linjc16/ctgov huggingface dataset:
An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is an extension study of ABT-806 for subjects with advanced solid tumors.

Official Title
-----------------
An Extension Study of ABT-806 for Subjects With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: ABT-806


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed a prior study utilizing ABT-806 or 111ln ABT-806 (ABT 806i) and the Investigator believes that continued treatment with ABT-806 is in the best interest of the subject. Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Subject is capable of understanding and complying with parameters as outlined in the protocol and the subject or the subject's legal acceptable representative is able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any or study-specific procedures. Exclusion Criteria: Subject discontinued ABT-806 or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other). Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities. Subject is a lactating or pregnant female.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: ABT-806 Arm<br> | Drug: ABT-806<br>* ABT-806 will be administered by intravenous infusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Number of subjects with adverse events) | Evaluation of vitals signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (at final visit) | At each treatment visit (every other week throughout the study or up to 51 weeks) | 
| Pharmacokinetic profile (assay for ABT-806) | Assay for ABT-806 | Every 8 weeks starting at Week 9 throughout the study or up to 51 weeks |
Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy

Official Title
-----------------
A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: MT-3995-Low
* Drug: MT-3995-High
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB) Glycosylated haemoglobin (HbA1c) ≤10.5% Subject with albuminuria Exclusion Criteria: History of Type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. Serum potassium level <3.5 or >5.0 mmol/L Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation Subjects with clinically significant hypotension

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-3995-Low<br>MT-3995-Low Dose | Drug: MT-3995-Low<br> <br> |
| Experimental: MT-3995-High<br>MT-3995-High Dose | Drug: MT-3995-High<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and nature of treatment-emergent adverse events and serious adverse events. |  | 20 weeks | 
| Plasma concentrations of MT-3995 and its major metabolite |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure |  | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Nephropathy
Establishment of the National Epidermolysis Bullosa Registry

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (EB). II. Generate a large data bank of clinical, historical, and genetic information concerning these patients. III. Accumulate donated tissue specimens, including selected cells and DNA, from selected patient subsets for the establishment of permanent tissue cell banks. IV. Promote and facilitate research in EB.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers. Clinical, epidemiological, and laboratory data are collected. Medical and family histories are obtained in a detailed interview in person, by phone, or by mail. Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated. A pedigree chart is completed on the first affected family member entered. Selected patients are followed at least biannually. A study duration of approximately 10 years is anticipated.

Conditions
-----------------
Epidermolysis Bullosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Clinical diagnosis of epidermolysis bullosa

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
Causes and Underlying Factors of Faltering Growth Among Infants

Study Overview
=================
Brief Summary
-----------------
to research in the different causes of failure to thrive in children including organic and non organic causes

Detailed Description
-----------------
Altered growth velocity in infants has been traditionally described by the term (failure to thrive ) . More recently the preferred terms are faltering growth ,slow weight gain or undernourishment as failure to thrive has been associated with negative connotations of parents failing in their job as careproviders. The expression 'to falter' means to hesitate. Faltering growth is an observation,without value judgement, of slower than expected rate of growth along an infant's previously defined growth curve. Faltering growth is a common pediatric problem with many untoward effects . More studies showed that children who failed to thrive in infancy are lighter and shorter at school age with adverse intellectual outcomes (corbett and drewett,2004)(Natale etal., 2014). Weight faltering in the first months of life is particularly associated with these adverse effects. Infants with faltering growth also have a higher prevalence of feeding problems (Young etal., 2013).Growth failure is more common during infancy than during any other stage of life because programmed growth rates and nutritional needs are high (

Official Title
-----------------
Causes and Underlying Factors of Faltering Growth Among Infants

Conditions
-----------------
Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital )

Intervention / Treatment
-----------------
* Diagnostic Test: complete blood count , electrolytes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: :Infants attending assiut university children hospital who are stunting(decrease height for age ), wasting(decrease weight for lenght ), and underweight (decreases weight for age ) . When all of theses less than -1 Z scores (normal Z-score from -1 to +1 ) . Also mid arm circumference below than 115 mm Exclusion criteria: Children complaining of any of the follolowing: Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: complete blood count , electrolytes|it is a labarotory test to assess hemoglobin white blood count plate let|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to recognize nutritional causes of faltering growth | o recognize nutritional causes of faltering growth by measuring weight ,height ,mid arm circumference ,skin fold thickness | from october 2017 to september 2018 |
Effect Of GW501516X On How The Heart Obtains And Uses Energy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a 4-week treatment period with GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. The data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.

Official Title
-----------------
A Two Part Study to Separately Evaluate the Effect of 4-week Treatment With GW501516X Relative to Placebo on Cardiac Energetics in a Randomized, Single-blind, Repeat Dose, Parallel Group Design in Healthy Male Subjects

Conditions
-----------------
Dyslipidaemias, Heart Failure

Intervention / Treatment
-----------------
* Drug: GW510516X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Non-smoking. Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches). Exclusion criteria: History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease). Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW510516X|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy-related chemicals and heart contraction, determined by MRI measurement of the heart. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peroxisome proliferator activated receptors,, PPARs,, Heart Failure,, cardiac energetics,, MRI,, GW501516X, fatty acid metabolism,
The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy

Study Overview
=================
Brief Summary
-----------------
Our study was planned as a prospective, single-center study between 20 January 2022 and 20 April 2022. All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study. All patients and parents whose family did not give consent to participate in the study will be excluded from the study. All patients will be seen by an anesthesiologist before the procedure and it will be stated that there is no harm in taking anesthesia. Anesthesia consent form will be given by the family. Study participation consent will be obtained from parents before starting the procedure. The patient's age, gender, height, weight, ASA score, the procedure to be performed, the parent's educational status, occupation and income level will be recorded. Children's anxiety will be evaluated with the Modified Yale Preoperative Anxiety Scale (mYPAS) in the presence of their parents 15-30 minutes before the procedure. The agitation that occurs when the patient leaves the families for processing, with the Parental Separation Anxiety Scale; Parental anxiety will be evaluated with the Stationary and Trait Anxiety Scale filled by families after the child is processed.

Official Title
-----------------
The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy

Conditions
-----------------
Anxiety, Anesthesia

Intervention / Treatment
-----------------
* Diagnostic Test: stationary and trait anxiety scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study. Exclusion Criteria: All patients and parents whose family did not give consent to participate in the study will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 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 |
| --- | --- |
| High Parent Anxiety<br>Stationary and Trait Anxiety Scale ≥ 44 points | Diagnostic Test: stationary and trait anxiety scale<br>* survey<br>|
| Low Parent Anxiety<br>Stationary and Trait Anxiety Scale < 44 points | Diagnostic Test: stationary and trait anxiety scale<br>* survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia agent dose |  | end of the gastrointestinal endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's anxiety |  | before gastrointestinal endoscopy |
Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.

Detailed Description
-----------------
Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation, which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that activates the acute phase CRP response. Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.

Official Title
-----------------
Effect of Statin Therapy on C-reactive Protein Levels in Patients With COPD

Conditions
-----------------
COPD, Inflammation

Intervention / Treatment
-----------------
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically optimized COPD patients Age 40-79 years. serum CRP levels >3mg/l Exclusion Criteria: Current smoker COPD exacerbation in the last 2 months. Active hepatic or severe renal dysfunction. connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (>10,000 white blood cells) or thrombocytosis (>450,000 platelets). Recent h/o myocardial infarction, angina in the last 6 months. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo drug | Drug: simvastatin<br>* 40 mg po daily<br>|
| Active Comparator: 2<br>simvastatin | Drug: simvastatin<br>* 40 mg po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum CRP levels |  | 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Inflammation, CRP levels, simvastatin
Partial Wave Spectroscopic Detection of Colon Cancer Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC).

Detailed Description
-----------------
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS)in patients who will undergo a colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). PWS has been recently developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. We believe that the PWS test will more accurately detect the risk of colon cancer.

Official Title
-----------------
Partial Wave Spectroscopic Detection of Colon Cancer Risk

Conditions
-----------------
Ulcerative Colitis, Colon Cancer

Intervention / Treatment
-----------------
* Procedure: PWS Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be 18 years old or older. Patient is already scheduled for a standard of care colonoscopy or flexible sigmoidoscopy. Patient has not received chemotherapy. History of ulcerative colitis. Exclusion Criteria: Patient is unable to give informed consent.. Patient has received chemo or radiation therapy within the past 3 months.

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 |
| --- | --- |
| Main Study Group<br>All subjects who are undergoing a standard of care colonoscopy for flexible sigmoidoscopy and have a history of UC and agree to participate will be in the main study group. | Procedure: PWS Testing<br>* Partial wave spectroscopy (PWS)has been developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study samples of rectal mucosa (the moist lining of the rectum) using PWS. | Samples will be collected and then shipped to Northwestern University for analysis using PWS. This is to assess accuracy of detecting the risk for colon cancer. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Flexible Sigmoidoscopy