linjc16/ctgov huggingface dataset:
Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects with prostate cancer prior to it becoming commercially available. The patient will receive bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this therapy and safety information is provided regularly to AstraZeneca. Treatment will be discontinued after bicalutamide 150-mg becomes commercially available.

Official Title
-----------------
A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer

Conditions
-----------------
Adenocarcinoma of the Prostate

Intervention / Treatment
-----------------
* Drug: Bicalutamide (Casodex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with adenocarcinoma of the prostate Subjects with locally advanced, and/or metastatic prostate cancer for whom surgical castration or other medical interventions are not considered appropriate or acceptable Exclusion Criteria: Any known history of abnormal liver function tests Any severe concomitant condition that would make it undesirable, in the clinician's opinion, for the subject to participate in the trial. Known hypersensitivity to bicalutamide or any of the components found in bicalutamide

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bicalutamide (Casodex)|150mg|

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
-----------------
Prostate cancer, Casodex
Study of URC102 to Assess the Safety and Efficacy in Gout Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate Lowering Effect of URC102 in gout patients.

Official Title
-----------------
A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients

Conditions
-----------------
Gout, Hyperuricemia

Intervention / Treatment
-----------------
* Drug: URC102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with gout Exclusion Criteria: Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URC102<br>URC102 | Drug: URC102<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trend of serum uric acid reduction rate (%) |  | 2 weeks | 
| Trend of serum uric acid levels (mg/dL) |  | 2 weeks |
PTSD Interview Regarding Future Study Design and Equipment.

Study Overview
=================
Brief Summary
-----------------
To gain insight and perspective unique to individuals with a diagnosis of PTSD, this study will utilize an experiential one-to-one interview format. During the interview, an investigator will walk the participants through several aspects of an ANS battery of tests, provide a tour and information about other equipment in the research lab and discuss tools and procedures associated with the application of chiropractic care. The aim of this research is to provide insight for future study designs that assess or provide care to individuals with PTSD.

Official Title
-----------------
An Experiential, One-to-one Interview Process Examining the Perception of Research Assessments and Equipment From Individuals With Post-traumatic Stress Disorder (PTSD)

Conditions
-----------------
Ptsd

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identify as having been diagnosed with PTSD. Between the ages 21-65 years old. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Interview|Interview discussion with individuals with ptsd.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview | Notes and further insights regarding individuals with PTSD's feelings toward the research space and the research equipment. | 1-2 hours |
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Malaysia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in subjects with type 2 diabetes in Malaysia.

Official Title
-----------------
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Malaysia

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 2 years and who have visited the centre within the last 3-6 months Patients willing to sign informed consent form Exclusion Criteria: Previous participation in this study Unable to comply with protocol requirements Confirmed or suspected pregnancy

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 |
| --- | --- |
| Subjects with diabetes (type 2)<br> | Other: No treatment given<br>* Patients will fill out a questionnaire by interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having HbA1c ((glycosylated haemoglobin) as measured during survey) less than 7% |  | Evaluated at the first visit (only one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fasting Plasma Glucose (FPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean Postprandial Plasma Glucose (PPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean HbA1c of patients |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having dyslipidemia |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having hypertension |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having cardiovascular complications |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having peripheral vascular disease |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic nephropathy |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic eye complications |  | Evaluated at the first visit (only one study visit) |
Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)

Study Overview
=================
Brief Summary
-----------------
Adherence to annual follow up is critical to achieving mortality benefits and optimizing cost-effectiveness of lung cancer screening (LCS). However, adherence to LCS follow-up in the real world is suboptimal. Using telehealth, the investigators will co-create Tele-Navigation of Lung Cancer Screening with patients and LCS stakeholders as an intervention to promote adherence of follow-up LCS. The investigators will then implement the Tele-Navi LCS intervention to a pilot sample of patients and evaluate its feasibility in the primary care setting. The investigators will measure the number of patient participants who completed Tele-Navi LCS and follow-up LCS within 180 days from Tele-Navi LCS.

Official Title
-----------------
Tele-Navigation of Lung Cancer Screening

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Tele-Navi LCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is eligible for LDCT for LCS follow-up Has technology to complete study activities (e.g., video call visit) English speaker Has undergone LCS at UMMH Is overdue for LDCT follow-up Exclusion Criteria: Has previous diagnosis of lung cancer Has active cancer diagnosis Is a nursing home or group care resident Is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 77 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tele-Navi LCS<br>Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS to access a patient portal and a video-call system. | Behavioral: Tele-Navi LCS<br>* Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS to access a patient portal and a video-call system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Tele-Navi LCS | Number of participants completed Tele-Navi LCS, | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Follow-up LCS | Number of participants who received a low-dose CT (LDCT) for LCS follow-up | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, cancer screening, health informatics
Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.

Official Title
-----------------
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect

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

Intervention / Treatment
-----------------
* Drug: AZD3241
* Drug: Placebo Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects 30-65 years Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Exclusion Criteria: History of any clinically significant disease or disorder History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Previous history of frequent pre-syncope or syncope

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD3241<br>AZD3241 Tablets | Drug: AZD3241<br>* Oral Tablet, Repeated Administration<br>|
| Experimental: Placebo<br>Placebo Tablets | Drug: Placebo Tablet<br>* Oral Tablet. Repeated Administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, ECG, safety lab) |  | Assessments performed at frequent timepoints during a 4-8 week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD3241 in plasma |  | Frequent sampling occasions during some study days for a 4-8 weeks period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, tolerability, healthy, Healthy volunteer study
Dose/Response of Exercise on Long Term Weight Loss

Study Overview
=================
Brief Summary
-----------------
To examine the dose-response of exercise on long-term weight loss in overweight adult women.

Detailed Description
-----------------
BACKGROUND: Exercise is a key component of behavioral weight loss programs because of its effect on weight loss, body composition, cardiovascular disease risk factors, and other obesity related diseases such as type 2 diabetes mellitus. Despite these benefits, it is unclear whether there is an optimal exercise duration and/or intensity that will enhance long-term weight loss. The current public health recommendation for physical activity is for individuals to participate in at least 30 minutes of moderate intensity physical activity on most days of the week (approximately 150 minutes per week total). However, it is unclear whether this amount of exercise is adequate for long-term weight loss. Moreover, cross-sectional studies have shown that individuals that have been successful at long-term weight loss participate in levels of physical activity that are greater than the current public health recommendations. DESIGN NARRATIVE: The researchers hypothesized that adopting higher levels of exercise duration and/or intensity, coupled with a strong behavioral intervention would enhance long-term weight loss. To test this hypothesis, they recruited 200 overweight women and randomly assigned them to one of four treatment groups: (1) moderate intensity, moderate 1000cal/wk duration exercise, (2) vigorous intensity moderate duration exercise, (3) moderate 2000cal/wk intensity, high duration exercise, and (4) vigorous intensity, high duration exercise. All subjects participated in a 24-month behavioral weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the interventionists. In addition, to facilitate the adoption of the exercise protocols, all subjects were provided with a home treadmill. Assessment of body weight occured at 0, 6, 12, and 24 months and exercise participation was measured throughout the program. In addition, body composition, cardiorespiratory fitness, cardiovascular disease risk factors, and mediators of behavior change were measured at 0, 6, 12, and 24 months. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Obesity, Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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 Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)

Study Overview
=================
Brief Summary
-----------------
Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan

Official Title
-----------------
Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient: a Prospective, Cross-sectional and Open-label 8 Week Switching Study

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Step1 Over 20 years old Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month Step2 Patients does not taking Fimasartan Patient's medication satisfaction score under 4 Exclusion Criteria: Patients with secondary hypertension Patients with orthostatic hypotension who has sign and symptom Patients with known severe or malignancy retinopathy Patients with significant investigations; abnormal renal function Childbearing and breast-feeding women Patients with history of allergic reaction to any angiotensin II antagonist

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| quality of life questionnaire for hypertension |  | up to 1 month | 
| medication satisfaction questionnaire |  | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug compliance questionnaire |  | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Medication satisfaction, Drug compliance
Utility of Bedside Ultrasound in the Prediction of Difficult Airway

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.

Detailed Description
-----------------
A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy, but their usefulness is limited in emergency department, intensive care unit, pre-hospital and combat settings. Patients in these settings are often confused, lethargic, obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be applied in a large number of emergency intubations. In the recent past, there has been growing interest in upper airway ultrasound. The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.

Official Title
-----------------
Utility of Bedside Ultrasound in the Prediction of Difficult Airway

Conditions
-----------------
Laryngoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for any surgery under general anesthesia with endotracheal intubation Exclusion Criteria: Upper airway pathologies (facial fractures, tumours, etc) Cervical spine fractures Tracheostomy tube unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Predictors of difficult laryngoscopy |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound
Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms of patients' responses to computed tomography and treatment.

Detailed Description
-----------------
Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.

Official Title
-----------------
Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women

Conditions
-----------------
COVID, Zinc Deficiency, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Other: Serum zinc, vitamin d vitamin b12 levels .


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: covid-19 positive pregnant women under 18 or more than 45 years old Exclusion Criteria: vitamin D , Vitamin B12 or Zinc supplement use Multivitamine use have taken vitamin supplements in the past 3 months use of medicines for vitamin deficiency having metabolic disease covid-19 negative pregnant women

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Serum zinc, vitamin d vitamin b12 levels .|Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum zinc, vitamin d vitamin b12 deficiency levels | Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients. | 2 months |