linjc16/ctgov huggingface dataset:
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.

Detailed Description
-----------------
Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 30 study subjects for a period of one year with serial testing of cognition and function.

Official Title
-----------------
Etanercept for Alzheimer's-Type Memory Loss Pilot Study II

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: etanercept given by perispinal administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NINCDS-ADRDA Criteria for Alzheimer's disease CT or MRI consistent with AD Exclusion Criteria: active infection CHF demyelinating disease uncontrolled diabetes mellitus vascular dementia clinically significant neurologic disease other than AD Hachinski >4 history of lymphoma TBC wbc<2500 platelets<100,000 HCT<30 pregnancy premenopausal, fertile not on acceptable birth control change in neuroactive medication within 4 weeks of study initiation

Ages Eligible for Study
-----------------
Minimum Age: 0 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: etanercept given by perispinal administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Cog |  |  | 
| SIB |  |  | 
| MMSE |  |  | 
| ADCS-ADLsev |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Category fluency |  |  |
Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.

Study Overview
=================
Brief Summary
-----------------
Psoriasis is an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. There is a study showed that PEDF level is up-regulated in the sera of psoriasis patients.

Official Title
-----------------
Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: serum samples and punch skin biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with psoriasis and group of age and sex-matched healthy volunteers will be included as a control group. Exclusion Criteria: Pregnancy. Patients with other inflammatory skin disorders. Patients on antioxidants or anti-inflammatory drugs. Patients on topical or systemic treatment for psoriasis in the last 4 weeks prior to enrollment in the study. Patients on systemic retinoids (Acitretin). Obesity: body mass index (BMI ) > 30. Malignancies e.g squamous cell carcinoma. Viral warts. Diabetes. Hypertension.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: patients with psoriasis<br> | Other: serum samples and punch skin biopsies<br>* we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.<br>|
| Placebo Comparator: Group 2: age-, sex-, BMI-, and weight-matched control subjects.<br> | Other: serum samples and punch skin biopsies<br>* we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in serum and tissue levels of (PEDF) in patients with psoriasis | evaluate serum and tissue level of (PEDF) in patients with psoriasis. | 12 months |
Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.

Detailed Description
-----------------
A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Official Title
-----------------
A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis of breast cancer according to ICD-10 with confirmed metastasis Confirmed diagnosis between 1st July 2010 and 30th June 2011. Female patient managed for her disease at the same setting where final diagnosis of MBC was performed. Exclusion Criteria: History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer).

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female patients diagnosed with metastatic breast cancer<br>Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of progression events on a per patient-year-basis |  | Up to 2 years 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed |  | Up to 2 years 5 months | 
| Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events |  | Up to 2 years 5 months | 
| Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first |  | Up to 2 years 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Cancer,, retrospective study,, disease progression,, clinical management
Identification of Large-Scale Mutations of POLG Gene by QMPSF in Patients With Mitochondrial DNA Instability.

Study Overview
=================
Brief Summary
-----------------
Mitochondrial diseases are a heterogeneous group caused by genetic defects in mitochondrial DNA or in nuclear genes. POLG is the most frequently involved gene in mtDNA instability diseases resulting in mtDNA multiple deletion and/or depletion. It encodes the DNA polymerase gamma (POLγ), the only known DNA polymerase found in mammalian mitochondria. Mutations in POLG could explain 45% of familial progressive external ophtalmoplegia associated with multiple mtDNA deletions. However, in more than 70%, the analysis of the genes involved in mtDNA instability remains unsuccessful. To date, these genes are screened by sequencing methods that are not able to detect large-scale rearrangements. In order to detect possible large-scale rearrangements, the investigators propose to develop a new assay based on QMPSF (Quantitative Multiplex PCR of Short fluorescent Fragments) able to detect exon deletions and duplications. the investigators propose to screen the POLG gene by QMPSF in at least twenty patients with either no mutation or only one mutation detected in POLG and no mutation in other genes such as TWINKLE and ANT1. This study would allow the investigators to know if large-scale rearrangements occur in the POLG gene and to estimate their frequency in patients with mtDNA instability. These data are important to know if the sequencing analysis of POLG should be completed by the screening for partial deletions and duplications to ensure an accurate molecular diagnosis of these syndromes. Moreover, this method could be extended to ANT1 and TWINKLE genes.

Official Title
-----------------
Identification of Large-Scale Mutations of POLG Gene by QMPSF in Patients With Mitochondrial DNA Instability.

Conditions
-----------------
Mitochondrial Diseases, Diagnosis, DNA Mutations

Intervention / Treatment
-----------------
* Genetic: mitochondrial DNA mutations diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients already diagnosed for mitochondrial pathology without mtDNA mutations yet detected by current diagnostic techniques
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mitochondrial disease<br>Patients already diagnosed for mitochondrial pathology without mtDNA mutations yet detected by current diagnostic techniques | Genetic: mitochondrial DNA mutations diagnosis<br>* Identification of large-scale mutations of POLG gene by QMPSF in patients with mitochondrial DNA instability.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving the diagnosis of mitochondrial pathology |  | 1 day |
Effectiveness of an 8-week Posterior Shoulder Stretching Program on Varsity-level Overhead Athletes

Study Overview
=================
Brief Summary
-----------------
To Determine whether an eight-week posterior shoulder stretch was effective in increasing dominant arm internal rotation(IR) and horizontal adduction (HAd) range of motion (ROM) in a group of overhead athletes identified as having tightness of their posterior shoulder structures.

Official Title
-----------------
Effectiveness of an 8-week Posterior Shoulder Stretch Program on Varsity-level Overhead Athletes

Conditions
-----------------
Athlete's Shoulder

Intervention / Treatment
-----------------
* Other: Sleeper Stretch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: varsity level athletes involved in volleyball, tennis and swimming with internal rotation deficit of greater than or equal to 15 degrees Exclusion Criteria: previous surgical procedure or fracture of either shoulder or presently receiving treatment for condition affecting either shoulder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| Experimental: sleeper stretch<br> | Other: Sleeper Stretch<br>* Posterior shoulder stretch technique<br>|
| No Intervention: no intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder internal rotation and horizontal adduction range of motion |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in internal rotation and horizontal adduction range of motion |  | 0 - 4 weeks and 4 - 8 weeks |
Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis, Eczema, Chronic Pruritus

Intervention / Treatment
-----------------
* Drug: Tradipitant
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive); Diagnosed with atopic dermatitis Suffering from chronic pruritus with pruritus being actively present Exclusion Criteria: Chronic pruritus due to condition other than atopic dermatitis (AD) Participation in a previous tradipitant (LY686017 or VLY-686) trial; Anyone affiliated with the site or sponsor and/or anyone who may consent under duress; Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oral | Drug: Placebo<br> <br> |
| Experimental: Tradipitant<br>Oral | Drug: Tradipitant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS). |  | Starting at week 2. |
Insulin and Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.

Official Title
-----------------
Determination if Direct Inhibition of Insulin Release With Diazoxide Decreases Renal Clearance of D-Chiroinositol (DCI) and Increases Circulating DCI in Obese Women With Polycystic Ovary Syndrome (PCOS)

Conditions
-----------------
PCOS

Intervention / Treatment
-----------------
* Drug: diazoxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese women with PCOS and normal women aged 18-40, PCOS less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia Normal regular monthly periods, no clinical evidence of androgen excess, All Acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements Exclusion Criteria: DM, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.

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

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCOS subjects<br>PCOS subjects given diazoxide | Drug: diazoxide<br>* 100mg orally three times per day for 10 days<br>|
| Active Comparator: Normal subjects<br>Normal subjects given diazoxide | Drug: diazoxide<br>* 100mg orally three times per day for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Clearance of D-chiroinositol (DCI) at 12 Days | Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay | 12 days | 
| Level of Circulating D-chiro Inositol (DCI) | Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide | 12 days |
Effects of Portion Size and Energy Density of a Single Meal in Preschool Children

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of varying both energy density and portion size of all foods at lunch on preschool children's intake. The foods used in this study are commercially-available, commonly-consumed foods with typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of energy density and portion size on preschool children's intake at a meal composed of foods typically served to this population.

Conditions
-----------------
Feeding Behaviors

Intervention / Treatment
-----------------
* Other: Varying meal energy density and portion size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children must be enrolled in participating childcare centers. Exclusion Criteria: Allergy or intolerance to any of the foods or beverages served.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Energy Density, Small Portions<br>Low meal energy density and small portion sizes | Other: Varying meal energy density and portion size<br> <br> |
| Experimental: Low Energy Density, Medium Portions<br>Low meal energy density and medium portion sizes | Other: Varying meal energy density and portion size<br> <br> |
| Experimental: Low Energy Density, Large Portions<br>Low meal energy density and large portion sizes | Other: Varying meal energy density and portion size<br> <br> |
| Experimental: High Energy Density, Small Portions<br>High meal energy density and small portion sizes | Other: Varying meal energy density and portion size<br> <br> |
| Experimental: High Energy Density, Medium Portions<br>High meal energy density and medium portion sizes | Other: Varying meal energy density and portion size<br> <br> |
| Experimental: High Energy Density, Large Portions<br>High meal energy density and large portion sizes | Other: Varying meal energy density and portion size<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food and energy intake (Food weight (grams) and energy (kcal) |  | Once a week for four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meal energy density (Energy density (kcal/g) | Energy density (kcal/g) | Once a week for four weeks |
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)
* Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men or women, 12 to 65 years of age Willing to participate and sign provide written consent Moderate to severe acne Exclusion Criteria: Pregnant or lactating women History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin Use of systemic, topical or facial products which may interfere with the study Participation in any clinical study in the 30 days prior to study entry Prolonged exposure to sunlight or excessive exposure to UV lights Chronic use of NSAIDS

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Clindamycin 1%/Benzoyl Peroxide 5%<br> | Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)<br>* Applied to the entire face twice daily for 10 weeks<br>|
| Active Comparator: Reference Product<br> | Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)<br>* Applied to the entire face twice daily for 10 weeks<br>|
| Placebo Comparator: Vehicle<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Inflammatory Lesions |  | 10 weeks | 
| Percent Change From Baseline in Non-inflammatory Lesions |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10. | 10 weeks |