linjc16/ctgov huggingface dataset:
Neurovascular Product Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
Post market surveillance registry

Detailed Description
-----------------
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke. This study is conducted under the Product Surveillance Registry (NCT01524276).

Official Title
-----------------
NeuroVascular Product Surveillance Registry (PSR) Platform

Conditions
-----------------
Intracranial Aneurysm, Stroke, Ischemic

Intervention / Treatment
-----------------
* Device: Treatment for intracranial aneurysms
* Device: Treatment for Acute Ischemic Stroke


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements Patient has, or is intended to receive or be treated with, an eligible Medtronic product Patient is consented within the enrollment window of the therapy received, as applicable Patient is at least 18 years of age at time of enrollment. Exclusion Criteria: Patient who is, or is expected to be inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.

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: Treatment for intracranial aneurysms|Embolization of aneurysms|
|Device: Treatment for Acute Ischemic Stroke|Revascularization of an intracranial blood vessel|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). | For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). | 1 year | 
| Functional Independence: mRS score ≤ 2 | For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2 | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolization Device, Flow Diverter, Intra saccular device, Vascular Reconstruction Device, Ruptured Intracranial Aneurysm, Unruptured Intracranial Aneurysm, Large Vessel Occlusion, Stent Retriever, Aspiration Catheter, Revascularization Device
Immuno-humoral Rejection Markers in Pulmonary Transplant

Study Overview
=================
Brief Summary
-----------------
Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.

Official Title
-----------------
Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.

Conditions
-----------------
Lung Transplant

Intervention / Treatment
-----------------
* Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders, more than 18 years of age. Patients with or without Cystic fibrosis Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant Patients with no current other disease can affect, in short term, the process or prognosis of the transplant Patients had given his agreement to be enrolled in the study Exclusion Criteria: Patient less than 18 year-old Patient had previous organ transplant Pregnant and/or lactating women Female subject in reproductive age does not use effective contraceptive methode Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary transplant<br> | Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers. |  | 12 months after pulmonary transplant |
Study on Management Thrombosis in Greek Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Study on Management Thrombosis in Greek cancer patients

Detailed Description
-----------------
The approach that Medical Oncologists encounter the prospect of a coagulation event occurrence in cancer patients.

Official Title
-----------------
Study on Management Thrombosis in Greek Cancer Patients (GMaT - Greek Management Thrombosis)

Conditions
-----------------
Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All patients diagnosed with histologically confirmed solid tumors that are under anticoagulation therapy, during the study timeline. Age ≥ 18 years Signed informed consent Exclusion Criteria Initiation of anticoagulation therapy before the initiation of the study in 2016 Age <18 years No signed informed 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical practice for patients under anticoagulation regime | Documentation of the clinical practice for patients under anticoagulation regime, for prophylaxis or treatment, in patients with solid tumors, for one year following the protocol initiation date, including high-risk patients as defined in the protocol. | 1 YEAR |
Study Evaluating IMA-638 in Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of, and blood drug levels for, single, ascending doses of IMA-638 in mild to moderate asthma subjects.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled, Sequential-Group, Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-638 Administered Subcutaneously and Intravenously to Subjects With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: IMA-638


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of non-childbearing potential with mild to moderate asthma as defined by forced expiratory volume in 1 second (FEV1) greater than 70% predicted. Well controlled asthma, as exhibited by completion of asthma questionnaire. Otherwise healthy, except for asthma.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IMA-638|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels in the blood and associated biomarkers will be evaluated. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Insulin Resistance and Hypertensive Disorders in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.

Official Title
-----------------
The Role of Insulin Resistance in Gestational Hypertension and in Preeclampsia.

Conditions
-----------------
Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS, BMI>/=30 previous pregnancy affected by hypertension or gestational diabetes thrombophilia Type I or II diabetes mellitus autoimmune diseases twin pregnancy renal diseases previous pre-eclampsia in relatives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br> | |
| 2<br> | |

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
-----------------
Pre-eclampsia, Gestational diabetes, Insulin resistance, hypertension in pregnancy
Camel's Milk as a Safe Alternative in Cow's Milk Allergy

Study Overview
=================
Brief Summary
-----------------
By performing a challenge with camel's milk in patients who are allergic to cow's milk, the investigators will examine if camel's milk is a safe alternative for these patients.

Conditions
-----------------
Cow's Milk Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: Camel's milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proved cows milk allergy Exclusion Criteria: Pregnant women
Sexes Eligible for Study
-----------------
All

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: Camel's milk, Cow's milk allergy<br> | Dietary Supplement: Camel's milk<br>* Patients with proved cow's milk allergy who have negative prick skin tests to came's milk will be administered gradually increased doses of pasteurized camel's milk at 30 minute intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of allergic symptoms after graded oral challenge with camel's milk |  | 3 hours follow-up after completion of the challenge |
HOPE Social Media Intervention for HIV Testing and Studying Social Networks

Study Overview
=================
Brief Summary
-----------------
This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase HIV prevention within African-American and Latino men who have sex with men. The peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase HIV prevention behaviors. Social media and online communities, such as Facebook, may be a cost-effective platform for scaling these models. Primarily upper middle-class White populations used the Internet in its early years, however, Internet use within African-American and Latino households has recently increased dramatically, especially on social media. People using the Internet may be at the highest risk for contracting HIV and are using novel Internet approaches to find sex partners, such as through social media. This is the first study to examine the effectiveness of the HOPE social media intervention to increase HIV testing among at-risk groups in the United States.

Official Title
-----------------
HOPE Social Media Intervention for HIV Testing and Studying Social Networks

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: social media intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Male Sexually active with another man in the last 12 months Willing and capable of understanding and assenting to an online informed consent form Has (or willing to create) a social media page. Exclusion Criteria: Does not satisfy inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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: intervention<br>experimental | Behavioral: social media intervention<br>* social media intervention<br>|
| Other: control<br>Other | Behavioral: social media intervention<br>* social media intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants requesting HIV Self-Testing | At home/self HIV testing kits will be provided to all participants. | 5 years |
User Surveillance in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The aim of the non-interventional study is to document the daily doses in acute and remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are added and, when and how long steroids are given.

Official Title
-----------------
Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapeutic need according to SPC written informed consent Exclusion Criteria: contraindications according to SPC

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 |
| --- | --- |
| Patients with Ulcerative Colitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription habits measured by daily dose of Mesalazine |  | 0 - 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance measured by questionnaire for drug intake |  | 0 - 8 weeks | 
| Quality of Life measured by EuroQol Questionnaire |  | 0 - 8 weeks |
Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation

Study Overview
=================
Brief Summary
-----------------
Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis and implantation outcomes.

Detailed Description
-----------------
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth factor that have multi-ways to might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between two arm of the same culture media and the same culture condition. One arm with Cytokines and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Official Title
-----------------
The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients Exclusion Criteria: over 40 years

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cytokines supplemented In Vitro single culture media<br>We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy. | Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media<br> <br> |
| No Intervention: Traditional Single step culture media<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate ( % ) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate ( % ) |  | 6 months | 
| implantation rate |  | 6 months | 
| fertilization rate |  | 6 days of culture | 
| top-quality embryo rate |  | 6 days of culture | 
| rates for blastocyst formation and quality |  | 6 days of culture | 
| embryo utilization rate |  | 6 days of culture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In Vitro culture of human embryos
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable NSCLC

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the efficacy and safety of Pembrolizumab Combined With Double Platinum-Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

Detailed Description
-----------------
Inclusion criteria: diagnosed with Non-small cell lung cancer EGFR and ALK and ROS1 negative Treatment naive Potentially Resectable identified by MDT

Official Title
-----------------
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology Potentially Resectable NSCLC Treatment Plan is Crizotinb or Standard Chemotherapy Exclusion Criteria: Patients with contraindication of chemotherapy Pregnant or breast feeding women

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 |
| --- | --- | --- |
| PFS | Progression free survival | may 2020- may 2021 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | may 2020- may 2021 (1 year) | 
| ORR | To measure the patients's overall response rate | may 2020- may 2021 (1 year) |
Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.

Official Title
-----------------
Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Heart scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18, <90 Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy. QRS duration >120ms on 12 lead ECG LVEF < 35% LVEDD >55 mm Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months. Exclusion Criteria: Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment Patients who had had an atrial arrhythmia within one month prior to recruitment Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg Patients with a heart rate of more than 140 beats per minute Patients with severe renal failure (eGFR < 30) Patients with a history of allergy to iodine based contrast agents Predicted life expectancy < 1 year Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: Scan<br>Heart scan prior to device insertion | Other: Heart scan<br> <br> |
| No Intervention: No scan<br>No heart scan prior to device insertion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test |  | 6 months |