linjc16/ctgov huggingface dataset:
To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Study Overview
=================
Brief Summary
-----------------
To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Official Title
-----------------
An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered On Demand to Men of Various Populations With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 3 months history of erectile dysfunction (ED) Anticipate a monogamous relationship with a female sexual partner Be able to make minimum required sexual intercourse attempts Abstain from using any other ED treatment Exclusion Criteria: Other primary sexual disorders History of penile implant or clinically significant penile deformity History or current nitrate use History of certain heart problems History of certain kidney problems

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>tadalafil | Drug: tadalafil<br>* 20 mg tadalafil tablet taken by mouth, as needed, no more than once a day, for 12 weeks.<br>* Other names: IC351;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile |  | 12 weeks | 
| Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions. |  | 12 weeks |
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

Detailed Description
-----------------
The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab

Official Title
-----------------
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Conditions
-----------------
Colorectal Cancer Metastatic

Intervention / Treatment
-----------------
* Drug: Cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years. Histology or cytology proven KRAS-WT mCRC. Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification) Life expectancy of more than 12 weeks. Written informed consent. In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab. Exclusion Criteria: Past systemic immune therapy for disease other than cancer. Past immune or other target therapy for cancer (not including bevacizumab). Presence of acne or acneiform rash prior to starting treatment with cetuximab. Patients with treatment plan of cetuximab and capecitabine combination. For female patients: the patient is pregnant or lactating.

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 |
| --- | --- |
| Cetuximab<br>All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy. | Drug: Cetuximab<br>* Once a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days.<br>* Other names: Erbitux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between acne and skin rash | To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment? | Within Erbitux treatment period (upto 12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin rash reaction, ERBITUX® (cetuximab), acne
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

Detailed Description
-----------------
Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results. This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.

Official Title
-----------------
Calcitriol and Dexamethasone for Myelodysplastic Syndromes

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: Calcitriol
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS) Evidence of cytopenia affecting at least 1 hematological cell lineage Adequate liver and renal function ECOG 0-2 Expected survival of at least 12 weeks Exclusion criteria: Symptomatic coronary artery disease Uncontrolled diabetes mellitus Uncontrolled and symptomatic glaucoma History of dangerous reactions to steroid therapy Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks History of nephrolithiasis Children Chronic myelomonocytic leukemia (CMML)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calcitriol|nan|
|Drug: Dexamethasone|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
-----------------
Hematopoiesis, Apoptosis, Cell Differentiation, Bone Marrow Cells
Anatomical Classifications of Henle's Trunk

Study Overview
=================
Brief Summary
-----------------
Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk, among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from people to people. As a result, a better understanding of the anatomical classification of Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very rare and often single-centered with minimal samples.In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of Henle's trunk and the surgical outcome of each type.

Official Title
-----------------
Multicenter Clinical Trial of Anatomical Classifications of Henle's Trunk in Laparoscopic Right Hemi-colectomy.

Conditions
-----------------
Mesenteric Vein, Colorectal Surgery, Henle's Trunk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergoing laparoscopic right hemi-colectomy with D3 lymphadenectomy Pathology: adenocarcinoma or high-grade intraepithelial neoplasia proven by colonoscopic biopsy. Localization: tumor located between cecum and proximal 1/3 portion of transverse colon. Patients have to be aware of the aim of the trial, and have signed the informed consent. Exclusion Criteria: History of any gastrointestinal surgery. Patients with ileus, perforation, bleeding and any other conditions required of emergent surgery.
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 |
| --- | --- | --- |
| classifications of Henle's trunk | based on the number of colic veins that conjoin the SMV | 2 yeas |
Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.

Official Title
-----------------
Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Medical Care

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Lung transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients benefiting from a lung transplant Patients on a list for a lung transplant from may 2010 Exclusion Criteria: Patients refusing to participate in the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung transplant<br>Pain evaluation | Other: Lung transplant<br>* Pain evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain measured by a digital scale |  | 3 years |
Interventions to Improve Asthma Management/Prevention at School

Study Overview
=================
Brief Summary
-----------------
To design, develop, implement, and test the effectiveness of a three component health services and health education intervention for primarily Hispanic inner-city elementary school students at high risk for asthma morbidity and mortality.

Detailed Description
-----------------
BACKGROUND: The study was part of an initiative Interventions to Improve Asthma Management and Prevention at School. The Broad Agency Announcement was released in June, 1994. DESIGN NARRATIVE: The study used a randomized intervention trial to test the effectiveness of a comprehensive school-based asthma program to increase linkages with primary care physicians, to increase self-management activities, and to reduce morbidity associated with asthma. The study used a nested design in which the schools were the unit of design, allocation, and analysis. Effects were measured from aggregate data about students and data from school measures to control asthma. There were three components to the intervention. First, case finding for asthma through screening in both intervention and control schools. Second, a linkage management system that connected the child with a source of primary care and enhanced communication among the school nurse, the primary care physician, and parents. Third, the development and implementation of interactive multimedia and decision support system techniques to tailor individualized learning opportunities for children with asthma. The interventions occurred in the school setting and included tailored feedback for children, teachers, nurses, primary care providers, and the family. Assessments were made of the potential for diffusion of the components to target audiences.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)

Study Overview
=================
Brief Summary
-----------------
The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.

Official Title
-----------------
A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Biological: EP1090
* Biological: EP1090


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 Infection CD4 Tcell count >350 HIV-1 RNA levels to <400 copies Negative HbsAg and anti-HCV antibody Exclusion Criteria: Recent receipt of experimental HIV-1 vaccines Recent use of immunomodulatory agents Hypersensitivity or serious reactions to study vaccine components Active opportunistic infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- |
|Biological: EP1090|Low dose|
|Biological: EP1090|High dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms. |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Human Immunodeficiency Virus, Vaccines, HIV Vaccines, Peptide, Peptide Vaccines, HIV 1
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

Study Overview
=================
Brief Summary
-----------------
The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion.

Official Title
-----------------
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Subjects.

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Drug: GAP-134


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Generally healthy men and women of nonchildbearing potential (WONCBP), aged 18 to 50 years. Body Mass Index (BMI) range of 18 to 30 kg/m2. Blood serum creatinine levels less than or equal to the upper limit of normal. Exclusion Criteria Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any history of clinically important cardiac arrhythmias and familial history of long QT syndrome or unexpected cardiac death. History of drug and alcohol abuse, positive HIV, HCV, and/or HBs Ag test, and any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GAP-134, IV and Oral<br>Experimental; Active Comparator; Placebo | Drug: GAP-134<br>* atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects |  | 3-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects |  | 3-4 months |
Evaluation of Cardiotoxic Effects of Bortezomib

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about how a drug commonly used to treat multiple myeloma can affect the heart. In this study, the investigators will learn whether a drug called how a drug (called bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of the standard treatment and its effects on multiple myeloma is not being studied here. The investigators want to learn whether damage occurs to the heart after taking bortezomib for multiple myeloma, whether it is reversible, and we can predict damage to the heart before it occurs.

Official Title
-----------------
Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma

Conditions
-----------------
Multiple Myeloma, Heart Failure, Systolic, Cardiotoxins

Intervention / Treatment
-----------------
* Drug: Bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of multiple myeloma have a treatment plan involving greater than 4 cycles of bortezomib-based chemotherapy Exclusion Criteria: pre-existing history of left ventricular systolic dysfunction congestive heart failure coronary artery disease significant valvular heart disease cardiac arrhythmias estimated glomerular filtration rate <30 mL/min/1.73m2

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 |
| --- | --- |
| Multiple Myeloma, Bortezomib<br> | Drug: Bortezomib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global longitudinal strain by echocardiography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of late gadolinium enhancement by cardiac MRI |  | 6 months | 
| High-sensitivity troponin T |  | 6 months | 
| C-reactive protein |  | 6 months | 
| Serum NT-proBNP |  | 6 months | 
| Carboxyl-terminal telopeptide of collagen type I |  | 6 months | 
| Amino-terminal peptide of procollagen type III |  | 6 months |