linjc16/ctgov huggingface dataset:
Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Detailed Description
-----------------
PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Official Title
-----------------
Clinical and Molecular Studies of the Tumour Suppressor Gene PTEN in Endometrioid Type Endometrial Cancer

Conditions
-----------------
Endometrial Neoplasms

Intervention / Treatment
-----------------
* Behavioral: questionnaire
* Procedure: Blood sample-DNA testing / Tumour-genetic markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older patients who had a hysterectomy patient able to provide consent and complete questionnaire

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: questionnaire|Using questionnaire to obtain patient's medical and family history of cancer.|
|Procedure: Blood sample-DNA testing / Tumour-genetic markers|Using Samples obtained to produce summary statistics on the tumour markers|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of endometrial cancer patients with inactivated PTEN tumor suppressor gene | Determining the association of PTEN inactivation and PKB expression, mutation of p53, microsatellite instability and progesterone receptor status in endometrial cancer | 6 months |
Operative Versus Conservative Treatment of Scaphoid Fractures

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the time to return to previous activity level between operative treatment and non-operative cast immobilization of patients with an acute complete fracture of the middle part of the scaphoid, without any dislocation or comminution visible CT-scan.

Official Title
-----------------
Comparison of Time to Return to Previous Activity Between Operative Treatment and Cast Immobilization of Complete Fracture of the Middle Part of the Scaphoid Without Dislocation

Conditions
-----------------
Scaphoid Fracture

Intervention / Treatment
-----------------
* Device: Scaphoid screw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mature skeleton Isolated, acute complete fracture of the mid third of the scaphoid Exclusion Criteria: acute fractures of both hands one hand missing other injuries than scaphoid fractures rheumatoid, osteoarthritis or polyarthritis previous soft tissue injuries of the hand drug or alcohol abuse participant in trial during the previous month

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Scaphoid screw|Conservative treatment versus application of scaphoid screw|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to previous activity level |  |  | 
| Time to return to full work and household duties |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH |  |  | 
| SF-36 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Return to work, Scaphoid fracture, Operative treatment, Activity level
Effect of Hypertonic Solutions on Allergic Rhinitis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectivity of using hypertonic nasal solutions alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients, retrospectively.

Detailed Description
-----------------
The medical records of the patients who admitted to outpatient clinic of otorhinolaryngology department of a tertiary referral center were retrospectively investigated. The symptom scores and nasal eosinophil levels of the patients were recorded. Patients using hypertonic solutions alone or steroid nasal spray alone were compared.

Official Title
-----------------
Do Hypertonic Solutions Have an Impact on Nasal Eosinophilia in Allergic Rhinitis Patients?

Conditions
-----------------
Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with positive Prick's test to at least one allergen and diagnosed as having allergic rhinitis were included Patients who used hypertonic nasal solution alone for at least one month were included as sthe study group Patients who used nasal steroid spray alone or at least one month were included as sthe study group Exclusion Criteria: Patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension, COPD and other systemic diseases were excluded
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 |
| --- | --- | --- |
| The number of eosinophils in nasal secretions |  | The number of eosinophils in nasal secretions that was counted before the therapy and after the first month of therapy would be recorded | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinonasal Outcome Test (SNOT-22) questionairre scores |  | SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic rhinitis, nasal steroid, hypertonic saline, eosinophil, symptom score
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with obsessive compulsive disorder.

Detailed Description
-----------------
The objective of the proposed study is to assess the efficacy of the herbal St. John's Wort (SJW) in the treatment of symptoms of obsessive-compulsive disorder (OCD). The approach is to conduct a 12-week, randomized, double blind, placebo controlled, parallel group pilot trial with 30 subjects in each of two arms. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) will be the primary measure for evaluating OCD. An intention-to-treat analysis will be done to compare the two arms.

Official Title
-----------------
St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: St. John's Wort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Female patients: at least 2 years post-menopausal, surgically sterile, or practicing a medically acceptable method of contraception. Meets DSM-IV criteria for obsessive compulsive disorder Exclusion criteria Primary diagnosis of major depression, dysthymia, panic disorder, social phobia, schizophrenia, schizo-affective disorder, bipolar disorder, or PTSD Substance abuse or dependence in the past 6 months Vascular dementia or primary degenerative dementia of the Alzheimer's type Treatment with MAOIs, TCAs, SSRIs, venlafaxine, nefazodone, remeron, citalopram, or bupropion within 14 days of first visit. Fluoxetine within 5 weeks of first visit. Failure to respond to at least two adequate antidepressant trials for obsessive compulsive disorder Investigational drugs within 30 days of baseline Known allergy or hypersensitivity to St. John's Wort Currently in behavior therapy for obsessive compulsive disorder ALL INQUIRIES WILL UNDERGO A PHONE SCREENING TO DETERMINE WHETHER THEY MEET ELIGIBLITY REQUIREMENTS.

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: St. John's Wort|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
-----------------
obsessive compulsive disorder, ocd, Anxiety, St. John's Wort, Wisconsin, Psychiatric, Mental health
Effect of Zinc Suplementation on Serum Hemosystein Level in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.

Detailed Description
-----------------
hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.

Conditions
-----------------
End Stage Renal Failure

Intervention / Treatment
-----------------
* Drug: Zinc Supplement
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis for 3 months older than 18 years old serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female Exclusion Criteria: acute renal failre malabsorption history of steroid or cytotoxic consumption

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo for 6 weeks | Drug: placebo<br>* placebo daily for 6 weeks<br>|
| Active Comparator: zinc<br>zinc sulfate 220 mg per day orally for 6 weeks | Drug: Zinc Supplement<br>* in 50 patients zinc sulfate 220 mg per day orally for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased hemocystein level |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemocystein zinc renal failure
CPAP In-home Assessment USA

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Detailed Description
-----------------
Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Official Title
-----------------
CPAP In-home Assessment USA

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Fisher & Paykel Healthcare CPAP Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 22 and over Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP) For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days. Exclusion Criteria: Contraindicated for PAP (CPAP or AutoCPAP) therapy Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea) Has obesity hypoventilation syndrome or congestive heart failure Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device Has implanted electronic medical devices (e.g cardiac pacemakers) Pregnant or think they may be pregnant Not fluent in spoken and written English.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational CPAP device<br>Fisher & Paykel Healthcare CPAP Device | Device: Fisher & Paykel Healthcare CPAP Device<br>* Fisher & Paykel Healthcare CPAP Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour. |  | 6 months | 
| Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults |  | 6 months | 
| Machine Reported Faults, Measured as Number of Patients With Machine Faults |  | 6 months | 
| Participant Reported Faults, Measured as Number of Participant Complaints |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device |  | 6 months |
Effects of Nerve Block on Knee Function After Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Early physical therapy after knee surgery is very painful on top of pain from surgery. Pain following surgery can limit recovery. One way to treat pain is by giving intravenous (IV) pain medication with morphine. Another method is to use a nerve block which involves placing a thin catheter (tube) into the lower back near the nerves that sense pain in the knee and give a local anesthetic to numb the nerves. Sometimes both methods are used together. This research is being done to determine whether nerve blocks with a local anesthetic improve knee recovery in addition to providing pain relief as compared to IV pain medicine alone

Official Title
-----------------
Effects of Continuous Lumbar Plexus Nerve Block on Functional Restoration and Outcome After Unilateral Total Knee Arthroplasty

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21-80 year old ASA Physical Status ASA I and II Mentally competent Intellectually competent Body mass index <35 No severe cardiac diseases No severe pulmonary diseases Unilateral knee disease No other lower extremity joint disease No chronic narcotic therapy or illicit drug use Exclusion Criteria: Age <21 or >80 year old ASA Physical Status >ASA II Mentally incompetent Intellectually incompetent or cognitively impaired Non-English speaking patient Worker's compensation patient Body mass index > 35 Bilateral knee disease Has other lower extremity joint disease Severe cardiac diseases Severe pulmonary diseases Chronic narcotic therapy or illicit drug use Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Nerve block|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
-----------------
Nerve block, postoperative pain, analgesia
Dynamic ASPECTS of Internal PRE-ACTIVATION of Effects Sensors of Voluntary ACTION in PARKINSON's Disease

Study Overview
=================
Brief Summary
-----------------
The ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Nevertheless, the question whether the action-effect anticipation is impacted or not by motor pathologies, such as the Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with Parkinson's disease and in matched control participants. Indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. Results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with Parkinson's disease.

Official Title
-----------------
The Impact of Parkinson's Disease on Internal Preactivation of Sensory Effects of Intention-based Actions. A Subliminal Priming Study

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Behavioral: Behavioral observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 years and older Parkinson's disease Exclusion Criteria: Other pathology or neurological or psychiatric history Known pregnancy or breastfeeding Absence of affiliation to social security or universal health coverage (CMU) Person under legal protection Patient's opposition to participate

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 |
| --- | --- |
| Parkinson's disease<br> | Behavioral: Behavioral observation<br> <br> |
| Healthy subjects<br>gender and age matched with Parkinson's disease patients, whose data will be extracted from an existing database | Behavioral: Behavioral observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time | time measured in seconds | baseline | 
| error rate |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Voluntary action, Action-effect preactivation, Action-effect prediction
EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry

Study Overview
=================
Brief Summary
-----------------
The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.

Detailed Description
-----------------
The Registry will be a prospective non-randomized single-arm trial of up to 150 patients enrolled in up to ten (10) centers in the United States. The overall duration of the registry is estimated to be 18 months per site. For the patients the registry duration will be from the time of procedure until discharge from the hospital, estimated to be approximately four (4) days. Prior to enrollment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be considered enrolled in the registry after written informed consent is obtained. As EpiAccess is only used for the access portion of the procedure, the safety performance and effectiveness endpoints are acute from the time of needle insertion until pericardial sac access is achieved. Follow up clinical examinations will be performed according to institutional standard of care. No special tests are required for this device.

Official Title
-----------------
EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry

Conditions
-----------------
Arrhythmias, Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years of age or older Pericardial access is clinically indicated Patient is willing and able to provide written informed consent Exclusion Criteria: Patients who have any condition which contraindicates pericardial access or who have any condition specified in the Contraindications section of the Instructions for Use. This includes: Previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis Congenital absence of a pericardium Absence of a free epicardial space Patients with active infection History of chronic pericarditis Patient requiring anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia Patient not in normal sinus rhythm Presence of thrombus in the left atrium Coagulopathy Known allergy to contrast media

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 |
| --- | --- | --- |
| Number of Participants with Adverse Events as Measure of Safety | Number of Participants with Adverse Events as Measure of Safety | Up to 4 days post procedure (or until time of discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Economics | Number of Participants with Extended Hospital Stay as a Measure of Health Economic Value | Up to 4 days post procedure (or until time of discharge) |