cyrilzakka/clinical-trials huggingface dataset:
International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center

The purpose of this study is to survey patients who underwent hematopoietic stem cell transplant (HSCT) to assess if they have traveled or not internationally after transplant. This information will help to improve the understanding of the needs for travel health strategies and interventions to provide healthy and safe travel to HSCT patients. The findings of this survey will also be used to develop travel health related interventions for patients living with cancer as well.


Eligibility Criteria:
Inclusion Criteria:

* Hematopoietic Stem Cell Transplant (HSCT) recipients at MSKCC from 1/1/2005 to 12/31/2010.
* Age at HSCT ≥ 18 years
* Permanent mailing address in the United States of America

Exclusion Criteria:

* Subject unable to fill the questionnaire due to language barriers.
Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

In this project, the investigators aim to evaluate the most appropriate design and implementation strategy of a decision-aid to promote shared-decision making in prostate cancer screening.

Prostate cancer (PC) screening using Prostate Specific Antigen (PSA) has led to a reduction in advanced disease and disease-specific mortality. However, screening with PSA can also cause harm and is associated with false-positive results and overdiagnosis.

Shared-decision making (SDM) has been defined as the key to successful patient-centered care. The promotion SDM when deciding on PSA screening will have proximal effects such as the development of collaborative deliberation between clinicians and patients, resulting in well-informed patients and in preference-based decisions. As long term effects, it will result in safer, cost-effective, patient-aligned healthcare, and its distant effects will include improvements in resource use, planning processes and improved health outcomes.

The project includes a mixed-method approach. The investigators will perform a quantitative survey (cross-sectional design) to evaluate the population, patients' and clinicians' knowledge about the benefits and risks derived from the PSA determination and the available recommendations.

The investigators will apply qualitative analysis through focus groups, to explore the challenges patients and clinicians face to deep in a prostate screening discussion and to assess the adequacy of different implementation strategies.

The investigators will carry out a user-testing design based on mix-methods (questionnaire and semi-structured review) to evaluate the prototype of the initial decision-aid.

Finally, the investigators will carry out a cluster randomised controlled trial, to assess the results derived from the application of the decision-aid, together with a process evaluation using a combination of both qualitative and quantitative methods to monitor the fidelity of the intervention, the clusters' and patients' response to the intervention as well as the mechanisms of adaptation and change at the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Patients:

   * Men \>40 years old
   * Men who have not had prostate cancer
2. General practitioners:

   * Primary care doctors working in the Valencian Community, Spain.
3. Urologists:

   * Urologists working in the Valencian Community, Spain.

Exclusion Criteria:

1. Patients: None
2. General practitioners: None
3. Urologists: None
Comprehensive Segmental Revision System

Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.

The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).

Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.

The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
* Rheumatoid arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity
* Oncology applications including bone loss due to tumour resection

Exclusion Criteria:

* Sepsis ( active)
* Infection ( active)
* Osteomyelitis (active)
Changes in Regional and Global Cardiac Contractility After Stimulation in Scar Zone with the NOGA System

Despite a decrease in voltage amplitude in post-infarction scar areas, greater voltage amplitudes are sometimes observed at the time of local extrasystoles mechanically induced by catheters.

However, no study has investigated whether these electrical changes are associated with mechanical changes in local contractility.

However, the voltage is closely correlated to the local contractile function as evidenced by the use of the NOGA system.


Eligibility Criteria:
Inclusion Criteria:

- Patients who should undergo ventricular tachycardia (VT) ablation after a myocardial infarction according to current recommendations, namely: patients with ischemic heart disease (ICD) and with episodes of sustained ventricular tachycardia responsible for internal electric shocks by the implantable automatic defibrillator (ICD) (grade IB recommendation)

OR

* patients with an MIC and an ICD, presenting a first episode of sustained ventricular tachycardia (grade IIa, B recommendation)
* Affiliated with a social protection scheme
* Having signed an informed consent

Exclusion Criteria:

* Contraindication or non-indication for ventricular tachycardia ablation
* Women who are pregnant or of childbearing age and without contraception, breastfeeding women
* Patients without ischemic heart disease
* Patients under guardianship, curatorship or legal protection.
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria

Exclusion Criteria:

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population with Obesity

This study aims to evaluate the feasibility of an open randomized controlled study which would assess the proportion patients with obesity who will have a favorable pharmacodynamic parameter (i.e. fT\> 100% MIC) after 24 hours of piperacillin-tazobactam administered as a prolonged intermittent infusion compared to a standard infusion.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older)
* Patients hospitalized at Hôpital Charles-Le Moyne
* Obesity (as defined by a body mass index of ≥ 30 kg/m\^2)
* Piperacillin-tazobactam prescription initiated within last 24 hours
* Planned duration of piperacillin-tazobactam of 24 hours or more

Exclusion Criteria:

* Documented allergy to beta-lactams of the penicillin class
* Patients with renal replacement therapy (hemodialysis, peritoneal dialysis, continuous venovenous hemodiafiltration)
* Pregnancy
* History of seizures or epilepsy, active seizures or epilepsy treated with antiepileptic drug therapy
* Patients on prolonged intermittent infusion or continuous infusion of piperacillin-tazobactam before randomization
Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease

In patients with polycystic kidney disease, pain may be resistant to drug therapy and may reduce quality of life. This study investigate the effect of renal denervation on this pain.


Eligibility Criteria:
Inclusion Criteria:

* Pain limiting daily activities in spite of pain killers, ADPKD

Exclusion Criteria:

* Pregnancy
Withings Study to Analyze the Accuracy of Pulse Wave Velocity Measurement With Bathroom Scales (WIVOP-Scales)

The aim of this study is to evaluate the diagnostic performance of Withings bathroom scales WBS08 and WBS12 to measure PWV (Pulse Wave Velocity).

Patients likely to have a high PWV (having hypertension, sleep apnea or chronic obstructive pulmonary disease) are included in hospitals. Each patient will have his PWV measured with Withings WBS08 and WBS12 and its reference the SphygmoCor CvMS.

Eligibility Criteria:
Inclusion Criteria:

* The subject is an adult, man or woman (18 years old or more),
* Subjects affiliated or eligible to a social security system,
* Subjects having expressed their consent to take part in the study.
* Two subsets of patients will be included in the study :

  * Hypertensive patient
  * Patient having sleep apnea or COPD (Chronic obstructive pulmonary disease)

Exclusion Criteria:

* Minors under 18 years old,
* Subject is pregnant,
* Subjects having a pacemaker or an ICD (Implantable cardioverter defibrillator),
* Subjects having refused to give their consent,
* Vulnerable subjects according to the French regulation in force:

  * Individuals deprived of liberty by a court, medical or administrative order,
  * Individuals legally protected or unable to express their consent to take part in the study,
  * Individuals unaffiliated to or not beneficiary of a social security system,
  * Individuals who fit in multiple categories above,
* Individuals linguistically or mentally unable to express their consent,
* Individuals having a lower limb amputation bigger than toes,
* Individuals not able to stand still for a few minutes.
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* ages 25-49

Exclusion Criteria:

* personal history of breast cancer
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)

This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.


Eligibility Criteria:
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
2. Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options
3. Serum HBsAg positivity
4. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
5. Life expectancy of at least 3 months
6. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\*02:01 or HLA-A\*24:02).

Key Exclusion Criteria:

1. Brain metastasis
2. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors
3. Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
4. Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.
5. Likelihood to require any immunosuppressive treatments during the period of the clinical trial.
6. 7. Last RFA/TACE treatment within 3 months prior to first LioCyx-M infusion; Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV/TCR T-cells
7. Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)
8. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
9. Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration
10. Serum HBV DNA levels ≥ 200 IU/ml at screening
11. Serum HBsAg levels ≥ 10,000 IU/ml at screening
12. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
13. Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation
14. Women who are pregnant or breast-feeding
Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve

The goal of this retrospective chart review is to contribute to the literature on the mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in children and young adults.

The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults. Investigators also aim to identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related complications, freedom from re-operation, and survival rate.

Eligibility Criteria:
Inclusion Criteria:

Subjects that have received the INSPIRIS Resilia device at participating institutions from 06/2017 through 12/2022.

Exclusion Criteria:

Subjects that have not received the INSPIRIS Resilia device.
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)

A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.


Eligibility Criteria:
Inclusion Criteria:

* You are between the ages of 40 and 75
* You have had a history for at least a year of COPD symptoms
* You have a history of smoking one pack of cigarettes per day for 10 years

Exclusion Criteria:

* You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
* You have donated blood in the last 4 weeks.
* You have been hospitalized or had major surgery in the last 4 weeks
* You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
* You have a history of heart problems in the last 6 months
* You have a history of stomach problems
* You are unwilling to avoid grapefruit juice throughout the study
MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)

This is a study for patients with previously-treated advanced non-small cell lung cancer (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to standard treatment with gemcitabine. The study will also try to identify the best dose of MK-3475 to give in combination with gemcitabine.

This study is an open-label, non-randomized phase I study, followed by open-label non-randomized phase II study. The first cohort of patients will receive 200 milligrams (mg) of MK-3475 by intravenous infusion over a 21-day period called a cycle along with Gemcitabine 1250 mg/m2 given on Days 1 and 8 of each 21-day cycle for up to 6 cycles. Patients will be seen in the study clinic 12 times over 126 days for an evaluation of signs and symptoms that may represent drug toxicity. Patients may continue to receive MK-3475 (without gemcitabine) for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Women or men with advanced, histologically proven NSCLC.
* Patients must have received at least one but no more than three prior systemic therapies for advanced disease.
* Any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-PD1 therapy or gemcitabine should be resolved to less than Grade 1.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Women of childbearing potential must have a negative pregnancy test
* Ability to give informed consent and comply with the protocol.
* Anticipated survival minimum 3 months.
* Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
* Patients must have normal organ and marrow function as seen on protocol-defined blood test results
* Archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) available
* Measurable disease by RECIST 1.1 criteria.
* Treated brain metastases will be allowed, provided they are asymptomatic.
* Radiation for symptomatic lesions outside the Central nervous system (CNS) must have been completed at least 2 weeks prior to study enrollment.

Exclusion Criteria:

* Prior therapy with any anti-PD-1, anti-PD-L1, or anti-CTLA4 antibody.
* Prior therapy with gemcitabine.
* Prior complications from radiation, such as history of radiation pneumonitis or pulmonary edema that, in the opinion of the investigator, may have risk of increasing toxicity with anti-PD1 therapy.
* Active autoimmune disease except vitiligo or stable hypothyroidism.
* Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, cardiopulmonary disease (COPD), allergic rhinitis).
* Active other malignancy, except for controlled basal cell skin carcinoma.
* HIV positive and/or Hepatitis B or C positive.
* Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in this protocol.
A Physiological Profile of Recovery From Resistance, Endurance, and Mixed Exercise Types

The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors.

This study utilised a between groups design, with a within-groups control. This allowed the within-subject profiling of recovery during both a control and exercise week. This design also allowed each group to perform an ecologically valid exercise session as well as having markers of recovery tailored to the areas of interest specific to each cohort. By having each group perform a non-exercise control week, this gives valuable information on the reliability and smallest worthwhile change for a range of both novel and commonly used recovery markers.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent (see Appendices 2-4) and has received a signed and dated copy of the informed consent form.
* Participant is male
* Good general and mental health as assessed by a health questionnaire and with, in the opinion of the investigator or medically qualified designee ,no clinically significant and relevant abnormalities in medical history or upon oral examination. As well as absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
* Participants will be fully briefed prior to agreeing to participate in the study and the research team will confirm that they are willing, able, and likely to comply with all procedures and complete the study.
* Only the following individuals will be recruited as participants for the study:

Group 1: Resistance trained individuals (≥3 sessions per week for ≥2 years with a minimum of 1 session per week including leg-based exercises).

Group 2: Trained cyclists (competing at a minimum of Category 3 roadracing/ estimated 10 mile TT of \<25 minutes and a training history of ≥5 hours per week for ≥2 years).

Group 3: Team sports players (minimum of University 1st team level e.g. soccer, rugby union, rugby league, hockey, and basketball, playing competitively ≥1x per week for ≥2 years).

Exclusion Criteria:

* Individuals that do not fit the training status inclusion criteria.
* Current use of any non-steroidal anti-inflammatory drugs (NSAID's) or other analgesics for pain relief.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Previous participation in this study.
* Recent history (within the last 1 year) of alcohol or other substance abuse.
* An employee of the sponsor or the study site or members of their immediate family.
* Have a heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity.
CARTOON: CoronAviRus (COVID-19) educaTional prOgram fOr childreN

Our study aims to investigate whether our CoronAviRus educaTional prOgram fOr children (CARTOON) facilitates the adherence to hygiene measures and is feasible to dispel fear in preschool children (3-6 years old) during the pandemic.

This prospective randomized controlled trial will be performed at four kindergartens in Vienna, Austria. About 60 children between three and six years of age attending kindergarten will be included in the study. Prior inclusion in the study eligible adults have to sign a parental consent form. We will randomly assign 30 children to the intervention group (n=30) and 30 children to the control group (n=30). Depending on the randomization (intervention group vs. control group), children either receive our CARTOON (intervention group) or no educational training (control group).

Eligibility Criteria:
Inclusion Criteria:

* Children between three and six years who are attending kindergarten
* consent of the parents and the participants

Exclusion Criteria:

* physically unable to complete any of the training exercises
* German skills not good enough to follow the instructions