linjc16/ctgov huggingface dataset:
Treatment of Angiotensin Peptide (1-7) for COVID-19

Study Overview
=================
Brief Summary
-----------------
Novel Coronavirus is reported to cause COVID-19, recently. It's known that this virus uses ACE (angiotensin converting enzyme) 2 receptors to enter human cells and also blocks the activity of ACE 2. Upon these data the investigators hypothesize that, mortal hyper-inflammation state which is shown in COVID-19 cases, can be a result of angiotensin peptide (1-7) deficiency. Therefore, the aim of this study is to evaluate the possible effect of angiotensin peptide (1-7) supplementation on treatment of COVID-19 cases.

Detailed Description
-----------------
Novel Coronavirus is reported to cause COVID-19, recently. It's known that this virus uses ACE (angiotensin converting enzyme) 2 receptors to enter human cells and also blocks the activity of ACE 2. Upon these data the investigators hypothesize that, mortal hyper-inflammation state which is shown in COVID-19 cases, can be a result of angiotensin peptide (1-7) deficiency. Therefore, the aim of this study is to evaluate the possible effect of plasma derived angiotensin peptide (1-7) supplementation on treatment of COVID-19 cases.

Official Title
-----------------
Evaluation of the Possible Role of Angiotensin Peptide (1-7) on Treatment of COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: Biological/Vaccine: Angiotensin peptide (1-7) derived plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: accepted to participate with an informed consent proven positive COVID-19 Exclusion Criteria: declined to participate genetic/chromosomal abnormalities any kind of history of previous adverse events with transfusion diagnosis of immune deficiency

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This group will receive angiotensin peptide (1-7) during their treatment at hospital.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: non-peptide group<br>This group will receive routine treatment and care for COVID-19. | |
| Active Comparator: peptide group<br>This group will receive angiotensin peptide (1-7) supplementation in addition to routine treatment and care for COVID-19. | Biological: Biological/Vaccine: Angiotensin peptide (1-7) derived plasma<br>* angiotensin peptide (1-7) derived plasma will be given to COVID-19 positive participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality rates in two groups will be compared | 4 months |
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Conditions
-----------------
Hormone-Refractory Prostate Cancer

Intervention / Treatment
-----------------
* Biological: sipuleucel-T
* Biological: APC-Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented adenocarcinoma of the prostate Metastatic disease as evidenced by soft tissue and/or bony metastases Prostate-specific antigen value of at least 5 ng/mL Tumor progression while on hormonal therapy Castration levels of testosterone (defined as less than 50 ng/dL) Life expectancy of at least 16 weeks Adequate hematologic, renal, and liver function Exclusion Criteria: Visceral organ metastases Metastatic disease expected to be in need of radiation therapy within 4 months. Concurrent therapy with experimental agents

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sipuleucel-T (APC8015)<br> | Biological: sipuleucel-T<br> <br> |
| Placebo Comparator: Placebo<br> | Biological: APC-Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Time to Disease Progression | Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo. | from randomization to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Subjects were followed for 3 years from the time of randomization or until death. | Time from randomization until 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asymptomatic metastatic hormone-refractory prostate cancer
Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic diagnosis and treatment compared to conventional standard care alone in stationary patients with Fibromyalgia Syndrome.

Official Title
-----------------
Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung

Conditions
-----------------
Fibromyalgia Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age between 18 and 70 years FMS according to current guidelines Exclusion Criteria: change of pharmacological FMS treatment >= 6 weeks before inclusion pregnancy or breat feeding acute psychiatric condition severe acute somatic disease severechronic comorbidity obesity WHO >= II degree bloodcoagulation-disease intake of opiods current treatment with hyperthermia simultaneous participant in other trial praticipation in other trial during 6 month before inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Add-on Ayurveda - Group<br>In the Āyurveda add-on-group 20 patients will receive individualized treatment according to the Āyurveda diagnosis which may include manual treatments, massages, dietary advice, specific consideration of selected food items, āyurvedic lifestyle & yoga posture advice and daily self-applied massage on top of standard care. | |
| Standard Care<br>20 Patients will receive the individually adjusted complex conventional standard care according to the current AWMF-guidelines including physiotherapy, occupational therapy, specific pain therapy and psychotherapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire (FIQ) | Change in FIQ after completion of IPD-treatment | max. 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Hanover Questionnaire (FFBH) |  | max. 3 weeks | 
| State Trait Anxiety Inventory (STAI) |  | max. 3 weeks | 
| Profile of Mood States (POMS) |  | max. 3 weeks | 
| Short Form 36 Health Survey (SF-36) |  | max. 3 weeks | 
| VAS for pain |  | max 3 weeks | 
| Likert-Scales |  | max 3 weeks | 
| FIQ |  | 6 month | 
| FFBH, STAI, POMS, SF-36, VAS, Likert-Scales. |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAM, Fibromyalgia Syndrome, Fibromyalgia, Ayurveda, Traditional Indian Medicine, Pain, Chronic Widespread Pain
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.

Official Title
-----------------
A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects With Resistant Hypertension Despite Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

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

Intervention / Treatment
-----------------
* Drug: Darusentan
* Drug: Guanfacine


Participation Criteria
=================
Eligibility Criteria
-----------------
SELECTED INCLUSION CRITERIA: Subjects must be competent to provide written informed consent; Subjects must have completed the Maintenance Period of the DAR-312 study. SELECTED EXCLUSION CRITERIA: Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE; Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darusentan<br>Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily | Drug: Darusentan<br>* Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily<br>* Other names: LU 135252;|
| Active Comparator: Guanfacine<br>Guanfacine 1 mg capsules administered orally once daily | Drug: Guanfacine<br>* Guanfacine 1 mg capsules administered orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure |  | Baseline to Week 14 | 
| Percentage of subjects who reach systolic blood pressure goal |  | Week 14 | 
| Change from baseline in estimated glomerular filtration rate (eGFR) |  | Baseline to Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in trough sitting systolic and diastolic blood pressures |  | Baseline to Week 14 |
Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients

Study Overview
=================
Brief Summary
-----------------
A non-MD-led adult education program consisting in 10 one-hour sessions designed to provide information and motivation will be offered to patients who have recently been hospitalized for acute myocardial infarction (STEMI and NSTEMI), regarding the management of their treatment and strategies to aggressively optimize control of cardiovascular risk factors.. The intervention arm will be compared to a control group of patients treated with usual care.

Official Title
-----------------
Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Adult education program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), Type Ι, according to the 3rd Universal Definition of MI, within the preceding 6 weeks Absence of substantial cognitive dysfunction (Mini Mental State examination score ≥24) Exclusion Criteria: - Age >80 years or <18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Post-MI patients attending an adult education program designed to inform and motivate them on how to best control cardiovascular risk factors as a means to offer optimized secondary prevention of cardiovascular events | Other: Adult education program<br>* A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment<br>|
| No Intervention: Controls<br>Usual care for post-MI patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons | Time from randomization to the composite endpoint of death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event) | 24 months |
Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)

Study Overview
=================
Brief Summary
-----------------
This is a cross-cultural adaptation, evaluation and validation study of Wang Qi's Constitution in TCM questionnaire (For Old Person) in Hong Kong to investigate the content validity, construct validity and reliability of the CTCMQ-C in Cantonese speaking Hong Kong Chinese elderly population.

Detailed Description
-----------------
The study includes two steps. Firstly, translation of the questionnaire into Cantonese, followed by cross-cultural adaptation. Ten Chinese Medicine Practitioners (CMPs) and 30 patients will be recruited from the community and the outpatient clinics of Hong Kong Baptist University (HKBU) to evaluate the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) for content validity by the cognitive debriefing interviews. The content validity indices (CVI) of clarity, relevance and appropriateness of each item of the questionnaire rated by CMPs and patients will be quantified. The interpretations of items and suggestions of rewording by the patients and CMPs will be analyzed qualitatively to identify any item of the questionnaire that is not valid for the Chinese population in Hong Kong. Secondly following the validation study, 264 patients will be recruited. A validated CTCMQ-C will then be generated and will be endorsed by expert panel to use in the subsequent cross-sectional and cohort studies to evaluate the preventive effect with Chinese Medicine approaches. The psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the CTMCQ-C will also be tested.

Official Title
-----------------
Cross-cultural Adaptation, Evaluation and Validation of Wang Qi's Constitution of TCM Questionnaire (For Old Person)

Conditions
-----------------
Cross-cultural Adaptation, Evaluation and Validation Study of Wang Qi's Constitution in TCM Questionnaire (For Old Person)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 65 and above; Hong Kong residents; capable of consenting and have agreed to participate. Exclusion Criteria: not fulfill the above inclusion criteria; having serious diseases with undesirable conditions that unable to complete the survey; having serious mental and behavioral disorders.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the psychometric properties including construct validity by scaling assumptions, confirmatory factor analysis (CFA) and reliability of the Constitution in TCM Questionnaire (For Old Person) (Cantonese version) (CTCMQ-C) (final version). |  | 30 minutes |
Major Depressive Disorder In The Elderly

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled study evaluating the effectiveness of medication in elderly subjects with Major Depressive Disorder (MDD).

Official Title
-----------------
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible Dose Study to Evaluate the Efficacy, Safety and Tolerability of Extended-release Bupropion Hydrochloride (150mg-300mg Once Daily) in Elderly Subjects With Major Depressive Disorder

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

Intervention / Treatment
-----------------
* Drug: bupropion XL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Major Depressive Disorder with DSM-IV criteria for their current episode for at least 8 weeks. Exclusion Criteria: Patient has current or past history of seizure disorder or brain injury. Patient has a diagnosis of anorexia or bulimia within the past 12 months. Patient has a past or current DMS-IV diagnosis of schizophrenia or any other psychotic disorder(s). Patient has had a myocardial infarction within 1 year or a history of uncontrolled hypertension or unstable heart disease with 6 months.

Ages Eligible for Study
-----------------
Minimum 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

| Intervention/Treatment |
| --- |
|Drug: bupropion XL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale Clinical Global Impression Improvement Scale Clinical Global Impression Severity Scale Hamilton Anxiety Rating Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, bupropion, Depression
CRP to Serum Albumin Ratio in Type 2 DM é Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
we aimed to compare C-reactive protein to serum albumin ( CAR) level of the T2DM patients with DN to those T2DM without DN

Detailed Description
-----------------
Diabetic Nephropathy (DN) is a serious complication of Diabetes Mellitus associated with chronic and low-grade inflammatory burden affects around 30 % of diabetic patients It is the leading cause of end-stage renal failure worldwide and associated with cardio vascular diseases and increases mortality of diabetic patients It characterized by persistent albuminuria, raise in arterial blood pressure ,decrease in glomerular filtration rate (GFR) It associated with chronic low grade inflammation that's leads to increase glucose and activities inflammation Despite of the pathogenesis of DN is multifactorial, but local inflammatory process may result from both the metabolic and hemodynamic affection seen in DN sustained diabetes-related metabolic and haemodynamic perturbations can induce subclinical low-grade renal inflammation and drive kidney from repair response to damage process, eventually to renal fibrosis Chronic inflammatory processes not only play a principle role in the progression of micro vascular but also macro vascular complications in type 2 diabetes mellitus. An association between low -grade inflammation and type 2 diabetes has been described in recent studies .C- reactive protein to serum albumin ratio has attracted great attention recently , and used as biomarker in detection disease severity , since type 2 Diabetes Mellitus and Diabetic Nephropathy(DN) is associated with low grade inflammation in recent studies. In this study investigator presume that C-reactive protein to serum albumin ratio ( CAR )levels could be associated with the progression of DN in patients with T2DM.

Official Title
-----------------
C-reactive Protein to Serum Albumin Ratio in Type 2diabetic Patients With Diabetic Nephropathy

Conditions
-----------------
Type 2 DM /Diabetic Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All type 2diabetic patients Exclusion Criteria: Type 1 diabetes is , patient t with liver cirrhosis, patient with active infection ,pregnant women,patients with cancer
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein to serum albumin ratio in type 2diabetic patients with diabetic nephropathy | comparison between CAR level è type 2 diabetic nephropathy patient and those without nephropathy | Baseline |