linjc16/ctgov huggingface dataset:
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.

Official Title
-----------------
A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.

Conditions
-----------------
Non-Hodgkin Lymphoma, Neoplasms

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Adequate kidney function and laboratory values Exclusion criteria: Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago Patients who had a heart attack or have unstable angina within past 6 months Heart disease including congestive heart failure and uncontrolled high blood pressure Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study 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 |
| --- | --- | --- |
| Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and efficacy of oral LBH589 throughout the study |  | at least every 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced cancer, solid tumors, lymphoma, HDAC, LBH589, adults, non-Hodgkin's lymphoma
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

Study Overview
=================
Brief Summary
-----------------
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Official Title
-----------------
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

Conditions
-----------------
Biliary Cirrhosis, Primary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age 18 or older) being treated or managed for PBC Exclusion Criteria: Inability to provide written informed consent Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC

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 |
| --- | --- | --- |
| Evaluate PBC treatment regimens being used in clinical practice |  | up to 5 years | 
| Examine populations underrepresented in phase III clinical trials |  | up to 5 years | 
| Examine biochemical response and its association with long term outcomes |  | up to 5 years | 
| Estimate adverse event frequency and severity and describe management practices |  | up to 5 years |
Dementia Care Challenges Among a Sample of Informal Caregivers in Egypt

Study Overview
=================
Brief Summary
-----------------
Dementia is a widespread incapacitating mental syndrome that carries a significant challenge for healthcare systems, persons with dementia, and their caregivers. The world health organization estimates that there is more than 55 million persons live with dementia worldwide, and there are nearly 10 million new cases every year In Egypt there are many studies had investigated caregiver burden with chronic ill elderly as physical or psychiatric diseases; however, studies focusing on caregiving Patients With Dementia (PWD), especially the psychological aspect, has been raised just few years ago. Some focused on psychiatric comorbidities of care givers, others correlated caregivers' quality of life with dementia staging. Other research groups designed educational programs and psychosocial interventions for training informal caregivers with significant psychological burden reduction at the end of the studies , also another group focused their study on the negative emotions expressed by caregiver towards PWD. Still there are many aspects of caregiving not explored considering the financial burden, lack of formal educational resources, stigma, cultural and religious values related to caregiving.

Detailed Description
-----------------
our study aims: To assess challenges of dementia-related knowledge among a sample of dementia informal caregivers To assess the needs of persons with dementia and their informal caregivers To assess the burden of caregiving among a sample of dementia informal caregivers To assess possible culturally related challenges of caregiving among a sample of dementia informal caregivers The study will be carried out through face-to-face interview, telephone interview, and online survey from community sources, including support groups in social media, memory clinics, outpatient clinics (Geriatric medicine, neurology, or psychiatry), and social support groups of non-governmental organizations.

Official Title
-----------------
Dementia Care Challenges Among a Sample of Informal Caregivers in Egypt

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informal Caregivers aged 18 years or older Informal Caregiver in daily contact for care with the person with dementia for at least one year. Exclusion Criteria: Informal caregivers who are unable or unwilling to communicate. Formal caregivers

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of caregiver burden | By using Zarit Burden Interview | one year |
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).

Official Title
-----------------
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

Conditions
-----------------
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Globe Pulsed Field System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: A diagnosis of recurrent symptomatic paroxysmal or persistent AF Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key exclusion criteria: Long-standing persistent AF (sustained >12 months) Atrial fibrillation secondary to a reversible cause or of non-cardiac origin History of thromboembolic events within the past six months Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months Any cardiac surgery within the previous six months Prior left atrial ablation or surgical procedure Presence of an implanted cardiac device Body mass index (BMI) >40 kg/m^2 Left ventricular ejection fraction (LVEF) <35% Anterior-posterior left atrial (LA) diameter >55mm

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Globe Pulsed Field System<br> | Device: Globe Pulsed Field System<br>* Ablation and atrial mapping with the Globe Pulsed Field System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness endpoint | Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure. | 12 months | 
| Safety endpoint | Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulsed Field Ablation, Irreversible Electroporation
Early Orthodontic Treatment of Dental Crowding

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. The randomized controlled trial study will be conducted in a public health care center.

Official Title
-----------------
Early Versus Late Orthodontic Treatment of Dental Crowding - a Randomised Controlled Trial

Conditions
-----------------
Dental Crowding

Intervention / Treatment
-----------------
* Device: Quad-helix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dental developmental stage of mixed dentition Crowding on both dental arches Skeletal discrepancy not suspected Exclusion Criteria: National criteria for publicly funded treatment not met by the severity of the malocclusion Other malocclusions Angle Class III relationship of the molars Malocclusion related to a syndrome Non-compliance to orthodontic treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 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: Early treatment<br>Treatment started in the early mixed dentition phase | Device: Quad-helix<br>* Fixed orthodontic appliance<br>|
| Experimental: Late treatment<br>Treatment started in the late mixed dentition phase | Device: Quad-helix<br>* Fixed orthodontic appliance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment time | Duration of treatment | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment burden | Number of orthodontic appliances used | Up to 48 months | 
| Alignment of dental arches | Occlusal end result of the treatment | up to 48 months |
Bupropion Treatment for Youth Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to 1) evaluate the safety and efficacy of two doses of bupropion SR (150mg/day and 300mg/day) when compared to placebo, as an aid to smoking cessation in adolescents and 2) to examine which factors, such as medication adherence, nicotine dependence, and motivation to quit, affect treatment outcome.

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Drug: bupropion SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14 to 17 years of age Smoked at least 6 cigarettes per day Exhaled CO greater than or equal to 10 ppm Made at least two previous quit attempts Weighed at least 90 pounds Able to read English at least the 6th grade level Motivated to quit smoking as evidenced by willingness to commit to study protocol requirements for the duration of the study provided active parental consent and youth assent Exclusion Criteria: Current use of tobacco products other than cigarettes, unless willing to abstain from these products for the study duration Current use of other treatments for smoking cessation History or current diagnosis of panic disorder, psychosis, bipolar disorder, or eating disorder History of abuse or dependence on alcohol or other recreational or prescription drugs in the three months preceding the study Current evidence of clinical depression or Attention Deficit/Hyperactivity Disorder Use of any psychoactive drug and/or any type of antidepressant with in four weeks of the treatment phase of the study Predisposition to seizure or tic disorders or a personal history of a seizure disorder, family history of seizure disorders, or treatment with medication or therapies that increase the risk of seizures Significant history of or current clinical evidence of cardiovascular disease (Females)Pregnancy (urine pregnancy test), lactation or, if sexually active, unwillingness to use a medically acceptable form of contraception for the duration of the study Only one member of a household was allowed to participate in the study concurrently.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bupropion SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified 7 day point prevalence abstinence from smoking. |  |  |
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure

Study Overview
=================
Brief Summary
-----------------
single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Detailed Description
-----------------
in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Official Title
-----------------
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Operation After Restrictive Bariatric Proceures

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: SAS-J


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study previous restrictive bariatric procedure Exclusion Criteria: patients unfit for surgery patients aged less than 18 and older than 60 patient with previous upper abdominal surgery either for obesity or other diseases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAS-J<br>single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures | Procedure: SAS-J<br>* Single Anastomosis Sleeve Jejunal Bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | percentage of excess weight loss in kilogram | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of improved co morbidity | the effect of the operation on co morbidity like diabetes and hypertension the effect of the operation on co morbidity like diabetes and hypertension the effect of single anastomosis sleeve jejunal bypass of comorbidities | 12 months | 
| the incidence of nutritional deficiency | the incidence of nutritional deficiency like anemia, hypocalcamia, hypoproteinemia. the incidence of nutritional deficiency like ca, iron, vitaminD and protein malnutrition | 12-24 months | 
| the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications | early operative complications like leak, bleeding complications like leak, bleeding, dumping, | 12-24 months |
Outcome Measures in Infant/Early Childhood Lung Disease w/ Chest CT Scanning & Lung Function Testing

Study Overview
=================
Brief Summary
-----------------
To implement a new method of performing chest CT imaging in young children at Packard Children's Hospital entitled controlled ventilation infant/young child chest CT scanning. This technique will be used to evaluate early lung disease comparing quantitative chest CT air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.

Official Title
-----------------
Differentiating Outcome Measures in Infant and Early Childhood Lung Disease Utilizing Controlled Ventilation Infant/Young Child Chest CT Scanning and Lung Function Testing

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Intubation with a cuffed ET Tube
* Procedure: CT scan Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1) Infants and young children (age <= 3 months to < 5 years) and either 2) or 3) below. 2) Respiratory condition (e.g. cystic fibrosis (CF), primary ciliary dyskinesia, bronchopulmonary dysplasia, asthma, or other pulmonary condition) and under the care of a pediatric pulmonologist at LPCH. 3) Oncology condition (e.g. young children with or without cancer, who are being screened for lung metastasis) and are being followed by pediatric oncologists at LPCH. 4) For minors, informed consent by parent or legal guardian. 5) Ability to comply with study visit procedures as judged by the investigator. Exclusion Criteria:1) Acute wheezing and/or respiratory distress at Study visit. 2) Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Study visit. 3) Oxygen saturation < 90% on room air at study visit. 4) Any medical condition that in the opinion of the investigator precludes subject participation.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intubation with a cuffed ET Tube|nan|
|Procedure: CT scan Radiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative CT air trapping & airway measurements |  | 6 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional residual capacity (FRC) & Lung Clearance Index (LCI). |  | 6 mo | 
| Differences between Quantitative CT air trapping & airway measurements & multibreath washout (MBW) FRC and LCI. |  | 6 mo | 
| Correlation between LCI and quantitative air trapping |  | 6 mo | 
| Correlation between bronchial wall thickness measurements/bronchiectasis measurements and LCI/FRC |  | 6 mo |