linjc16/ctgov huggingface dataset:
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Detailed Description
-----------------
The duration of treatment is 26 weeks.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous Sitosterolemia

Conditions
-----------------
Lipid Metabolism, Inborn Errors, Heart Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry. Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: MK0653, ezetimibe|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitosterol concentrations after 26 weeks. |  | After 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Campesterol concentrations; Achilles tendon thickness; safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sitosterolemia
HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the original HeartLight catheter in the treatment of persistent atrial fibrillation.

Official Title
-----------------
Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Persistent Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: HeartLight X3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early persistent AF, failure of at least one AAD, others Exclusion Criteria: overall good health as established by multiple criteria

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartLight X3<br>Pulmonary vein isolation using HeartLight X3 | Device: HeartLight X3<br>* Pulmonary vein isolation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation time | Ablation time | Acute - at the end of the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Procedure time | Acute - at the end of the index procedure | 
| PV Isolation | Percent of isolated pulmonary veins | Acute - at the end of the index procedure | 
| PAE Rate | Primary Adverse Event rate | 30 Days | 
| AF Free Rate | 6- and 12-month chronic results | 6 and 12 months |
The Evaluation of Cow's Milk Formula - Study B

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the growth and development of term infants fed either a marketed cow's milk formula, or an experimental cow's milk formula with prebiotics + a different calcium source + a different level of fatty acids and fat, or an experimental cow's milk formula with prebiotic + a different calcium source + a different level of fatty acids and fat

Official Title
-----------------
The Evaluation of Cow's Milk Formula - Study B

Conditions
-----------------
Healthy Term Infants

Intervention / Treatment
-----------------
* Other: Infant formula
* Other: Infant formula
* Other: Cow's milk infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infant 12-16 days of age 37-42 weeks GA Exclusion Criteria: History of chronic disease, congenital malformation Feeding difficulties or formula intolerance LGA

Ages Eligible for Study
-----------------
Minimum Age: 12 Days
Maximum Age: 16 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Marketed cow's milk-based formula | Other: Infant formula<br>* Marketed cow's milk base infant formula 20 kcal/oz<br>* Other names: Similar to Enfamil LIPIL with iron;|
| Experimental: 2<br>Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source | Other: Infant formula<br>* cow's milk based infant formula with prebiotics, different level of fatty acids and fat and a different calcium source<br>* Other names: No other similar brand names; experimental formula;|
| Experimental: 3<br>Cow's milk based formula with prebiotic, different level of fatty acids and fat and a different calcium source | Other: Cow's milk infant formula<br>* Cow's milk based formula with prebiotics, different level of fatty acids and fat and a different calcium source<br>* Other names: No other similar brand names; experimental product;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of weight gain |  | 106 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length and head circumference |  | 106 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Term, Infant, Formula
Study to Determine the Immunization Status Among Nephrological Health Care Personnel Against SARS-CoV-2 in a Single Center Over the Course of 12 Months During the Worldwide COVID-19 Pandemic.

Study Overview
=================
Brief Summary
-----------------
Infections with Corona-Viruses have shown to be a menace for patients with comorbidities such as hypertension, diabetes, cardiovascular disease or immunosuppression. Those are features almost every nephrological patient brings along, especially those on maintenance dialysis and those with renal transplant. Since the emergence of the novel coronavirus SARS-CoV-2 in November 2019 in Mainland China the fear for pandemic infections has increased. But not only is the course of infection itself important, the prevention of transmission to and by attending medical personnel should be put into perspective. Thus there is a lack of sufficient data of occult immunization or persistent state on immunization. In our study up to 400 health care personnel will be screened serologically for IgM, IgA and IgG against the SARS-CoV-2 virus. Blood and urine samples throughout 12 months will be sampled and analyzed. The aim of the study is to identify the rate of occult immunization and at the same time to gather data about the persistence of immune response to an infection with SARS-CoV-02. The results will help provide sufficient safety measures for health care providers and renal patients undergoing unavoidable clinical treatment.

Official Title
-----------------
COVID-19 Serology in Nephrology Health Care Workers

Conditions
-----------------
SARS-CoV 2, Immunization; Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health Care Personnel and other staff at the Division of Nephrology & Dialysis at the Medical Exclusion Criteria: Not matching the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Status of Immunization |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nephrology, SARS-CoV-2, Vienna, Health Care Personnel
Lyspro Insulin vs Regular Insulin in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
OBJECTIVE: To compare lispro insulin and regular insulin in the glycemic control of patients with liver cirrhosis and type 2 diabetes subjects. METHODS: 108 patients with liver cirrhosis and type 2 diabetes were randomly treated with regular insulin or lispro. After 122 weeks a cross-over was carried out and patients followed-up for 122 weeks. Then, all patients received a standard breakfast of 145 kcal following 12 U.I. of regular insulin or lispro, and C-peptide and insulin serum levels were determined over 300 minutes.

Conditions
-----------------
Diabetes Mellitus, Cirrhosis

Intervention / Treatment
-----------------
* Drug: lyspro
* Drug: regular insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin-treated diabetes mellitus and liver cirrhosis Exclusion Criteria: Oral hypoglycemic agents treated diabetes mellitus Liver cancer

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 67 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lyspro|nan|
|Drug: regular insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control in lyspro vs regular insulin treated patients |  |  | 
| Glycemic control in lyspro vs regular insulin in cirrhotic patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance to treatment and reduced postprandial hypoglycemia episodes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lyspro, regular insulin, cirrhotic patients
Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.

Conditions
-----------------
Cholecystitis

Intervention / Treatment
-----------------
* Other: video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients 18 years of age or older scheduled to receive the percutaneous cholecystostomy Exclusion Criteria: clinically unstable refuse to participate are unable to understand the study process

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: video<br> | Other: video<br>* The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge and satisfaction measure | One questionnaire will be used as an outcome measure tool. Participants will be asked to complete one questionnaire with knowledge test and satisfaction evaluation with the process of informed consent after the educational sessions. | immediately after intervention |
Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

Study Overview
=================
Brief Summary
-----------------
To investigate safety and efficacy on Japanese subjects treated with nelarabine injection for intravenous use in clinical settings of the following diseases: T-cell acute lymphocytic leukemia (T-ALL) T-cell lymphoblastic lymphoma (T-LBL) Also, any adverse events involving neurological disorder, hypotension, and blood disorder and their details are to be investigated as an item of particular concern. In addition, subject outcome (alive or dead) at one year after the start of treatment will also be investigated.

Official Title
-----------------
Drug Use Investigation for ARRANON G (Nelarabine) Injection 250mg

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Nelarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) Exclusion Criteria: Subjects with hypersensitivity to nelarabine
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects administered nelarabine<br>Subjects with T-cell acute lymphocytic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) prescribed nelarabine during study period | Drug: Nelarabine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects treated with nelarabine based on prescribing information under the conditions of general clinical practice. |  | 1 year | 
| Any incidence of adverse events related to neurological disorder, hypotension, and blood disorder and their details |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome (alive or dead) at one year after the start of treatment |  | 1 year |
Dynamic Laryngotracheal Separation for Aspiration

Study Overview
=================
Brief Summary
-----------------
People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

Detailed Description
-----------------
Data pending

Official Title
-----------------
Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator

Conditions
-----------------
Aspiration Pneumonia

Intervention / Treatment
-----------------
* Device: Placement of laryngeal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aspiration pneumonia after neurological insults (e.g. stroke) Ability to understand the purpose of the research Appropriate hand motor control Inability to improve under standard treatments (speech-language pathologists) Acceptance of a tracheostomy Exclusion Criteria: Lack of understanding the research Poor hand motor coordination Uncontrolled seizures Pregnancy Refusal to accept a tracheostomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br> | Device: Placement of laryngeal implant<br>* Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both<br>* Other names: Huntington perineural electrodes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Videotaping vocal cords and modified barium swallows |  | several months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of implanted device |  | immediate to several years | 
| comfort in swallowing |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspiration pneumonia, Implanted laryngeal stimulator, Vocal cord closure, Modified barium swallow
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987516)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF Signed and dated Informed Consent Form Signed and dated HIPAA Form An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY987516<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987516)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-64-R84-070)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |