linjc16/ctgov huggingface dataset:
Combination Medications vs. Patch Alone for Medically-Ill Smokers

Study Overview
=================
Brief Summary
-----------------
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness

Detailed Description
-----------------
Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).

Official Title
-----------------
Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness

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

Intervention / Treatment
-----------------
* Drug: Nicotine patch, nicotine inhaler, bupropion
* Drug: Nicotine patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO)) 18 years or older interested in quitting within the next 30 days one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections) Exclusion Criteria: contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications) current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications unable to give consent

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nicotine patch, nicotine inhaler, bupropion | Drug: Nicotine patch, nicotine inhaler, bupropion<br>* Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily<br>|
| Active Comparator: 2<br>Nicotine patch | Drug: Nicotine patch<br>* 21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco use abstinence |  | 26 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first relapse |  | varies | 
| Duration of medication use |  | 26 weeks | 
| Adverse clinical events |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco dependence treatment
Polymorphids an mRNA Expression in Obese Genes

Study Overview
=================
Brief Summary
-----------------
Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP). Are there any difference in polymorphids and/or mRNA expression in genes significant for developing obesity, between normal weight and obese individuals, with or without diabetes typ 2 . Are there any difference in polymorphids and/or mRNA expression in different types of fat tissue

Official Title
-----------------
Polymorphids and mRNA Expression in Genes, Significant for Developing Obesity and Typ II Diabetes in Different Types/Localisations of Fat Tissue

Conditions
-----------------
Polymorphism, mRNA Expression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older laparoscopic surgery (Gastric by-pass, cholecystectomy, antireflux surgery) Normal weight without type 2 diabetes BMI 18-25 Obese without type 2 diabetes BMI>35 Obese with type 2 diabetes BMI>35 Exclusion Criteria: under 18 years open surgery pregnancy BMI >27-<35

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Type 2 Diabetes and BMI>35<br>Patients with type 2 diabetes and body mass index 35 or more. | |
| BMI>35<br>Patients undergoing surgery, gastric bypass or cholecystectomy, without diabetes type 2 and body mass index 35 or more | |
| BMI 18-27<br>Patients undergoing surgery, cholecystectomy or reflux, without type 2 diabetes and body mass index between 18-27 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity | fat biopsy taken from abdomen, omenta and thigh at surgery | approximatly 30 minutes after start of operation | 
| Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2 | fat biopsy; abdomen, omenta and thigh taken at surgery | approximatly 30 minutes after start of operation |
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)

Study Overview
=================
Brief Summary
-----------------
This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.

Official Title
-----------------
ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)

Conditions
-----------------
Malignant Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of the age of 18 years or older Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study Exclusion Criteria: Patient was treated with vemurafenib as part of a clinical trial or expanded access program Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non-cutaneous squamous cell carcinoma |  | 2 years | 
| Incidence of cutaneous squamous cell carcinoma |  | 2 years | 
| Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms) |  | 2 years | 
| Incidence of abnormal liver function |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a second (or subsequent) primary melanoma |  | 2 years | 
| Incidence of gastrointestinal polyps |  | 2 years | 
| Incidence of adverse events |  | 2 years |
Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.

Detailed Description
-----------------
The field of plastic surgery, unlike most other surgical specialties, has no anatomic or functional area to which it can lay claim; the plastic surgeon practices methods and techniques applicable to all specialties and anatomic areas. Reconstructive surgery is the process of restoring the human body to whole following tumor extirpation, infection, trauma or congenital or acquired deformity - restoring both form and function. The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.

Official Title
-----------------
Thoracodorsal Artery Perforator Flap Versus Other Conventional Free Flaps in Soft Tissue Reconstruction

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Procedure: thoracodorsal artery perforator flap
* Procedure: latissimus dorsi flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Soft tissue loss anywhere in the body. Exclusion Criteria: • Patients with chronic debilitating diseases e.g. chronic renal failure, uncontrolled diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 6 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Thoracodorsal artery perforator flap | Procedure: thoracodorsal artery perforator flap<br>* fascio-cutaneous flap used in cases of trauma or burns<br>|
| Active Comparator: control group<br>Conventional free flaps | Procedure: latissimus dorsi flap<br>* musculo-cutaneous flap used in cases of trauma or burns<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean operative time | the time from the start to the end of operation | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with Flap viability | The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering) | 1 week |
Study of Aripiprazole in Patients With Acute Bipolar Mania

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Aripiprazole
* Drug: Haloperidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Placebo<br>* Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).<br>|
| Experimental: B<br> | Drug: Aripiprazole<br>* Tablets, oral, 15-30 mg, once daily, 12 weeks.<br>* Other names: Abilify;|
| Active Comparator: C<br> | Drug: Haloperidol<br>* Capsule, oral, 5-15 mg, once daily, 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in a mania rating scale at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate and Clinical Global Impression scale at endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Mania
Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

Study Overview
=================
Brief Summary
-----------------
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection

Detailed Description
-----------------
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time

Official Title
-----------------
TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

Conditions
-----------------
Prostate, Hyperplasia

Intervention / Treatment
-----------------
* Procedure: total intravenous anaesthesia
* Procedure: spinal anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older signed informed consent elective transurethral prostata resection Exclusion Criteria: ASA more than 3 kidney disease, liver disease intolerance against bupivacaine, fentanyl, propofol og remifentanil chronic pulmonary disease dementia

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 |
| --- | --- |
| Active Comparator: TIVA<br>Total intravenous anaesthesia (TIVA) with propofol and remifentanil | Procedure: total intravenous anaesthesia<br>* propofol and remifentanil<br>|
| Active Comparator: Spinal<br>Spinal anaesthesia with bupivacaine and fentanyl | Procedure: spinal anaesthesia<br>* bupivacaine and fentanyl<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | Patient satisfaction was measured asking the patient about satisfaction with anaesthesia using a 5-point Linkert scale: totally satisfied - satisfied - neither satisfied nor dissatisfied - dissatisfied - totally dissatisfied Time frame: Start anaesthesia to end post anaesthestic care unit | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in PACU | period in post anaesthetic care unit | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostata hyperplasia, transurethral resection, TIVA, spinal anaesthesia
Study Evaluating Management of Patients With Moderate and Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
This is an observational, naturalistic, multicenter, retrospective study to describe the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice in Spain.

Official Title
-----------------
Management of Patients With Moderate and Severe Psoriasis Under Treatment With Topical and/or Systemic Drugs

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: Clinical record review


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: ·Over 18 years of age.·Diagnosed with moderate or severe psoriasis.·Initiated treatment with topical and/or systemic treatment between two and five years before enrollment in the study. ·Has a clinical record at the dermatologist office. Main Exclusion Criteria: ·Currently participating in a clinical study. ·Clinical record lacks minimum data required for observational analysis.

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 |
| --- | --- |
| 1<br>Patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs | Other: Clinical record review<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs including sequence, doses and duration of treatment. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of therapeutic management depending on patients' disease severity, using absolute and relative frequencies for qualitative variables and centralization and dispersion measures (mean, SD, median, minimum, maximum..) for quantitative variables. |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: To study the effect of niche mesenchymal stromal cells (MSC) exposure on microRNAs (miR) expression in pediatric AML at different time points and compare those profiles to the miR profiles at baseline. To focus on four pediatric AML-specific miRs (miR34a, miR538e, miR193e, and miR198) which show the most significant differential expression after in vivo niche exposure at four months (hematogenous spread). To determine whether altered miR expression reflects or causes the metastatic invasion pattern of AML. OUTLINE: Bone marrow-derived mesenchymal stromal cell (MSC) samples are implanted subcutaneously in NOD/SCID mice. Cells are then harvested at day 0, 1 month, and 4 months post-implantation. miRNA is isolated and analyzed by Ilumina MicroRNA Expression Profiling single Beadchip. The obtained data is then analyzed by the Illumina Genome Studio Analysis Software.

Official Title
-----------------
Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia Fresh human bone marrow samples obtained from orthopedic surgery at the Tissue Donation Program of The Feinstein Institute and the Children Oncology Group (COG) Myeloid Disease Biorepository PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment |  |  | 
| Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles |  |  | 
| Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia/other myeloid malignancies