linjc16/ctgov huggingface dataset:
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)

Study Overview
=================
Brief Summary
-----------------
The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

Detailed Description
-----------------
The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed though screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.

Official Title
-----------------
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)

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

Intervention / Treatment
-----------------
* Other: Sample of Blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 30 years AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer. Those over 18 are also eligible if they have 2 or more family members with a blood cancer Exclusion Criteria: * • Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy. • Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia First-degree relatives would not need to be identified by the participant. We will include all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Specimen Collection<br>Samples of blood (2-4 tablespoons) from 3 tubes will be collected Analysis will be performed on the blood to test for multiple myeloma precursor conditions once sent to outside labs at Mayo Clinic and the Broad Institute | Other: Sample of Blood<br>* Collection of blood sample from participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) from MGUS/SMM to overt multiple myeloma. | Progression to symptomatic multiple myeloma | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma
Nexfin®-Monitoring System

Study Overview
=================
Brief Summary
-----------------
In many surgical procedures, anaesthesiological care is provided according to the best scientific and clinical information available. However, since hemodynamic monitoring until recently did not allow for beat-to-beat information of the haemodynamical changes, many fast-changing events may have been unnoticed or have not been investigated as precisely as is possible today. Moreover, in several surgical procedures - like eye surgery - the invasiveness of the classical haemodynamical monitoring devices was of such a degree that until now, in these circumstances these vital parameters were not investigated yet. Therefore, the availability of this new device, which allows for noninvasive beat-to-beat assessment of these haemodynamical parameters gives a unique opportunity to investigate our anaesthesiological management and to elucidate whether improvements are desirable and possible. The Nexfin monitor consists of a cuff-micromanometer that is located around the third finger. It simultaneously uses continuous pressure readings and light-absorption spectrometry to determine valuable haemodynamical information. Data is recorded and available for subsequent offline analysis.

Official Title
-----------------
Electronic Registration of Noninvasively Acquired Hemodynamic Parameters Using Nexfin®-Monitoring System

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are accepted for surgery Exclusion Criteria: Patients unable or unwilling to provide 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients, that are having a routine surgical procedure.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemodynamical changes after several surgical and anaesthesiological interventions. | Beat-to-beat determination of stroke volume, cardiac output, blood pressure and systemic resistance measurement | 30 minutes - 2 hours |
A Multicentre, Retrospective Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors

Study Overview
=================
Brief Summary
-----------------
The primary endpoint of the study was the acute GvHD incidence, the secondary endpoints were chronic GvHD incidence, overall survival (OS), transplant related mortality (TRM) incidence, relapse incidence (RI) and neutrophil and platelets engraftment after GvHD prophylaxis with ATG-CSA-MTX or PTCy-MMF-FK506

Official Title
-----------------
Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors

Conditions
-----------------
Leukemia, Myeloid

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children and adults) HSCT from a one-antigen mismatch unrelated donors Treated at the Centro Trapianti Metropolitano di Torino between 2012 to 2017 Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention, observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute GvHD incidence |  | 2012-2017 |
Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Background: Motor impairment limits social and recreational activities in children with cerebral palsy (CP), compromising participation and impacting on quality of life. Improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. While Botulinum toxin (BTX) injections are effective and safe treatment for spasticity in children with CP, there is insufficient evidence for improvement of motor function and enhanced participation in this population. Objective: To examine outdoor activity as a functional outcome following lower limb BTX in children with CP. Methods: In this pilot study the investigators will use Global Positioning Systems (GPS) to measure walking speed, distances, number of walking events and destinations in ambulatory children with CP following BTX injection to the lower limbs; age and gender matched sibling will be studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires. Significance: Improvement in outdoor activity following BTX injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with CP.

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory children with CP following BTX injection to the lower limbs Exclusion Criteria: significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ambulatory CP<br>ambulatory children with cerebral palsy undergoing Botulinum toxin injections to lower limbs | |
| controls<br>age and gender matched sibilings | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outdoor activity |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leisure activity preferences and quality of life |  | 9 months for the pilot | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional outcome, Quality of life, Global Positioning System (GPS), Advanced tracking technologies, Time-space activity., walking speed, distances, number of walking events and destinations
Endotracheal Intubation Using Macintosh Laryngoscope, Glidescope, Airwayscope During Chest Compression With Adjustment Height of a Bed

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a bed height make an effect to endotracheal intubation with Macintosh laryngoscope, Glidescope and Airwayscope during chest compressions in- hospital simulation cardiac arrest.

Conditions
-----------------
Tracheal Intubation, Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Macintosh laryngoscope
* Device: Glidescope
* Device: Airwayscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experience of Intubation > 50 times Postgraduates year 1,2,3,4 and Emergency physicians in emergency department Exclusion Criteria: Wrist or low back disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a 65 cm bed height<br>1) Bed height : approximately 65cm (Lowest) | Device: Macintosh laryngoscope<br>* Direct Laryngoscope<br>Device: Glidescope<br>* Videolaryngoscope-1<br>Device: Airwayscope<br>* Videolaryngoscope-2<br>|
| Experimental: a 95cm bed height<br>2) Bed height : approximately 95cm (highest) | Device: Macintosh laryngoscope<br>* Direct Laryngoscope<br>Device: Glidescope<br>* Videolaryngoscope-1<br>Device: Airwayscope<br>* Videolaryngoscope-2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure a time to expose the glottis view with a laryngoscope |  | 1 day | 
| To measure a time to intubate the tube with a laryngoscope |  | 1 day | 
| To estimate the success rate of Intubation |  Failure  means that tube is inserted in esophagus and the time is over than 120 seconds | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the grade for the glottis view with a laryngoscopy | Using the Cormack-Lehane Grade system | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, Cardiopulmonary resuscitation, Manikin study
Efficacy and Safety of Tadalafil in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to check the safety and efficacy of a pde5 inhibitor, tadalafil, is a special group of patients: Renal chronic patients in hemodialysis treatment.

Detailed Description
-----------------
In our country, the number of patients in hemodialysis for the treatment of renal chronic dysfunction is very huge. As we know this group has a greater prevalence of sexual dysfunction than the general population, and among these dysfunctions erectile disfunction(ED) occupies maybe the most important position. With the advent of the increase aging of the nation´s population and the small number of organ donations, the number of men suffering from ED in hemodialysis surely will be very significant causing a very important problem for our health system. Up to now there´s little indexed publications supporting the use of tadalafil in this special group of men. Another PDE 5 inhibitor, sildenafil, was used in this patients with success and safety but obviously we need other options with the same efficacy. We intend this study to give us more background to treat ED in this already unfortunate ones.

Official Title
-----------------
Efficacy and Safety of Tadalafil 20mg for the Treatment of Erectile Dysfunction in Chronic Renal Patients in Hemodialysis.

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men between 18 and 70 years old Diagnosticated ED for 6 months at least Accept the protocol Sign the informed consent Renal chronic patients in hemodyalisis Exclusion Criteria: History of another PDE5 inhibittor use. C.C.I. grade III (NYHA)

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

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

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: tadalafil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF 5 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects reported |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erectile dysfunction, chronic renal dysfunction, tadalafil
A Study of GW842166 in Adults With Osteoarthritis Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.

Official Title
-----------------
A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: GW842166


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female outpatient, >= 40 years of age meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months meets ARA functional status requirements meets WOMAC pain subscale score requirements has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen Exclusion Criteria: any pre-specified clinical/biological/ECG abnormality any pre-specified drug sensitivity history of peptic ulceration or GI bleeding use of protocol-specified medications secondary cause of knee OA lower extremity surgery within 6 months of screening use of analgesics other than allowed per protocol use of corticosteroids or hyaluronan outside of allowed window prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW842166|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline |  | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments |  | 4 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis,, knee,, GW842166,, pain,, efficacy,, safety
Hatha Yoga for Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. It is used in India since centuries to improve well-being and cope with diseases and is gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. The purpose of this study is to investigate the effect of Hatha Yoga in patients with colorectal cancer.

Official Title
-----------------
Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Hatha yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer UICC stage I-III between 2 and 48 months post-surgery age at least 18 years physical and cognitive ability to follow the yoga intervention Exclusion Criteria: UICC stage IV further active oncological diseases diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder pregnancy or breastfeeding

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hatha yoga<br>10 weeks of Hatha yoga, designed for patients with colorectal cancer, as a group intervention 1 weekly class (90 minutes) | Behavioral: Hatha yoga<br> <br> |
| No Intervention: Usual care<br>Patients continue their self-directed usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) | Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | - Functional Assessment of Cancer Therapy - Colorectal Cancer (FACT-C) | Week 22 | 
| Fatigue | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | Week 10, week 22 | 
| Anxiety, depression | Hospital Anxiety and Depression Scale (HADS) | Week 10, week 22 | 
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Week 10, week 22 | 
| Safety | Number and severity of adverse events | Week 0-22 | 
| Spiritual well-being | - Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) | Week 10, week 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga, Colorectal Neoplasms, Quality of Life, Randomized Controlled Trial
Molecular Characterization of Primary Mucosal Melanoma

Study Overview
=================
Brief Summary
-----------------
Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans.  The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM. The principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.

Official Title
-----------------
Molecular Characterization of Primary Mucosal Melanoma

Conditions
-----------------
Mucosal Melanoma

Intervention / Treatment
-----------------
* Genetic: Somatic Genetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014 Exclusion criteria: Cutaneous melanoma Uveal melanoma

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 |
| --- | --- |
| Mucosal melanoma<br>Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014 | Genetic: Somatic Genetic<br>* NGS analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of main mutations identified using the NGS panel | NGS panel | Day 0 |