cyrilzakka/clinical-trials huggingface dataset:
A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation

The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
* \<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
* Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods
* Willing to wear the ActiGraph monitor during assessment periods
* Access to internet to complete REDCap survey assessments

Exclusion Criteria:

* Non-English speaking/not able to read English
* Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
* Currently pregnant
* History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
* Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8)
* Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener)
* Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener
Therapy Coil Electrogram Collection Study

This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead and will evaluate the electrogram signals.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign and date the study Informed Consent form
* Subject is at least 18 years of age (or older, if required by local law)
* Subject is willing and able to wear a Holter monitor for up to 24 hours
* Subject has been implanted with a Medtronic ICD or CRT-D device
* Subject has an increased risk of lead insulation breach

Exclusion Criteria:

* Subject has medical conditions that would limit study participation
* Subject is enrolled in one or more concurrent studies that would confound the results of this study
Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game

This study evaluates the efficacy of a rehabilitation intervention for people with Autism Spectrum Disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket.

Serious games are innovative computer-based interventions to support children and adults with Autism Spectrum Disorder (ASD). However, few studies have assessed the efficacy of these interventions in real-life contexts. The present study investigates the generalisation of daily living skills related to shopping activities after a rehabilitation intervention administered via a personalised serious game (ShopAut). The underlying hypothesis of this study is that training with an individualised serious game can improve performance in a real-life environment. In order to prove this hypothesis, a small sample of subjects with ASD will play an individualised serious game, ShopAut, for ten sessions. Subjects will undergo real-life experiences in a supermarket pre- and post-virtual training to determine whether there had been a generalisation of skills from the virtual environment to the real environment. Improvements in skills and performance in the real shopping activity are evaluated using specific tools.

The serious game ShopAut is developed integrating an individualised design that provides both the personalisation of the game's scenario, contents, difficulty, and user interface; and the customisation of game modes, player perspectives, and input devices. It is a three-dimensional game that provides a realistic shopping experience where the player can practice and engage with, above all, shopping activities, experiment their problem-solving skills, and take on unexpected events.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Autism Spectrum Disorder, in keeping with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
* chronological age between 8 and 16 years
* a rehabilitation plan already underway in accordance with the study's goals
* Representatives of parental authority who gave informed written consent
* native Italian speakers

Exclusion Criteria:

* no physical impairments
* participant to another research protocol
* known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities
Environmental Contaminants and Infant Development

This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland.

Due to prevailing weather patterns and ocean currents, certain environmental contaminants are transported to the Arctic region. The Inuit are among the most heavily exposed populations on earth due to the prevalence of these contaminants in traditional foods that comprise a large portion of their diet. The contaminants assessed in this study include polychlorinated biphenyls (PCBs), methylmercury, selenium, organochlorine pesticides, and lead. These contaminants are measured in umbilical cord blood samples obtained at birth, milk samples obtained from breast-feeding mothers and, in the case of mercury, hair samples obtained from the mothers. Omega-3 and omega-6 fatty acids are also assessed in these samples to examine the degree to which these nutrients may protect against adverse effects attributable to these contaminants.

Eligibility Criteria:
infant born during recruitment period to a mother who is a resident of Povungnituk, Inukjuak, and Kuujjuarapik, Quebec or Nuuk, Greenland
Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning

The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis.

The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.

PHSTT-01 is a multi-center, prospective clinical trial to evaluate the diagnostic performance of prostate HistoScanning (HS) analysis in men at risk of PCa that have been scheduled for a first prostate biopsy. The purpose of this study is to determine if prostate HS analysis can improve the detection of clinically significant PCa, and potentially reduce the burden and number of biopsies in routine clinical practice. Subjects are men with serum total prostate-specific antigen (PCA) \<= 20ng/mL (\<= 10ng/mL if taking the 5-alpha reductase inhibitor).

In a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores.

Eligibility Criteria:
Inclusion Criteria:

* Men at risk of PCa scheduled for first biopsy with serum total PSA

  ≤ 20 ng/ml (≤ 10 ng/mL if taking 5-alpha reductase inhibitors) from maximally 3 months ago
* Signed informed consent

Exclusion Criteria:

* Previous prostate biopsy
* Confirmed PCa
* PSA \> 20 ng/ml (or \> 10 ng/mL if taking 5-alpha reductase inhibitors)
* Active urinary tract infection
* Presence/history of any confirmed cancer
* Recent prostatic surgery (past 6 months)
* History of pelvic radiotherapy
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)

Purpose:

The study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients.

Study Design:

This is a single-center, prospective randomized study.

Population:

The study will include 30 patients with active rheumatoid arthritis: 15 patients treated with Filgotinib. 15 patients treated with Adalimumab (used as a comparison group).

Procedures:

Participants will have blood samples taken at the start and then every 4 weeks up to 12 weeks. These samples will be used to analyze changes in proteins and micro-RNA. Participants will continue their regular rheumatoid arthritis treatment during the study.

Primary Objective:

To observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib.

Secondary Objectives:

Compare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib.

Safety and Data Management:

Adverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws.

Study Duration:

Recruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.

Eligibility Criteria:
Inclusion criteria

* Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein \[DAS28 CRP\] \>5.1 and/or Clinical Disease Activity Index \[CDAI\] \>22)
* Age \> 18, \<65 years
* Patients for whom treatment with filgotinib or adalimumab might be planned

Exclusion criteria

* History of major cardiovascular events or stroke
* History of venous thromboembolism
* Active smokers or past smokers \>10 pack/years
* History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)
* Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)
* Chronic treatment with moderate to high dose of glucocorticoids (≥7.5 mg/day of prednisone equivalent for more than 3 months prior to enrollment), short term (\<3 months) will be accepted if tapered, as clinically feasible, to \<7.5 mg/day before enrollment)
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.

The aim of this study was to show consistency with the EMPHASIS-HF trial (NCT00232180), which was defined as a HR of the primary endpoint of below 1.

Eligibility Criteria:
Inclusion Criteria:

* Japanese chronic systolic heart failure patients with LVEF =\<30% by echocardiography and NYHA II or more
* Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion Criteria:

* Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.
* Patients with serum potassium \>5.0 mmol/L or eGFR \<30 ml/min/1.73 m2.
Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes

We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA).

In a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (GADAb). Sixty GADAb-positive non-insulin requiring diabetic patients with duration of diabetes =/\<5 years were assigned to either the SU group (n = 30) or the Insulin group (n = 30). Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values \[sigma C-peptide\] \<4 ng/ml).

Eligibility Criteria:
Inclusion Criteria:

* Subjects should use SU agents to obtain as a goal good glycemic control.
* Duration of diabetes within 5 years from the onset (or diagnosis).

Exclusion Criteria:

* Subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded.
* Subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.
Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks

Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.

Phase I Study of PM01183 in Non-Colorectal (non-CRC) Cancer Patients to determine the recommended dose (RD) of PM01183, to characterize the safety profile, compliance and feasibility of the schedule, to optimize and individualize PM01183 dosing in non-CRC patients according to individual tolerance, to characterize the pharmacokinetics (PK) of the schedule, to obtain preliminary information on the clinical antitumor activity and to perform an exploratory pharmacogenomics (PGx) analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signed and dated written informed consent
2. Age ≥ 18 years.
3. Non or minimally daily activities-interfering disease related symptoms.
4. Life expectancy ≥ 3 months.
5. Patients with solid tumor other than CRC.
6. Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).
7. Normal cardiac function cardiac function by appropriate image testing.
8. Women of childbearing potential must have a negative serum pregnancy test before study entry.

Exclusion Criteria:

1. Primary colorectal cancer diagnosis
2. Prior treatment with PM01183.
3. Concomitant diseases/conditions:

   a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.
4. Symptomatic and progressive or corticosteroid-requiring documented brain metastases
5. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
6. History of extensive prior pelvic irradiation.
7. History of previous bone marrow and/or stem cell transplantation.
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kg/m² inclusive and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Evaluation of Performance Over Dwell Time and Safety of the Central-venous Catheters Certofix® Paed

Central venous catheterisation is a medical technique that has become established over many decades and can be rated as State of the Art. However, there is only few clinical evidence for the use of Certofix® Paed and additional clinical data need to be collected to underline the long-term performance and safety in paediatric patients. An updated summary overview of Binninger and Roschke describes the potential incidence rates of the classically catheter-related complications, e.g. catheter malposition, catheter fracture, occlusion, thrombosis and catheter-related bloodstream infections (CRBSI) which may have an impact on overall morbidity, mortality and treatment costs. These catheter-related complications should be evaluated in this non-interventional study in paediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed assent from patients as well as written informed consent from legal representatives / parents (as applicable)
* Patient's first catheter placement during current hospital stay
* Placement of catheter according to IFU (Instruction for Use)

Exclusion Criteria:

* Contraindications according to IFU
* Patient has a documented or known allergy/sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
* Inclusion in another interventional study in the field of central-venous catheters which could interfere with the routine clinical practice regarding the application and care of the product until removal
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.

The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.

The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:

1. 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
2. have inadequate popliteal, tibial, or pedal revascularization target

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥18 years of age
2. Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target
3. Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups.

Exclusion Criteria:

1. Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
2. Subject is participating in the PROMISE II Clinical Trial.
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult, Age\>44 years, competent to provide consent
* Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days

Exclusion Criteria:

* Participants already prescribed chloroquine, hydroxychloroquine, or azithromycin
* Allergy to hydroxychloroquine or azithromycin
* History of bone marrow transplant
* Known G6PD (Glucose-6-Phosphate Dehydrogenase Deficiency) deficiency
* Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate \< 20ml/min/1.73m2
* Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase)\>2 times upper limit)
* Psoriasis
* Porphyria
* Known cardiac conduction delay (QTc \> 500mSec) or taking any prescription medications known to prolong QT interval
* Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
* Prisoner
* Weight \< 35kg
* Inability to follow-up - no cell phone or no address or not Spanish or English speaking
* Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
* No symptoms attributable to COVID-19
* Pregnant or nursing