linjc16/ctgov huggingface dataset:
Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

Official Title
-----------------
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SELA-070 in Healthy Adult Smokers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Biological: SELA-070
* Biological: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Healthy Smokers Subjects must smoke a minimum of 10 but not more than 25 cigarettes per day for at least 3 months prior to enrollment Written informed consent Primary Exclusion Criteria: Prior exposure to nicotine vaccines Female subjects of childbearing potential Current use of immunosuppressive agents History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection) Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: SELA-070<br> | Biological: SELA-070<br>* Sub-cutaneous injection, multiple dose<br>|
| Placebo Comparator: Saline<br> | Biological: Saline<br>* Sub-cutaneous injection, multiple dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity |  | 21 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). |  | 21 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine vaccine, smoking vaccine, smoking cessation, SELA-070
Dolastatin 10 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Hormone Therapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

Detailed Description
-----------------
OBJECTIVES: I. Determine the objective response rate in patients with hormone refractory prostate cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population. OUTLINE: Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Official Title
-----------------
Phase II Evaluation of Dolastatin-10 in Patients With Hormone Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: dolastatin 10


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Hormone refractory metastatic prostate cancer (stage D1 or D2) with no greater than 3 prior endocrine manipulations PSA level increased on 3 consecutive measurements at least 2 weeks apart PSA at least 10 ng/mL (not required if measurable disease) PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL AST no greater than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: No other serious medical illness No serious infection No other prior malignancy within the past 5 years except nonmelanoma skin cancer or any in situ carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Concurrent LHRH-agonist therapy allowed without antiandrogens At least 4 weeks since prior flutamide and nilutamide At least 6 weeks since prior bicalutamide At least 4 weeks since other prior hormone therapy including steroids Radiotherapy: At least 4 weeks since prior radiation therapy and recovered No prior strontium Surgery: Recovered from prior surgery
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dolastatin 10|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
-----------------
stage IV prostate cancer, recurrent prostate cancer
Retrospective Study of Patient Surveys

Study Overview
=================
Brief Summary
-----------------
To collect data from Allergan Patient Surveys (patient surveys) and Allergan Patient Information Form (patient information form) to describe: Patient demographics Treatment patterns Patient feedback and overall experience with MMS treatment

Official Title
-----------------
Retrospective Study of Patient Surveys of MMS Experience

Conditions
-----------------
Body Fat Disorder

Intervention / Treatment
-----------------
* Other: Questionnaire review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subject has received MMS treatment in the abdomen and/or buttocks (with CoolTone prototype) Subject has completed the Allergan patient survey and information form on MMS experience between July 1, 2019 and December 1, 2019. Exclusion Criteria • There are no exclusion criteria for this study.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

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

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

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 |
| --- | --- |
| Other: Questionnaire Review<br> | Other: Questionnaire review<br>* Review data from questionnaires received about MMS experience.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint: Overall Experience Questionnaire | Evaluation of patient overall experience with MMS treatment as measured by patient survey. | Immediately post subjects final treatment. |
A Study to Evaluate Corrected QT Interval From Clinical Studies Conducted With Bevacizumab

Study Overview
=================
Brief Summary
-----------------
This is a supplemental study designed to evaluate the effect of bevacizumab on QTc interval in cancer patients. Patients who have consented to participate in selected randomized controlled bevacizumab clinical trials will be invited to participate in this study.

Official Title
-----------------
Evaluation of Corrected QT Interval From Clinical Studies Conducted With Bevacizumab

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form Enrollment in one of a list of certain randomized, controlled bevacizumab trials Exclusion Criteria: Implantable pacemaker or automatic implantable cardioverter defibrillator (AICD) Congenital long QT syndrome Family history of long QT syndrome Clinically significant bradycardia (defined as < 50 beats/minute)
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Avastin
Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.

Detailed Description
-----------------
Subjects will need to complete two questionnaires on admission and on discharge from the PRC program to measure self-efficacy and depression. The first is the Pain Self-Efficacy Scale (PSEQ) which is a measure of self-efficacy in persons with chronic pain. The second questionnaire is the Center for Epidemiologic Studies Depression Scale (CES-D) which is a measure of depressive symptoms in persons with chronic pain. Both scales will also be used for clinical information. Persons who score 27 or higher on the CES-D will be approached for potential consent to this evidence based project. Each patient in the PRC will participate in up to 6 CBT sessions but only persons who, upon admission, score 27 or greater on the CES-D will be studied for any changes in scores from admission to discharge.

Official Title
-----------------
Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 and over with chronic pain and score of 27 or higher on CES-D scale Exclusion Criteria: 17 or younger, no chronic pain, cognitively unable to participate in programming

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 |
| --- |
|Other: cognitive behavior therapy|6 cognitive behavior therapy groups|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on a depression and self-efficacy scale |  | 3 weeks |
Roles of T Helper 1 Cytokines in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.

Detailed Description
-----------------
T helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (T1D). Significant increase in IFN-γ-producing Th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. This data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. We aimed to investigate the relationship between Th1 cytokines (IFN-γ, IL-2 and TNF-α) and T1D and the effect of those cytokines on β-cell function.

Official Title
-----------------
Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients giving consent to participate the study Patients with type 1 diabetes according to WHO definiton Exclusion Criteria: Acute and chronic inflammatory diseases, significant concomitant diseases which may interfere with glucose metabolism cancers, hemoglobinopathies, recently received antibiotics, drugs influencing β-cell function and insulin sensitivity or anti-inflammatory drugs recent history of trauma
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 |
| --- | --- |
| Group 1a<br>Patients with type 1 diabetes who have undetectable c-peptide ( ≤0.1 ng/mL) levels after mixed meal tolarance test: group 1a | |
| Group 1b<br>Patients with type 1 diabetes who have c-peptide levels between 0.1-0.8 ng/mL after mixed meal tolerance test: group 1b | |
| Group 1c<br>Patients with type 1 diabetes who have c-peptide levels ≥0.8ng/mL after mixed meal tolerance test: group 1c | |
| Control<br>Healthy subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes |  | 3 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1diabetes, IFN γ, IL-2, TNF α
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of ERB-257 in healthy subjects

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: ERB-257
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women of non-childbearing potential between the ages of 18 and 50. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg2. Have a high probability for compliance with and completion of the study. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERB-257<br>7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1,4, 15, 45, 90, 180, and 300 mg | Drug: ERB-257<br> <br> |
| Placebo Comparator: placebo<br>2 placebo subjects per group | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects |  | 4 days per group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects |  | 4 days per group |
Preoperative Pain, Function, and Activity for Total Hip and Knee Arthroplasty Patients

Study Overview
=================
Brief Summary
-----------------
This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria.

Detailed Description
-----------------
The investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. With this knowledge the investigators will be able to initiate sufficient treatment already before operation.

Official Title
-----------------
The Influence of Preoperative Pain, Function, and Activity on Time to Fulfill Discharge Criteria for Total Hip and Knee Arthroplasty Patients

Conditions
-----------------
Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total hip arthroplasty patients Total knee arthroplasty patients Exclusion Criteria: Inability to speak and understand Danish Inability to perform the functional measurements due to other conditions

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 |
| --- | --- |
| Total arthroplasty<br>Patients with osteoarthrosis going for hip or knee arthroplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg muscles strength | Maximal muscle force tested for one leg at a time in a Power Rig Mashine | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance | Tested by: Timed Up & Go test, 10 meter fast speed walking test | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle strength, functional performance, joint replacement
Oral Health, Microbial Burden and COVID-19

Study Overview
=================
Brief Summary
-----------------
An observational study of patients with COVID-19 confirmed cases (with various degrees of severity) and controls. Oral and nasal swabs will be taken from 150 patients (50 with mild form and 50 with severe form of COVID-19 with or without mechanical ventilation, 50 healthy controls).

Official Title
-----------------
Oral Health, Microbial Burden and COVID-19

Conditions
-----------------
Covid19, Periodontitis

Intervention / Treatment
-----------------
* Other: Swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must provide written informed consent Subjects have to be tested (PCR) positive or negative for SARS-CoV2 infection Must be able to provide oral and nasal swabbing within 48 hours of polymerise chain reaction (PCR) test results Exclusion Criteria: a. Under the age of 18 years old

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 |
| --- | --- |
| Controls tested PCR (-) for COVID-19<br> | Other: Swab<br>* PCR test for SARS-CoV2, oral and nasal swab<br>|
| Tested PCR (+) for COVID-19, Mild - not admitted to the hospital<br> | Other: Swab<br>* PCR test for SARS-CoV2, oral and nasal swab<br>|
| Tested PCR (+) for COVID-19, Severe - admitted to ICU (Intensive Care Unit)<br> | Other: Swab<br>* PCR test for SARS-CoV2, oral and nasal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral microbial signature | To assess the oral microbial signatures that relates to SARS-CoV2 in patients with no, mild and severe disease. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal microbial signature | To assess the nasal microbial signatures related to SARS-CoV2 in patients with no, mild and severe disease and to assess the role of the oral expression of ACE2-Ang II system during SARS-CoV2 in relation to disease outcome (mild, severe COVID). | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Human microbiome, Oral microbiome, SARS-CoV-2 infection