linjc16/ctgov huggingface dataset:
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.

Official Title
-----------------
A Study to Evaluate the Ability of the HM74A Agonist GSK256073A to Block Niacin-induced Flushing in Healthy Adult Subjects

Conditions
-----------------
Healthy Subjects, Dyslipidaemias

Intervention / Treatment
-----------------
* Drug: GSK256073A tablets + IR niacin tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males between 18 and 55 years of age, inclusive. Healthy subjects Body weight > 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where: Subjects with QTc < 450 msec at screening Exclusion Criteria: History of significant cardiac arrhythmias Active peptic ulcer disease (PUD) and/or history of PUD History of gout and/or hyperuricemia History of Gilbert's syndrome History of recurrent indigestion, stomach upset or diarrhea History of other than rare (once yearly or less) flushing Recurrent skin rash or psoriasis History of kidney stones

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK256073A tablets + IR niacin tablets|single dosing for 4 to 5 sessions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of reported flushing - visual analogue scale; self reported assessment of flushing |  | up to 8 hours post dose | 
| Safety and tolerability of GSK256073A and immediate release niacin |  | up to 36 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard and Secondary pharmacokinetic endpoints of interest |  | up to 36 hours post dose | 
| Pharmacodynamic response |  | up to 36 hours post dose | 
| Pharmacodynamic response |  | up to 24 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flushing, GSK256073A,, Dose Escalation,, Immediate Release Niacin,
Electrophysiological Properties of the Pulmonary Veins

Study Overview
=================
Brief Summary
-----------------
The pulmonary veins are the predominant sources of AF induction and maintenance. This study aims to assess the electrophysiological properties of the pulmonary veins and their relation to AF in humans.

Official Title
-----------------
Electrophysiological Properties of the Pulmonary Veins

Conditions
-----------------
Electrophysiology of Pulmonary Veins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years No antiarrhythmic drug treatment Indication for an electrophysiological study Exclusion Criteria: Structural heart diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
Intervention for Comorbid Substance Use and Bipolar Disorders

Study Overview
=================
Brief Summary
-----------------
This trial aims to evaluate the effectiveness of a novel intervention for patients with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.

Official Title
-----------------
RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders

Conditions
-----------------
Bipolar Disorder, Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Integrated Treatment Adherence Program (ITAP)
* Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Diagnosis of a bipolar-spectrum disorder Diagnosis of a substance use disorder Taking at least one mood-stabilizing medication Exclusion: Unable to speak and read English Younger than age 18

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Treatment Adherence Program (ITAP)<br>A combination of in-person and phone sessions along with significant other involvement over 6 months post-hospitalization. | Behavioral: Integrated Treatment Adherence Program (ITAP)<br>* Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.<br>|
| Active Comparator: Safety Assessment and Follow-up Evaluation (SAFE)<br>Enhanced symptom monitoring and safety evaluation over 6 months post-hospitalization. | Behavioral: Safety Assessment and Follow-up Evaluation (SAFE)<br>* Enhanced assessment and evaluation with clinician feedback.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) | The Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) assesses depressive symptom severity. Total scores range from 0 to 27 and higher scores indicated higher symptom severity. | 6 months | 
| Clinician-Administered Rating Scale for Mania (CARS-M) | The Clinician-Administered Rating Scale for Mania (CARS-M) assesses mania symptom severity. Total scores range from 0 to 50 and higher scores indicated higher symptom severity. | 6 months |
Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, placebo-controlled, parallel groups study to determine whether prosptide is effective in relieving pain in patients who have sensory neuropathic pain related to their HIV infection or the drugs used to treat it.

Detailed Description
-----------------
Sensory neruopathies are the most frequent neurological complicaton of HIV infection and its treatmet with antiretrovirals. To date, there are few effective treatments, and all are symptomatic treatments for pain. Management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of HAART regimens. In precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms. Hypothesis: Prosaptide will improve neuropathic pain in HIV-associated sensory neuroathies,and will be safe and well tolerated in subjects. Comparisons: 4, 8, or 16 mg prosaptide vs. placebo

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of Prosaptide Over 6 Weeks of Treatment for the Relief of Neuropathic Pain Associated With HIV-1

Conditions
-----------------
HIV, Peripheral Nervous System Disorders

Intervention / Treatment
-----------------
* Drug: prosaptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 years and older

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

| Intervention/Treatment |
| --- |
|Drug: prosaptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differnece between the pain rating at Baseline vs. Week 6 (or last week)of treatment, based on the 13-point Gracely pain intensity scale as rated by subjects and captured in an electronic diary |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the Beline pain rating and each week of treatment. |  |  | 
| Number of subjects whoe were treatment successes at each week of the active treatment period. |  |  |
Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Detailed Description
-----------------
Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Official Title
-----------------
A Multi-center Phase II Study Evaluating the Efficacy and Tolerance of the Association of Liposomal Doxorubicin and Docetaxel in First Line Chemotherapy in Patients With Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Pegylated liposomal doxorubicin
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first metastatic chemo line presence of measurable or bone lesion at least one lesion outside the radiated areas can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks Exclusion Criteria: only local tumoral progression symptomatic cerebral metastasis neuropathy > NCI-CTC 2 previous cancer within 10 years _ previous cancer within 10 years

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caelyx - Taxotere<br> | Drug: Pegylated liposomal doxorubicin<br>* Caelyx 30 mg/m² day 1 every 3 weeks<br>* Other names: Caelyx;Drug: Docetaxel<br>* Taxotere 75 mg/m² day 2 every 3 weeks<br>* Other names: Taxotere;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-progression rate after 6 cycles |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerance and toxicity |  | 6 months | 
| Tumor response and duration |  | 5 years | 
| Time to Progression |  | 5 years | 
| Overall survival |  | 5 years |
The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
To explore the effects of wheat sprouts supplements on the key health indicators of the patients with breast cancer after chemotherapy, Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy and nutritional status, immune function, quality of life were measured and evaluated. Through data analysis, we found that Maiji tablets may improve the symptoms of appetite loss, nausea and vomiting, and fatigue in patients with breast cancer during chemotherapy. Meanwhile it may help patients maintain weight, keep appetite and improve the food intake.

Official Title
-----------------
The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy

Conditions
-----------------
Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy

Intervention / Treatment
-----------------
* Dietary Supplement: wheat sprouts supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients diagnosed with breast cancer, receiving chemotherapy for the first time Exclusion Criteria: - Patients with severe liver or kidney disease or other infectious diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: wheat sprouts supplement|Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Quality of life was measured by quality of life assessment form | 28 days | 
| weight | the weight of patients | 28 days | 
| nutritional status | nutritional status of patients | 28 days |
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.

Official Title
-----------------
A 12-month, Single-blind, Randomized, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of ERL080A Compared With MMF in de Novo Heart Recipients

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-coated Mycophenolate Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Male or female cardiac patients 18-65 years old undergoing primary heart transplantation treated with CS-ME and corticosteroids as basic immunosuppression. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained. Exclusion criteria Patients with donor hearts greater than 60 years of age and/or with cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary disease or are known to have heart disease at time of transplant. Patients on Left Ventricular Assist Device who have received any immunotherapy prior to transplantation or who are scheduled to receive immunotherapy thereafter. Patients with Panel Reactive Antibodies (PRA) 25%. Patients with serum creatinine 3.0mg/dL.. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low aspirin treatment is allowed). Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br> | |
| Active Comparator: 1<br> | Drug: Enteric-coated Mycophenolate Sodium<br> <br> |

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
-----------------
ERL080A, Heart Transplantation, Mycophenolate, EC-MPS
Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).

Official Title
-----------------
A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: udenafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subjects aged 18 and over who have any of the following diseases primary Pulmonary Arterial Hypertension secondary Pulmonary Arterial Hypertension caused by connective tissue disease [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome) Exclusion Criteria: Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria BMI(Body Mass Index) < 18.5kg/m2 Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg) Creatinine clearance ≤ 30mL/min History of non-arteritic anterior ischemic optic neuropathy(NAION)

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 |
| --- | --- |
| Experimental: udenafil<br>Phase IIa Experimental : Udenafil Dose 1, Dose 2 Phase IIb Experimental : Udenafil | Drug: udenafil<br>* Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID)<br>|
| Placebo Comparator: placebo<br>Phase IIa Placebo Comparator : Placebo Phase IIb Placebo Comparator : Placebo | Drug: placebo<br>* Phase IIa - placebo Phase IIb - placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase IIa - Pulmonary vascular resistance index(PVRI) |  | 4 hours | 
| Phase IIb - 6-minute walk distance |  | 16weeks |
Ovarian Clear Cell Adenocarcinoma Review

Study Overview
=================
Brief Summary
-----------------
Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40% of the patients with clear cell carcinoma are diagnosed in the advanced stage. The investigators studied the response to chemotherapy and survival for either paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with pure, advanced, clear cell ovarian carcinoma were also evaluated.

Detailed Description
-----------------
Several authors have reported frequent admixtures of clear cell ovarian carcinoma with serous, mucinous, and endometrioid tumors. However, few papers addressed the difference in response to chemotherapy and survival between patients with pure and mixed-type advanced clear cell carcinoma. Recent trends in the clinical management of advanced ovarian cancer include increased attention to maximal cytoreduction and general acceptance of paclitaxel-platinum-based adjuvant chemotherapy. The introduction of paclitaxel markedly changed the postoperative management of ovarian cancer patients, but the results and value of these newer efforts and therapies applied to clear cell carcinoma are as yet undetermined. Today, paclitaxel-platinum-based chemotherapy is becoming the standard regimen for ovarian cancer worldwide. Previous research suggests a potential benefit of paclitaxel plus carboplatin regimens for stage I clear cell carcinoma. However, few papers specifically addressed the efficacy of paclitaxel-platinum-based chemotherapy for advanced clear cell carcinoma because clear cell carcinoma occurs only rarely in Western countries.

Official Title
-----------------
Retrospective Multi-institutional Survey of Clinical Characteristics in Ovarian Clear Cell Adenocarcinoma Cancer Patients

Conditions
-----------------
Ovarian Cysts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Ovarian clear cell carcinoma Exclusion Criteria: not undergo operation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Overall survival (OS) |  | Overall survival (up to 6 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian cancer, Clear cell carcinoma, Paclitaxel-platinum, Chemotherapy, response to chemotherapy, survival of clear cell ovarian carcinoma, Prognostic factors