linjc16/ctgov huggingface dataset:
Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to offer subjects from centers in Taiwan who successfully complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF for up to three additional years (144 weeks). Subjects will be followed per local standard of care. Serious adverse events (SAEs), drug accountability and patient disposition will be recorded.

Official Title
-----------------
A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Tenofovir DF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. Complete all end of study visit procedures for the GS US 174-0108 study. Willing and able to provide written informed consent. A negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study GS-US-174-0141) for GS US 174-0108 (unless surgically sterile or greater than two years post-menopausal) All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion. Exclusion Criteria: • Not Applicable

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Tenofovir DF<br> | Drug: Tenofovir DF<br>* Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators<br>* Other names: Viread®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs. |  | 3 years |
Biological Functions of Carotenoids in Humans

Study Overview
=================
Brief Summary
-----------------
This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation. The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.

Official Title
-----------------
Functional Bioavailability of Carotenoids in Humans

Conditions
-----------------
Oxidative DNA Damage

Intervention / Treatment
-----------------
* Drug: mixed carotenoids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting. Exclusion Criteria: Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mixed carotenoids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA damage |  |  | 
| plasma carotenoid concentrations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid peroxidation |  |  | 
| Total antioxidant capacity |  |  |
Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points

Study Overview
=================
Brief Summary
-----------------
A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa. Samples will be taken from the same participant at different timepoints. DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit and will be quantified by a nano-drop spectrophotometer. We will determine global and gene-specific methylation and hydroxymethylation alterations by UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter genes, and genes involved in the oxidative stress pathways will be assessed by PCR-pyrosequencing.

Official Title
-----------------
Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points

Conditions
-----------------
DNA Methylation

Intervention / Treatment
-----------------
* Procedure: Buccal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volunteers<br>30 volunteers, half men and half women Buccal swab | Procedure: Buccal swab<br>* Buccal swabs will be taken from the volunteers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %Methylation (%) |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %Hydroxymethylation (%) |  | 5 weeks |
A Comparison of Bowel Preparation for Colonoscopy Between Digestive Physicians and Non-digestive Physicians

Study Overview
=================
Brief Summary
-----------------
The diagnostic accuracy of colonoscopy depends on the quality of bowel preparation, which is a critical element associated with the diagnostic yield, difficulty, time required, and the completeness of colonoscopy. The non-digestive physicians seemed to have a lower quality of bowel preparation compare to the digestive physicians. Therefore, investigators planned to evaluate the risk factors for suboptimal intestinal preparation in outpatients from the perspective of digestive doctors and non-digestive.

Official Title
-----------------
A Comparison of Bowel Preparation for Colonoscopy Between Digestive Physicians and Non-digestive Physicians

Conditions
-----------------
Bowel Preparation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All outpatients who have already completed the colonoscopy during December 2019 and October 2020. Exclusion Criteria: Patients with incomplete critical information, primary outcome, and baseline characteristics missing as well as examinations in hospitalized patients were excluded.
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 |
| --- | --- | --- |
| Adequate bowel preparation | BBPS score (defined as a BBPS score of 2 or higher in any segment and the total BBPS≥6) | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Predictive factors, Outpatients, Colonoscopy
Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo

Study Overview
=================
Brief Summary
-----------------
Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.

Detailed Description
-----------------
The invited population will be offered ultrasound investigation of their abdominal aorta. Further information regarding risk factors will be noted and measurement of ankle-brachial index will be measured/calculated. A further step in the future will be to sample blood with focus on different cytokines and genmediators.

Official Title
-----------------
Screening for Abdominal Aortic Aneurysm

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males aged 65 years Exclusion Criteria: None

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

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

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 |
| --- | --- | --- |
| Abdominal Aortic Aneurysm (AAA) | AAA definition: diameter equal or more than 30 mm. The number of identified patients with AAA will be yearlig assessed. | Yearly the number of patients with AAA among the screened population will be assessed during the inclusion period of 18 years.. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Arterial Disease (PAD) | Investigate the prevalence of PAD among patients with AAA defined as having Ankle-Arm Index (AAI) less than 0.9. The number of these patients will be assessed yearly. | Yearly the number of patients with PAD among the screened poplulation will be assessed during the inclusion period of 18 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm, atherosclerosis
Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
This study aims to look at the impact on patient outcomes arising from measures implemented during the COVID-19 pandemic. The information and knowledge from this study will be useful for the management and allocation of hospital resources and patients in tne event of a disease outbreak.

Official Title
-----------------
Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study involves the extraction of patient records from the enterprise dataware house. As such, we do not stipulate the age limits. Patients who had the following surgeries during over the period of 1 Jan 2017 to 31 December 2020 From the identified surgical procedure type or the following cancer-related procedures: Breast Colon Liver Rectum Selected non-cancer surgeries: Abdominal Wall Gallbladder Patients from SGH and its related institute NCC Only local Singapore Citizens Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Analysis of patients according to type of surgical procedures, medical condition and dates of surgical treatment retrospectively. | These patients are classified according to the institution, type of surgical procedures, the medical condition and the dates of surgical treatment. The study will be compared across four time periods. | 1 Jan - 31 Dec 2017, 1 Jan - 31 Dec 2018, 1 Jan - 31 Dec 2019, 1 Jan - 31 Dec 2020 | 
| Comparing surgical indices for high volume cancer and non-cancer diagnoses | The study focus on surgical indices for selected high-volume cancer and non-cancer diagnoses over the period 1st January2020 to 31 December 2020 and compare them with similar indices across the same period of time in the preceding 3 years in particular, for the following surgical procedures: Surgeries for the following cancer diagnoses: breast cancer, [XIV- N60, no malignancy], [Malignant, IINeoplasms- C50], colorectal cancer, [C18, 19, 20], hepatocellular carcinoma, [C22] Selected non-cancer surgeries: Cholecystectomy Abdominal hernia repair | 1 Jan 2020 - 31 Dec 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19 pandemic, emergency, cancer, elective surgery, postponement
Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

Detailed Description
-----------------
This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: ZGN-433


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese, otherwise healthy females Post menopausal or infertile Weight ≥ 50 kg BMI ≥ 32 and ≤ 45 kg/m2 Exclusion Criteria: Use of weight loss agents in the past month History of eating disorder History of diabetes or other endocrine disorder History of gastric bypass Current smokers Unstable body weight during the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZGN-433<br> | Drug: ZGN-433<br>* Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.<br>* Other names: Beloranib hemioxalate;|
| Placebo Comparator: Normal Saline<br> | Drug: ZGN-433<br>* Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.<br>* Other names: Beloranib hemioxalate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests. |  | Approximately 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Approximately 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obese, Obesity, Overweight
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.

Detailed Description
-----------------
Bioequivalence

Official Title
-----------------
Bioequivalence Study Of 10ml Dose Of Phenytoin 0.75g/100ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus Epamin® 0.75g/100ml Made By McNeil LA LLC, Study In 34 Healthy Volunteers Under Fasting Conditions.

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

Intervention / Treatment
-----------------
* Drug: Epamin: Reference Drug
* Drug: Phenytoin: Study Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive A Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight >50 kg (110 lbs) An informed consent document signed and dated by the subject or a legally acceptable representative. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) Any condition possibly affecting drug absorption (eg, gastrectomy) A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epamin: McNeil LA LLC<br> | Drug: Epamin: Reference Drug<br>* Single dose of 75 mg (10 ml in suspension) of Epamin<br>|
| Experimental: Phenytoin: Laboratorios Pfizer SA DE CV<br> | Drug: Phenytoin: Study Drug<br>* Single dose of 75 mg (10 ml in suspension) of Phenytoin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To prove the bioequivalence of Phenytoin versus Epamin by measuring; Area under the curve (AUC), Maximum Concentration (Cmax), Time maximum concentration (tmax), Constant of elimination (ke), Elimination half life (t1/2) |  | April 2010 - May 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence, Phenytoin, Epamin
The Relationship Between NK Cell and Graves' Disease

Study Overview
=================
Brief Summary
-----------------
Graves' disease (GD) is one of organ specific autoimmune diseases, the pathogenesis is not elucidated.Natural Killer (Natural Killer, NK) cells is a kind of important immune regulator, several abnormalities of NK cell function and number in GD patients have been described in the investigators' previous study. It is remain unclear whether the NK cell disfunction is a consequence of GD.Based on the investigators' previous study, the investigators plan to monitor NK cell function in participants in the whole course of disease, analyze the association with relevant factors, such as thyroid function, immune state or treatment,to find out influences of thyroid hormones and thyroid receptor antibody affecting the function of NK cell. The investigators will reveal whether the disfunction of NK cell secondary to GD abnormal thyroid function and/or immune disorders, and realize the mechanics.

Official Title
-----------------
Mechanism of NK Cell Disfunction in Graves' Disease

Conditions
-----------------
Graves Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New GD patients without any treatment Aged of 18 to 75 years old Exclusion Criteria: Pregnant or lactating woman; Known autoimmune disease; Receiving psychotropic or hormonal drugs; Taking drugs that affect the body's immune function; Obviously poor compliance.

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 |
| --- | --- |
| New untreated GD patients<br>Before treatment and application of anti-thyroid drugs (methimazole) or radioactive iodine treatment | |
| Healthy control<br>No thyroid related diseases and other immune diseases | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and function of NK cells changes of hyperthyroidism | Flow cytometry used to measure the related changes of NK cells in hyperthyroidism | measured after 2 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum levels | Detection of related cytokines by ELISA | measured after 2 years of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atuoimmune thyroid disease, Graves' disease, Natural killer cell