linjc16/ctgov huggingface dataset:
Smoking Cessation Treatment for Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch. The study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.

Official Title
-----------------
Smoking Cessation Treatment for Head and Neck Cancer Patients

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

Intervention / Treatment
-----------------
* Drug: Varenicline (Chantix)
* Drug: Nicotine Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older smoking 10 or more cigarettes per day diagnosed with and completed an initial course of treatment for any type of head and neck cancer life expectancy of 12 months or more Exclusion Criteria: history of allergic reactions to adhesives unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia females of childbearing potential who are pregnant, nursing, or not practicing effective contraception

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 |
| --- | --- |
| Active Comparator: Varenicline (Chantix)<br> | Drug: Varenicline (Chantix)<br>* 2 mg<br>* Other names: Chanitx;|
| Active Comparator: Nicotine Patch<br> | Drug: Nicotine Patch<br>* 21 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for 2 mg varenicline compared to nicotine patch. |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer. |  | Eight weeks | 
| To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation. |  | Eight weeks | 
| To examine the effect of varenicline and nicotine patch on alcohol consumption. |  | Eight weeks |
A Lifestyle Change Program to Prevent Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.

Official Title
-----------------
A Lifestyle Change Program to Prevent Type 2 Diabetes

Conditions
-----------------
Prediabetes

Intervention / Treatment
-----------------
* Behavioral: Enhanced standard care
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria age 21 or older medically stable and safe to exercise at high risk for type 2 diabetes able to speak English. Exclusion Criteria Type 2 diabetes Cardiovascular disease Cancer requiring treatment in the past 5 years Anemia Hepatitis Renal disease Gastrointestinal disease Recent or significant abdominal surgery Pulmonary disease with dependence on oxygen or daily use of bronchodilators Chronic infection (ie., HIV, active tuberculosis) Unable to walk 0.25 miles in 10 minutes Participation in commercial diet program Currently pregnant or within 3 months postpartum Currently nursing or within 6 weeks of having completed nursing Treatment of impaired glucose tolerance (IGT) with metformin Currently taking any glucocorticoid or beta-blocker Recently prescribed or changed dose of a statin (within 2 months)

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced standard care<br> | Behavioral: Enhanced standard care<br>* One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)<br>|
| Experimental: Lifestyle counseling<br> | Behavioral: Lifestyle counseling<br>* Enhanced standard care Six appointments with nurse practitioner (20 minutes)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Met Weight Loss Goal of 5% Weight Loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet and Exercise Behavior |  | 6 months | 
| Lipids |  | 6 months | 
| Quality of Life |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes prevention, primary care
MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis

Study Overview
=================
Brief Summary
-----------------
Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Detailed Description
-----------------
This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Official Title
-----------------
Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells (MSC) as aGVHD Prophylaxis

Conditions
-----------------
Leukemia, Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide
* Biological: Mesenchymal stromal cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory forms of acute leukemia, but in complete remission (CR) Second and third remission of acute leukemia 2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL) relapsed multiple myeloma advanced leukemia Exclusion Criteria: ICU Mechanical ventilation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC+CY<br>Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1*10^6/kg at day of recovery | Drug: Cyclophosphamide<br>* Dose 50 mg/kg at day +3,+4 once daily<br>Biological: Mesenchymal stromal cells<br>* Dose 1 million per kg, at day of recovery once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year |
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products

Study Overview
=================
Brief Summary
-----------------
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.

Official Title
-----------------
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products

Conditions
-----------------
Glaucoma, Cataracts, Refractive Error, Clear Lens Exchange

Intervention / Treatment
-----------------
* Device: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months. Exclusion Criteria: Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial Use of surgical devices not in accordance with the product labeling or indications for use Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period Use of systemic or ocular medications that may affect vision during the retrospective data collection period Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intervention|No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with subject devices of this study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints. | up to 12 months post-operation | 
| BCDVA | The proportion of eyes achieving 20/40 or better BCDVA. | up to 12 months post-operation |
Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.

Conditions
-----------------
Reduction or Absence of Lactobacilli in Neovaginal Flora

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants underwent the sex reassignment surgery (SRS) with the technique of the inverted penile skin flap longer than 1 year. All transsexual women treated according to the Standards of Care of the World Professional Association of Transgender Health (WPATH). Exclusion Criteria: clinical signs of vaginal or urinary tract infection, abnormal neovaginal discharge, neoplasia, bleeding, diarrhoea, constipation, rectal pathologies including hemorrhoids, antibiotic therapy in the previous 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacilli<br>30 Participants with verum | Dietary Supplement: Probiotics<br>* lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate<br>|
| Placebo Comparator: Placebo<br>30 Participants | Other: Placebo<br>* control group would receive a oral lactose placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Nugent score between baseline and end of treatment (improvement or no improvement). | Using Nugent scoring system, from each participant first swab from neovagina and rectum will be taken before start of oral probiotic use.(baseline information) Second swab from neovagina and rectum will be taken on the day following the last administration.(information about change in Nugent) | day 0 day 7 of oral probiotic application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic | From each participant, the swab from neovagina and rectum for microbiologic cultures will be taken on the day following the last administration. Isolation of oral applied probiotic strains. | Day 7 of oral probiotic application |
Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients

Study Overview
=================
Brief Summary
-----------------
This is a study of the registration of tobacco, coffee and substance abuse among acutely admitted psychiatric patients.

Detailed Description
-----------------
We will include all patients acutely admitted to Østmarka Psychiatric Hospital to register this population's use of coffee, tobacco and substances. We will determine whether this differs from other populations, between diagnoses, age, etc. We will also compare results of substance in immunologic rapid urine tests taken by the nurse at the hospital with substance in urine tested in laboratory with LC/MS (liquid chromatography/mass spectrometry).

Official Title
-----------------
Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients

Conditions
-----------------
Substance Abuse, Tobacco Use Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients acutely admitted to Østmarka Psychiatric Hospital Exclusion Criteria: Dementia Serious brain damage

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?
-----------------
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
-----------------
Emergency Services, Psychiatric, Tobacco use cessation, Coffee use cessation, substance use detection, Substance Abuse Detection
Trefoil Peptides in Lung Diseases

Study Overview
=================
Brief Summary
-----------------
The study focuses on trefoil family factor (TFF) peptides in sputum in lung diseases. The investigators hypothesize that TFF peptides are upregulated in lung diseases characterized by mucus hypersecretion.

Official Title
-----------------
Trefoil Peptides in Lung Diseases

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Informed consent Exclusion Criteria: Upper and lower airway infection 2 weeks prior to visit 1

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 |
| --- | --- |
| COPD<br>Chronic obstructive pulmonary disease | |
| Asthma<br> | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TFF in sputum |  | Monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.

Study Overview
=================
Brief Summary
-----------------
This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description
-----------------
The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve. The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.

Official Title
-----------------
Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography

Conditions
-----------------
Pituitary Adenoma

Intervention / Treatment
-----------------
* Procedure: Endoscopic endonasal pituitary surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 45 years diagnosis of pituitary adenoma treatment-naive with endoscopic endonasal pituitary surgery absence of other neurological disease absence of vitreoretinal and vascular retinal diseases Exclusion Criteria: age younger than 45 years No diagnosis of pituitary adenoma previous treatment with endoscopic endonasal pituitary surgery presence of neurological disease presence of vitreretinal and vascular retinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic endonasal pituitary surgery|Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of vessel density of the retinal vascular network in patients underwent endoscopic endonasal pituitary surgery, by optical coherence tomography angiography, during long-term follow up. | To evaluate the changes in vessel density of the retinal vascular network 48 hours and 1 year after endoscopic endonasal pituitary surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve, using optical coherence tomography angiography. The parameter analyzed by optical coherence tomography angiography was the vessel density of the retinal vascular network. | one year |
Phenytoin in the Healing of Clean Surgical Wounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the potential healing properties of phenytoin. The investigators will use the donor site of a split skin thickness graft (SSTG) to model a basic wound in a randomized controlled trial of topical phenytoin against current best clinical practice. The investigators aim to demonstrate a dose dependent effect. The investigators hypothesis, based on previous clinical experience at our center and on current available literature, that phenytoin will reduce wound healing time.

Official Title
-----------------
Phenytoin in the Healing of Clean Surgical Wounds

Conditions
-----------------
Wound, Re-Epithelialization

Intervention / Treatment
-----------------
* Drug: Phenytoin
* Drug: Sugar solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing split thickness skin graft during trial time period at Children's Surgical Centre Exclusion Criteria:

Ages Eligible for Study
-----------------
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Dressings of best current clinical practice, sugar solution. | Drug: Sugar solution<br> <br> |
| Experimental: Phenytoin 1<br>Dressings using phenytoin solution 20mg/ml | Drug: Phenytoin<br>* Topical use of phenytoin solution on dressings of split thickness skin graft sites.<br>* Other names: Dilantin, Dilantin-125;|
| Experimental: Phenytoin 2<br>Dressings using phenytoin solution 40mg/ml | Drug: Phenytoin<br>* Topical use of phenytoin solution on dressings of split thickness skin graft sites.<br>* Other names: Dilantin, Dilantin-125;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage rate of re-epithelialization | Pictures taken of wound site every other day will be analysed using imaging software for size of wound. Percentage rate will be calculated from this. | Participants will be followed for the duration of hospital stay, an expected average of 20 days | 
| Appearance of infection | Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale | Participants will be followed for the duration of hospital stay, an expected average of 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phenytoin, Skin graft donor site, Clean surgical site, Wound model