linjc16/ctgov huggingface dataset:
PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.

Official Title
-----------------
A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: PHA-739358
* Drug: PHA-739358


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy Adequate bone marrow, liver and kidney function Exclusion Criteria: More than one prior chemotherapy line Uncontrolled hypertension Brain or leptomeningeal disease Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: PHA-739358<br>* 6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle<br>|
| Experimental: B<br> | Drug: PHA-739358<br>* 24-hr IV infusion every 2 weeks in a 4-week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group |  | within the first three months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit |  | all cycles | 
| Overall safety profile |  | all cycles |
Quality of Life With TESTIM®

Study Overview
=================
Brief Summary
-----------------
The present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.

Official Title
-----------------
Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism

Conditions
-----------------
Hypogonadism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapeutic need according to SPC written informed consent Exclusion Criteria: contraindications according to SPC

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TESTIM® - drug given by prescription<br>Male patients with Hypogonadism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Testosterone Level | Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - (determined by the MFI questionnaire) | Determined at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6) | 6 months | 
| Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL) | Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6) | 6 months | 
| Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5) | Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6) | 6 months | 
| Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency) | Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6) | 6 months | 
| Laboratory Parameters: PSA and Haematocrit levels | Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6) | 6 months |
Prospective Study of Hormone Levels After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.

Detailed Description
-----------------
Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure. The groups will not be randomized. Rather, they will decide on their choice of surgery along with their physicians. The patients will be evaluated pre-operatively and followed post-operatively for 5 years. Initial evaluation will include a complete history and physical examination, measurement of calcium, parathyroid hormone (PTH) and vitamin D, and assessment of skeletal health using markers of bone turnover and bone mineral density.

Official Title
-----------------
Prospective Study of Hormone Levels and Appetite After Bariatric Surgery

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

Intervention / Treatment
-----------------
* Procedure: Gastric bypass
* Procedure: Gastric banding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult male or female > 18 years of age Scheduled to undergo bariatric surgery Exclusion criteria: Vitamin D deficiency Primary hyperparathyroidism Treatment with lithium or thiazide diuretics which may alter PTH levels Osteomalacia Untreated hyperthyroidism, liver disease, Cushing's syndrome, rheumatoid arthritis, myeloma or Paget's disease Impaired renal function (serum creatinine >2.0mg/dl) or history of renal osteodystrophy Use of any anti-obesity medications for over 2 weeks 90 days prior to study Participation in any research study 90 days prior to study Any malabsorption syndromes such as celiac sprue Previous bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Surgery<br>Obese adult men and women who are undergoing bariatric surgery (gastric bypass or gastric banding). | Procedure: Gastric bypass<br>* NOTE: Surgery will not be paid by the study<br>* Other names: GBP;Procedure: Gastric banding<br>* NOTE: Surgery will not be paid by the study<br>* Other names: GB;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | linear mixed model analysis will be used to study change over time and between surgery | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Insulin Resistance, Bariatric Surgery, Gastric Banding, Gastric Bypass
Italian Multicenter Retrospective Observational Study on Transformed Lymphomas

Study Overview
=================
Brief Summary
-----------------
Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma.

Official Title
-----------------
Italian Multicenter Retrospective Observational Study on Transformed Lymphomas

Conditions
-----------------
Non-Hodgkin Lymphoma Transformed Recurrent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed transformed Follicular Lymphoma Age > 18 years Histological transformation between January 2002 and December 2014 Availability of data about treatment and outcome Exclusion Criteria: Other lymphoma diagnosis

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Time from last response to nearest relapse or follow-up | From first response to last follow-up for at least 2 years (up to 15 years) | 
| Overall Survival | Time to last follow-up or death | Date of last follow-up for at least 2 years (up to 15 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Hodgkin Lymphoma Transformed Recurrent, Discordant Lymphomas, Composite Lymphomas, Follicular Lymphoma, Aggressive Lymphoma
Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Study Overview
=================
Brief Summary
-----------------
The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Detailed Description
-----------------
Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide. Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Official Title
-----------------
Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Conditions
-----------------
Recurrent High Grade Glioma

Intervention / Treatment
-----------------
* Radiation: IMRT with or without radiosensitive therapy
* Drug: Radiosensitive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Karnosky performance status (KPS) ≥70 Patients aged >70 years with KPS ≥80 Histopathologically confirmed grade III-IV glioma Estimated survival ≥ 3 months Any Tumor volume Unifocal tumor Interval time from previous radiotherapy ≥ 6mesi Normal liver, Kidney and bone marrow function Written informed consent Exclusion Criteria: KPS < 70 Multifocal tumor Other primary cancer Pregnant women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recurrent high grade glioma<br>IMRT with or without radiosensitive therapy | Radiation: IMRT with or without radiosensitive therapy<br>* Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc<br>* Other names: Hypofractionated Stereotactic Radiation;Drug: Radiosensitive therapy<br>* Radiosensitive therapy with Temozolomide<br>* Other names: Chemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free of participants |  | 4 years | 
| Overall survival of participants |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of radionecrosis |  | 3 months | 
| Questionnaire assessment of neurocognitive function |  | 6 months |
Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to isolate genotype-specific DBP/Gc from homozygous human volunteers and use these purified proteins to cross-validate existing or novel assays for this serum protein and to evaluate the binding characteristics of these variants of DBP/Gc for different vitamin D metabolites.

Official Title
-----------------
Isolation of Genotype-specific Isoforms of Human Vitamin D-binding Protein (DBP/Gc)

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy adults (≥ 18 years), non pregnant, with known DBP/Gc genotype Exclusion Criteria: Inability to provide written informed consent No children or pregnant women Persons with known abnormal serum proteins

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| DBP/Gc1f-1f genotype<br>Human volunteers homozygous for the 1f-1f (fast) genotype of DBP. | Other: Blood draw<br>* Sampling of 100-150 ml of blood<br>|
| DBP/Gc1s-1s genotype<br>Human volunteers homozygous for the 1s-1s (slow) genotype of DBP. | Other: Blood draw<br>* Sampling of 100-150 ml of blood<br>|
| DBP/Gc 2-2 genotype<br>Human volunteers homozygous for the 2-2 genotype of DBP. | Other: Blood draw<br>* Sampling of 100-150 ml of blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D binding protein binding characteristics (affinity constant) | In vitro characterization | single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient (r) of different DBP assays | In vitro characterization | single blood draw at time of consultation, an expected average 4 years after curative treatment for breast cancer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D binding protein (DBP)
Firibastat in Treatment-resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

Detailed Description
-----------------
The primary objective of this study is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die [bid]) on blood pressure (BP) over 12 weeks in subjects with uncontrolled primary HTN.

Official Title
-----------------
A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ≥18 years of age at Screening Diagnosis of primary HTN for at least 6 months prior to Screening Exclusion Criteria: Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease). Automated office SBP >180 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour. Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Firibastat<br>Capsules | Drug: Firibastat<br>* Oral administration 2×250 mg capsules bid<br>* Other names: QGC001;|
| Placebo Comparator: Placebo<br>Matching capsules | Drug: Placebo<br>* Oral administration 2 capsules bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure at office (mmHg) | Automatic Office Blood Pressure measurement | From Day 1 to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure at office (mmHg) | Automatic Office Blood Pressure measurement | From Day 1 to Day 84 | 
| Mean 24-hour ambulatory Systolic Blood Pressure (mmHg) | Ambulatory Blood Pressure Monitoring | From Day 1 to Day 84 | 
| Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg) | Ambulatory Blood Pressure Monitoring | From Day 1 to Day 84 |
Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).

Official Title
-----------------
Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Tissue Plasminogen Activator,bevacizumab ,follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy patients with refractory DME CSME (patients with the last MPC at least 3 months before and no improvement was observed in BCVA, macular thickness inOCT, clinical examination and fundus photographs of patients ) Absence of PVD in the B-scan Absence of PVD in OCT of macular area and optic disk Absence of PVD in slit lamp biomicroscopy(SLE) the last PRP session was at least 3 months ago. Absence of traction on macula in clinical examination and OCT Exclusion Criteria: One eye patients Patients who are candidates for intraocular surgery. Patients with the history of glaucoma or ocular hypertension Patients with a history of vitrectomy in the study eye Not being able to refer for the next visits Eyes with cataract that makes the assessment of the macula impossible. Intraretinal hemorrhage at fovea that will interfere with OCT. BCVA ≤ 0.1
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPA,IVB,F/U<br> | Drug: Tissue Plasminogen Activator,bevacizumab ,follow up<br>* 25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing<br>* Other names: bevacizumab :avastin;|

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
-----------------
Tissue Plasminogen activator,, Clinically significant macular edema,, Refractory Diabetic macular edema ,, posterior vitreous detachment
Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).

Conditions
-----------------
Carcinoma, Renal Cell, Kidney Neoplasms

Intervention / Treatment
-----------------
* Drug: ZD6126
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed metastatic renal cell carcinoma Suitable for nephrectomy Exclusion Criteria: Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer Significant cardiac event within 3 months of entry Any history of coronary angioplasty or history of myocardial infarction

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: ZD6126|nan|
|Drug: Placebo|nan|

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
-----------------
Kidney Cancer, Metastatic, Newly diagnosed renal cell carcinoma