linjc16/ctgov huggingface dataset:
Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Study Overview
=================
Brief Summary
-----------------
Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .

Official Title
-----------------
Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Conditions
-----------------
Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heartburn for at least 3 days in the week prior to screening Regurgitation for at least 3 days in the week prior to screening Stable dose PPI therapy > 4 weeks Incomplete relief on daily PPI therapy > 4 weeks Exclusion Criteria: Evidence of structural abnormality of the gastrointestinal tract or disease/conditions Previous gastrointestinal surgery that may influence esophageal motor function Evidence of cathartic colon or a history of laxative use Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline) |  |  | 
| To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments) |  |  | 
| To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients |  |  | 
| To assess patient satisfaction with treatment (end of treatment) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, PPI, heartburn, regurgitation
Multicenter Study of Generation Comorbidity Score

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to generate and valid a co-morbidity score with updated definitions and suitable for use in Argentina in both public and private settings. These tools would allow us to compare different populations in Argentina adjusting for comorbidities. Also, this would potentially help attending physicians and health administrators.

Detailed Description
-----------------
The investigators will generate a co-morbidity score, perform the score validation and generate an online calculator for the score (open access). Finally, a score validation for extreme values of score will be performed to ensure representativeness of these patients.

Official Title
-----------------
Multicenter Study for the Generation of a Score of Comorbidities

Conditions
-----------------
Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 17 older admitted to hospital within 72 hours of admission non programed admission Exclusion Criteria: negative to participate 72 hs mortality expected obstetrics admissions

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| generation cohort<br>Included 5 hospitals from Buenos Aires, Argentina | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| generate a co-morbidity score | Generate a co-morbidity score that measures the weight for individuals morbidities with respect to death. | 12 months follow up |
Prediction of 18F-FES-PET/CT Parameters on Palbociclib Combined With ET

Study Overview
=================
Brief Summary
-----------------
To investigate parameters based on 18F-FES-PET/CT so as to estimate the outcome of palbociclib combined with endocrine therapy in patients with HR+/HER2-MBC.

Official Title
-----------------
A Retrospective Study of Prediction of 18F-FES-PET/CT Parameters on the Outcome of Palbociclib Combined With Endocrine Therapy in Patients With HR+ and HER2-metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Palbociclib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged 18-70 years. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer. HR+ was defined as estrogen receptor- or progesterone receptor-positive status by immunohistochemistry. HER2 status was determined by immunohistochemistry or fluorescence in situ hybridization. Palbociclib treatment of metastatic breast cancer for at least one cycle. Available medical history. Exclusion Criteria: 1.Incomplete medical history.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients cohort<br>Patients with MBC in the Fudan University Shanghai Cancer Center who underwent whole-body 18F-FES PET/CT before the initiation of Palbociclib was included. | Drug: Palbociclib<br>* Palbociclib 125mg/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | Through study completion, an expected average of 12 months |
Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital (RMH)

Study Overview
=================
Brief Summary
-----------------
To document pre-diagnosis educational abilities, to document any change in educational achievements following treatment, to document educational support given within the statement process and to document the timing of support.

Detailed Description
-----------------
This will be a retrospective study. Cases will be identified by looking at the Royal Marsden Hospital (RMH) coding database. All the patients will have completed treatment for a brain tumour. The children all need to have started school before the diagnosis of their brain tumour so that we can look at easily defined educational assessments in this cohort. Children will be identified by looking at RMH coding of diagnosis and include children aged between 4 years and 18 years old (school age).

Official Title
-----------------
Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital, Following the Treatment of a Brain Tumour

Conditions
-----------------
Brain Tumour

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients/parental consent for RMH accessing educational information from them and their school patients with a primary brain tumour Exclusion Criteria: children with secondary brain tumours children who have had treatment for a relapse of primary brain tumour

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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 |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare educational achievements of children of different tumour types following treatment. |  |  | 
| To document if there are any differences in educational achievements depending on the age at diagnosis of the brain tumour. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain tumour
Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication

Study Overview
=================
Brief Summary
-----------------
Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.

Detailed Description
-----------------
The investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (SET) and additional transcutaneous electric stimulation (TES) of the calf muscle. SET program consists in once weekly walking training for 75 min under supervision of a professional trainer. Patients are encouraged to continue the training modules at home. TES is performed using the mobile Veinoplus arterial device (AdRem Technology, France) on a daily base for 60-120 min at home. Patient outcome will be compared to the retrospectively analyzed results of patients, that received the same SET program alone in the past.

Official Title
-----------------
Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication

Conditions
-----------------
Intermittent Claudication, Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: transcutaneous electrical calf muscle stimulation + supervised walking therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intermittent claudication due to peripheral arterial disease ankle brachial index </=0.9 occlusion or stenosis of the superficial femoral artery Exclusion Criteria: rest pain or peripheral arterial lesions contraindications for supervised walking therapy non-vascular conditions that limit patients´ walking ability patients that have already received supervised walking therapy occlusion of the deep femoral artery occlusion or high-grade stenoses of the iliac arteries stroke in the last 12 months premenopausal women diabetes mellitus, dialysis, sclerodermia and other conditions that impair leg perfusion active cilostazol therapy or alprostadil-infusion in the last 3 months pacemaker, defibrillator systems, life vest visible muscle contraction is not achieved without pain

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

| Intervention/Treatment |
| --- |
|Device: transcutaneous electrical calf muscle stimulation + supervised walking therapy|transcutaneous electrical calf muscle stimulation + supervised walking therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance | Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test | 6 months |
Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients

Study Overview
=================
Brief Summary
-----------------
To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.

Detailed Description
-----------------
This cross sectional study will evaluate a sample of 360 subjects with luminal Crohn's disease who are receiving infliximab in 15-20 Canadian infusion centres. The sample will be stratified by disease activity [mild = CDAI <150, moderate/severe = CDAI ≥150] and whether or not subjects are on concomitant immunosuppressive therapy. Thus 4 strata will be created consisting of 90 subjects each. Consent will be obtained prior to or at Visit 1, subjects will retrospectively complete a CDAI diary card for the preceding 7 days and blood work will be drawn prior to infliximab infusion. Four weeks thereafter at Visit 2, subjects will provide an additional blood sample to measure serum infliximab concentrations and CRP levels. Between Visits 1 and 3, subjects will complete daily CDAI diary entries. Visit 3 will take place at the next scheduled infusion, 8 weeks after Visit 1 (+/- 7 days ).

Official Title
-----------------
A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects (18 years of age or older at time of consent) Confirmed diagnosis of inflammatory luminal Crohn's Disease Receive infliximab therapy and have received a minimum of 5 consecutive infusions at prescribed intervals (minimum of 24 weeks and maximum of 156 weeks on infliximab therapy) Plan to receive the next 2 infliximab infusions at 8-weekly intervals (+/- 7 days) Able to provide written consent Exclusion Criteria: Active draining fistulizing Crohn's Disease Presence of an ostomy Diagnosis of ulcerative colitis Infliximab dose of >5mg/kg

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 |
| --- | --- |
| Observation<br>Subjects with Luminal Crohn's Disease receiving infliximab | |

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
-----------------
Luminal Crohn's Disease, Infliximab
Alemtuzumab and Rituximab in Aplastic Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.

Official Title
-----------------
Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia

Conditions
-----------------
Aplastic Anemia

Intervention / Treatment
-----------------
* Drug: Alemtuzumab and Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with aplastic anemia diagnosis Exclusion Criteria: Patients with prior treatment with monoclonal antibodies and/or antithymocyte globulin. Patients with a diagnosis or history of HIV/AIDS, Hepatitis B, Hepatitis C, Cytomegalovirus. Patients who do not agree to sign a Letter of Informed Consent.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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 |
| --- | --- |
| Other: Rituximab, Alemtuzumab<br> | Drug: Alemtuzumab and Rituximab<br>* Alemtuzumab 10 mg (5 mg/m2 in patients under 30 kg weight) subcutaneous days 1,2 and 3 Rituximab 100 mg (50 mg/m2 in patients under 30 kg weight)intravenous days 4,11,18,25 Cyclosporine 3 mg/kg starting day 21<br>* Other names: Campath;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia. | Evaluate the hematological response after the administration of alemtuzumab and rituximab | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alemtuzumab, Rituximab, Aplastic anemia, cyclosporine
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).

Official Title
-----------------
A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Gabitril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S). Exclusion Criteria: Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months Have been diagnosed with any eating disorder within the past six months Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder Have any history of alcohol or substance abuse within 3 months of screening Have any history of seizures, including febrile seizures Have any history of head trauma associated with loss of consciousness within the past 15 years

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gabitril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD |  |  |
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis

Study Overview
=================
Brief Summary
-----------------
The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.

Detailed Description
-----------------
The investigators obtained baseline Cobb angles on simple and complex curves, and collected previous, earlier studies of each adolescent idiopathic and degenerative scoliosis patient. The investigators then taught them to do the side-plank pose with the convex side of lumbar and thoracolumbar scoliotic curves downward, and a slightly altered version of the the half moon pose of yoga with the convex side of thoracic and cervicothoracic curves downward. The half moon pose was altered in that a belt was looped around the horizontal leg's foot, and held in a vertically extended upper arm's hand, and pulled tightly in that vertical position. Each pose was held as long as the patient could at least once daily. Cobb angles were again measured in films taken 4-10 months later.

Official Title
-----------------
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis

Conditions
-----------------
Scoliosis, Scoliosis Idiopathic

Intervention / Treatment
-----------------
* Behavioral: Yoga poses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scoliosis Willingness to do pose at least once daily for 4 -10 months Willingness to have a second X-ray 4-10 months after starting to do pose Exclusion Criteria: Neuromuscular disease Previous Spinal surgery Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 105 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Patient's change in previous X-ray compared with baseline, and baseline compared with X-ray done 4-10 months later
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Patients will have an X-ray before beginning to do one or two yoga poses daily for 4 - 10 months. After that period, they will have a second X-ray. | Behavioral: Yoga poses<br>* Patients are asked to perform one or two yoga poses daily for 4-10 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cobb angle | Baseline scoliotic curve - scoliotic curve measured after treatment | 4 - 10 months |