linjc16/ctgov huggingface dataset:
REGistry of Long-term AnTithrombotic TherApy-2

Study Overview
=================
Brief Summary
-----------------
To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation

Detailed Description
-----------------
The register is a Russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with atrial fibrillation

Official Title
-----------------
Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Anticoagulants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented atrial fibrillation with CHA2DS2VASC > 1 Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent. ACS within 12 months before inclusion Severe CHF (NYHA IV) Stroke within 6 months before inclusion Severe liver or muscle disease Severe kidney disease / renal failure with creatinine > 3 mg/dl Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention

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 |
| --- |
|Drug: Anticoagulants|oral anticoagulants, dual or triple antithrombotic theraphy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of major cardiovascular events | stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization, cqrdiac death | unclusion up to 5 years | 
| composite of any bleeding events | major, clinically relevant nonmajor, minor (BARC, ISTH,GARFIELD AF) | unclusion up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutations in following genes | CYP2C9*, VKORC1 | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, coronary artery disease
Ulimorelin Study of Efficacy and Safety (ULISES 007)

Study Overview
=================
Brief Summary
-----------------
Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

Conditions
-----------------
Gastrointestinal Dysmotility

Intervention / Treatment
-----------------
* Drug: Ulimorelin Intravenously (IV)
* Drug: Ulimorelin Intravenously (IV)
* Drug: 5% dextrose in water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women, 18 to 80 years of age, inclusive Scheduled to undergo open bowel resection with colonic anastomosis. For women who can potentially become pregnant a pregnancy test at screening and admission must be negative. Exclusion Criteria: Weight more than 200kg (441 pounds) Pregnant or breastfeeding Known history of drug or alcohol abuse within the previous year.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 2<br> | Drug: Ulimorelin Intravenously (IV)<br>* 480 microg/kg daily (QD)<br>|
| Experimental: experimental 1<br> | Drug: Ulimorelin Intravenously (IV)<br>* 160 microg/kg daily (QD)<br>|
| Placebo Comparator: Placebo<br>Placebo comparator daily (QD) | Drug: 5% dextrose in water<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of GI Function |  | up to 7 days of dosing or until hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ancillary GI Functions |  | up to 7 days of dosing or hospital discharge |
Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

Study Overview
=================
Brief Summary
-----------------
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs. There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia. The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.

Official Title
-----------------
Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

Conditions
-----------------
Anoxic-Ischemic Encephalopathy

Intervention / Treatment
-----------------
* Other: Questionaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-term children, gestational age> 36 weeks of amenorrhea Between the 1st of January 2012 and the 31st of December 2016 Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon Perinatal asphyxia with clinical signs of encephalopathy Indication of therapeutic hypothermia not retained because EAI mild Where parents were informed and did not object to participation in the study Exclusion Criteria: Dysmorphic syndrome Stroke Children transferred for other criteria (respiratory distress, heart failure ...)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 7 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionaire|Evaluation of psychomotor development in children with mild EAI without indication of therapeutic hypothermia. Precise analysis of the type (motor, sensory, language, epilepsy) and the severity of sequelae by sending a questionnaire to parents. Investigation of early, clinical and paraclinical prognostic factors of good or bad neurodevelopmental outcome. Evaluation of the height-weight growth and the cranial perimeter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of abnormalities | Abnormalities researched are : abnormal motor, sensory (auditory or visual), delayed psychomotor acquisition compared to the expected (norms), or epilepsy at 2 years. These anomalies will be collected by sending a questionnaire to the parents. | maximum 1 years |
Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761. SECONDARY OBJECTIVES: I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell). OUTLINE: Previously collected tissue samples are analyzed via hematoxylin and eosin (H&E) staining and immunohistochemistry (IHC).

Official Title
-----------------
Evaluation of a Novel Molecular NSCLC Classification System

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

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have been registered on CALGB-9761 Stage I disease Treatment-naive patients A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761 Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required

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 |
| --- | --- |
| Novel Molecular NSCLC Classification (H & E staining, IHC)<br>Previously collected tissue samples are analyzed via H&E staining and IHC. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of a novel 4-protein signature's ability to subtype NSCLC |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSCLC misclassification rate |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic

Study Overview
=================
Brief Summary
-----------------
Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia syndromes.

Detailed Description
-----------------
The long-term objective of this research is to find genes and biologic pathways causing arrhythmia syndromes and other diseases or conditions. In order to achieve this objective the investigators will collect comprehensive phenotypic data and corresponding blood and/or tissue samples into a biorepository registry of patients, presenting for cardiac arrhythmia evaluation and/or treatment, and control subjects without arrhythmias. This biorepository will be composed of two parts: 1) An Arrhythmia Biorepository of blood and tissue from patients undergoing arrhythmia procedures, cardiac surgery, or inpatient or outpatient evaluations for arrhythmias, and 2) A Collaborative Sample Biorepository for de-identified samples and data from outside institutions and clinical trials.

Official Title
-----------------
Cleveland Clinic Arrhythmia Biospecimen Repository (Cleveland Clinic Arrhythmia BioBank)

Conditions
-----------------
Arrhythmias, Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 18 years old Subjects with a history of or current cardiac arrhythmia, family members of subjects with cardiac arrhythmias, or no cardiac arrhythmia if a Control Subject. Exclusion Criteria: Subjects previously enrolled in the Arrhythmia BioBank

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 |
| --- | --- |
| Arrhythmias<br>Patients with arrhythmias | |
| Control Subjects<br>Subjects that do not have a history of cardiac arrhythmias. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variants associated with arrhythmias | Genome-wide association study of arrhythmias | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetics, biorepository, cardiac death, atrial fibrillation, ventricular fibrillation, ventricular tachycardia, supraventricular tachycardias, premature ventricular complexes, premature atrial complexes, atrioventricular and intraventricular blocks, sinus node dysfunction, syncope, vasovagal reactivity, postural orthostatic tachycardia syndrome
Pilot Study of 18F-FLT PET

Study Overview
=================
Brief Summary
-----------------
Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission

Official Title
-----------------
Pilot Study of 18F-FLT Pet Imaging in Cancer Patients

Conditions
-----------------
CNS Brain Metastasis, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: Imaging with 18F-FLT PET
* Procedure: Imaging with 18F-FLT PET
* Procedure: Imaging with 18F-FLT PET
* Procedure: Imaging with 18F-FLT PET
* Procedure: Imaging with 18F-FLT PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to tolerate a PET/CT scan Age of 18 or older signed informed consent being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer Exclusion Criteria: Prior XRT to site being studied severe claustrophobia or inability to tolerate PET/CT unable to provide written consent pregnant or breastfeeding women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2. Head and neck<br>Imaging with 18F-FLT PET | Procedure: Imaging with 18F-FLT PET<br>* Imaging with 18F-FLT PET<br>|
| Experimental: 3. Lung<br>Imaging with 18F-FLT PET | Procedure: Imaging with 18F-FLT PET<br>* Imaging with 18F-FLT PET<br>|
| Experimental: 4. prostate<br>Imaging with 18F-FLT PET | Procedure: Imaging with 18F-FLT PET<br>* Imaging with 18F-FLT PET<br>|
| Experimental: 5. esophagus<br>Imaging with 18F-FLT PET | Procedure: Imaging with 18F-FLT PET<br>* Imaging with 18F-FLT PET<br>|
| Experimental: 1.CNS<br>Imaging with 18F-FLT PET | Procedure: Imaging with 18F-FLT PET<br>* Imaging with 18F-FLT PET<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients |  | end of study |
Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance

Study Overview
=================
Brief Summary
-----------------
This study evaluates the ability of the MAKO 7 device to collect various cells

Detailed Description
-----------------
Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to collect cells from the fallopian tubes for cytological evaluation for determination and/or differentiation of normal versus atypical versus malignant cells.

Official Title
-----------------
Cytological Evaluation of Specimens Collected With the MAKO 7 Device in Pre Salpingo-Oophorectomy Subjects for Determination and/or Differentiation of Normal Versus Atypical Versus Malignant Cells

Conditions
-----------------
BRCA1 Mutation, BRCA2 Mutation, Atypia Suspicious for Malignancy

Intervention / Treatment
-----------------
* Device: MAKO 7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is medically cleared for surgery Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations Subject must be 18 years of age Subject must be able to provide informed consent Exclusion Criteria: Contraindication to hysteroscopy Acute pelvic inflammatory disease Active or recent lower pelvic infection Pregnancy Delivery or termination of a pregnancy in the past 6 weeks Known tubal obstruction including tubal ligation Invasive carcinoma of the cervix or endometrium Intolerance of anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Pre-Salpingo-Oophorectomy<br>Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that will undergo pre-salpingo-oophorectomy. | Device: MAKO 7<br>* Hysteroscopic cell sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results. | Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology. | Up to 60 days post-operatively |
DP-R213 Pharmacokinetics Study

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.

Official Title
-----------------
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: DP-R213
* Drug: Raloxifene
* Drug: Cholecaliferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBW ±20% signed the informed consent form prior to the study participation Exclusion Criteria: Clinically significant disease Previously donate whole blood within 2 months or component blood within 1 month Clinically significant allergic disease Taken IP in other trial within 3 months An impossible one who participates in clinical trial by investigator's decision including laboratory test result

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

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

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: RT group<br>combination dose of Raloxifene and Cholecaliferol and DP-R213 in order | Drug: DP-R213<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Raloxifene<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Cholecaliferol<br>* Investigational product is prescribed to all of randomized subjects<br>|
| Experimental: TR group<br>combination dose of Raloxifene and Cholecaliferol and DP-R213 in order | Drug: DP-R213<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Raloxifene<br>* Investigational product is prescribed to all of randomized subjects<br>Drug: Cholecaliferol<br>* Investigational product is prescribed to all of randomized subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | up to 96 hours post dose | 
| Peak Plasma Concentration (Cmax) |  | up to 96 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DP-R213
TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.

Official Title
-----------------
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: TLK286


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer Recurrent epithelial ovarian cancer or persistent disease following primary treatment At least one, but no more than four, prior platinum-containing chemotherapy regimens At least one prior taxane-containing regimen Exclusion Criteria A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years Known leptomeningeal metastases or carcinomatous meningitis Have received prior Doxil or other liposomal doxorubicin Having received whole pelvis radiation therapy

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

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

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: TLK286|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |