linjc16/ctgov huggingface dataset:
Observational Study on Endometrial Stromal Tumors

Study Overview
=================
Brief Summary
-----------------
Observational, retrospective and prospective study on Endometrial Stromal Tumor (EST)

Detailed Description
-----------------
Observational, retrospective and prospective study on EST aimed to understand more about its biology, natural history and antitumor activity of different treatment options. This study will collect data in prospective and retrospective way of patients affected by EST and treated according disease guidelines and local practices. The study will also review the diagnosis by a central expert pathologist in order to its confirmation

Official Title
-----------------
Endometrial Stromal Tumors: an Observational Study

Conditions
-----------------
Endometrial Stromal Tumors

Intervention / Treatment
-----------------
* Other: Treatment for EST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a diagnosis of Endometrial Stromal Tumor (EST) according to the World Health Organization (WHO) classification 2003 or 2014 Informed consent signature Exclusion Criteria: patients with different diagnosis from EST

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Retrospective Observational Group<br>Patients who received treatment for EST Patients with EST diagnosis prior August 2016 | Other: Treatment for EST<br>* Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study)<br>|
| Prospective Observational Group<br>Patients who will receive treatment for EST Patients with EST diagnosis after August 2016 | Other: Treatment for EST<br>* Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease natural history | Collection of data on the natural history of endometrial stromal tumors | Through survival, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease diagnosis and classification | Highlight some main issues in pathologic diagnosis of these tumors and their classification | At the time of diagnosis, an average of 1 month | 
| Chemotherapy received treatment | Number and type of chemotherapy agents received for EST treatment | Through treatment completion, an average of 24 month |
The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and advance stage head and neck cancer (stage III, IV)

Official Title
-----------------
A Double-blind, Placebo-controlled Randomized Trial Phase II Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer

Conditions
-----------------
Cancer Cachexia, Head and Neck Cancer, Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Dietary Supplement: Curcumin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck cancer stage III-IV Cancer anorexia cachexia syndrome by 2011 Cancer cachexia an International Consensus Enteral feeding with Nasogastric Tube or Gastrostomy ECOG 0-2 Normal Bone marrow, kidneys, and liver function Normal function of enteral digestion and absorption Exclusion Criteria: Pregnancy History of allergy to Curcumin or herbal medicine History of Herbal medicine used History of Billiary of obstruction History of Antiplatelete or anticoagulant.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>Curcumin 4000mg/day x 60 days | Dietary Supplement: Curcumin<br>* We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.<br>|
| Placebo Comparator: Placebo<br>Placebo x 60 days | Other: Placebo<br>* We give a control arm to consume placebo for 60 consecutive days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | We measure muscle mass by Bioelectrical Impedance Analysis (BIA) | 60 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | We measure BMI by Bioelectrical Impedance Analysis (BIA) | 60 days after intervention | 
| Hand grips muscle strength | We measure hand grips power by Hand grip test | 60 days after intervention | 
| serum NF-kB level | We measure serum NF-kB by ELISA | 60 days after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer cachexia, Head and neck cancer, Curcumin, Tumuric, Cancer anorexia cachexia
Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.

Official Title
-----------------
An International, Multicentre, Open Label Study To Assess The Effectiveness Of Amlodipine/Atorvastatin Combination In Subjects With Hypertension And Dyslipidaemia. (The JEWEL II Study)

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Amlodipine/atorvastatin single pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated or untreated subjects with concurrent hypertension and dyslipidemia with BP and LDL-C not at target according to governing guidelines Exclusion Criteria: High liver enzymes

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine/atorvastatin single pill|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing percentage of subjects who reach target BP and LDL-C targets as defined by their governing guidelines. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses changes since baseline of lab parameters, BP, safety of titration of amlodipine.atorvastatin to reach targets, to validate Expectations and Satisfaction with Treatment questionnaires. |  |  |
Does Notch Regulate Glioma Proliferation ?

Study Overview
=================
Brief Summary
-----------------
The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1

Detailed Description
-----------------
Main objectives: To examine the expression of TAL1 and SNAI2 in protein extracts and glioma sections of different grades (glioblastomas and diffuse low-grade tumors). To examine the effect of overexpression of Tal1 and Snai2 in high grade glioma cultures. To show the expression of Tal1 and SNAI2 by tumor cells by FISH technique. Show that TAL1 and SNAI2 could be regulated by endothelial cells

Official Title
-----------------
Study of the Activity and Role of Notch1 Signalling in Glioma

Conditions
-----------------
Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient ≥18 years old Patient affected with brain glioma classified according to WHO 2016 classification Exclusion Criteria: Patient who reject the study protocol Radiotheray or chemotherapy treatment

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 |
| --- | --- | --- |
| Effect of Notch1 activation on Tal1 | highthroughput gene analysis (DNA arrays) with cells transduced with activated form of Notch1 | 1 day | 
| Snai2 gene and protein expression | western blot for Tal1 and Snai2 in protein extracted from low grade and high gliomas | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pathologist-graded gliomas
Improving Osteoporosis Care in a Home Health Setting

Study Overview
=================
Brief Summary
-----------------
Study aims to improve osteoporosis care through patient tailored education materials in a group-randomized trial of patients referred to home health care with a history of fracture and/or an osteoporosis diagnosis. Project investigators will conduct telephone surveys and examine electronic medical record data to assess fracture related morbidity and mortality, osteoporosis treatment and adherence, and use of calcium and vitamin D supplements. We hypothesize that patients that receive the intervention materials will be more likely to initiate or maintain osteoporosis treatment.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Other: patient magazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prior fracture osteoporosis diagnosis received home health care Exclusion Criteria: hospice active cancer treatment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Tailored Magazine<br>Patient responses from computer assisted telephone interviews will be used to develop a patient tailored educational magazine. | Other: patient magazine<br>* patient magazine individually tailored to patient's prior feedback<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation/Maintenance of Anti-osteoporosis prescription medication |  | Three months post initial survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation/Maintenance of calcium and vitamin D |  | Three months post initial survey |
Study of the Incidence of SARS-CoV-2 Infection (COVID-19)

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study. The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality. The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

Official Title
-----------------
Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement

Conditions
-----------------
Coronavirus Infections

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme, Exclusion Criteria: Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: volonteers<br> | Other: blood sampling<br>* blood sampling at J0, M6, M12, M24, M36, M48, M60<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive serologies | number of positive serologies | 12 months |
A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy

Study Overview
=================
Brief Summary
-----------------
To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

Detailed Description
-----------------
To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into. Establishment of risk assessment model for Grade B fistula.

Official Title
-----------------
A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy

Conditions
-----------------
Postoperative Pancreatic Fistula

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery. Surgery performed by the same surgical team. Exclusion Criteria: PD or LPD combined with another organ resection. PD or LPD performed due to trauma. PD or LPD for emergency treatment, such as the rupture and bleeding of tumor. Palliative resection. Patients with severe organ dysfunction before surgery. Patients treated with preoperative neoadjuvant chemotherapy or other treatments (Radiotherapy, targeted immunotherapy, etc.). Patients with missing data for clinical or radiographic variables.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic fistula group<br>no intervention(s) | Other: No intervention<br>* No intervention<br>|
| non-pancreatic fistula group<br>no intervention(s) | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications for each patient | up to postoperative 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pancreatic fistula
Evaluation of Benztropine for Cocaine Craving - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of benztropine (or DA reuptake inhibitor) with atropine and placebo in affecting stimulated craving to cocaine cues.

Official Title
-----------------
Evaluation of Efficacy of Benztropine for Cocaine Craving

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Benztropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 48 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulated and non-stimulated craving |  |  |
Cognoa ASD Diagnosis Aid Validation Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

Detailed Description
-----------------
To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

Official Title
-----------------
Cognoa ASD Diagnosis Aid Validation Study

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Cognoa ASD diagnostic device


Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: Caregiver must be able to read, understand and sign the Informed Consent Form (ICF). Caregiver or HCP concern for developmental delay. Female or Male, >18 to <72 months of age General Exclusion Criteria: Subjects with a prior diagnosis of ASD rendered by a healthcare professional. Subjects whose age on the date of enrollment is outside the target age range. Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 72 Months

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will undergo both investigational and comparator diagnosis for ASD.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognoa Assessment<br>Cognoa diagnostic ASD device. | Diagnostic Test: Cognoa ASD diagnostic device<br>* Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation | Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population: | 6 Weeks | 
| No Result Percentage | Measurement of the percentage of children for whom the device has provided no result. | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Sensitivity and Specificity | Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population. | 6 Weeks |