusion Criteria: Severe hepatopathy Pregnant woman

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

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

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: NPC-01<br>Norethisterone, Ethinyl Estradiol | Drug: NPC-01<br>* This study consist of the following steps. Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles. Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg): After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain. | 52 weeks |