linjc16/ctgov huggingface dataset:
Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the response rate and overall survival in patients that have been diagnosed with mesothelioma and will undergo chemotherapy, surgery and intensity modified radiation therapy (IMRT) as part of their standard of care.

Detailed Description
-----------------
The investigators will consent patients that have been diagnosed with mesothelioma and will undergo chemotherapy followed by surgery and then IMRT as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.

Official Title
-----------------
Chemotherapy Followed by Surgery and Neoadjuvant Hemothoracic Intensity Modified Radiation Therapy (IMRT) for Patients With Malignant Pleural Mesothelioma

Conditions
-----------------
Mesothelioma, Solitary Fibrous Tumor of the Pleura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides informed consent Subject is >18 years of age Subject is deemed competent for making medical decisions Subject is scheduled to undergo chemotherapy followed by surgery and then IMRT Subject is a surgical candidate A negative pregnancy test is required in women of child-bearing potential, as standard of care. Exclusion Criteria: •Subject is <18 years old.

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 |
| --- | --- | --- |
| Survival status upon review of patients every 6 months |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival as evidenced by CT scan review |  | 2 years |
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

Study Overview
=================
Brief Summary
-----------------
Participants who were previously Viome costumers who signed informed consent to participate and self reported type 2 diabetes or pre-diabetes were enrolled. They provided stool samples to VIOME and were provided with precision diet and supplement recommendations. The information obtained from this study is used to train a model to predict diabetes and/or risks of developing diabetes.

Official Title
-----------------
Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes

Conditions
-----------------
Diabetes Type 2, Diabetes, Pre-diabetes

Intervention / Treatment
-----------------
* Behavioral: VIOME Precision Nutrition Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Viome customer GI test collected at home using Viome test kit US citizen 18+ years old Is not participating in any other Viome study Must have answered the following on-boarding question with the indicated answer: Do you or did you ever have diabetes or prediabetes? Signed and dated informed consent prior to any trial-specific procedures are performed Able to speak and read English Willing and able to follow the trial instructions Exclusion Criteria: Unable/unwilling to complete the informed consent form and the questionnaires

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: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Participants all received diet and supplement recommendations based on their microbiome results.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>All participants received the intervention in this trial. They received recommendations on their diets and supplements based on their results of microbiome expression. | Behavioral: VIOME Precision Nutrition Program<br>* Precision diet and supplement recommendations based on participants' microbiome results.<br>* Other names: VPNP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in VIOME's Type 2 diabetes risk score | Type 2 diabetes risk score is computed using Viome's molecular data from stool and HBA1C level self reported. The risk score is 1-100. 1 Indicates a low chance of developing T2D and 100 indicates a high chance of developing T2D. |  3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Type 2, Viome, Diabetes, Pre-diabetes, VPNP, Nutrition, Supplements, Precision
Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide.

Study Overview
=================
Brief Summary
-----------------
Patients with multiple myeloma have seen their survival rate strongly improved with the use of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE) up to 20%. In these conditions, a prevention of this risk can be proposed by physician with either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending the new recommendations on the management of VTED, the purpose of this study is to describe in real life conditions the management by oncologists of the thrombo embolic risk for such patients

Official Title
-----------------
Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple myeloma receiving a chemotherapy protocol including thalidomide or lenalidomide Exclusion Criteria: Patients involved in an interventional clinical trial

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 |
| --- | --- | --- |
| Disease history and VETD risk factors. Chemotherapy protocol for multiple myeloma. Therapeutic used for VETD prevention (LWMH, anticoagulants, antiplatelets or none) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PE and DVT rate at 4 months and one year. Bleedings and all relevant SAE and AE at 4 months and one year. |  | 12 months |
Skeletal Muscle Dysfunction in Heart Failure

Study Overview
=================
Brief Summary
-----------------
Patients suffering from congestive heart failure report reduced exercise capacity. This skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart. We hypothesize that congestive heart failure has systemic effects that causes the skeletal muscle dysfunction.

Official Title
-----------------
Training and Congestive Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Behavioral: One-knee extension ergometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary Heart Failure Ejection fraction <35% NYHA 2-3 Spirometry FEV1 > 80% Exclusion Criteria: Cardiomyopathy Transplantation candidate Active malignancy Restraining skeletal-muscular disease Claudication in legs Hospitalized last 30 days due to acute ischemic episode Intravenous inotrope or vasodilatating drugs last 14 days prior to inclusion AMI last 8 weeks prior to inclusion Organized training last 4 months Smoking on daily basis last 4 months Creatinin < 150microliters/liter

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 78 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: One-knee extension ergometer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.

Official Title
-----------------
A Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of AV411 to Assess Its Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in the Treatment of Neuropathic Pain

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: AV411


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration VAS score of 4 cm or higher at Screening No clinical abnormality in laboratory and urine analyses Electrocardiogram within normal limits at Screening Negative pregnancy test on Study Day 1 for female subjects of childbearing potential On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment Willing to use barrier contraceptive during the period of the study Exclusion Criteria: Known hypersensitivity to AV411 or its components Conditions which might affect drug absorption, metabolism or excretion Untreated mental illness, current drug addiction or abuse or alcoholism Donated blood in the past 90 days or have poor peripheral venous access Platelets <100,000mm3 or a history of thrombocytopenia Known or suspected chronic liver disease GFR <=90mL/min/1.73m2 (Cockcroft-Gault) Female subjects who are pregnant or nursing mothers Received an investigational drug in the past 90 days Unable to swallow large capsules

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: AV411|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Tolerability |  |  | 
| Pharmacokinetic profile |  |  | 
| Pharmacodynamic profile |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory |  |  | 
| Visual Analog Scale |  |  | 
| Clinical Global Impression of Change |  |  | 
| Use of analgesic or adjuvant medications for neuropathic pain |  |  | 
| Correlation between plasma concentrations of AV411 and pain intensity assessments |  |  |
The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred

Study Overview
=================
Brief Summary
-----------------
In a context the respect of the autonomy of the patients is important, it is necessary to pay a sustained attention to the experiences and the lived experience as well of the patients suffering or in remission of cancer as of their family. It is therefore, for the family, to deepen the synthesis carried out by the Societal Cancer Observatory which is a societal observatory of cancer

Official Title
-----------------
The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: biographical interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be over 18 years old with a diagnosis of CRC before 65 years. able to give their non-opposition and to nominate at least 2 family members who would be willing to participate in the study The spouse and / or children and / or parents will be eligible: if they are at least 18 years old, if they can be considered a caregiver or are first-degree relatives of the index patient for whom a diagnosis of CRC has been made. . Exclusion Criteria: Patients under 18 years of age or with a diagnosis of CRC after 65 years. Near a deceased patient or under 18 years old.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with a diagnosis of colorectal cancer before 65 years. | Other: biographical interviews<br>* A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual<br>|
| Family<br>The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years. | Other: biographical interviews<br>* A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients before 65 years old with colorectal cancer | semi-structured patients interview | 2 hours | 
| Assess how the patients, their relatives and their family members, face the disease. | semi-structured patients interview | 1 hour |
Multicenter Validation of a Predictor Model of ACHD Patients and Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This multicentre study is to validate prediction modeling for the ACHD population undergoing cardiac surgery. The validation of this prediction model will support and generalize its use as a risk stratification tool in the ACHD population.

Detailed Description
-----------------
The prediction model resulted from a preceding study, which uniquely based on comorbidities, was developed using 783 adults (>16 years) who underwent surgery for congenital heart disease at Toronto General Hospital (TGH) during 2004-2015. It identifies five pre-operative variables, namely presence of cognitive impairment, hepatic function, >3 chest incisions, anatomy diagnosis, and Body Mass Index <20 and >28, as significant predictors of composite adverse outcomes such as in-hospital mortality, prolonged ventilation (exceeding 7 days) and acute kidney injury. This newly prediction model developed in a single-center has only been internally validated. It requires further external validation to demonstrate its utility in ACHD populations who require cardiac surgery in other cardiac institutions both nationally and internationally.

Official Title
-----------------
Novel Model of Preoperative Predictors of Outcome for Adults Undergoing Congenital Cardiac Surgery: Multicenter Model Validation

Conditions
-----------------
Adult Congenital Heart Disease, Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all ACHD patients >16 years of age undergoing cardiac surgery requiring an open sternotomy or thoracotomy and cardiopulmonary bypass (CPB) or CPB standby at TGH and the collaborating institutions from April 2019. Exclusion Criteria: CHD patients <16 years of age ACHD patients undergoing chest wall debridement and chest re-explorations for bleeding Non-cardiac surgery procedures and cardiology laboratory interventions

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Composite adverse events | The composite adverse outcome is defined by in-hospital mortality, prolonged ventilation (exceeding seven days), or acute kidney injury requiring dialysis. | 30 days from the day of surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year mortality | One-year is defined as 365 days from the day of surgery. | 365 days from the day of surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prediction model
The German Plug - Registry

Study Overview
=================
Brief Summary
-----------------
In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk

Detailed Description
-----------------
In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk. For a number of years, the catheter-based closure of the defect has been increasingly used by means of the implantation of plug-devices as a new treatment method for patients with a high surgical risk. The existing data on the operation method and safety of the method already used at some centers are promising. In order to demonstrate the clinical routine of patients with an interventional occlusion of a PVL in a timely manner, the Stiftung IHF Ludwigshafen will publish a multicentric register entitled Deutsches Plug Register The goal is, among other things, the documentation of patient characteristics, indications, and complications of treated patients.The German Heart Foundation promotes the setting up of the plug register. In this time, 200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.

Official Title
-----------------
Interventional Therapy of Paravalvular Post-surgical or Post-interventional Valve Replacement Leaks With Plug Devices: The German Plug - Registry

Conditions
-----------------
Heart Valve Replacement

Intervention / Treatment
-----------------
* Other: paravalvular leak


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart valve replacement Valve Replacement Leaks Plug Device Exclusion Criteria: no written consent
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: paravalvular leak|Observational study on patients with paravalvular leak|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality risk | observation of the mortality risk | five years |
Neurocognitive Visual Reaction Training

Study Overview
=================
Brief Summary
-----------------
Incorporating neurocognitive visual reaction training has been shown to increase bating performance in collegiate baseball players. However, poor methodology, such as lack of a control group and use of an unreliable outcome measure, limit the strength of the previous study. Therefore the purpose of this study is to determine the effects of neurocognitive visual reaction training on reaction time and coordination in an athletic population. The purpose of this study is to determine the effects of neurocognitive visual reaction training on reaction time and coordination.

Official Title
-----------------
Neurocognitive Visual Reaction Training

Conditions
-----------------
Reaction Time

Intervention / Treatment
-----------------
* Other: Reaction Time Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects that participate in a structured sport team between the ages of 18-65 with or without a history of mild traumatic brain injury. Exclusion Criteria: subjects currently under medical supervision and not fully cleared to participate in structured sport team.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reaction Time Training<br> | Other: Reaction Time Training<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of colored balls correctly identified |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ball catches on alternate ball toss |  | 5 weeks | 
| Reaction time on dynavision reaction board |  | 5 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurocognitive visual reaction training, baseball