linjc16/ctgov huggingface dataset:
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

Study Overview
=================
Brief Summary
-----------------
The morbidly obese frequently present with mood and anxiety disorders, which are often treated with serotonin reuptake inhibitors (SRI) antidepressant drugs. The investigators hypothesized that gastric bypass surgery would decrease the absorption of SRI. The investigators also wished to determine whether a reduction in SRI levels would increase the likelihood of worsening depressive symptoms.

Detailed Description
-----------------
Twelve RYGB candidates who were successfully treated with an SRI for primary mood or anxiety disorders were studied prospectively. Blood samples for SRI plasma levels were drawn immediately after dose for pharmacokinetic studies (PK) preoperatively. Maximum concentration (CMAX), time to CMAX (TMAX), and Area Under Concentration/Time curve (AUC) were determined. PK studies were repeated at one, six, and twelve months post-operatively. PK data were corrected for dose at each study time point. The Structured Interview Guide for the Hamilton Depression Rating Scale- Atypical Depression Symptom Version was used to quantify depressive symptoms.

Official Title
-----------------
The Effect of Gastric Bypass on the Pharmacokinetics of Serotonin Reuptake Inhibitors

Conditions
-----------------
Gastric Bypass, Depression, Anxiety Disorder

Intervention / Treatment
-----------------
* Procedure: Roux-en-Y gastric bypass (RYGBP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to tolerate general anesthesia Able to document prior unsuccessful attempts at weight loss under medical supervision during the last 6 months Able to provide informed consent Cleared for surgery by primary care MD, dietician, and psychiatrist SRI treatment specifically for depression for ≥6 wks at constant dose for last 2 out of 6 wks Exclusion Criteria: pregnancy Unwilling or unable to comply with postoperative requirements for diet, supplements, exercise, or followup

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 |
| --- | --- |
| Gastric bypass patients<br> | Procedure: Roux-en-Y gastric bypass (RYGBP)<br> <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
-----------------
pharmacokinetics, serotonin reuptake inhibitors, gastric bypass, depression, bioavailability, drug absorption, area under curve
A Study of MDX-1106 to Treat Patients With Hepatitis C Infection

Study Overview
=================
Brief Summary
-----------------
This study examines the safety, tolerability, and immunogenicity of a single dose of MDX-1106 in patients with active hepatitis C genotype 1 or mixed hepatitis C genotype infection.

Official Title
-----------------
A Phase I, Double-blind,Multicenter,Randomized,Placebo-controlled,Safety and Pharmacokinetic Dose-escalation Study of a Single Intravenous Administration of MDX-1106, a Fully Human Monoclonal Antibody to PD-1, in Subjects With Active Hepatitis C Genotype 1 Infection

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: MDX1106-02
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infection with hepatitis C genotype 1 or mixed hepatitis C genotype; Asymptomatic or nearly asymptomatic from hepatitis C; Previous therapy with interferon and ribavirin or peginterferon and ribavirin without an SVR or relapsed following an SVR;or Interferon naive subjects Chronically infected (at least 6 months since diagnosis) HCV-positive subjects; No evidence of bridging necrosis or cirrhosis; Liver biopsy within the last 2 years Exclusion Criteria: Acute hepatitis C infection History of prior malignancy, acquired or inherited immunodeficiency or autoimmune disease either documented or anecdotal;

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MDX1106-02<br>* Single dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, tolerability, and immunogenicity |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hep C
An Epidemiological Study of Acute Coronary Syndromes in The Greek Population. The TARGET Study

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, 2-phase observational study of acute coronary syndromes (ACS) in Greece, designed to provide real world data on the risk factors of patients presenting to a hospital emergency department with an index event, as well as to depict the current management practices and outcomes of these clinical conditions in Greece.

Official Title
-----------------
An Epidemiological Study of Acute Coronary Syndromes in The Greek Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of an ACS (STEMI, NSTEMI, UA). Informed Consent Exclusion Criteria: Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study sites). Participation in other clinical study in period between the index event and 6- month follow-up assessment with the exception of registering in registries or surveys not influencing the management of the ACS.

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 |
| --- | --- |
| 1<br>Patients over 18 years old admitted to the hospital with Acute Coronary Syndrome. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of patients who are on target for LDL-C according to the 2004-updated NCEP ATPIII guidelines as calculated within the first 24-hours of hospital admission for an ACS. |  | first visit - 1st day (cross-sectional part) | 
| To estimate the proportion of patients enrolled in the cross-sectional part of the study that experiences a Major Adverse Cardiovascular Event (MACE) within a 6-month follow-up period. |  | follow up visit - 6th month (prospective part) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the proportion of patients admitted to the hospital with STEMI, NSTEMI and unstable angina. |  | first visit - 1st day (cross-sectional part) | 
| To estimate the pain-to-door-time throughout different regions in Greece. |  | first visit - 1st day (cross-sectional part) | 
| To estimate the time to first MACE and to estimate CV, non-CV and all cause mortality within the 6-month period following the index ACS event. |  | follow up visit - 6th month (prospective part) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndromes, Epidemiology, Management of disease, Outcomes, Greece
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.

Official Title
-----------------
Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention

Conditions
-----------------
Adenomatous Polyposis Coli

Intervention / Treatment
-----------------
* Drug: Sulindac (drug)
* Drug: VSL#3 (probiotic)
* Drug: Inulin (probiotic)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically or genetically proven familial adenomatous polyposis Restorative proctocolectomy with ileal pouch anal anastomosis Exclusion Criteria: Chronic or acute renal or hepatic disease History of oesophageal, gastric or duodenal ulcers Known hypersensitivity to sulindac Daily use during the last three months of: Aspirin Non-Steroidal Anti-Inflammatory Agents Probiotics

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulindac (drug)|nan|
|Drug: VSL#3 (probiotic)|nan|
|Drug: Inulin (probiotic)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pouch mucosal proliferation index at 0, 1 and 2 months |  |  | 
| Pouch mucosal apoptosis index at 0, 1 and 2 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months |  |  | 
| Faecal genotoxicity at 0, 1 and 2 months |  |  | 
| Faecal cytotoxicity at 0, 1 and 2 months |  |  |
Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the role of magnesium on bone and vitamin D metabolism in patients receiving anti-epileptic medications.

Official Title
-----------------
Magnesium as a Mediator of Bone and Vitamin D Metabolism in Patients on Antiepileptic Drug Therapy

Conditions
-----------------
Epilepsy, Magnesium Deficiency, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Other: No Intervention. Study is Cross Sectional in nature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals receiving anti-epileptic drugs as a treatment for epilepsy Exclusion Criteria: Individuals who are pregnant or breastfeeding, receiving cancer treatments, have liver or kidney diseases, autoimmune diseases, or other diseases that may interfere with vitamin D and magnesium metabolism.

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

| Intervention/Treatment |
| --- |
|Other: No Intervention. Study is Cross Sectional in nature|No Intervention. Study is cross sectional in nature|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Will be measured at Tibia, Hip and Total Body using a DXA scan | 1 time point - baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ionized Magnesium in serum | This will be assayed in the serum | 1 time point - baseline | 
| Vitamin D - 25 hydroxy vitamin D | This will be assayed in the serum | 1 time point - baseline |
Pain After Breast Surgery

Study Overview
=================
Brief Summary
-----------------
This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.

Official Title
-----------------
A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain

Conditions
-----------------
Breast Cancer, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking undergoing elective breast cancer surgery Exclusion Criteria: Patients with recurrent cancer, metastasis, and previous breast surgery

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

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

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 |
| --- | --- | --- |
| Acute Pain | Maximum pain score reported postoperatively | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Pain | pain score ≥ 3 or pain that impacts daily life as indicated by a score >0 on any of the 7 daily activity questions more than 6 months after surgery | More than 6 months after surgery |
A New Designed Balance Platform for Children

Study Overview
=================
Brief Summary
-----------------
People always come across with different floors which gradually affect dynamic balance. Dynamic balance is important in activities of daily life of all people. There are various reliable and valid tests for both children and adults, but no test design which includes different floor materials has been developed. Thus, this study aimed to describe a new designed balance test platform and investigate its reliability and validity in 3-5 years old children.

Detailed Description
-----------------
Children whose families signed consent form will be included. Height and weight will be measured. Then they will be taken to the balance measurements. Design will firstly be shown to child and one trial will be permitted before starting the test. Timed-up and Go test will also be used as a reliable and valid test for dynamic balance in this age group. Single leg standing will also be used to investigate the discrimination feature of the dynamic balance tested by new design platform. All tests will be done without socks and shoes. Timing will be the only results for all tests. Calibrated chronometers will be used for this aim. After all measurements complete, statistical analysis will be conducted.

Official Title
-----------------
Reliability and Validity of a New Designed Balance Platform for Children

Conditions
-----------------
Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chid aged 3-5 years (birth date: December 2013 - December 2015) Parents who signed consent form. Exclusion Criteria: Children who have problem about musculoskeletal system, neurological disorder, vestibular system disorders. Children who mention painful situations which may possibly prevent to walk on the platform Children who have visual problems

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New designed test | This is a walking platform which has different floor materials | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed-up and go test | This is a reliable and valid test which is used to assess dynamic balance in children. There is a three meter pathway. Two chairs are used for the starting point and to specify the returning point. The test will be repeated 3 times and the best completion time will be recorded. | at baseline | 
| Single leg standing | Children are asked to stand on dominant leg. Their standing duration will be recorded. | at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Balance
Nerve Morphology in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS.

Official Title
-----------------
Posterior Interosseous Nerve Pathology May Provide Novel Insights Into Both Predisposition and Potential Vascular Basis for the Development of Carpal Tunnel Syndrome in Diabetic Patients.

Conditions
-----------------
Peripheral Neuropathy, Carpal Tunnel Syndrome, Entrapment Neuropathies, Diabetes Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosis of carpal tunnel syndrome based in clinical history and symptoms Confirmed by nerve conduction studies Exclusion Criteria Other focal nerve entrapments Cervical radiculopathy Inflammatory joint disease Renal failure Thyroid disorders Previous wrist fracture Long-term exposure to vibrating tools Age under 18

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Diabetic patients with carpal tunnel syndrome | |
| 2<br>Non-diabetic patients with carpal tunnel syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space |  |  |
Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16 myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic stem cell transplantation.

Official Title
-----------------
Melphalan vs Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Autologous Hematopoietic Stem Cell Transplantation, Conditioning, Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Busulfan (BU)
* Drug: Cyclophosphamide (CY)
* Drug: Etoposide (VP-16)
* Drug: Melphalan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple Myeloma patients Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision

Ages Eligible for Study
-----------------
Minimum Age: 14 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUCY+VP-16<br>For MM patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -8 and -6；CY 60 mg/kg/day on days -5 and -4; VP-16 10mg/kg/day on days -3 and -2. | Drug: Busulfan (BU)<br>* Busulfan was administered at 3.2 mg/kg/day on days -8 to -6. -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.<br>Drug: Etoposide (VP-16)<br>* Etoposide was administered at 10 mg/kg/day on days -3 to -2. -3 to -2.<br>|
| Active Comparator: Melphalan<br>For MM patients undergoing auto-HSCT，Melphalan conditioning regimen was Melphalan 200mg/m2 on day -2. | Drug: Melphalan<br>* Melphalan was administered at 200mg/m2 on day -2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival (OS) | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate relapse rate | relapse rate | 3 year | 
| DFS | disease-free survival (DFS) | 3 year | 
| TRM | transplant-related mortality (TRM) | 3 year |
Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors

Official Title
-----------------
A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: ABT-869
* Drug: Tarceva


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have a histologically or cytologically confirmed non-hematologic malignancy. Subject must have an ECOG Score of 0-2. Adequate organ function. Exclusion Criteria: Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed. Subject has untreated brain or meningeal metastases. History of greater than 10% weight loss. Has clinically relevant hemoptysis. Subject has proteinuria CTC grade > 1. Must not have had radiation therapy or major surgery within 21 days of study day 1. The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) > 100 mmHg or systolic blood pressure (SBP) > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention. The subject has a documented left ventricular ejection fraction (LVEF) < 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: ABT-869<br>* 0.25 mg/kg. daily.<br>Drug: Tarceva<br>* 150mg, daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Day 7, 15, 21, 35 and Day 1 of every 8 weeks |