linjc16/ctgov huggingface dataset:
Phase II Trial of Allovectin-7® for Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.

Detailed Description
-----------------
Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.

Official Title
-----------------
A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma

Conditions
-----------------
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer

Intervention / Treatment
-----------------
* Genetic: Allovectin-7®


Participation Criteria
=================
Eligibility Criteria
-----------------
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria. You have been diagnosed with Stage III or Stage IV melanoma Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment You are able to carry out your normal daily activities Your melanoma has not spread to your brain

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Allovectin-7®|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
-----------------
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer, Tumor, Experimental Treatment, Clinical Trial, Gene Therapy, Gene Delivery, Gene Transfer, Immunotherapy, Cancer, Neoplasm, Lesion, Metastasis, Cancerous mole, Melanoma vaccine, Cancer research, Cancer cells, Allovectin-7®
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of a weight reduction program in adults, seen in a primary care setting, with overweight/obesity perceived as a health problem or with diseases related to overweight/obesity and ambitions to achieve weight reduction as part of treatment.

Detailed Description
-----------------
Patients seeking advice for overweight/obesity or illness related to overweight/obesity at eight primary health care centers in Sweden were randomized either to intervention or control care groups with both dietary advice and individualized advice on increased regular physical activity. Main outcome measures were reduction in body weight of 5 percent or more from study start.

Official Title
-----------------
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care

Conditions
-----------------
Overweight/Obesity

Intervention / Treatment
-----------------
* Other: Intensive lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients between 18 and 70 years of age who consulted or were in care for overweight/obesity with or without type 2 diabetes Hypertension, CVD Coronary heart disease (CHD) Dyslipidemia Gallstone or musculoskeletal disorders Exclusion Criteria: Patients were not eligible if they were already taking part in another weight control program Understood the Swedish language poorly Were mentally ill or had an alcohol or drug addiction. Nor were they eligible if they had a physical disability preventing intensified physical activity or were pregnant at study start.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive lifestyle counseling<br>Both dietary advice and individualized advice on increased regular physical activity. | Other: Intensive lifestyle counseling<br>* Both dietary advice and individualized advice on increased regular physical activity<br>|
| No Intervention: Usual care<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieved target weight at two years |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical or laboratory manifestations of their baseline illness (type 2 diabetes, hypertension, CHD, dyslipidemia) or death of any cause. |  | 5 years |
Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

Study Overview
=================
Brief Summary
-----------------
This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.

Detailed Description
-----------------
The objective of this study is to determine the ability of cell free tumor DNA genomic profiling to predict disease relapse or progression while on therapy for advanced stage NSCLC in comparison to current standard objective measures of disease relapse or progression. This study is a prospective observational study. The investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. CT images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. These methods of measuring disease progression will be compared in a lead time analysis.

Official Title
-----------------
Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC Baseline CT imaging available Exclusion Criteria: Patients unable to undergo biopsy for initial tissue diagnosis Patients who do not wish to pursue standard of care therapy Patients with another diagnosis of malignancy

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 | Cell free tumor DNA based PFS | 24 months | 
| Progression Free Survival | Clinical or radiographic based PFS | 24 months |
Safety of Hib Vaccine (Bio Farma)

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed Description
-----------------
This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Official Title
-----------------
Phase 1 Study of Hib Vaccine (Bio Farma)

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

Intervention / Treatment
-----------------
* Biological: Hib/PRP-T vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age 18 - 40 years old) Provision of written informed consent Good health according to the clinical investigator Willingness and ability to adhere to the regimen of the study Exclusion Criteria: Known not enrolled in other study Pregnancy or lactation Known or suspected allergy to any of the vaccine component (by medical history) History of unusual reaction to any previous vaccination Known or suspected immune deficiency, or use of medication that may influence the immune system Prior respiratory infection Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study Acute febrile illness (temperature > 37.5 Celsius) Present evidence of serious diseases demanding medical treatment Any significant congenital or chronic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hib/PRP-T vaccine<br>One dose, correspond to 0.5 ml, composed of: PRP-T 10ug NaCl 0.85% Frequency: 1 injection | Biological: Hib/PRP-T vaccine<br>* Hib liquid vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse event of Hib vaccine (Bio Farma) | Local and systemic reactions | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the antibody function serum using serum bactericidal activities test | Presence of serum of bactericidal activities after immunization. | 28 days | 
| Incidence rate of adverse event of Hib vaccine (Bio Farma) | Local and systemic reaction | 28 hours, 48 hours, 72 hours, 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adults, Hib vaccines, Immunogenicity, Safety
Transcriptomal and Molecular Characterization of Tumor Associated Monocytes/Macrophages in Human Cancers

Study Overview
=================
Brief Summary
-----------------
Recent studies from both human and mice cancer models have demonstrated a crucial role for monocytes/macrophages in contributing to cancer progression and disease prognosis. However, since each cancer subtypes is associated with a unique tumor microenvironment in terms of its anatomical location, cytokine/chemokine profiles and stromal components, the functional contribution of tumor infiltrating cells such as the monocytes/macrophages can be equally diverse, depending on the type of cancer. Therefore to obtain a global understanding of the role of host immune cells in cancer progression, it is necessary to accurately characterize these cells in the context of the tumor microenvironment for several cancer subtypes rather than a single cancer. In view of this, this pilot proposal aims to carryout a systems approach in characterizing the functional phenotype of monocyte/macrophage lineage in 4 diverse human cancer types [e.g., Colorectal Cancer, Nasopharyngeal carcinoma, Hepatocellular (liver) cancer and Renal cell carcinoma (kidney cancer)] and the molecular basis of tumor-induced immunosuppression in each of these conditions. Besides providing a global view of the host innate immunity and its molecular basis in these human cancer, the outcome of this investigation will be crucial in defining the scopes of specific immunotherapy strategies to overcome tumor-induced immunosuppression and induce monocyte/macrophage-mediated antitumor response.

Official Title
-----------------
Transcriptomal and Molecular Characterization of Tumor Associated Monocytes / Macrophages in Human Cancers

Conditions
-----------------
Tumor, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet all of the inclusion criteria to participate in this study: Diagnosed NPC, RCC, HCC or colorectal cancer patients. (Preoperative histologic diagnosis is not required for RCC and HCC.) All stages of disease are eligible. Adult patients above 21. Ability to provide informed consent. Exclusion Criteria: Subjects meeting any of the exclusion criteria at baseline will be excluded: Active infection. Immunocompromised or other active immune disorders. Have received chemotherapy or other immunomodulating therapy in the past 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
MR-Evaluation of Renal Function-After-Pancreas-transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the beneficial effect of pancreas transplantation for long term kidney function in patients undergoing single-pancreas transplantation.

Detailed Description
-----------------
Renal failure in patients who have performed a pancreas transplantation is a hazard for the outcome for these patients. The beneficial effect of pancreas transplantation for renal function is not clear. It is of major importance to early find patients who develops a decrease in renal function and start treatment early and closely monitor these patients in order to avoid further deteriorating renal function. In order to achieve this, there is a need for a easy, fast and sensitive method to evaluate renal function. In this study the investigators plan to use the non-invasive MR to evaluate changes in renal function.

Official Title
-----------------
MR-Evaluation of Renal Function-After-Pancreas-transplantation

Conditions
-----------------
Diabetes, Renal Failure, Pancreas Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus Patients undergoing a pancreas transplantation Exclusion Criteria: Patients undergoing a pancreas transplantation and a renal transplantation at the same time.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients with pancreastransplantation<br>All patients undergoing pancreas transplantation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function | Improvements in kidney function (GFR) and proteinuria after pancreas transplantation. | Within 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney hemodynamics and oxygenation | Improvements in renal blood flow and kidney tissue oxygenation after pancreas transplantation. | Within 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Pancreas, Renal failure, Transplantation
Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.

Official Title
-----------------
A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to provide written informed consent before beginning any study related procedures Patient has a documented clinical diagnosis of schizophrenia Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: Patients with a history of non-compliance as judged by the study investigator Patients with a known lack of response to previous treatment with quetiapine Patients who have participated in another drug study within 4 weeks prior to enrollment into this study Patients who have previously participated in this study or study D1444C00132

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Quetiapine Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Schizophrenic disorder
Study To Estimate The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Official Title
-----------------
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.

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

Intervention / Treatment
-----------------
* Drug: Treatment A
* Drug: Treatment B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. Pregnant or nursing females.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A - PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment A<br>* Inhaled, 750/150, single dose<br>|
| Active Comparator: Treatment B - PF-04764793<br>PF-04764793 using inhaler B | Drug: Treatment B<br>* Inhaled, 750/150, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUClast and Cmax |  | 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life. |  | 48 |
Efficacy and Safety Outcomes of Optometrist Performed Selective Laser Trabeculoplasty (SLT)

Study Overview
=================
Brief Summary
-----------------
To measure the efficacy and safety outcomes of SLT performed by optometrists.

Detailed Description
-----------------
Participants will undergo a pre-procedure examination in order to record baseline findings and to determine if they meet the inclusion criteria in order to undergo the procedure. Participants will undergo the SLT procedure and will be examined at 1 hour, 1 week and 6 weeks. Follow up examinations will evaluate eye pressure reduction and post-procedure complications. The rate complication post-procedure are typically low.

Official Title
-----------------
Selective Laser Trabeculoplasty (SLT): Efficacy and Safety Outcomes of Optometrist (OD) Performed SLT

Conditions
-----------------
Primary Open-Angle Glaucoma, Unspecified Eye, Ocular Hypertension

Intervention / Treatment
-----------------
* Device: Selective Laser Trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent; At least 18 years of age, male or female, of Native American or Alaskan Native descent; Diagnosed with primary open angle glaucoma or ocular hypertension; Documented intraocular pressure greater than or equal to 23 mmHg; No prior glaucoma treatment unless treated with one topical drop. Exclusion Criteria: History of trauma or ocular surgery within the last 6 months; History of corneal dystrophy; Current use of topical or systemic steroids; Advanced or severe glaucomatous findings based on comprehensive examination; Diagnosed with other types of glaucoma such as pseudoexfoliation syndrome, pigmentary glaucoma, normal tension glaucoma, and other additional glaucoma subtypes.

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

| Intervention/Treatment |
| --- |
|Device: Selective Laser Trabeculoplasty|Selective Laser Trabeculoplasty Laser|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure via Goldmann tonometry | Pre and Post Procedure Intraocular Pressure will be measured using a Goldmann tonometer and will be measured in millimeters of Mercury (mmHg). Percent change in intraocular pressure will be determined. | 6 weeks |