linjc16/ctgov huggingface dataset:
Efficacy of Treatment for Panic Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of these questionnaires is to give us an overview of how panic has affected your life and perhaps also to give us some clues about things that may have set you up to experience panic.

Detailed Description
-----------------
For us to evaluate the efficacy of our treatment programs, we are interested in your responses before and after treatment. We use two methods to evaluate the efficacy of our treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As part of standard clinic procedure, each person in the program completes an in-person interview with a staff member who will determine your suitability for treatment. If you have received this questionnaire packet, it is likely that your concerns will be appropriately addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to assess the severity of your panic disorder; its impact on your functioning, and factors that may contribute to the onset or maintenance of your panic (e.g., depression, anxiety sensitivity). We will ask you to complete this questionnaire again when you have completed your treatment along with a brief telephone interview with a staff member of the Anxiety Disorders Clinic.

Official Title
-----------------
Efficacy of Treatment for Panic Disorder

Conditions
-----------------
Panic Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to the Anxiety Disorders Clinic who receive a primary diagnosis of Panic Disorder, and are accepted for treatment at the clinic. Exclusion Criteria: Individuals who either have not sought treatment for anxiety at the Anxiety Disorders Clinic or patients who did not receive a primary diagnosis of Panic Disorder.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Panic Disorder, Anxiety, Treatment efficacy
Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.

Official Title
-----------------
Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Rabeprazole Sodium Tablets 20 mg
* Drug: Aciphex® Tablets 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rabeprazole Sodium Tablets 20 mg | Drug: Rabeprazole Sodium Tablets 20 mg<br>* 20mg, single dose fed<br>|
| Active Comparator: 2<br>Aciphex® Tablets 20 mg | Drug: Aciphex® Tablets 20 mg<br>* 20mg, single dose fed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 24 hours |
Evaluation of Loratadine for G-CSF Induced Bone Pain in Patients With Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.

Detailed Description
-----------------
Objectives The primary objective is to determine the incidence of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. Incidence will be determined via patient-reported incidence following G-CSF administration. Secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).

Official Title
-----------------
Evaluation of Loratadine for Granulocyte-Colony Stimulating Factor Induced Bone Pain in Patients With Hematologic Malignancies

Conditions
-----------------
Leukemia, Lymphoma

Intervention / Treatment
-----------------
* Drug: Loratadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving a G-CSF after the institution practice change Receiving a G-CSF for one of the following indications: Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma Mobilization of hematopoietic progenitor cells Neutropenia prevention following autologous hematopoietic cell transplant Took loratadine per protocol with G-CSF administration Completed a survey Exclusion Criteria: Taking daily antihistamines for allergies, asthma, or other indications, not including bone pain Taking daily NSAIDs, with the exception of aspirin, for chronic conditions Treatment for solid tumor cancers Receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions

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 |
| --- | --- |
| Treatment with Loratadine<br>Treatment with Loratadine | Drug: Loratadine<br> <br> * Other names: Claritin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bone pain following G-CSF administration |  | Day 1 |
ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults

Study Overview
=================
Brief Summary
-----------------
Chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on the Scottish population. Obesity and inflammation have strong links to these diseases. One of the mechanisms explaining the relationship between low-grade inflammation and excess weight is endotoxaemia. We wish to study this phenomenon, when small components coming from our gut bacteria can pass into the bloodstream, raising the body's defences. Diet can modulate endotoxaemia. In this study, we propose to use curcumin, in a capsule form, to modulate endotoxaemia. Curcumin comes from turmeric, which is widely used as a spice. In this study, we want to test the effect of consuming curcumin extract to the composition of the gut microbiota, post-meal endotoxaemia, and inflammatory markers in blood.

Official Title
-----------------
Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: BCM-95
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - BMI > 25 kg/m2. Exclusion Criteria: having chronic inflammatory or autoimmune disease, gastrointestinal complaints or known biliary obstruction (past and present) use of anti-inflammatory drugs 2 weeks before the start of the study use of antibiotics during the 12 weeks preceding the trial pregnancy lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial<br>350 mg of BCM-95, 1 capsule per day, for 21 days. | Dietary Supplement: BCM-95<br>* Consuming 1 capsule of BCM-95 per day.<br>* Other names: Bio-Curcumin;|
| Placebo Comparator: Control<br>350 mg of starch, 1 capsule per day, for 21 days | Dietary Supplement: Placebo<br>* Consuming 1 placebo capsule per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of endotoxin in plasma. |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endotoxaemia, Curcumin.
Food Effect Study of a Single Dose of ZD4054 (Zibotentan)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effect of food on the pharmacokinetics of a 10 mg single oral dose of ZD4054 (Zibotentan)

Official Title
-----------------
A Randomised, Open-label, Single-centre, Crossover Study in Healthy Male Volunteers to Assess the Effect of Food on the Pharmacokinetics of a 10 mg Single Oral Dose of ZD4054 (Zibotentan)

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

Intervention / Treatment
-----------------
* Drug: ZD4054


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18 and 30 kg/m2 Medical and surgical history and physical examination without any clinically significant findings Able to consume standard FDA specified high-fat breakfast. Exclusion Criteria: Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan Medical diagnosis of migraine with an attack during the 12 months prior to Screening Use of prescription medication within 2 weeks before dosing

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fasting state | Drug: ZD4054<br>* one single 10mg dose<br>* Other names: Zibotentan;|
| Experimental: 2<br>after high-fat breakfast | Drug: ZD4054<br>* one single 10mg dose<br>* Other names: Zibotentan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | frequent sampling occasions during study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ZD4054, Zibotentan, Healthy Volunteers
Cognition and Imaging With Tigertriever

Study Overview
=================
Brief Summary
-----------------
The objective of the COGNITIVE Study is to evaluate whether successful reperfusion with Tigertriever is associated with cognitive benefit.

Official Title
-----------------
COGNITIVE Study- Cognition and Imaging With Tigertriever

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as indicated per the approved IFU. Tigertriever was used as the first line treatment in the target vessel. A signed informed consent. Age 18-75 years (inclusive). No known significant pre-stroke disability (pre-stroke mRS 0 or 1). Exclusion Criteria: Use of any other IA recanalization device prior to the Tigertriever in the target vessel, including aspiration catheter. Evidence of acute brain hemorrhage on CT and/or MRI at admission. Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months. Probable cerebral amyloid angiopathy. Pre-stroke diagnosed dementia and/or prescribed cholinesterase inhibitors. Pre-stroke diagnosed and/or currently treated major depression. Pre-stroke learning or intellectual disability. Anticipated inability to obtain 6-month follow-up assessments. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between successful reperfusion* and cognitive benefit** | *successful reperfusion is defined as eTICI ≥2b50 with the Tigertriever device. Cognitive benefit is defined as change in Montreal Cognitive Assessment (MoCA) of 1.5 Standard Deviations (SD) from 4 days post treatment (or discharge if earlier) and 180 days post treatment; or MoCA ≥26 at 180 days post treatment. | 180 days post treatment |
Mother's Gift Project

Study Overview
=================
Brief Summary
-----------------
This prospective randomized evaluation of pneumococcal vaccine immunization of pregnant mothers, followed by pneumococcal conjugate immunization of their children is designed to assess the effects of these strategies on the immunogenicity and safety of both vaccines. We hypothesize that maternal followed by infant immunization will be safe and will provide higher levels of antibody from birth through 12 months of age.

Detailed Description
-----------------
This is a randomized vaccine evaluation in 4 groups of mothers and their infants, to assess the effect of maternal immunization on the infants' response to pneumococcal vaccine.

Official Title
-----------------
Comparison of Maternal and Infant Immunization Strategies to Prevent Pneumococcal Disease

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: pneumococcal polysaccharide and protein conjugate vaccines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers from 18 to 14 years of age in the third trimester of pregnancy, with normal medical and obstetric history, who plan to deliver their infant in Dhaka city and remain there for 12m Exclusion Criteria: Maternal history of systemic disease, Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies. Maternal hypersensitivity to any vaccination, or Maternal receipt of pneumococcal vaccine in the last 3 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pneumococcal polysaccharide and protein conjugate vaccines|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age |  |  | 
| local and systemic reactions within 2 weeks of vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level and duration of serum IgG antibody to pneumococcus up to 1 year of age. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant antibody,, gestational immunization,, cord antibody
Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy

Study Overview
=================
Brief Summary
-----------------
SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.

Official Title
-----------------
Single-photon Emission Computed Tomography for Prediction of Treatment Results in Sequential Intraperitoneal Chemotherapy at Peritoneal Carcinomatosis

Conditions
-----------------
Peritoneal Carcinomatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cytoreductive surgery and intraperitoneal chemotherapy Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 74 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 |
| --- | --- |
| Peritoneal carcinomatosis<br>Patients undergoing cytoreductive surgery and intraperitoneal chemotherapy treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detected volume measured by SPECT compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraperitoneal volume, peritoneal carcinomatosis, cytoreductive surgery, SPECT, intraperitoneal chemotherapy
Allograft and Tantalum Cone Reconstruction in TKA Revision

Study Overview
=================
Brief Summary
-----------------
A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft. Study of radiological and clinical outcomes.

Official Title
-----------------
Clinical and Radiological Outcomes of Composite Tibial and Femoral Allograft and Tantalum Cone Reconstructions in Total Knee Replacement Revision

Conditions
-----------------
Tantalum, Bone Loss, Allograft

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: > 18 years old TKA revision using tantalum cone or allograft Exclusion criteria: <18 years old no reconstruction used in TKA revision

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Survivorship of the implant | Survivorship of the implant | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tantalum, Allograft, TKA revision using tantalum cone and/or allograft
Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.

Detailed Description
-----------------
The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.

Official Title
-----------------
Impact of Mitral Valve Annuloplasty on the Tricuspid Valve Complex

Conditions
-----------------
Tricuspid (Valve); Deformity

Intervention / Treatment
-----------------
* Procedure: Mitral Valve Annuloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty Exclusion Criteria: concomitant tricuspid valve surgery atrial fibrillation at the moment of surgery poor echocardiographic windows

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 |
| --- | --- |
| Mitral Valve Annuloplasty<br>All eligible patients | Procedure: Mitral Valve Annuloplasty<br>* Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative geometric changes in tricuspid valve annulus (TA) | Measurement of changes in 3D descriptors of the TA (e.g. changes from baseline in the TA area of the best-fit plane in cm^2, and changes from baseline in the height of each TA point to the TA best-fit plane in mm) | day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Diseases, Heart Valve Diseases, Mitral Valve Annuloplasty, Tricuspid Valve Insufficiency