linjc16/ctgov huggingface dataset:
Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

Study Overview
=================
Brief Summary
-----------------
The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

Official Title
-----------------
A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib

Conditions
-----------------
Gastro Intestinal Stromal Tumor

Intervention / Treatment
-----------------
* Drug: masitinib
* Drug: sunitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological proven, metastatic, or locally advanced and non-operable GIST Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available Patients resistant to imatinib at dose of 400 mg/day Exclusion Criteria: Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: masitinib<br>masitinib 12 mg/kg/day | Drug: masitinib<br>* masitinib 12 mg/kg/day<br>|
| Active Comparator: sunitinib<br>sunitinib 50 mg/day | Drug: sunitinib<br>* sunitinib 50 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall progression free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks | up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | From date of randomization until the date of death from any cause, assessed up to 36 weeks | up to 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GIST, resistant, imatinib, gastro intestinal stromal tumor resistant to imatinib
Evolution of the Rate and Causes of Death in Geriatric SSR

Study Overview
=================
Brief Summary
-----------------
In view of the ageing population and the increasing fragility of geriatric patients, it seems interesting to carry out a retrospective epidemiological observational study, on the evolution of the mortality rate and the causes of death in services of suite care and geriatric rehabilitation, in order to apprehend at best the supports, in particular palliative

Official Title
-----------------
Epidemiological Study on the Evolution of the Rate and Causes of Mortality in Geriatric SRH in the HUS

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patients (≥ 18 years) All patients who died during their stay in geriatric SSR between 01/01/2013 and 31/12/2017 Patients who have not expressed their living refusal to reuse their medical data for research purposes Exclusion Criteria: - Refusal on the part of patients of their living to reuse their medical data for research purposes

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 |
| --- | --- | --- |
| Study of the different causes of death in geriatric SSR unit |  | The period from January 1st, 2013 to December 31st, 2017 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
evolution of the rate, causes of death in geriatric SSR
Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the safety and efficacy of chemotherapy usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.

Detailed Description
-----------------
Autologous cytokine-induced killer (CIK) cells transfusion(>2*10^9 cells count) within 2 weeks after regular chemotherapy every 3 months.

Official Title
-----------------
A Randomized Controlled Clinical Trial of Cytokine-induced Killer (CIK) Cells Treatment in Patients With Refractory Non-Hodgkin Lymphoma

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Biological: Cytokine-induced killer cells (CIK)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as non-Hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy Exclusion Criteria: patients refuse the therapy or have no tolerance for the therapy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: regular chemotherapy<br>Patients after chemotherapy are just followed up. | |
| Experimental: CIK regimen<br>Patients after chemotherapy will receive at least 3 cycles of Cytokine-induced killer cells (CIK) treatment every 3 months. | Biological: Cytokine-induced killer cells (CIK)<br>* Cytokine-induced killer (CIK) cells are able to eradicate lymphomas and other malignancies. CIK cells are generated by incubation of peripheral blood lymphocytes with an anti-cluster of differentiation 3 (anti-CD3) monoclonal antibody, interleukin-2 (IL-2), interleukin-1 (IL-1) and interferon-gamma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free-Survival (PFS) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 1 month |
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta

Study Overview
=================
Brief Summary
-----------------
To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.

Detailed Description
-----------------
A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta

Official Title
-----------------
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta

Conditions
-----------------
Acute Coronary Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Acute Coronary Syndromes Patients who are taking ticagrelor and ASA daily(75-150mg), or Patients who are taking ticagrelor only(In the case that the patients have contraindication with ASA. Contraindication should be recorded in accordance with local PI on CRFs) Patients who have signed the Data release consent form prior to enrollment in this surveillance Exclusion Criteria: Patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage Patients with pathological hemorrhage at the time of administration Patients being administrated strong CYP3A4 inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 130 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>Unstable angina, Non ST-segment Elevation Myocardial Infarction or ST-segment elevation myocardial infarction including patients managed medically, and those who are managed with percutaneous coronary intervention or coronary artery by-pass grafting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hemorrhage events |  | up to 54 months | 
| Number of other AEs |  | up to 54 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Stroke events | for efficacy | up to 54 months | 
| Number of Cardiovascular (CV) related deaths events | for efficacy | up to 54 months | 
| Number of Myocardial Infarction events | for efficacy | up to 54 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unstable angina
Promethazine vs. Lorazepam for Treatment of Vertigo

Study Overview
=================
Brief Summary
-----------------
This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.

Official Title
-----------------
Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial

Conditions
-----------------
Peripheral Vertigo.

Intervention / Treatment
-----------------
* Drug: Promethazine
* Drug: Lorazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Background history of positional vertigo Exclusion Criteria: Unable to provide informed consent Pregnant or possibly pregnant Known allergy to study medications Use of antiemetic agents in the previous 24 hours Evidence of drug-induced vertigo or orthostatic hypotension Central pathologies/central origin for vertigo

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Promethazine<br>IV promethazine (25 mg) | Drug: Promethazine<br> <br> Drug: Lorazepam<br> <br> |
| Active Comparator: lorazepam<br>IV lorazepam (2 mg) | Drug: Promethazine<br> <br> Drug: Lorazepam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in vertigo intensity. | The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications. | At 2 hours after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety outcome measures (nausea change-second dose-adverse events). | Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention. | At 2-8 hours after intervention. |
A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.

Official Title
-----------------
A Phase 1, Single-center, Randomized, 2-way Crossover, Open Label Study to Evaluate the Effect of Renvela on the Pharmacodynamics of AZD1722 in Healthy Volunteeers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1722
* Drug: Renvela


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy man or woman Body mass index between 18 and 29.9 kg/m2 Exclusion Criteria: Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk to the subject.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1722 alone<br>15 mg BID | Drug: AZD1722<br> <br> * Other names: Tenapanor;|
| Experimental: AD1722 with Renvela<br>AZD1722 15 mg BID and Renvela 800 mg TID | Drug: AZD1722<br> <br> * Other names: Tenapanor;Drug: Renvela<br> <br> * Other names: Sevelamer carbonate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium levels in stool and urine | Pharmacodynamic activity | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of AZD1722, measured by Adverse events | Adverse events | 8 days | 
| Evaluate the safety of AZD1722, measured by clinical laboratory changes | clinical laboratory changes | 8 days | 
| Plasma drug concentration to calculate AUC | Evaluate the Pharmacokinetics of AZD1722 | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volunteer
Long COVID-19 and MAB Study

Study Overview
=================
Brief Summary
-----------------
This study will be observational only. It will provide real-world evidence generated from a representative and large-scale COVID patient base. The adoption, pilot testing and use of NIH PROs among viral tested patients with research purpose on long COVID will be unique and innovative. With the existing and proven scientific rigor, NIH PRO system will be adopted, then modified and tailored to form the long hauler specific, comprehensive instrument, helping generalize future knowledge regarding COVID-infected patients.

Official Title
-----------------
Setting up a Community Based Patient Cohort to Understand Long COVID: Monoclonal Antibody and Post-Infection COVID Vaccine Administration as the FOCI

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been tested for COVID at one of the MultiCare facilities, AND 18 years old or older at the viral test, AND have no problem understanding English or Spanish. Exclusion Criteria: Pediatric patients younger than 18 years old at the time of testing, OR patients who are pregnant, OR patients who plan to get pregnant in 3 months, OR patients who are hospitalized at the time of recruitment, OR patients who have cognitive impairment(s) at the recruitment.

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 |
| --- | --- |
| COVID positive case with mAb treatment<br> | |
| COVID positive case having not received mAb treatment<br> | |
| COVID negative cases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adopt the NIH PROMIS system (The Assessment Center Instrument Library, which includes all Fixed Length Short Form and Computer Adaptive Test/Item Bank instruments from PROMIS) to construct a modified comprehensive PRO instrument. | Using a modified NIH PRO measurement system. This system will involve different domains and instruments. Patients will answer PRO questions at the time of recruitment (baseline), then followed up 3 months and 6 months after the first survey (follow-up). The modified comprehensive PRO instrument will specifically ask patients to report symptoms based on their health status within a fixed time window, and at the time when the survey questions are given. | 18-month study length, with a pilot reliability study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selected comorbidities, all-cause hospitalization and ER visits. | Extracted from patients' electronic health records. | 3 months and 6 months follow-up. | 
| Patients' COVID vaccination and mAb therapy history will be verified based on self report and EHR. |  | 18-month study length |
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Study Overview
=================
Brief Summary
-----------------
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity. Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is: one source to higher health care costs (hospitalization, additional examinations) Selection of the bacterial ecology of the newborn and neonatal services and stress for the newborn and parents

Official Title
-----------------
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

Conditions
-----------------
Neonatal Bacterial Infection

Intervention / Treatment
-----------------
* Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth to motherhood. Term > 34 weeks . Presence of at least one of the factors of major or minor infection risk Exclusion Criteria: cord blood sample unavailable. Death in the delivery room Corticosteroids prenatally (modification of cytokine production ) .

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 30 Minutes

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord blood procalcitonin<br>dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP | Biological: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| value of the procalcitonin in the umbilical cord blood |  | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonatal bacterial infection, procalcitonin