linjc16/ctgov huggingface dataset:
A Retrospective Review of Malignant Liver Tumors

Study Overview
=================
Brief Summary
-----------------
This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.

Detailed Description
-----------------
Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.

Official Title
-----------------
A Retrospective Review of Malignant Liver Tumors

Conditions
-----------------
Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary or metastatic hepatic malignancies Exclusion Criteria: Patients not diagnosed with primary or metastatic hepatic malignancies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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>Patients with primary or metastatic hepatic malignancies | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | lifetime | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | lifetime | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, colorectal carcinoma metastatic to liver, primary liver cancer
Study in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.

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

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Require the regular use of an inhaled beta-2-selective adrenergic agent. No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests. Exclusion Criteria: Active acute or chronic disorders of the respiratory system within one month prior to screening. Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history. Debilitating systemic and/or life-threatening diseases.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: The primary efficacy outcome is measure of lung function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Pediatric, Formoterol Fumarate, Foradil
A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy Male Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Nateglinide
* Drug: Nateglinide/Metformin
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 40 Signed informed consent Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypertension or hyportension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: Nateglinide+Metformin<br>coadministration of nateglinide and metformin | Drug: Nateglinide<br> <br> Drug: Metformin<br> <br> |
| Experimental: Nateglinide/Metformin<br>Nateglinide/Metformin tablet | Drug: Nateglinide/Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC last |  | 0- 24hrs | 
| Cmax |  | 0 24hrs |
Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Dietary Supplement: colostrum enriched with anti flu antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers ages 18-60 If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication Men > 18 years. Ability and willingness of subject to provide informed consent Screening tests' results within 15% of normal values Exclusion Criteria: Female Continuous use of the following medications for more than 3 days within 30 days of study entry: Immunosuppressives Immune modulators Systemic glucocorticoids Anti-neoplastic agents Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry. Subjects with a clinically significant infectious, immune mediated or malignant disease Subjects with anemia (Hb <10.5 gm/dl) Subjects with thrombocytopenia (platelets <100K/µl) Subjects with lymphopenia (absolute lymphocyte count <0.7) Subjects who were previously vaccinated against flu. Subject who received any vaccination within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br> | Dietary Supplement: colostrum enriched with anti flu antibodies<br>* each volunteer will receive six 1.2 g oral tablets (equivalent to 600 mg of bovine colostrum powder each) once a day for two weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alterations in immune response to flu antigen |  | during and after administration of colostrum enriched with anti flu antibodies | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
modulating immune response to flu antigen
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in subjects with CF who are 6 years of age and older with F/MF genotypes.

Official Title
-----------------
A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed study drug treatment in parent study (VX19-445-116, NCT04353817), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study Key Exclusion Criteria: History of study drug intolerance in the parent study Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 6 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: ELX/TEZ/IVA<br>Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening. | Drug: ELX/TEZ/IVA<br>* Fixed dose combination (FDC) tablet for oral administration.<br>* Other names: elexacaftor/tezacaftor/ivacaftor;Drug: IVA<br>* Tablet for oral administration.<br>* Other names: ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Week 100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Sweat Chloride (SwCl) |  | From Baseline up to Week 96 | 
| Absolute Change in Lung Clearance Index 2.5 (LCI 2.5) |  | From Baseline up to Week 96 |
Future of Beta Cells in Adults With Genetic Abnormality Behind Neonatal Diabetes

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate Beta cells in patients with a neonotal diabetes linked to a genetic abnormality Metabolic caracteristics will described using a transversal cohort study.

Official Title
-----------------
Devenir au Long Cours de la Cellule bêta Chez Les Adultes Porteurs d'Anomalies génétiques à l'Origine du Diabète Néonatal

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 18 à 65 year diabetic patient with a neonatal diabetis (before 1 year old) and need for insuline or patient with a relative having neonatal diabetis Exclusion Criteria: Diabète induit (médicaments - ex corticoïdes) ou syndromique infection cancer pegnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Adult with neonatal diabetes<br>Adult with neonatal diabetes (before 1 year ) and need for insulin | |
| non diabetic adults with a relative with neonatal diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean insulin secretion output |  | Week after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin secretion outout after arginine perfusion |  | during hospitalisation (3 days) | 
| sensitivity to insulin |  | during hospitalisation (3 days) | 
| glucago secretion output |  | during hospitalisation (3 days) |
Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Official Title
-----------------
Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Conditions
-----------------
Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Biological: AL0704rP
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic rhinoconjunctivitis attributable to grass pollen Positive SPT Positive EAST Positive provocation test Exclusion Criteria: serious disease other perennial allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>strict subcutaneous | Biological: AL0704rP<br>* strict subcutaneous<br>* Other names: na;|
| Placebo Comparator: 2<br>strict subcutaneous | Biological: Placebo<br>* strict subcutaneous<br>* Other names: na;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Symptom and Medication score |  | during the baseline and the following two pollen seasons | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Grass pollen allergy, specific immunotherapy
Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

Study Overview
=================
Brief Summary
-----------------
Lead survivability will be summarized.

Detailed Description
-----------------
The purpose of this study is to evaluate long-term performance of the 4296 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

Official Title
-----------------
Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive an Attain Ability Model 4296 LV lead Patient within 30 day post implant enrollment window Exclusion Criteria Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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 |
| --- | --- | --- |
| Model 4296 LV Lead-related complication rate | To demonstrate that the Model 4296 lead-related complication-free probability | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of lead-related adverse device effects | To summarize all lead related adverse events | 5 years | 
| Percent of subjects with changes in electrode programming | To characterize any changes in electrical programming | 5 years | 
| Number of fractures with and without loss of function | To characterize fractures with and without loss of function | 5 years | 
| Bipolar electrical performance at 1 year | To summarize bipolar electrical performance at one year post implant | 1 year | 
| Bipolar pacing impedance | To characterize threshold measurements and impedance for both conductors | 1 year | 
| Bipolar pacing capture threshold | To characterize standard bipolar pacing voltage thresholds | 1 year |
Gene-guided Warfarin for Anticoagulation Therapy

Study Overview
=================
Brief Summary
-----------------
This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.

Official Title
-----------------
Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Gene detection (CYP2C9*3, VKORC1)
* Drug: Warfarin Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism patients) Clinicians judge that long-term oral anticoagulation with warfarin is required No anticoagulation treatment in the past 10 days Agree to participate in this project Exclusion Criteria: Patients who had a tendency to bleed when taking warfarin High-risk groups using warfarin anticoagulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gene-guided Warfarin<br> | Device: Gene detection (CYP2C9*3, VKORC1)<br>* Warfarin is administered at the recommended dose by detecting CYP2C9*3 and VKORC1 gene polymorphismsand. The doctor adjusts the dosage according to the fluctuation of INR value in time.<br>Drug: Warfarin Sodium<br>* Warfarin is administered at a gene-guided dose or at a regular dose.<br>|
| Other: Routine use<br> | Drug: Warfarin Sodium<br>* Warfarin is administered at a gene-guided dose or at a regular dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke recurrence rate, compliance rate of INR value | Evaluation and analysis of the stroke recurrence rate and compliance rate of INR value at 12 months after treatment | 12 months |