linjc16/ctgov huggingface dataset:
the Quality of Life Assessment of Lung Cancer Patients in China

Study Overview
=================
Brief Summary
-----------------
The goal of this study is assess the quality of life of advanced non-small cell lung cancer (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the subscales and constructs of FACT-L. The assumption is the quality of life will be better after 2 cycle of chemotherapy.

Detailed Description
-----------------
Lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (NSCLC). The quality of life of NSCLC patients become more and more important, because of most NSCLC is incurable. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Official Title
-----------------
A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: >18 and <75 years old pathological or cytological diagnosis confirmed advanced non-small cell lung cancer Eastern Cooperative Oncology Group Performance Status: 0-2 have never receive any kind of anti-cancer chemotherapy agree to regularly assessment of quality of life sign the informed consent form Exclusion Criteria: Currently attending any antitumor drug clinical trials Pregnancy or breast-feeding women Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously. not suitable to participate in this test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| the change of quality of life | use Functional Assessment of Cancer Therapy-Lung (FACT-L) scales assess the quality of life to all subjects. before chemotherapy; after 1st chemotherapy; after 2nd chemotherapy; | Change from baseline quality of life at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FACT-L, lung cancer, quality of life
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.

Official Title
-----------------
Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker

Conditions
-----------------
Pacemaker Indication

Intervention / Treatment
-----------------
* Device: EVIA Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the indications for pacemaker therapy Understand the nature of the procedure Give informed consent Able to complete all testing required by the clinical protocol Available for follow-up visits on a regular basis at the investigational site Exclusion Criteria: Meet none of the pacemaker indications Meet one or more of the contraindications Patients with chronic atrial fibrillation (dual chamber pacemaker only) Have a life expectancy of less than six months Cardiac surgery in the next six months Enrolled in another cardiac clinical investigation Have other medical devices that may interact with the implanted pacemaker
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pacemaker therapy<br> | Device: EVIA Pacemaker<br>* patient has standard indication for pacemaker therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) | atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually. | 1 month follow-up completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Free Rate | Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients) | 1- and 3- month follow-up completed |
Trial of Asthma Patient Education (TAPE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate the way that educational approaches and presentation of a drug may affect the response to montelukast and placebo (an inactive medication) in subjects with asthma.

Detailed Description
-----------------
This is a study of the effects of education and drug presentation on efficacy of montelukast and placebo in asthma. This trial will answer the following questions: 1) Is there a true placebo response in asthma that is not due to non-specific factors? 2) Can the placebo effect in asthma be augmented by interventions that increase expectancy of benefit? 3) Can interventions that increase expectancy augment the effect of active treatment? 4) Are placebo effects additive or interactive with treatment effects?

Official Title
-----------------
Trial of Asthma Patient Education (TAPE)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Montelukast
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 15 or older physician diagnosed asthma regular use of prescribed asthma medication over preceding year post-bronchodilator FEV1 of at least 75% of predicted inadequate asthma control over preceding two months Exclusion Criteria: current or past smoking (greater than 10 pack-years) serious asthma exacerbation within previous three months regular use of oral corticosteroids history of respiratory failure due to asthma current use of montelukast or history of adverse reaction to montelukast concomitant interfering medical condition participation in another clinical trial inability or unwillingness to perform study procedures pregnancy, lack of effective contraception (when appropriate), lactation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Montelukast|nan|
|Behavioral: Education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning peak expiratory flow |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry |  |  | 
| Asthma diaries |  |  | 
| Asthma questionnaires (Asthma Control Score, Asthma Symptom Utility Index, Asthma Quality of Life) |  |  | 
| Generic health quality of life (SF-36) |  |  | 
| Shortness of Breath Questionnaire |  |  | 
| Adherence monitoring |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Placebo, Education
Monroe County Inflammatory Bowel Disease (IBD) Registry

Study Overview
=================
Brief Summary
-----------------
This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).

Official Title
-----------------
Epidemiologic Study of Inflammatory Bowel Disease in Monroe County, New York

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with IBD who sign consent from 1995-2001 Exclusion Criteria: Patients without IBD
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 |
| --- | --- | --- |
| not complete | paper is still in progress | not complete | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Disease in Monroe County, NY
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the satiety value of different bran fibers on appetite & subsequent food intake with acute consumption. Satiety will be measured subjectively by visual analogue scales (VAS).

Detailed Description
-----------------
Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes

Official Title
-----------------
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite

Conditions
-----------------
Food

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women between the ages of 18-40 body mass index between 18.5-29.9kg/m2 eat breakfast regularly nonsmoking not taking weight loss medications non-dieting (weight stable over the past 3 months) spoken and written English literacy. Exclusion Criteria: antibiotic use within the past 6 months cardiovascular disease diabetes mellitus cancer in the past 5 years renal or hepatic disease recent bacterial infection gastrointestinal conditions affecting digestion or absorption weight loss>5kg in prior 3 months (intentional or unintentional) history of drug or alcohol abuse in prior 6 months food allergies high fiber intake(3 or more servings of high fiber foods per day) lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use restrained eater(score>10 on the dietary restraint factor of the Three Factor Eating Questionnaire) concurrent or recent (within 30 days) participation in an intervention study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fiber<br> | Dietary Supplement: Dietary fiber<br>* Wheat, barley, oat and bran fibers added to a breakfast product<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety response |  | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The focus of this study is to determine satiety
Laparoscopic Pyeloplasty Registry and Database

Study Overview
=================
Brief Summary
-----------------
The gold standard for the treatment of ureteropelvic junction obstruction (UPJO) is the open pyeloplasty. As a minimally invasive alternative, many centers are currently offering laparoscopic pyeloplasty (LP) as primary therapy for UPJOs. Recent data has shown that laparoscopic pyeloplasty has comparable success rates to open pyeloplasties and produces durable results. The researchers are compiling a registry and database to review outcomes of laparoscopic pyeloplasty patients.

Official Title
-----------------
Laparoscopic Pyeloplasty: A Registry and Database

Conditions
-----------------
Ureteral Obstruction

Intervention / Treatment
-----------------
* Other: Registry and database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients of Methodist Urology in Indianapolis, IN over the age of 18 with ureteropelvic junction obstruction Exclusion Criteria: Patients unable to give informed consent Patients with active bleeding diatheses Women who are pregnant or in whom pregnancy status cannot be confirmed Patients with medical conditions precluding laparoscopy Patients with active urinary tract infection

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>Registry and database of subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction | Other: Registry and database<br>* Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction at Methodist Urology in Indiana will be asked to participate in a registry and database to review outcomes of the surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To record and review the surgical outcomes of our population of UPJO patients who have been treated with LP. Once all retrospective data has been reviewed, we will continue to collect outcome data on a prospective basis |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UPJ Obstruction, Renal Obstruction, Delayed Renal Flow
Study of the Treatment of Tendinopathy Unruptured of Rotator Cuff by Intramuscular Injection of Botulinum Toxin

Study Overview
=================
Brief Summary
-----------------
Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible. It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.

Conditions
-----------------
Tendinopathy Rotator Cuff

Intervention / Treatment
-----------------
* Drug: Botox arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed consent Active social care Compliant patient with protocol Patient more than 18 years Positive Neer Test Exclusion Criteria: Prior study exclusion period Protected patient Study refusal Deficient patient Rheumatoid arthritis, osteoarthritis, chondrocalcinosis. Microcrystalline arthritis. Active infection . History of hypersensitivity reaction during a previous injection of botulinum toxin Bilateral involvement Neurological deficit Depression History of shoulder surgery Pregnant or breast feeding women Systemic disease (diabeta, vascularitis) Known neurological disease Intraarticular associate disease Acromioclavicular associate disease Myasthenia Botulinum toxin is not recommended in combination with aminoglycosides

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox arm<br>intramuscular injection of botulinum toxin | Drug: Botox arm<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant improvement in shoulder pain objectified by analogy Visual Scale (VAS) in patients with unruptured tendinopathy of the rotator cuff impingement, debilitating, lasting for more than 3 months and resistant to usual medical treatment. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant improvement in life quality : functional clinical scores (Constant, ASES, Oxford) |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder Joint, A02.835.583.748
Study of Talabostat and Cisplatin in Advanced Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma.

Conditions
-----------------
Melanoma, Skin Cancer

Intervention / Treatment
-----------------
* Drug: talabostat (PT-100) tablets
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002) Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins ECOG Performance Status of 0, 1, or 2 Expected survival ≥12 weeks Written informed consent Exclusion Criteria: More than 1 prior chemotherapy or biotherapy regimen for metastatic melanoma Radiation therapy to >50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation. Clinically significant laboratory abnormalities Symptomatic CNS metastases Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled. Pregnant or lactating women.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: talabostat (PT-100) tablets|nan|
|Drug: cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Globus Pallidus Stimulation to Treat Insomnia

Study Overview
=================
Brief Summary
-----------------
Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).

Official Title
-----------------
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: DEEP BRAIN STIMULATION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40-80 years of age Symptomatic with Parkinsonism for 7-20 years Severe insomnia based on ISI score Exclusion Criteria: Clinically significant dementia (MMSE <23) Hoehn & Yahr [Hoehn, 1967 #1839] stage I or V disease Other significant neurological or psychiatric disease Previous pallidotomy or thalamotomy Previous placement of other implantable devices Secondary parkinsonism (non-idiopathic parkinsonism) Inability to travel to Jacksonville for post-operative study visits Severe sleep apnea Insomnia due to pain or untreated mood disorder Contraindications to 3T MRI Circadian rhythm sleep disorders. Current use of hypnotics

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults with Parkinson's disease and severe insomnia<br>1 arm study | Device: DEEP BRAIN STIMULATION<br>* NEUROMODULATION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index | Change in self-reported insomnia severity index questionnaire score, using a total score scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe) | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parkinson's Sleep Scale (PDSS) | Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never | 3 and 6 months |