linjc16/ctgov huggingface dataset:
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.

Official Title
-----------------
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Tadalafil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Forced expiratory volume in 1 second (FEV1) <80% (FEV1/FVC <0.70) Right ventricular systolic pressure (RVSP) > 30 mmHg or Pulmonary Acceleration time <120 ms Exclusion Criteria: Pulmonary stenosis or echo left ventricular outflow tract obstruction Left ventricular ejection fraction < 45% Patients taking nitrates, nicorandil or doxazosin. Drug contraindications: Systolic Blood Pressure <90 mmHg recent stroke unstable angina past history of non arteritic anterior ischaemic optic neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: Tadalafil<br> | Drug: Tadalafil<br>* Tadalafil 10mg once daily for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking distance | The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | The investigators will measure baseline quality of life (0 months) using St George's Respiratory Questionnaire, SF-36v2, Minnesota Heart Failure Questionnaire. These questionnaires will be repeated at 2 and 3 months (final measurement). | 3 months | 
| B- Natriuretic Peptide (BNP) | Will be measured at 0, 2 and 3 months | 3 months | 
| Diffusion lung capacity for carbon monoxide (DLCO) | Will be measured at 0 and 3 months | 3 months | 
| Echocardiographic measurements | Will be measured at 0 and 3 months | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondary Pulmonary Hypertension
The Continuation of Erlotinib

Study Overview
=================
Brief Summary
-----------------
Newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. Given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.

Official Title
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The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Erlotinib (TARCEVA®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven non small cell lung cancer New developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib patients who are receiving erlotinib as salvage therapy At least one unidimensionally measurable lesion with a diameter > 10mm using brain MRI at least on unidimensionally measurable or evaluable lesion male or female patients aged >18 years ECOG performance status 0-2 Adequate hematologic function adequate renal function adequate hepatic function Exclusion criteria leptomeningeal metastases acute severe infection requiring antibiotic therapy significant cardiovascular disease uncontrolled DM severe ophthalmologic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tarceva<br>continuation of tarceva | Drug: Erlotinib (TARCEVA®)<br>* Erlotinib 150mg/day, everyday<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 6 months | 
| response rate |  | 6 months | 
| time to treatment failure |  | 6 months | 
| toxicity profiles |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small Cell Lung Cancer, Erlotinib, brain metastasis
Older Adult Training Study With Creatine and CLA

Study Overview
=================
Brief Summary
-----------------
We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (> 65 y). Our study hypothesized that administering CrM and CLA would yield greater strength and body composition benefits than the placebo group over the six months of resistance exercise

Detailed Description
-----------------
Men (N=19) and women (N=20) completed six months of resistance exercise training with Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized, double-blind, allocation.Outcomes included; strength and muscular endurance, functional tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose, systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption (Ν-telopeptides).

Official Title
-----------------
Creatine Monohydrate and Conjugated Linoleic Acid Improve Strength and Body Composition Following Resistance Exercise in Older Adults

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Behavioral: Training
* Drug: Creatine Monohydrate, Conjugated Linoleic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, Ambulatory, Recreationally active, Community dwelling Exclusion Criteria: Evidence of coronary heart disease; Congestive heart disease; Uncontrolled hypertension; Chronic obstructive pulmonary disease; Diabetes mellitus; Renal failure; Major orthopedic disability; and Smoking

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Training|nan|
|Drug: Creatine Monohydrate, Conjugated Linoleic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption) |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a. Functional capacity b. Strength with weight machines |  | six months |
The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family

Study Overview
=================
Brief Summary
-----------------
Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Thanks to families and relatives data, it will allow to improve the analyses carried out by the Societal Cancer Observatory in 2016.

Official Title
-----------------
The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: biographical interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients will be: over the age of 65 and under 80 with a colorectal cancer operated between 65 and 80 years with a documented histological diagnosis, dating from 2 to 5 years. be able to provide informed consent and appoint a caregiver who would be willing to participate in the study. The spouse and / or children and / or parents will be eligible: if he is at least 18 years old, if he can be considered a caregiver of the index patient for whom a diagnosis of CRC has been made. Exclusion Criteria: Patients with a diagnosis of colorectal cancer before the age of 65 or after the age of 80 from 2 to 5 years old. Near a deceased patient or under 18 years old.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient<br>Patients with a diagnosis of colorectal cancer after 65 years. | Other: biographical interviews<br>* A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual<br>|
| The spouse and /or children and /or parents<br>The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years. | Other: biographical interviews<br>* A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients after 65 years old with colorectal cancer | semi-structured patients interview | 2 hours | 
| Assess how the patients and their family members face the disease | semi-structured patients interview | 1 hour |
Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to determine the association between factors known to be associated with the development of chronic low back pain (psychological and biological) and the evolution of functional disability in individuals with a history of low back pain. To do so, 100 individuals with a history of nonspecific low back pain will be followed over a period of 18 months. During this time frame, participants will be evaluated three times in the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for functional disability and pain intensity levels of their low back pain as well as for psychological symptoms usually associated with the development of chronic low back pain. It is hypothesized that high psychological symptoms measured initially will be associated with high functional disability throughout the study .

Official Title
-----------------
Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To have experienced at least one episode of disabling (resulting in loss of work or modified tasks at work) nonspecific low back pain in the past three years. Exclusion Criteria: Specific causes of low back pain, arthritic conditions, other chronic pain conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Change from baseline in disability (Roland-Morris Disability Questionnaire) | Roland-Morris Disability Questionnaire | baseline, 3 months, 6, months. 9 months, 12 months, 15 months, 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychological factors, functional disability, pain thresholds, tolerance thresholds, motor adaptations, natural course
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to as needed sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as as needed basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.

Official Title
-----------------
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy

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

Intervention / Treatment
-----------------
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male sex Age < 65 IIEF erectile function domain score > 26 (out of 30 points possible for this subscale) Steady sexual partner Untreated prostate cancer TNM stage < cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason grade < 8. Willingness to participate in a clinical trial as manifested by informed consent Actually undergo nerve-sparing LRP surgery Exclusion Criteria: Not fulfilling all of the criteria for entry above Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy) Contraindication to sildenafil (e.g. nitrates, hypersensitivity) Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively Obstructive sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>Placebo nightly | Drug: Sildenafil<br>* 50 mg daily at bedtime<br>* Other names: Viagra;|
| Active Comparator: Drug<br>Sildenafil 50mg nightly | Drug: Sildenafil<br>* 50 mg daily at bedtime<br>* Other names: Viagra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF score |  | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic Radical Prostatectomy, Nightly sildenafil
Comparison Between Two Surgical Methods for Eyelid Ectropion: Tarsal Strip Alone Versus Tarsal Strip With Punctoplasty (Three Snips With or Without Diamond-shaped Resection)

Study Overview
=================
Brief Summary
-----------------
Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of lacrimal point. The objective of the study is to compare two surgical strategies for eyelid ectropion combined with ectropion of the lacrimal point

Detailed Description
-----------------
Were included patients underwent eyelid ectropion surgery in ophthalmology department from Oct 2014 to Oct 2015. The first procedure is lateral tarsal strip alone (group 1); the second one is lateral tarsal strip with three snips with or without diamond-shaped resection (group 2). The authors focused on the alteration of the quality of life related to watering, before and after operation. Quality of life related to discomfort due to watering was evaluated before and after surgery using a questionnaire. Informations have been gathered via phone with a ten items questionnaire, each item is worth 0 (no or minim discomfort due to watering) or 1 (discomfort due to more than moderated watering)

Conditions
-----------------
Ectropion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent eyelid ectropion surgery Exclusion Criteria: -

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 |
| --- | --- | --- |
| Quality of life related to discomfort due to watering after eyelid ectropion surgery | questionnaire quality of life | 1 year |
7T MRS in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan. The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis markers myo-inositol and glutamine will be higher due to inflammation (glial activation) and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage. There will be a relationship between neurochemical changes and disease severity.

Official Title
-----------------
Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease Group Parkinson's disease (clinical diagnostic criteria) Age 45-75 years inclusive Able to safely undergo MRI scanning Absence of diabetes and smoking Capable of giving informed consent Healthy Control Group Age 45-75 years inclusive Able to safely undergo MRI scanning Absence of diabetes and smoking Capable of giving informed consent Exclusion Criteria: Parkinson's disease Group Dementia (clinically determined by PI Dr. Tuite) Diagnosis of atypical parkinsonism Inability to safely undergo MRI scanning Inability to give informed consent Unstable medical conditions Present smoker Diabetic (on oral or injectable medications for diabetes) Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan Does not meet age criteria Healthy Control Group Has a 1st degree relative with PD Dementia (clinically determined by PI Dr. Tuite) Inability to safely undergo MRI scanning Inability to give informed consent Unstable medical conditions Present smoker Diabetic (on oral or injectable medications for diabetes) Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan Does not meet age criteria

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Magnetic resonance spectroscopy (MRS) | We will utilize optimized magnetic resonance spectroscopy (MRS) methodology to address theories of pathogenesis of Parkinson's disease (PD) by quantifying glutathione (GSH), lactate, glutamine and myo-inositol levels of the unilateral substantia nigra (SN) of healthy volunteers and patients with PD. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, PD, magnetic resonance spectroscopy