linjc16/ctgov huggingface dataset:
Casodex/Zoladex Biomarkers in Localised Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones

Official Title
-----------------
A Randomised Pilot Study to Evaluate the Effect(s) of Casodex 150 mg and Zoladex 3.6 mg on Pathological and Genomic Tumour Markers in Subjects Undergoing Radical Prostatectomy for Localised Prostate Carcinoma

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

Intervention / Treatment
-----------------
* Drug: bicalutamide (Casodex), goserelin (Zoladex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed localised prostate biopsy specimen that contains sufficient tumour for evaluation of cell proliferation and apoptosis markers Patients who are scheduled for radical prostatectomy with curative intents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: bicalutamide (Casodex), goserelin (Zoladex)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proliferation by Ki67, |  |  | 
| apoptosis marker (TUNEL assay), |  |  | 
| Gleason score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of known androgen-regulated genes, |  |  | 
| biomarkers of apoptotic pathway, |  |  | 
| (novel) genomic transcripts |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker study, Patients with clinically localised prostate cancer
Leucotrichia in Vitiligo

Study Overview
=================
Brief Summary
-----------------
The incidence of leucotrichia has been reported to range from 9 to 48.4% of all vitiligo patients.Leucotrichia is more often observed in segmental vitiligo with a very high percentage. However, further studies considering the prevalence of leucotrichia in different types of vitiligo need to be conducted.

Official Title
-----------------
Leucotrichia in Vitiligo Patients : A Cross Sectional Study

Conditions
-----------------
Leucotrichia

Intervention / Treatment
-----------------
* Other: Examination of leukotrichia in vitiligo patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Vitiligo patients with/ without leukotrichia within the vitiliginous areas Exclusion criteria: Age < 18 Premature hair graying in the trunk before the age of 30

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

| Intervention/Treatment |
| --- |
|Other: Examination of leukotrichia in vitiligo patients|Examination of leukotrichia will be enhanced by wood's light and dermoscopy for better enhancing of the lesions and good magnification|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of prevalence of leukotrichia within vitilignous areas in vitiligo patients | Detection of prevalence of leukotrichia within vitilignous areas in vitiligo patients | within 6 months |
Remote Simultaneous Medical Interpreting and Medical Outcomes

Study Overview
=================
Brief Summary
-----------------
All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration. All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.

Official Title
-----------------
Remote Simultaneous Medical Interpretation: Medical Outcomes

Conditions
-----------------
DIabetes

Intervention / Treatment
-----------------
* Other: remote simultaneous medical interpreting
* Other: usual and customary
* Other: ENglish speaking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Limited English-speaking English-speaking New patient in medicine clinic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>remote simult med interpret | Other: remote simultaneous medical interpreting<br>* remote simultaneous medical interpretation<br>|
| Active Comparator: 2<br>Usual & Customary | Other: usual and customary<br>* usual and customary interpreting<br>|
| Other: 3<br>comparison group | Other: ENglish speaking<br>* English speakers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence with care |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| care parameters |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immigrant, Interpreting
T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients

Study Overview
=================
Brief Summary
-----------------
The designed study follows up on the previous one by the international T-cell project (Bellei et al,, 2012) and its purpose is to verify whether a prospective collection of data would permit access to more accurate information permitting a better definition of prognosis and investigation of more adequate treatment strategies for these neoplasms. The analysis of patients distributed in all five macro regions of the country and a comparison among them will provide a real picture of the disease in Brazil, limiting the bias probably found in the previous projects.

Detailed Description
-----------------
Patients with diagnosis histologically confirmed T-cell or NK-cell lymphoma will be registered in the study, despite of their planned treatment. Registration will be made on-line on a key restricted accessible web-database after obtaining the informed consent dated and signed by the patient. Every registered patient has as well to undergo a central histopathology review by a panel of experts. The referring pathologist will collect and review the patological material sent by the participating centers, without knowing the clinical outcome of the patient. Validated cases have to be supplied of information regarding treatment procedures and follow up updating for at least 5 years. The primary endpoint is the overall survival and other endpoints such as event free survival; progression free survival, complete and partial response rates.

Official Title
-----------------
Prospective Collection of Data in Patients With T-cell Lymphomas Distributed in the Five Distinct Macro Regions of Brazil

Conditions
-----------------
T-cell Lymphoma Adults, T-cell Lymphoma, NK-Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dated and signed informed consent; T-cell or NK-cell diagnosis; Tissue biopsies adequate for diagnosis and classification and available for centralized review; clinical, laboratory, image data available and registred in the website. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Descriptive analysis during the first year of T-cell Brazil Registry | Descriptive analysis and Overall survival | 12 months of registring |
Electrophysiologic Measures of Treatment Response in Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the electrophysiological effects of cholinergic therapy (cholinesterase inhibitors and transdermal nicotine) in Alzheimer disease. The attempt will be to locate electrophysiological markers and predictors of cognitive and clinical treatment response.

Official Title
-----------------
Verbal Memory ERPs as Indices of Treatment Response in Alzheimer Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Aricept
* Drug: Exelon
* Drug: Nicoderm Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients diagnosed with mild to moderate probable Alzheimer's disease (mini-mental state exam scores between 15-27), and normal controls (age generally between 60-85). Subjects must either be planning to start daily cholinesterase therapy (e.g. Aricept, Exelon) or willing to try a transdermal nicotine patch for two 8 hour periods.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aricept|nan|
|Drug: Exelon|nan|
|Drug: Nicoderm Patch|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.

Official Title
-----------------
Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery, Randomized Clinical Trial

Conditions
-----------------
Mechanical Ventilation During Anesthesia

Intervention / Treatment
-----------------
* Device: anesthesia ventilator machine
* Device: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physical status American Society of Anesthesiologist(ASA) I or II Exclusion Criteria: Patients refuse ASA physical status more > II Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and signiﬁcant cardiac dysfunction. Patients with pulmonary hypertension.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dynamic lung compliance for detection of optimum PEEP<br>detection of optimum PEEP by measurement of the dynamic lung compliance (by the ventilator machine) after lung recruitment | Device: anesthesia ventilator machine<br>* dynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment<br>|
| Active Comparator: Lung ultrasound for detection of the optimum PEEP<br>Lung ultrasound will be used to detect the optimum PEEP after lung recruitment | Device: lung ultrasound<br>* lung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of the optimum PEEP which is measured in mmHg | the optimum PEEP will be detected after alveolar recruitment either by dynamic lung compliance or by lung ultarsound views | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of postoperative pulmonary complications | patients will be monitored for detection of postoperative pulmonary complictaios as atelectasis , pneumothorax , respiratory failure | 1st 24 hour |
Chemical Dependency and Smoking Cessation: Patient's Views - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses patient views on smoking cessation and tobacco harm reduction during drug treatment.

Detailed Description
-----------------
Participants included 34 patients who had never voluntarily quit smoking for longer than 24 hours (continuous smokers), 34 smokers who had quit smoking for at least 24 hours before but had relapsed (relapsers), and 10 former smokers who had been abstinent for at least the past 6 months (successful quitters). We held 7 focus groups, 3 with continuous smokers and 4 with relapsers. Focus groups lasted 2 hours and were held at participants' clinics to preserve confidentiality. We conducted hour-long individual interviews with successful quitters. All participants completed a brief written survey immediately before their session. Survey items included questions on demographics, smoking behaviors, and motivation for cessation, reduction, and nicotine maintenance. We reimbursed all participants $40 and provided a meal to focus group attendees.

Official Title
-----------------
Chemical Dependency and Smoking Cessation: Patient's Views

Conditions
-----------------
Tobacco Use Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Selection criteria included being 18 years or older, smoking 5 or more cigarettes per day for at least 2 years, and being enrolled continuously in methadone maintenance treatment (MMT) for at least the past 2 years. Exclusion Criteria: Being less than 18 years of age, smoking 4 or fewer cigarettes per day, smoking less than daily for less than 2 years, and not being enrolled continuously in methadone treatment for at least the 2 past years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if certain MRI sequences can accurately diagnose adrenal masses of unknown origin.

Official Title
-----------------
Lipid-poor Adrenal Masses: Evaluation With Chemical Shift MRI

Conditions
-----------------
Adrenal Gland Disease

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients can participate in this study if they are 18 years of age or older and if they have had a Cat Scan (CT scan) performed with and without contrast media (medication given intravenously to enhance the CT images) or if patients are scheduled to have a CT scan performed and if the reason their physician ordered the CT is because they have an adrenal mass of an unknown type. Exclusion Criteria: Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator. Pregnant patients or patients who are lactating. A patient who is claustrophobic and would require sedation to complete the MRI exam.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adrenal mass group<br> | Procedure: MRI<br>* Magnetic Resonance Imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of either benign or malignant adrenal mass on pathology | definitive diagnosis of adrenal mass | 0-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of growth of mass on follow up imaging | evidence for benign or malignant mass based on assessment of stability or growth | 3-24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenal glands, adrenal masses
The Patient's Experience With Physician Assistant Providers (PEPAP)

Study Overview
=================
Brief Summary
-----------------
Our investigation was a prospective cross-sectional survey evaluating the patient experience to new patients that presented to an outpatient private practice specialized in total joint reconstruction. New patients seeing a PA during their initial visit were randomized to intervention and control groups and all were given a descriptive survey at checkout. Inclusion criteria (1) new patient (2) English speaking (3) appointment with PA. There was no exclusion criteria. Eligible patients were randomized to the intervention group (received biosketch card) or the control group (no card) using random number generator. Patients within the intervention group received a biosketch card during rooming, pre-clinician encounter, and were not informed about involvement. Both groups received standard care that was independent of the study. To blind the outcome measure, the research assistant did not explain the reason for the card upon rooming. The provider PA was not informed which patient received the card. Upon discharge, the patient completed a five-question survey regarding the clinic visit.

Official Title
-----------------
The Patient's Experience With Physician Assistant Providers: a Descriptive Survey and Randomized Intervention

Conditions
-----------------
Joint Diseases, Midlevel Providers, Nurse Practitioners, Physician Assistants, Patient Perceptions, Patient Preferences

Intervention / Treatment
-----------------
* Other: Biosketch Card


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New Patient Appointment with a PA Exclusion Criteria: Non-English Speaker

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biosketch Card<br>Patients within the experimental group received a biosketch card during rooming, pre-clinician encounter, and were not informed about their involvement. To blind the outcome measure, the research assistant did not explain the reason for the card upon rooming the patient nor did they inform the midlevel provider. | Other: Biosketch Card<br>* The experimental group received a biosketch card during rooming, pre-clinician encounter that gave an overview of the midlevel providers qualifications.<br>|
| No Intervention: No Card<br>No bio sketch card was provided to these participants. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey | Five question survey following the visit | Immediately following the visit |