linjc16/ctgov huggingface dataset:
A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.

Conditions
-----------------
Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 12 to 30 years of age, with diagnosis of Down Syndrome Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder can participate in the study provided they are on stable medication for at least 8 weeks prior to screening and likely to cooperate and take part successfully in the study assessments Exclusion Criteria: Subjects with DSM-IV axis I and II psychiatric disorders, except those authorized in the inclusion criteria Subjects who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment Subjects with evidence of dementia or meeting clinical diagnosis for dementia Subjects with thyroid dysfunction or diabetes that is not adequately controlled and stabilized on treatment for at least 8 weeks prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive batteries/tests/scales: Suitability for individuals with Down syndrome assessed by number of tests completed/subjects completing, ceiling/floor effect, variance estimate of baseline/change from baseline |  | approximately 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test/re-test reliability: Changes in test results over 4 weeks |  | approximately 1.5 years | 
| Changes in test results over 6 month interval |  | approximately 1.5 years | 
| Correlations between test results on functioning, adaptive behavior and cognition and IQ level |  | approximately 1.5 years |
Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.

Detailed Description
-----------------
The investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic surveillance first started with NBI for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to Lugol chromoendoscopy with histology serving as a gold standard.

Official Title
-----------------
Endoscopic Surveillance Comparing Narrow Band Imaging (NBI) Against Lugol Chromoendoscopy for Detection of Synchronous Superficial Squamous Esophageal Neoplasia Among High Risk Patients

Conditions
-----------------
Superficial Esophageal Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Head and Neck Cancer Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years Patients with esophageal cancer treated by endoscopic resection Age 18 to 80 Exclusion Criteria: Allergy to Lugol iodine Pregnancy Previous esophagectomy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NBI Magnify Endoscopy<br>Detection of esphageal neoplasia through recognition of brownish discolored area via NBI and characterize the lesion using IPCL upon magnifying endoscopy | |
| Lugol Chromoendoscopy<br>Detection of esophageal neoplasia through recognition of discolored area | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of superficial esophageal neoplasia |  | 1 month |
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma

Study Overview
=================
Brief Summary
-----------------
Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: Endothelin Receptor B inhibitor BQ788
* Drug: PBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Informed consent Histologically confirmed melanoma Disease stage III or IV At least 2 injectable and surgically removable cutaneous metastasis Age > 18 years Clinically stable medical condition Exclusion Criteria: Primary ocular melanoma Symptomatic intracranial melanoma History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease Pregnancy or lactation

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endothelin receptor B inhibitor BQ-788<br>Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) | Drug: Endothelin Receptor B inhibitor BQ788<br> <br> |
| Experimental: PBS<br>Intra-lesion administration of vehicle | Drug: PBS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response by size measurement and histological examination |  | 3 to14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring changes in tumor cell proliferation by histological analyses using Ab staining |  | 3 to 14 days | 
| Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining |  | 3 to 14 days | 
| Evaluation of changes in blood vessels formation by histological examination using Ab staining |  | 3 to 14 days | 
| Evaluation of changes in immune cell infiltration by histological examination using Ab staining |  | 3 to 14 days |
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Our objective is to assess whether pre-treatment with a fixed dose of insulin, based on weight, given to pregnant patients with gestational or preexisting diabetes receiving betamethasone can provide adequate glycemic control. Our hypothesis is that pre-treatment with a weight-based calculated insulin dose will help maintain euglycemia for pregnant patients with gestational and preexisting diabetes after steroid administration, and possibly impact length of hospital admission.

Official Title
-----------------
Insulin Pre-treatment for Steroid-associated Hyperglycemia in Pregnant Diabetic Patients

Conditions
-----------------
Hyperglycemia in Pregnant Diabetic Patients

Intervention / Treatment
-----------------
* Drug: insulin pre-treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with gestational or pre-existing diabetes admitted to the University of Minnesota Must be 18 years or older Must speak English, Spanish, or Somali Patients must receive steroids for fetal lung maturity as part of their hospital course Exclusion Criteria: Pregnant women with Type 1 Diabetes, or Type 2 diabetes with evidence of end-organ disease Pregnant women who need to be emergently delivered due to maternal or fetal complications of pregnancy

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

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

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: insulin pre-treatment<br>insulin pre-treatment of pregnant diabetic patients who receive betamethasone | Drug: insulin pre-treatment<br>* insulin pre-treatment of pregnant diabetic patients who receive betamethasone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital days until euglycemia in pregnant diabetic patients receiving steroids who are pre-treated with insulin. | Pregnant diabetic patients admitted to the hospital who receive steroids for fetal lung maturity will have their blood glucose levels checked before and after receiving steroids. Blood glucose levels will be checked fasting and postprandial until the levels are consistently less than 160. This will vary for patients, but will be on average 2 to 14 days. | number of hospital days |
To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

Official Title
-----------------
An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke

Conditions
-----------------
Muscle Spasticity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper limb spasticity following stroke At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion Decision already been agreed to inject BoNT-A Agreement with the subject on goal setting Exclusion Criteria: Contraindications to any BoNT-A preparations

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 |
| --- | --- | --- |
| Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices |  | Around 3 to 5 months post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall attainment of the treatment goals using the GAS T score |  | Around 3 to 5 months post injection | 
| Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) |  | Around 3 to 5 months post injection | 
| Global assessment of benefits by both the investigator and the subject (or guardian) |  | Around 3 to 5 months post injection |
PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma

Study Overview
=================
Brief Summary
-----------------
PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma

Official Title
-----------------
PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma

Conditions
-----------------
Pancreas Adenocarcinoma, Pancreas Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection) Age =>18 years written informed consent Exclusion Criteria: papillary cancer neuroendocrine pancreatic tumors

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 |
| --- | --- | --- |
| General assessment of applied therapy modalities in pancreatic cancer |  | First diagnose to death or end of surveillance (5 years after curative resection) | 
| Quality of life in pancreatic cancer patients | EORTC QLQ c30 and PAN 26 | First diagnose to death or end of surveillance (5 years after curative resection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General epidemiologic assessment | Epidemiologic questionaire | First diagnose to death or end of surveillance (5 years after curative resection) | 
| Assessment of tumor surveillance in pancreatic cancer patients |  | First diagnose to death or end of surveillance (5 years after curative resection) | 
| Evaluation of predictive and prognostic markers |  | First diagnose to death or end of surveillance (5 years after curative resection) |
Smoking and Body Weight: Analysis of HHANES

Study Overview
=================
Brief Summary
-----------------
To evaluate the relationships between smoking rate, gender, and body weight in the Hispanic Health and Nutrition Examination I Survey (HHANES) I. Also, to evaluate the independent and additive contribution of smoking rate and fasting glucose on body weight in HHANES I and NHANES II.

Detailed Description
-----------------
BACKGROUND: The study was supported by the Small Grants Program established by the National Heart, Lung, and Blood Institute in January 1990 to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education research studies. DESIGN NARRATIVE: The first study used HHANES I data and analysis of variance to determine the possible body composition differences between subgroups of gender and smoking categories. Caloric differences in dietary intake were analyzed in a second ANOVA design. The second study used data from HHANES I and NHANES II to evaluate the independent and additive or synergistic contribution of smoking rate and fasting glucose on body weight.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases

Study Overview
=================
Brief Summary
-----------------
ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median survival of about 7-8 months in patients with extended disease (ED). In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen in SCLC. Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16 females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2, Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks. Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).

Official Title
-----------------
PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: ifosfamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically proven SCLC measurable disease defined by RECIST criteria Exclusion 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ifosfamide|PEI regimen may be a possible therapeutic option, with high activity and an acceptable toxicity profile.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial response (PR) |  | 1 year | 
| complete response (CR) |  | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time to progression (TTP) |  | 1 YEAR | 
| overall survival (OS) |  | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small cell lung cancer, extended disease, limited disease, chemotherapy, cisplatin, etoposide, ifosfamide
Pediatric Atopic Dermatitis (AD) Internet Survey

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.

Official Title
-----------------
Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Behavioral: Weekly Internet survey
* Drug: Topical Triamcinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian. Exclusion Criteria: Child is less than 2 or greater than 8 years of age. Known allergy or sensitivity to topical triamcinolone in the child. Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access. Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Internet survey w medication<br>Weekly survey via email plus topical triamcinolone | Behavioral: Weekly Internet survey<br>* Parents will complete a weekly online survey about medication use.<br>Drug: Topical Triamcinolone<br>* Topical triamcinolone to all affected areas once daily<br>|
| Active Comparator: Topical triamcinolone only<br>Standard of care | Drug: Topical Triamcinolone<br>* Topical triamcinolone to all affected areas once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to topical triamcinolone |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area Severity Index |  | 12 weeks | 
| Investigator's Global Assessment |  | 12 weeks |