linjc16/ctgov huggingface dataset:
Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.

Detailed Description
-----------------
Thromboelastography can provide more in-depth and quicker analysis of the complex coagulation processes during surgery

Official Title
-----------------
Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Conditions
-----------------
Coagulopathy, Mesothelioma

Intervention / Treatment
-----------------
* Procedure: Blood draw for TEG analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female patients undergoing elective surgery for malignant pleural mesothelioma Exclusion Criteria: Unwilling or unable to provide consent History of bleeding disorder On medications that may affect hemostasis

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 |
| --- | --- |
| Blood draw for TEG analysis<br>TEG analysis of blood from patients at different points in time | Procedure: Blood draw for TEG analysis<br>* Blood drawn for TEG analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulation profile during extrapleural pneumonectomy or pleurectomy | Reaction time, alpha angle, maximum amplitude and clot lysis from thromboelastography give a better picture of coagulation at different phases of surgery | Surgical period (4-6 hours) |
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.

Official Title
-----------------
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment

Conditions
-----------------
Heart Failure, Congestive, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: KW-3902IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable congestive heart failure Impaired renal function Taking oral loop diuretic Exclusion Criteria: Acutely decompensated (unstable) and end stage heart failure Diuretics other than loop diuretics Pregnant or nursing Inability to follow instructions Participation in another clinical trial within past 30 days

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KW-3902IV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of KW-3902IV alone or with loop diuretic on renal function. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal insufficiency, diuretic, heart failure, congestive
A Study of Evacetrapib in Japanese and Non-Japanese Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time. This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

Official Title
-----------------
Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects

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

Intervention / Treatment
-----------------
* Drug: Evacetrapib
* Drug: Pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overtly healthy participants, as determined by medical history and physical examination Have a body mass index of 18 to 32 kilograms per square meter (kg/m²) Japanese participants must be first generation Japanese

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pravastatin<br>Single 40 milligram (mg) oral dose of pravastatin administered on Day 1. | Drug: Pravastatin<br>* Administered orally<br>|
| Experimental: Evacetrapib + Pravastatin<br>Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11. | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;Drug: Pravastatin<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin |  | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin |  | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose | 
| PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin |  | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
Automated Embedded Polysomnography (AEP)

Study Overview
=================
Brief Summary
-----------------
To develop and validate a reliable automatic analysis of the signals recorded during a polysomnography.

Official Title
-----------------
Automated Embedded Polysomnography

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

Intervention / Treatment
-----------------
* Other: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insured by social security Speak french Exclusion Criteria: Sleep disorder Neurologic, respiratory or cardiac disease

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polysomnography<br>Three polysomnographic recordings will be made on 3 consecutive nights with Electroencephalogry. | Other: Polysomnography<br>* Complete polysomnography with : Electroencephalogry, electro-oculography, surface electromyography (chin muscle, anterior tibial muscles), nasal pressure, respiratory movements (plethysmography of thoracic and abdominal inductance), pulse oximetry and electrocardiography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the automatic analysis | Comparison between polysomnographic analysis by two expert physicians and an automatic analysis | 72 hour |
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.

Official Title
-----------------
Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Abacavir/Lamivudine
* Drug: Abacavir/Lamivudine
* Drug: Lersivirine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2. Total body weight >50 kg (110 lbs). Exclusion Criteria: History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. History of hypersensitivity to abacavir, lamivudine and/or lersivirine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abacavir/Lamivudine<br> | Drug: Abacavir/Lamivudine<br>* Abacavir/Lamivudine 600/300 mg QD for 5 days<br>|
| Experimental: Lersivirine + Abacavir/Lamivudine<br> | Drug: Abacavir/Lamivudine<br>* Abacavir/Lamivudine 600/300 mg QD for 10 days<br>Drug: Lersivirine<br>* Lersivirine 750 mg QD for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine. |  | 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. |  | 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lersivirine, UK-453, 061, NNRTI, Abacavir, Lamivudine, Combivir, Pharmacokinetics, Drug Interaction, HIV, AIDS
Treatment of Depressed Women Who Have Been Sexually Abused

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication and antidepressant medication alone for the treatment of major depression in women with a history of childhood sexual abuse.

Detailed Description
-----------------
Schema-Focused (SF) Therapy is an extension of cognitive therapy that was developed to address the treatment needs of patients with long-standing mental disorders. SF therapy focuses on early maladaptive schemas (EMS): broad, pervasive themes regarding oneself and one's relationship with others, developed during childhood and elaborated throughout one's lifetime, which are dysfunctional to a significant degree. SF Therapy involves the identification of the particular EMS that is most relevant for each patient and attempts to modify the relevant schemas by altering the distorted views of self and others. Participants are assessed pretreatment, after 12 weeks, posttreatment, and 3 and 6 months posttreatment. The severity of depressive symptomatology is measured and a self-report Beck Depression Inventory is administered. At the end of the study and at the follow-up intervals, participants are given the Longitudinal Interval Follow-up Evaluation, an instrument that assesses the severity of depression and dysthymia symptoms.

Official Title
-----------------
Treatment of Women With Depression and Sexual Abuse

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Schema Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major depression History of childhood sexual abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Schema Therapy|nan|

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
-----------------
Child Abuse, Sexual
Study of Anemia in Chronic Kidney Disease (CKD) Among High-Risk Hypertensive and Diabetic Patients in Pakistan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. The information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with CKD.

Official Title
-----------------
Prevalence of Anaemia Secondary to Early Stage Chronic Kidney Disease in High Risk Diabetic and/or Hypertensive Population

Conditions
-----------------
Anemia, Diabetes, Kidney Disease, Chronic, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 40 years Known hypertension and/or diabetes for at least 3 years Positive dipstick test result for proteinuria Exclusion Criteria: Known CKD Receiving erythropoietin Blood transfusion within 8 weeks History of acute or chronic bleeding, hemolysis, or hemoglobinopathy

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Study Population<br>Hypertensive and diabetic patients who meet eligibility criteria will be enrolled and evaluated for the presence of anemia secondary to CKD. The first visit will capture medical history including risk factors for CKD; laboratory assessments will be performed at the second and third visits to evaluate glomerular filtration rate (eGFR) and anemia profile, respectively. Participants who are not diagnosted with CKD based upon the second visit will not return for the third visit. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with anemia secondary to CKD |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of treatment modalities for the management of anemia secondary to CKD |  | Up to 12 months |
The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple. Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment. Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone. In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.

Conditions
-----------------
Cancer, Anemia

Intervention / Treatment
-----------------
* Drug: Ferinject®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who diagnosed with solid cancer or lymphoma Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment anticancer therapy: chemotherapy, and/or chemotherapy + radiotherapy, and/or target agent Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment Exclusion Criteria: Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment Subjects with uncontrolled infection Subjects with ongoing bleeding Deteriorated organ function poor performance state (ECOG 3-4) Subjects whose disease involves bone marrow Ferritin > 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects<br> | Drug: Ferinject®<br>* intravenous Ferinject 1000mg injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Hemoglobin response |  | visit 4th after Ferinject injection |
Cyproheptadine as an Appetite Stimulant

Study Overview
=================
Brief Summary
-----------------
Cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. Otherwise, no randomised control trial demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. Our hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.

Official Title
-----------------
Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive

Conditions
-----------------
Failure to Thrive

Intervention / Treatment
-----------------
* Drug: Cyproheptadine
* Drug: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 to 4 years of age failure to thrive Exclusion Criteria: Medication affecting appetite Medication interacting with Cyproheptadine Prematurity under 36 weeks of gestation Neurologic impairment underlying organic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 4 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyproheptadine<br>Cross-over study | Drug: Cyproheptadine<br>* 0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month<br>|
| Placebo Comparator: Sugar pill<br>Cross-over study | Drug: Sugar pill<br>* liquid placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | January 2011 to January 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding behaviour |  | January 2011 to January 2012 |