linjc16/ctgov huggingface dataset:
Correlation Between Five Asthma Control Questionnaires

Study Overview
=================
Brief Summary
-----------------
This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why. The investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).

Official Title
-----------------
Assessment of Correlation Between Five Asthma Control Questionnaires

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma confirmed by a pulmonologist Patient have had a lung function testing on the same day than the questionnaires are fulfilled. Age equal or upper than 18 years Agreement to participate to this study Exclusion Criteria: Age under 18 years Refusal to participate to this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Asthma control level assessment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of asthma control | The five questionnaires are completed succesively on the same time. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Questionnaires
Pos -Extubation High Flow Nasal Cannula

Study Overview
=================
Brief Summary
-----------------
comparing high flow nasal cannula & conventional oxygen tharapy in post-extubation period for patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU outcome &28 days mortality

Detailed Description
-----------------
patients with respiratory failure either type I or type II planned for extubation will be divided into 2 groups post extubation : Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute group II: will receive nasal cannula up to 10 litres / minute Data of the patients will be collected for 28 days postextubation and analysed

Official Title
-----------------
Post Extubation High Flow Nasal Cannula Versus Conventional Oxygen Therapy in Extubation Failure.

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: High flow nasal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory failure type I and Type II Exclusion Criteria: Mechanical ventilation due to other cause such as disturbed conscious level or respiratory muscle weakness

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High flow nasal cannula<br>A device og high flow nasal cannula giving 60 litres / min | Device: High flow nasal cannula<br>* Device gives high flow oxygen comparable to non invasive ventilation<br>|
| Placebo Comparator: Conventional oxygen<br>Nasal cannula giving oxygen up to 10 litres / minute | Device: High flow nasal cannula<br>* Device gives high flow oxygen comparable to non invasive ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with post extubation respiratory failure | Number of participants with post extubation hypoxemia with or without hypercapnea | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ICU stay and mortality | Duration of ICU stay and incidence of mortality | 28 days |
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.

Official Title
-----------------
A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.

Conditions
-----------------
Relapsed/Refractory Leukemia

Intervention / Treatment
-----------------
* Drug: Herceptin (trastuzumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years B-ALL in relapse refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal creatinine < 2 times the upper limit of normal) > 20% blasts in bone marrow, > 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping Exclusion Criteria: Previous treatment by trastuzumab FEVG < 50%

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

| Intervention/Treatment |
| --- |
|Drug: Herceptin (trastuzumab)|Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trastuzumab efficiency concerning transfusional needs |  |  | 
| Overall survival |  |  | 
| Leukemia free survival |  |  | 
| cytogenetic response rate |  |  | 
| Trastuzumab tolerance profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsed/refractory, HER2, positive, B-ALL, trastuzumab
The Health of Women Study

Study Overview
=================
Brief Summary
-----------------
The HOW Study is a first-of-its-kind international online study for women and men with and without a history of breast cancer. The investigators will collect information about your health, your job, your diet, and your family history, among other topics that can help us get a better understanding of breast cancer and its potential causes. Periodically, the investigators will send you questionnaires about anything and everything. All you have to do is fill them out online. It's that simple. This is a partnership and the investigators need you for the long haul. The more questionnaires you fill out, the more information the investigators will have that can help us have a better understanding of why women get breast cancer.

Official Title
-----------------
The Health of Women (HOW) Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Women 18 years and older Exclusion Criteria: Under the age of 18

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HOW study participants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer diagnosis question | In the My Health Overview questionnaire, the participant will be asked have you been diagnosed with breast cancer? Responses available are yes, no, I don't know / I can't remember, and I'd rather not say. This question will be asked in the initial questionnaire and every five years following that. | Participants will be followed for the duration of the cohort study, up to 20 years. |
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.

Official Title
-----------------
Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Biological: Cyclophosphamide, Docetaxel, Dendritic cells, OK-432


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with relapsed and refractory head and neck squamous cell carcinoma 20 years and older ECOG performance status 0-1 More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy Tumor lesions are accessible to intratumoral dendritic cells injection Patients who are able to do oral ingestion Patients must have normal organ and marrow functions as follows: Hb>9.0 mg/dl Ht>25% WBC>4000/mm3 Platelet count>100,000/mm3 T-Bil<1.5mg/dl GOT<x2.5 institutional upper limit of normal GPT<x2.5 institutional upper limit of normal Creatinin<1.5mg/dl signed informed consent Exclusion Criteria: Less than 20 years Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. Patients with clinically active infection Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency Concomitant malignant diseases, brain metastases Psychiatric illness Treatment with steroids Decision of unsuitableness by physician

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- |
|Biological: Cyclophosphamide, Docetaxel, Dendritic cells, OK-432|Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and feasibility of chemo-immunotherapy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and function of immune effector cells in treated patients |  | 1 year |
Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients

Study Overview
=================
Brief Summary
-----------------
Obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC).

Detailed Description
-----------------
The purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by Ohio State University Medical Center (OSUMC) surgeons during the late 1970s, 1980s, and 1990s. Our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.

Official Title
-----------------
Long-Term Follow-up of Ohio State University Medical Center (OSUMC) Bariatric Patients

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Treated by OSUMC physicians for obesity Informed Consent Exclusion Criteria: Informed consent not given

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Failure to lose and maintain loss of > or equal to 50% of excess body weight will be considered failure of the bariatric surgery. |  | 10 or more years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for additional surgical or other intervention for treatment of morbid obesity following bariatric surgery will be considered failure of the surgery. |  | 10 or more years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, long term follow up, gastric partitioning surgery, Roux-en-Y gastric bypass surgery, obesity
The Fontan Education Study: A Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
The Fontan Education Study is a cluster randomized controlled trial evaluating the impact of a novel education program in combination with usual care, versus usual care alone, on preparing parents of children undergoing Fontan surgery for the challenges of the postoperative course.

Official Title
-----------------
The Fontan Education Study: A Randomized Control Trial

Conditions
-----------------
Heart Defects, Congenital

Intervention / Treatment
-----------------
* Other: Fontan Education Videos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children who are planned to undergo Fontan surgery within 4-6 weeks and their parent(s)/guardian(s) Exclusion Criteria: parents with < grade 6 level of English reading.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Intervention<br>Participants in the intervention group will have access to the 3 teaching videos,  3:30-5:00 minutes in duration each, beginning several weeks prior to the preadmission clinic (as soon as written consent is obtained). | Other: Fontan Education Videos<br>* The intervention will consist of three brief ( 5 minute) professionally-developed whiteboard videos, available online. The videos will feature lay language at a grade 7 level or below and will be engaging. Topics are based on key findings of the Family Resilience Study, namely: Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic. Anticoagulation Prolonged pleural drainage<br>|
| No Intervention: Usual Care<br>Participants in the usual care will not be offered an intervention and will not be made aware of the existence of the teaching videos. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent's State Anxiety Inventory (STAI)-State score preoperatively | The primary endpoint is the parent's STAI-State score within 1 week preceding surgery. | within 1 week preceding surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STAI-State score postoperatively | Parent STAI-State score 1- week and 1-month postoperatively | 1 week and 1 month postoperatively | 
| Post-Hospital Behaviour Questionnaire (PHBQ) score postoperatively | child's PHBQ score 1 week and 1 month postoperatively | 1 week and 1 month postoperatively |
Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.

Detailed Description
-----------------
The Access Program will be provided as long as appropriate according to the judgment of the provider. If Denileukin diftitox (ONTAK) becomes commercially available without restriction, then the access program will be discontinued.

Official Title
-----------------
Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Denileukin diftitox (ONTAK)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To receive denileukin diftitox (ONTAK) under this protocol, the patient's physician must request this therapy for the specific patient. Patients may continue treatment with denileukin diftitox if they: Are currently on therapy with denileukin diftitox and require ongoing therapy to maintain control of their disease. Are willing and able to comply with all aspects of the Access Protocol Provide written informed consent to participate Exclusion Criteria: Patients are not eligible for the Access Program with denileukin diftitox if they: • Are not currently on denileukin diftitox therapy
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Denileukin diftitox (ONTAK)|Given at a dose of 9 or 18mcg/kg/day by intravenous infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles.|

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
-----------------
Cancer, ONTAK, Denileukin diftitox, persistent or recurrent disease, requiring continued delivery of essential cancer therapy
Pediatric Pain Rehabilitation Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the demographic, medical, and psychological/behavioral characteristics of children and adolescent patients admitted to the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be used to evaluate the clinical outcomes of patients admitted to the program as well as to examine the impact of various background factors on clinical outcomes.

Official Title
-----------------
Registry: Pediatric Pain Rehabilitation Program

Conditions
-----------------
Pediatric Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted into the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Pain Rehab Patients<br> | Behavioral: Questionnaires<br>* Questionnaires are completed at admission, discharge, 1-month, 6 month, and yearly follow-up.<br>|

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
-----------------
Pediatric, Chronic Pain