linjc16/ctgov huggingface dataset:
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

Detailed Description
-----------------
The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Official Title
-----------------
A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CP-945,598 Treatment A
* Drug: CP-945,598 Treatment B
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese adults with a body mass index > or = 30 kg/m2; > or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia Exclusion Criteria: Pregnancy Diabetes Adults with serious or unstable current or past medical conditions

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-945,598 Treatment A<br> | Drug: CP-945,598 Treatment A<br>* Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling<br>|
| Experimental: CP-945,598 Treatment B<br> | Drug: CP-945,598 Treatment B<br>* Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with 5% weight loss |  | 1 year | 
| Change in body weight |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, blood lipids and glucose, waist circumference, quality of life |  | 2 years |
Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.

Conditions
-----------------
Hematological Disease

Intervention / Treatment
-----------------
* Other: Supervised exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 Hematological disease Treatment with high-dose chemotherapy followed by autologous stem cell transplantation Understanding of written German Exclusion Criteria: Cardiorespiratory, metabolical, osteoarticular or immunological diseases which can be aggravated by exercise Pathological stress-ECG at admission

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise<br> | Other: Supervised exercise<br>* The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.<br>|
| No Intervention: Control group<br>The patients will not carry out a structured exercise program. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max |  | At recruitment and after 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood |  | At recruitment and after 3 weeks | 
| Duration of aplasia |  | 3 weeks | 
| Complications during hospitalization |  | 3 weeks | 
| Need for transfusion of platelets and red blood cells |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-dose chemotherapy, Hematological neoplasties, Fatigue, Cancer, Exercise, Sport, Hematologic neoplastic disorders
N Acetyl Cysteine for Cystinosis Patients

Study Overview
=================
Brief Summary
-----------------
This study intends to verify the interference of N acetyl cysteine in the progression of chronic kidney disease in patients with Nephropathic Cystinosis.

Detailed Description
-----------------
Patients with Nephropathic Cystinosis have an increased oxidative stress and go to end-stage renal disease, even when all steps of the treatment are done. Therefore, this study is conducted to verify the interference of the stress oxidative in the progression of the renal disease with the use of an oxidant drug, N acetyl cysteine (NAC). The investigators selected patients with good compliance of the treatment. In these patients the investigators evaluate the serum creatinine, creatinine clearance estimated by Schwartz Formula, cystatin C and a marker of oxidative stress, TBARS ( thiobarbituric acid substances). The variables are analyzed 6 months before the introduction of NAC and the three months after NAC.

Official Title
-----------------
N Acetyl Cysteine Can Decrease the Progression of Renal Disease in Cystinosis Patients

Conditions
-----------------
Renal Disease, Cystinosis

Intervention / Treatment
-----------------
* Drug: N acetyl cysteine
* Drug: N acetyl cysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cystinosis patients age under 18 years with good compliance to the treatment with Chronic Kidney Disease 1 to 4 according to KDOQI Exclusion Criteria: patients with CKD stage 5

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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: N acetyl cysteine<br>NAC will be given to cystinosis patients and we will observe the renal function status and a marker of oxidative stress (TBARS) | Drug: N acetyl cysteine<br>* N acetyl cysteine to cystinosis patients with CKD stages 1 to 4<br>* Other names: N acety cysteine;Drug: N acetyl cysteine<br>* N acetyl cysteine for cystinosis patients CKD stages 1 to 4<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| creatinine clearance | creatinine clearance will be evaluate 6 months beforw and at baseline and after 3 months with NAC | change in creatinine clearance evaluated 6 months before , at baseline and after 3 months with NAC | 
| cystatin c | Cystinosis patients will be evaluated 6 months before and at baseline and after 3 months after the use of NAC | change in cystatin C from baseline and after 3 months with NAC | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal function, before and after N acetyl cysteine, Cystinosis patients
Impact of Patient-Prosthesis-Mismatch on Coronary Flow Reserve

Study Overview
=================
Brief Summary
-----------------
Complete normalization of CFR following AVR for aortic stenosis was observed only for stentless valves. Besides the superior hemodynamic performance this might explain the excellent long term results of this valve design.

Official Title
-----------------
Impact of Patient-Prosthesis-Mismatch and Aortic Valve Design on Coronary Flow Reserve Following Aortic Valve Replacement

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic valve stenosis Exclusion Criteria: Coronary artery disease

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?
-----------------
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
-----------------
Coronary artery disease, Coronary flow reserve, Heart failure, prospective randomised
An Exploratory Investigation of a Male Focused Skincare Supplement

Study Overview
=================
Brief Summary
-----------------
Most skincare products on the market are topical and do not take a holistic approach to understanding skin health. This trial will examine a dietary supplement designed to support the gut microbiome and promote skin health from an internal perspective. Research has previously supported the link between the gut microbiome and skin health and the supplement tested in this trial will further the knowledge on the effectiveness of supporting gut health to improve skin outcomes.

Official Title
-----------------
An Exploratory Investigation of a Male Focused Skincare Supplement

Conditions
-----------------
Acne, Skin Abnormalities

Intervention / Treatment
-----------------
* Dietary Supplement: Daily Skin Supplement - Fountain of Youth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Between the ages of 18-55 Frequently experience different forms of acne Frequently experience breakouts Must be in good health with no long term health conditions BMI must be under 40 Must follow a consistent dietary regimen Must be willing to stop any oral supplementation targeting their skin while in the trail Exclusion Criteria: Anyone who does take prescription medication (oral or topical) targeting their skin including reinoid, over the counter retinol, or retinal Not willing to stop any oral supplementation targeting their skin Severe chronic conditions, including oncological and psychiatric disorders Previous severe allergic reactions Unwilling the follow the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Intervention arm<br>Daily Skin Supplement - Fountain of Youth | Dietary Supplement: Daily Skin Supplement - Fountain of Youth<br>* Skincare supplement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult Acne | Change in overall frequency and intensity of adult acne (Likert Scale 0-5 with higher scores representing a reduction in the appearance of adult acne) | 12 week |
Acute Cardiovascular Effects of Cigarette Smoking

Study Overview
=================
Brief Summary
-----------------
Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure, electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette. The measurements will be compare for any cardiovascular effects of a cigarette smoking on these parameters.

Detailed Description
-----------------
Twenty male persons habituated to smoking (at least 5 cigarettes/day) will be recruited after an informed consent. Healthy persons with no systemic illness will be included. After a history and a routine examination, subjects will be asked to abstain from smoking for 3 hours and then their pulse, BP, ECG and echo recorded. The measurements will be repeated after 15 min. and the average of these two taken as baseline readings. Then, they will be asked to smoke a cigarette and the measurements taken again. Special focus will be on Doppler measures of left ventricular (LV) function. The measurements are repeated immediately and at 5,10 and 15 min. The data will be analyzed for any cardiovascular effects of smoking a cigarette. Chi square test for proportions and t-test for means will be done. A p value < 0.05 will be taken as significant.

Official Title
-----------------
Acute Cardiovascular Effects of Cigarette Smoking

Conditions
-----------------
Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male smokers (at least 5 cigarettes /day) >18 years old. Exclusion Criteria: Any cardiac or respiratory or systemic illness,including hypertension.

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

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

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
-----------------
Cigarette, Smoking, Cardiovascular Effects, 2D Echocardiography, Doppler
A Prospective, Pilot Evaluation of Device Equivalence

Study Overview
=================
Brief Summary
-----------------
Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Detailed Description
-----------------
Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Official Title
-----------------
Validation of MolecuLight Phoenix Prototypes in Clinic

Conditions
-----------------
Wound

Intervention / Treatment
-----------------
* Device: Fluorescence Imaging Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects (inpatient/outpatient) presenting with a wound Wound size less than 15 cm in length 18 years or older Exclusion Criteria: Treatment with an investigational drug within 1 month before study enrolment Subjects with recent (<30 days) biopsy or curettage of target wound Subjects with wounds that cannot be completely imaged by study device due to anatomic location Unable or unwilling to consent

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

| Intervention/Treatment |
| --- |
|Device: Fluorescence Imaging Device|Hand-held, real-time fluorescence imaging device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance | Estimate concordance of moderate/heavy bacterial load present in images acquired with each of 3 devices | 2 months |
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.

Official Title
-----------------
Randomized Comparison of the Abbott WHITESTAR Signature System With Ellips Tranversal Ultrasound vs. the Alcon Infiniti With the Ozil Torsional Handpiece in Phacoemulsification: A Contralaterally-Controlled Trial

Conditions
-----------------
Cataracts, Astigmatism

Intervention / Treatment
-----------------
* Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound
* Device: Alcon Infiniti wiht the OZIL Torsional Handpiece


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal IOLs. Both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of <2.00D as well as similar globe axial length as measured by the IOL Master of <0.5mm). Visual potential of UCVA 20/25/ or better. Clear intraocular media other than cataract. Exclusion Criteria: Clinically relevant differences between eyes in ocular disease or pathology. Presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree. Asymmetrical use of ocular medications.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Abbott WHITESTAR Signature System<br>Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound | Device: Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound<br>* Comparison of vision after cataract surgery based on two different types of equipment.<br>|
| Experimental: Alcon Infiniti<br>Alcon Infiniti with the OZIL Torsional Handpiece | Device: Alcon Infiniti wiht the OZIL Torsional Handpiece<br>* Comparision of vision after cataract surgery based on two different types of equipment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 1 year |
A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia (CLL) Used in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).

Official Title
-----------------
Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients

Conditions
-----------------
Cancer, Chronic Lymphocytic Leukemia (CLL)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants diagnosed with chronic lymphocytic leukemia who have been prescribed Venetoclax for the first time according to the approved label Participants (and/or legal representative) who voluntarily agree to participate in this study and sign informed consent Exclusion Criteria: -Participants with contraindications to venetoclax as listed on the approved local label

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Venetoclax Participants<br>Participants receiving venetoclax for chronic lymphocytic leukemia according to the approved local label, and the decision to prescribe Venetoclax is independent from the enrollment into the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section. | Up to Approximately 7 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response | Overall Response will be assessed by the physician in charge of the study in accordance with the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. | Up to Approximately 7 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Chronic Lymphocytic Leukemia (CLL), Venetoclax