cyrilzakka/clinical-trials huggingface dataset:
Incentives for Moving

Employees of Blue Shield of California (BSC) will be recruited to participate to regularly use Walkstations. Some participants will be randomly assigned to a "hold out" control condition and the remainder will be assigned to one of two experimental treatments: Personal Incentive vs. Charitable Incentive. In the Personal Incentive condition people will be paid $3 for every completed Walkstation session, whereas for participants in the Charitable Incentive condition $3 will be donated to a specific charity. The incentives will operate for approximately 45 days and then for an additional 45 days participants in the two experimental conditions will have access to the Walkstations. Participants in the hold out control condition will begin using the Walkstations after the initial 90 day period.


Eligibility Criteria:
Inclusion Criteria:

* Must pass the ParQ

Exclusion Criteria:

* Ineligible if person did not pass ParQ AND did not provide doctor's note authorizing their participation.
Mi-RNAs and Specificity of Hs-TnT in Symptomatic ED Patients

Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency department ("chest pain unit"), Dept. of Cardiology, University Hospital Heidelberg
* Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain
* Age \>= 18 years
* Written informed consent

Exclusion Criteria:

* Mental disorders, dementia
* Pregnancy, breast feeding
* Age \< 18 years
COVID-19 Vaccination in Oncologic Patients

Evaluating the vaccination willingness in oncologic patients over six months as well as estimating the effects of radiotherapy/systemic anticancer treatment on the efficacy and toxicity of currently approved SARS-CoV-2 vaccines

All patients that present themselves newly at the outpatient-clinic of the Department of Radiooncology at the Ordensklinikum Linz GmbH, Barmherzige Schwestern during a period of six months are eligible for participation. After being informed about the study, the participants answer a short structured interview regarding vaccination status and vaccination willingness. Patients who already received one or two doses of SARS-CoV-2 vaccine are eligible for the study's subpopulation 1, with the main focus of quantifying SARS-CoV-2 S binding antibody titres after at least 35 days from initial vaccination. Patients who are to receive at least one dose of vaccine during or up to six weeks after radiotherapy are eligible for subpopulation 2, comprising serial measurements of SARS-CoV-2 S binding antibody titres before and after vaccination.

Eligibility Criteria:
Inclusion Criteria:

Study population for the cross-sectional study (patients with previous SARS-CoV-2 infection of previous vaccination, evaluation of willingness to get vaccinated:

* Patients with solid tumors/haematooncologic diseases regardless of stage that seek treatment in the outpatient clinic of the department of radiooncology from April to September 2021 who will undergo active treatment.
* Age: 18-120 years Patients that undergo radiotherapy, radio-chemotherapy, radio-hormonotherapy or radio-immunotherapy during the investigation period.

Longitudinal study:

* Patients that have not yet received SARS-CoV-2 vaccination, but are scheduled to get the first dose during or up to six weeks after active therapy.
* Age: 18-120 years

Exclusion Criteria:

* Lack of written consent
* Patients, that are mentally or physically incapable of completing a questionnaire
* Age: \< 18 years
* A previous SARS-CoV-2 infection is no exclusion criteria!
ISE to Support Constipation Management

This study is a single site prospective controlled trial assessing two educational interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on collaboratively developed treatment guidelines for pediatric constipation. The study aims to assess the impact of an Spaced Education game to aid the implementation of the management guideline. PCP adherence to recommended treatment will be assessed in addition to PCP satisfaction with the educational methods, constipation knowledge and patient outcomes.

Primary care practices in the Greater Cincinnati region, that are part of the Ohio Valley Pediatric Care Association (OVPCA) will be recruited to take part in the study. It is estimated that approximately 170 providers in 40 practices will take part overall. The study participants will be the PCPs and nurses in their practices.

Prior to the educational intervention (described below), participating PCPs and nurses will be asked to complete Constipation Action Plan (CAP) forms detailing the treatments they prescribed to each patient with constipation symptoms at each new visit and the subsequent follow up visits for constipation. The CAP form will contain a section to describe the patient's symptoms as well as fields to be checked for each treatment the PCP instructed the patient to follow.

Practices will be clustered by size (number of providers) and randomly assigned to 1 of 2 educational interventions (Dissemination or Dissemination +Interactive Spaced Education).

Dissemination will include webinars and e-mail distribution of the Constipation Management Guideline and a slide set containing the evidence-based rationale as well as clinical tips for advanced management of functional constipation. All PCPs will receive the guideline and slide set and be offered an opportunity to ask questions of a gastroenterologist.

Participating PCPs and nurses randomized to the Interactive Spaced Education (ISE) arm will complete an online ISE course assessing their understanding of the constipation guidelines.

Constipation knowledge will be tested via quiz in multiple choice format. Online surveys to assess satisfaction with the educational intervention, likelihood to change practice, ease of participation in the SE course (if applicable) and feedback for ways to improve future educational efforts will be administered at three time-points.

Eligibility Criteria:
Inclusion Criteria:

* PCPs and nurses who are willing and able to complete the education intervention throughout the study time-frame, as outlined in the protocol (education intervention does not need to be completed prior to taking part in the study)
* PCPs and nurses who are willing to complete Constipation Action Plans and submit them in a timely fashion to the CCHMC Quality Improvement program staff

Exclusion Criteria:

* PCPs or nurses who are unwilling and/or unable to follow protocol requirements.
L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde

Atrophic gastritis with hypochlorhydric milieu is a risk factor for gastric cancer. Microbes colonizing the acid-free stomach oxidize ethanol into acetaldehyde, a group 1 carcinogen. The aim is to assess gastric production of acetaldehyde and its inert condensation product, non-toxic 4-methyltiazolidine-2-carboxylic acid (MTCA), after alcohol intake under treatment with slow-release L-cysteine or placebo.

Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17 are studied. On separate days, patients will be randomly assigned to receive 200 mg slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg) ethanol. After intake, gastric concentrations of acetaldehyde, ethanol, L-cysteine and MTCA are analysed for 4 hours.

Expected results show mitigated exposure of the gastric mucosa to acetaldehyde.

Gastric infection with Helicobacter pylori induces chronic active gastritis which over the years develop atrophic gastritis with a hypochlorhydric milieu which is a risk factor for gastric cancer. Microbes colonizing acid-free stomach oxidize ethanol into acetaldehyde, considered a group 1 carcinogen.

The aim of the study is to assess the gastric production of acetaldehyde and its inert condensation product, non-toxic 4-methyltiazolidine-2-carboxylic acid (MTCA), after alcohol intake under treatment with slow-release L-cysteine. Identical placebo tablets will be used for comparison.

Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17 will be studied with case-control design. All subjects will be their own control. On separate days, patients are randomly assigned to receive 200 mg slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg) ethanol (corresponding to two glasses of wine). After intake, gastric sampling of fluid for a period of four hours is done and concentrations of acetaldehyde, ethanol, L-cysteine and MTCA are analysed.

L-cysteine is expected to decrease gastric acetaldehyde concentrations and increase the MTCA level. Gastric L-cysteine and MTCA concentrations are expected to be maintained over the study period. With placebo, acetaldehyde is expected to be elevated along with ethanol concentrations.

Based on these assumptions slow-release L-cysteine binds acetaldehyde to form inactive MTCA, which remains in gastric juice resulting in reduced local exposure of the gastric mucosa to carcinogenic acetaldehyde.

Eligibility Criteria:
Inclusion Criteria:

* Helicobacter-associated chronic gastritis
* Hypochlorhydria
* Hypergastrinemia
* Hypopepsinogenemia

Exclusion Criteria:

* Active peptic ulcer disease
* Other inflammatory gastrointestinal disease
* Gastrointestinal bleeding
* Gastrointestinal surgery
* Neurological disease
* Alcohol abuse
* Mental disorder
* Not able to sign informed consent
Strimvelis Registry Study to Follow-up Patients With Adenosine Deaminase Severe Combined Immunodeficiency (ADA-SCID)

Adenosine deaminase (ADA) enzyme deficiency results in severe combined immunodeficiency (SCID), a fatal autosomal recessive inherited immune disorder. Strimvelis (or GSK2696273) is a gene therapy intended for patients with ADA-SCID and for whom no suitable human leukocyte antigen (HLA) matched related stem cell donor is available. This therapy aims to restore ADA function in hematopoietic cell lineages, and in doing so prevents the pathology caused by purine metabolites (i.e., impaired immune function). This registry evaluates the long term safety and effectiveness outcomes of subjects who have received Strimvelis (or GSK2696273).

This is a prospective, non-interventional follow-up registry of patients with ADA-SCID treated with Strimvelis™. The registry does not have a comparator group and the product will have been given on a single occasion prior to entering this registry. Safety and effectiveness will be assessed for a target number of 50 patients who will have received Strimvelis™ (or GSK2696273) comprising patients treated prior to marketing authorisation (i.e. clinical studies and compassionate use programs) and those treated after marketing authorisation (including within compassionate use and early access programs). The registry will close to enrolment when 50 patients have been enrolled but will not close completely until the 50th patient finishes their 15 year follow-up.

Eligibility Criteria:
Inclusion Criteria

1. Patient with ADA-SCID, treated with Strimvelis™ or GSK2696273, as part of its clinical development program.
2. Adult patients, or patients for whom their parents or legal guardians have signed the informed consent form for participation in the registry.

There are no formal exclusion criteria for participation as this registry will follow all patients who have received Strimvelis™ prior to enrollment, subject to informed consent.
Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.


Eligibility Criteria:
Inclusion Criteria:

* Age18-65 years (inclusive of 18 and 65), no restriction on gender;
* HBsAg positive history for at least 6 months;
* Family history of liver cancer \[including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer\];
* Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;
* Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);
* Willing to receive treatment and sign an informed consent form.

Exclusion Criteria:

* Allergy to interferon;
* History of using telbivudine for antiviral treatment;
* ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;
* Decompensated liver cirrhosis;
* Neutrophil count \< 1.5 x 10\^9/L or platelet count \< 80 x 10\^9/L;
* Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;
* Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);
* Confirmed or suspected liver cancer or other malignant tumors;
* Post-organ transplant or preparing for organ transplantation;
* Currently using immunosuppressants;
* Pregnant or planning to become pregnant within 2 years;
* Alcohol or drug addicts;
* HIV co-infection;
* Other conditions deemed unsuitable for interferon use by the attending physician.
CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly

This is a multicenter, prospective, randonmized study. Our previous retrospective study showed that for SAA patients who were intolerant to ATG, CsA+ eltrombopag (EPAG) had similar efficacy to CsA+ATG+EPAG. Since the action mechanism of AVA and EPAG is not exactly the same, and the metabolic level of the elderly is not the same as that of younger patients, it is unknown whether there are predictive factors of efficacy in the treatment of AVA. We wondered whether CsA+AVA could achieve an efficacy similar to CsA+ATG+AVA in the Elderly. Meanwhile, to explore the predictive factors of efficacy, to find out a safe and effective treatment strategy for the Elderly.

Aplastic anemia (AA) can be divided into severe AA (SAA) and non-severe AA (NSAA), according to the severity of the disease. For SAA patients with o condition of hematopoietic stem cell transplantation, guideline recommended ciclosporin A (CsA) + anti-thymocyte immunoglobulin (ATG) + thrombopoietin receptor agonists (TPO-RA) as the first-line therapy. Our previous retrospective study showed that for SAA patients who were intolerant to ATG, CsA+ eltrombopag (EPAG) had similar efficacy to CsA+ATG+EPAG. However, the adverse effects such as hepatotoxicity and gasrointestinal disorder limit its application in elderly SAA.Compared with EPAG, AVA has no hepatotoxicity and less other adverse effects, but there was few studies for AA. Our previous study demonstrated that AVA was effective in 55% of refractory AA. Since the action mechanism of AVA and EPAG is not exactly the same, and the metabolic level of the elderly is not the same as that of younger patients, it is unknown whether there are predictive factors of efficacy in the treatment of AVA. Thus, we wondered whether CsA+AVA could achieve an efficacy similar to CsA+ATG+AVA in the Elderly.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed severe aplastic anemia, aged greater than 60 years.
2. Patients met the diagnostic criteria of severe aplastic anemia (SAA).
3. Complete all screening assessments as outlined in the test protocol.
4. Without or with no more than 1 month treatment of ciclosporine, tacrolimus, glucocortocoid, or TPO-RAs.
5. Agree to sign the informed consent form.

Exclusion Criteria:

1. Known diagnosis of congenital hematopoietic failure disorders (e.g. Fanconi anemia) and other causes of cytopenia.
2. Patients with uncontrolled bleeding and/or infection despite standard treatment.
3. Patients with previous history of hematopoietic stem cell transplantation.
4. Patients with previous history of thrombosis in 1 year.
5. Patients with concurrent malignancy.
6. Those who are considered unsuitable for enrollment by the investigator.
7. Abnormal renal function: creatinine \> 1.2 normal upper limit, albumin \< 0.9 normal lower limit, or CLcr \< 30 ml/min.
8. Abnormal liver function: transaminase \> 2.5 normal upper limit, or tota bilirubin \> 2.5 normal upper limit.
9. Patients with severe heart, liver or renal disease.
Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)

The purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. This is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for SWL at St. Joseph's Hospital;
* 18 years of age or older;
* Willing and able to complete Questionnaires;
* Willing to submit urine sample for analysis at Day 7;
* Able to read and speak English.

Exclusion Criteria:

* Pre-SWL urine analysis positive for nitrites or urine culture reveals \>105 CFU/ml of bacteria (positive urine culture);
* Taking antibiotics for UTI or other cause;
* Requires an antibiotic post SWL;
* Suspected struvite stone (based on previous stone analysis, or partial staghorn);
* Presence of nephrostomy tube;
* Requiring cystoscopy on the day of SWL;
* Requiring ureteral stent on the day of SWL;
* Presence of indwelling urinary catheter or on regular clean intermittent catheterization (CIC);
* Presence of urinary diversion (ie: ileal conduit);
* Any history of urosepsis;
* Known allergic reaction to ciprofloxacin/quinolones;
* Patient known to be pregnant;
* Previous randomization in this trial;
* In the opinion of the urologist, it is not in the patient's best interest to participate.
Functional Neural Connectivity at Rest as a Diagnostic Tool for Intolerance to Heat

Functional neural connectivity at rest of 3 groups (heat tolerant, heat intolerant and healthy subjects) will be assessed using the anatomical and functional MRI scans and compared.

20 healthy subjects that had already underwent Heat Tolerance Test (HTT) at the Heller Institute of Medical Research (Sheba Medical Center) will be recruited and divided into 2 groups: heat tolerant and heat intolerant (according to the HTT results). They will be asked to arrive to one experimental day at the imaging department in Sheba Medical Center and undergo anatomical and functional MRI scans.

Third group will consist of 10 existing brain scans (separated from personal details) of healthy males, at the same age range and who had never gone through heat injury.

Data will be analysed by fMRI expert in order to compare the functional neural connectivity at rest between the three groups.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy subjects
* underwent heat injury in the past two months
* underwent Heat Tolerance Test at the Heller Institute of Medical research

Exclusion Criteria:

* drug or alcohol use
* history of neurological disorders, mental retardation or head injury
* history or diagnosis of psychiatric disorders
* claustrophobia
Job-Seekers Training for Patients With Drug Dependence - 1

The purpose of this study is to examine the effectiveness of a 12-hour basic job-training program designed to give drug abuse treatment patients the skills they need to find and secure a job and set vocational goals and methods for locating employment. The intervention to be evaluated is modeled after the Job Seekers' Workshop, which was manualized and has been tested in trials.


Eligibility Criteria:
* DSM-IV drug/alcohol abuse/dependence
* enrolled in drug treatment for at least 30 days
* unemployed or underemployed
* expressed interest in employment
* demonstrate English comprehension
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).


Eligibility Criteria:
Key Inclusion Criteria:

* Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
* Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

Key Exclusion Criteria:

* Evidence of CNV due to any cause other than nAMD in either eye
* Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
* Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
* Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
* Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
* History of vitreoretinal surgery (including scleral buckling) in the study eye
* Any other intraocular surgery within 12 weeks (84 days) before the screening visit
* History of corneal transplant or corneal dystrophy in study eye

NOTE: Other protocol defined inclusion/exclusion criteria apply.