linjc16/ctgov huggingface dataset:
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589

Study Overview
=================
Brief Summary
-----------------
This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.

Official Title
-----------------
An Open-label, Single Center, Study to Determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of LBH589 After a Single Oral Administration of 20 mg (14C) LBH589 in Advanced Cancer Patients

Conditions
-----------------
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

Intervention / Treatment
-----------------
* Drug: LBH589


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies. Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2 Normal renal and hepatic function Exclusion criteria Patients with central nervous system (CNS) involvement or brain metastases Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago Patients with congenital long QT syndrome or uncontrolled hypertension Patients with a myocardial infarction or unstable angina within 6 months Congestive heart failure Impairment of gastrointestinal (GI) function Use of any anti-cancer therapy Female patients who are pregnant or breast feeding Other protocol inclusion/exclusion criteria may apply.

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: LBH589<br> | Drug: LBH589<br> <br> * Other names: Panobinostat;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589 | oral dose of [14C] LBH589 | during the first 8 days on study | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced cancer, lymphoma, chronic hematological malignancies, adult
Observational Study With Investigation of Two Second Generation Laryngeal Masks

Study Overview
=================
Brief Summary
-----------------
In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

Detailed Description
-----------------
After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.

Official Title
-----------------
Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study

Conditions
-----------------
Airway Remodeling

Intervention / Treatment
-----------------
* Device: Success


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Years No concurrent participation in another study capacity to consent Present written informed consent of the research participant Elective surgery under general anesthesia Exclusion Criteria: Age <18 years Existing pregnancy Lack of consent inability to consent emergency patients Emergency situations in the context of a Difficult Airway Management ASA classification> 3 situations where the possibility of accumulated gastric contents Participation in another study

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 |
| --- | --- |
| Supreme Group<br>Measuring Success rate and Insertion Time | Device: Success<br>* Success rate and time for insertion<br>|
| Gain Group<br>Measuring Success rate and Insertion Time | Device: Success<br>* Success rate and time for insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | overall and first attempt success rate | 70-98 Percent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for insertion |  | 5-120 seconds | 
| Leakage in ml.min |  | 0-300 ml.min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway leakage, laryngeal mask, airway morbidity
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

Official Title
-----------------
An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome

Conditions
-----------------
Xerostomia, Sjogren's Syndrome

Intervention / Treatment
-----------------
* Drug: Rebamipide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare) Patients aged 20 years or older at time of consent Patients with dry mouth Patients with decreased salivation Exclusion Criteria: Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.) Patients who have received rebamipide within 3 months prior to obtaining informed consent Patients who are pregnant, possibly pregnant, or lactating Patients with a history of hypersensitivity to rebamipide Patients who have received any other investigational drug within 3 months prior to obtaining informed consent Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Intervention/Treatment |
| --- |
|Drug: Rebamipide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Improvement Rate in Dry Mouth Symptoms | At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse). The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved. | Weeks 2, 4, and 8 |
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This is a new inguinal hernia repair technique.

Detailed Description
-----------------
In this study we are revealing a new inguinal hernia repair technique. It is constructed from two layers. Deep layer is modified Shouldice technique, the other superficial one is moloney technique.

Official Title
-----------------
A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Procedure: modified shouldice and double


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inguinal hernia Exclusion Criteria: Recurrences, child

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: study, control<br>Control: Only modified shouldice repair performed Study: Modified Shouldice + Moloney repairs performed | |
| No Intervention: modified shouldice and double<br>one arm is only modified shouldice, other one is double | Procedure: modified shouldice and double<br>* one arm modified shouldice, other one is double repair<br>* Other names: control group, study group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications, recurrences |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal, hernia, new, repair, modified shouldice, double
Genetic Abnormalities and Biological Changes of Panic Disorder Patients After Pharmacotherapy

Study Overview
=================
Brief Summary
-----------------
We plan to examine genetic polymorphism of catechol-O-methyltransferase in panic disorder and neurobiological changes of panic disorder patients after 12 weeks of pharmacotherapy with paroxetine. We plan to include 40 panic disorder patients and 40 normal control subjects in this study for 3 years.

Official Title
-----------------
Genetic Abnormalities and Changes of Autonomic Nervous System, Serotonin System, and Neuroendocrine System According to Pharmacotherapy in Panic Disorder

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Panic disorder Exclusion Criteria: Other major medical or psychiatric illnesses

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| 2<br>paroxetine treatment group vs. normal control group | |

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, paroxetine, genetic polymorphism, serotonin
Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?

Study Overview
=================
Brief Summary
-----------------
In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.

Detailed Description
-----------------
Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher transfusion rate, this is not really known in paediatric cardiac surgery. In this retrospective study, the investigators will analyse our database for paediatric cardiac surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single cardiac surgery will be compared to patients with a second cardiac operation under extracorporeal bypass. The investigators will test the variables for normal distribution using a Shapiro-Wilk test. Non normal distributed variables will be compared by a non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A univariate analysis will determine predicting factors for transfusion. Factors with a P value < 0.1 will be analysed by a multivariate analysis to determine independent factors for transfusion. Odds with 95% confidence intervals will be calculated. A P value < 0.05 will be considered statistically significant.

Official Title
-----------------
Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?

Conditions
-----------------
Pediatric Cardiac Surgery, Transfusion

Intervention / Treatment
-----------------
* Other: Redo op


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 0 and 16 years Cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Jehova's witness

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No redo op<br>Patients with a single cardiac operation under extracorporeal bypass | |
| Redo op<br>Patients with a redo cardiac operation under extracorporeal bypass | Other: Redo op<br>* Patients with a redo operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion of packed red cells (mL/kg) | Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight | Day of operation up to 5 days postop |
Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH

Official Title
-----------------
Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study

Conditions
-----------------
Hemoglobinuria, Paroxysmal

Intervention / Treatment
-----------------
* Drug: eculizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PNH > 6 months Type III PNH red blood cell (RBC) clone by flow cytometry >10% At least one transfusion in the past 2 years but no more than 3 transfusions in the past 12 months; or personal beliefs that preclude the use of transfusion with severe hemolytic PNH Lactate dehydrogenase (LDH) >1.5 x upper limit of normal Must avoid conception Willing and able to give written informed consent Exclusion Criteria: Platelet count of <30,000/mm3 Absolute neutrophil count <500/ul Active bacterial infection Hereditary complement deficiency History of bone marrow transplantation Participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days Pregnant, breast-feeding, or intending to conceive History of meningococcal disease

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

| Intervention/Treatment |
| --- |
|Drug: eculizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable safety (adverse events [AEs], labs, electrocardiograms [ECGs], vital signs) |  |  | 
| Primary surrogate of efficacy endpoint is hemolysis measured by LDH area under the curve. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemolysis measured by the change of LDH from baseline; |  |  | 
| Quality of Life |  |  |
Spontaneous Haematomas of Psoas Occurring in Intensive Care

Study Overview
=================
Brief Summary
-----------------
Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.

Official Title
-----------------
Spontaneous Haematomas of Psoas Occurring in Intensive Care: Incidence, Patient Characteristics and Treatment, a Retrospective Study

Conditions
-----------------
Psoas Hematomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patients Psoas hematoma diagnosed during hospitalization Exclusion Criteria: Refusal to participate in the study

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 |
| --- | --- | --- |
| Number of psoas hematomas |  | 72 hours after admission to intensive care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoas hematomas
Effect of Mechanical Loading With PTH on Cortical Bone

Study Overview
=================
Brief Summary
-----------------
Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.

Official Title
-----------------
Effect of Mechanical Loading With PTH on Cortical Bone

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Device: Upper extremity voluntary loading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 45+ postmenopausal osteoporotic with high risk of fracture Exclusion Criteria: no significant previous use of bone health modifying treatments

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Loaded upper extremity<br>This is a one-arm study. In postmenopausal women prescribed teriparatide for osteoporosis treatment, enrolled subjects will perform voluntary loading exercises on one upper extremity. A data logger device will assist in recording exercises and determining goal force during the exercises. Each subject's non-loaded upper extremity will serve as a control. | Device: Upper extremity voluntary loading<br>* Subjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radius bone mineral density |  | 12 month change |
Evaluation of the Proliferative Activities of Insulin Analogues in Primary Human Tumor Cells

Study Overview
=================
Brief Summary
-----------------
Recently the general medical literature has become aware that the use of certain long-acting insulin analogues could potentially increase cancer risk.During the last few years the investigators group generated information of both scientific and clinical relevance on the proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to evaluate the hypothesis that the proliferative and signalling activities elicited by insulin analogues may have a impact on tumor behavior. In this study the investigators will asses the biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.

Conditions
-----------------
Endometrial Cancer, Colon Cancer

Intervention / Treatment
-----------------
* Other: Tissue sample from tumor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Endometrial and Colon Cancer Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Tissue sample from tumor|Endometrial cancer specimens will be obtained from patients operated and treated at the Gynecologic Oncology Unit at Meir Medical Center. Colon cancer specimens will be obtained from patients that underwent colonoscopy at the Gastrointestinal Department at Meir Medical Center.|

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
-----------------
To asses the biological actions of insulin analogs in primary tumor cells