cyrilzakka/clinical-trials huggingface dataset:
COUREUR Study Myocardial Inflammation in Cyclist Part 2

The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.

Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study. Each participant will complete a detailed questionnaire detailing their training history. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.

In part 2 of the study cardiac MRI will be performed at rest before the EDT cycling ride completion. An ECG registration using a RootiRx will be realized during and up to 6 hours after the cycling ride. An echocardiography and cardiac MRI will be repeated in each cyclist between 3 and 6 hours after EDT cycling ride completion. A blood sample will be obtained at that time after the ride. This time point is chosen based on the highest troponin release that 3 to 6 hours post-exercise would allow a sufficient amount of time for inflammation to develop and be detectable, corresponding with the time when cardiac Troponin T is typically detectable and representing the liberation of enzymes from damaged myocytes.

Finally, a third cardiac MRI will be repeated 24 hours after start of the cycling ride to verify the evolution of possible inflammation over this time period.


Eligibility Criteria:
Inclusion Criteria:

* Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride

Exclusion Criteria:

* presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases, active SARS-CoV-2 infection and the intake of anti-inflammatory drugs.
PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities

This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. English and Spanish speaking patients are eligible, with a planned sample size of up to 500 adults.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old,
* Fluency in English or Spanish
* Manage their own prescription medicines, and
* Have recently filled at least 1 new prescription medication (e.g, a medicine or medication dose that they have not taken before) and have their new prescription bottle information with them.

Exclusion Criteria:

* Excludes health professionals (such as a doctor, nurse or pharmacist)
* Too ill to participate in an interview
* Do not have a telephone
* Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
* Persons picking up new medicines for others
* Inability to communicate in either Spanish or English
* Overt psychiatric illnesses, overt delirium or dementia
Two Patterns of Micropulse Laser in the Treatment of Chronic Central Serous Chorioretinopathy

Central serous chorioretinopathy (CSC) is a common eye disease mainly involving the macular area, causing central visual acuity loss. Recently, subthreshold micropulse laser used in treating chronic CSC is proved to be safe and effective. However, some studies indicate that it's less effective than half dose photodynamic therapy (PDT). Certain physicians, including us, think that this may be related to micropulse laser parameters. Thus we need to explore better laser patterns to replace PDT in treating chronic CSC. The aim of this study is to compare the treatment effect of two different patterns of laser parameters (small and regular spot diameter) in treating chronic CSC. In this randomized, double blinded, controlled trial, by comparing the subretinal fluid regression ratio, central retinal thickness, macular microvisual field, macular vascular density, chroidal volume changes and visual acuity of two groups 6 months after micropulse laser treatment, we aim to evaluate the safety and efficacy of refined micropulse laser in treating chronic CSC.


Eligibility Criteria:
Inclusion Criteria:

* Patients age range 18-50 years
* Patients diagnosed with chronic Central serous chorioretinopathy
* Patients have signed informed consent

Exclusion Criteria:

* A history of other fundus diseases or refractive media opacity
* Patients have underwent other treatment methods for chronic Central serous chorioretinopathy
* Diopter\>-6D
* A history of system diseases such as hypertension or diabetes
* A history of using local or systemic corticosteroids
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma

To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months
* patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC);
* acceptable hematological indicators, no chemotherapy contraindications;
* total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group;
* At least one measurable lesion by CT or PET-CT（Positron Emission Tomography-Computed Tomography）;
* exclude other major diseases, normal heart and lung function;
* Female patients of childbearing age are negative for pregnancy test;
* Cooperate with follow-up;
* There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms);
* Signing informed consent \*: Pathological histology must be consulted by a pathologist at a provincial hospital.

Exclusion Criteria:

* Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma
* rejecting providing blood preparation;
* allergic to drug in this study and with metabolic block;
* rejecting adopting reliable contraceptive method in pregnancy or lactation period;
* uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas）；
* with severe infection;
* with primary or secondary central nervous system tumor invasion;
* with immunotherapy or radiotherapy contraindication;
* ever suffered with malignant tumor;
* having peripheral nervous system disorder or dysphrenia;
* with no legal capacity,medical or ethical reasons affecting research proceeding;
* participating other clinical trials simultaneously;
* adopting other anti-tumor medicine excluding this research;
* Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients
* Human immunodeficiency virus (HIV)-positive patients
* the researchers considering it inappropriate to participate in the study.
* Patients with immune system diseases
LEft Atrial Pacing in Diastolic Heart Failure

The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65
* Sinus rhythm, PR \< 220ms, QRS \< 110ms
* Heart failure (NYHA class III-IV or II with hospitalization for heart failure)
* Ejection Fraction \> 50%, restrictive mitral inflow, Lateral E/e' \> 12 or septal E/e' \> 15, Left atrial index volume \> 34 ml/m²
* Atrial dyssynchrony syndrome: (TTE) inter-atrial time delay ≥ 70ms (difference between tricuspid and mitral P-A intervals or between mitral and tricupsid P-A' intervals with DTI)
* Left atrio-ventricular asynchrony: Time Difference between tricupsid and mitral A wave duration ≥ 35ms.
Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer

This is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. This is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (LRC).

This is prospective randomized trial in high risk urothelial bladder cancer that includes 2 arms. The randomization will be done by permuted block method to 2 equal comparable groups. The total number of subjects will be 50 in each arm (Total=100 subjects).

This study include patients who may receive neoadjuvant chemotherapy \[Gemcitabine+Cisplatin\]) or not.

Arm (1) in this study (N=50) will received irradiation of both the bladder tumor bed and pelvic lymph nodes using IMRT technique. For Arm (2) (N=50) will undergo observation following radical cystectomy.

Eligibility Criteria:
Inclusion Criteria:

Patient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion with negative safety margin and belongs to one or more of the categories:

* ≥ 18 years old.
* PT3 or PT4a tumors.
* Grade 3 urothelial cancer.
* Positive infiltration of the dissected pelvic lymph nodes.

Exclusion Criteria:

* Residual tumors upon cystectomy.
* Previous pelvic irradiation.
* Non-urothelial bladder tumors.
* WHO performance status above 2.
* Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.
Involuntary Memories Investigation in Schizophrenia

Patients with schizophrenia suffer from autobiographical memory disorders. Patients have difficulty to remember vividly personal past events when they are specifically asked for. Indeed, this task requires a good executive functioning to retrieve precise information stored in long term memory. Interestingly, executive functioning has been showed impaired in schizophrenia and studies showed that their autobiographical memory impairments were directed related to their executive dysfunction.

Yet, in daily life people remember more often autobiographical memories spontaneously, without trying voluntarily to recall them.

In that case, the involuntary recall of personal past events is much less sustained by executive functioning.

In this protocol the investigators would like to investigate and compare subjective characteristics of involuntary and voluntary autobiographical memories in order to highlight the role of executive dysfunction in patients' autobiographical memory impairments.


Eligibility Criteria:
Inclusion Criteria:

* - for patients only
* male or female
* age limits : 18-55 years old
* under the protection of health insurance
* who have signed up the consent form
* schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).
* clinically stable for at least 2 months
* patients under guardianship or curatorship need agreement of their legal representative
* informed of the results of prior medical examination for controls only
* male or female
* age limits : 18-55 years old
* under the protection of health insurance
* who have sign up the consent form
* recruited from the general population and matched on gender, age years of schooling
* no psychiatric history (DSM-5)

Exclusion Criteria:

* for both patients and controls
* current severe or unstable somatic illness
* neurological history (brain injury \> 15 minutes loss of consciousness , epilepsia, brain surgery...)
* current substance use disorder (DSM-5)
* current major depressive disorder (CDSS,BDI, HDRS)
* mental retardation (IQ \< 70, WAIS-4, f-NART)
* history of general anesthesia 3 months prior to the experiment
* pregnancy declared by the subject
* breast feeding
* current legal control
* in emergency situation
* included during exclusion period in another experiment
* for controls only
* taking of antipsychotic drugs for the 3 weeks prior to inclusion
* under guardianship or curatorship
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients

The purpose of this study is to assess the acceptability and effectiveness of utilizing vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs) among sexually active female-to-male (FTM) transgender adults.

This observational study will examine sexual health in a bio-behavioral cross-sectional mixed-methods design among 150 FTM patients in Boston, Massachusetts, and will determine the acceptability as well as collect epidemiologic data on the comparative performance characteristics of several biological screening modalities in this patient population. Patients and stakeholders are key partners throughout the project and are involved in all phases of study development, implementation, and plans for dissemination.

Eligible participants will participate in a one-time clinical visit. Following written consent, the one-time clinical visit will include: 1) Quantitative assessment; 2) Collection of biological specimens/biomarkers (HPV DNA vaginal self-swab, HPV DNA cervical swab collected by provider, Pap test with cytology, STI testing self- and provider-collected); 3) Qualitative Interview.

A series of national, online focus groups with FTMs, providers, and key stakeholders will occur to gather information on the sexual health needs of FTM individuals outside the Boston area and to ensure that the dissemination of study findings take differing demographic concerns into consideration.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-64
* Assigned a female sex at birth and now self-identifies as a man, trans masculine, trans man, FTM, transgender, genderqueer/non-binary, transsexual, male, and/or another diverse transgender identity or expression
* Have a cervix
* Sexually active in the past 36 months (with sexual partner(s) of any gender)
* Able to speak and understand English
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent due to severe mental or physical illness
* Substance intoxication at the time of interview
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects

The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy.

This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks.

The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
* Had adequate bone marrow reserve and organ function
* Are not pregnant and are willing to use contraception, if, of childbearing potential
* Are willing and able to comply with the protocol and to give written informed consent
* Other protocol defined inclusion criteria may apply

Exclusion Criteria:

* Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
* History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
* Any cause for the liver disease other than chronic hepatitis C
* Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
* Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
* Previous systemic treatment for Hepatitis C with an interferon or ribavirin
* Presence of systemic disease that might interfere with subject safety, compliance or evaluation
* Known allergies to acetaminophen, human serum albumin or mannitol;
* Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment
* Bearing organ transplants (except cornea)
* Other protocol defined exclusion criteria may apply
Childhood Acute Lymphoblastic Leukaemia: Follow-Up

Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce.

The aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.

Investigators have identified a cohort of children with B-precursor ALL and T-ALL enrolled in the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-92, ALL-2000 and ALL-2008 trials and experienced a relapse or an SMN as the first event after cessation of maintenance therapy (368 patients). From medical charts and blood test results it will be decided whether the relapse/SMN was diagnosed at a routine visit (including routine blood tests) or if the relapse was diagnosed because of symptoms at a non-scheduled visit or blood test.

As the NOPHO database probably is one of the most complete databases globally, it is an advantage to perform this study as a NOPHO study.

Results of this population based relapse study will provide an evidence-based background for planning optimal and relevant follow-up programs for children after therapy of ALL treated according to contemporary Nordic ALL protocols.

The study is important and relevant in the light of today's high ALL cure rates and a need for optimal follow-up programs after cessation of ALL treatment and possible prediction of relapse.

The timing of the project is an increased focus on the clinical relevance of routine clinical follow-up of patients treated for cancer.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway, Finland or Iceland)
* included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials
* treated in a Paediatric Department
* developing a relapse/SMN after cessation of maintenance therapy before 31st of December 2016

Exclusion Criteria:

* hematopoietic stem cell transplantation in first complete remission
The Impact of Leg Immobilization on Postabsorptive and Postprandial Muscle Protein Breakdown in Healthy Young Males

The present study will seek the quantify the simultaneous muscle protein synthesis and breakdown response with and without amino acid provision in humans following 2 days of immobilisation.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-40 years of age
* Body mass index between 18.5 and 30

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension
* Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism)
* A personal or family history of epilepsy, seizures or schizophrenia
* Any known disorders in muscle metabolism
* Regular use of nutritional supplements
* Allergy to lidocaine
* Allergy to one or multiple amino acids
* Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture) as these could be exacerbated by the intervention e.g. unilateral leg immobilisation, or mean the participant is unable to use crutches.
* Having received or ingested a stable isotope tracer in the past
Multidisciplinary Approach to Novel Therapies in Cardiology Oncology Research

While trastuzumab has been shown to prevent recurrences of breast cancer, some women may also experience damage to their heart muscle (including heart failure) as a result of their treatment. The investigators hope to learn if standard medications used in heart failure can prevent heart damage caused by trastuzumab in women with breast cancer. The investigators would also like to know if there are any ways to detect this damage earlier using magnetic resonance imaging (MRI) and blood tests.

We propose a randomized, placebo-controlled, double-blind study evaluating the efficacy of an ACE-inhibitor (perindopril) or a beta blocker (bisoprolol) for the prevention of LV remodeling among women with early breast cancer scheduled for chemotherapy and one year of trastuzumab. Participants will undergo cardiac MRI at baseline and 3 and 12 months, replacing the usual MUGA, as well as a post-treatment cardiac MRI at 24 months to evaluate long-term effect.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of HER2 positive breast carcinoma
* Eligible to receive trastuzumab
* Age \> 18 years
* Able to give informed consent
* No contraindications to MRI

Exclusion Criteria:

* Known contraindication to beta-blocker therapy
* Known contraindication to ACEI therapy
* Current treatment with ACEI or beta blocker for other indication
* History of heart failure, cardiomyopathy or baseline LVEF \< 50%
Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus

A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years old who had a positive test for SARS-COV-2 virus
* Patients with a severe and critical disease by SARS-COV-2, who were treated at the ICU of Fundación Valle del Lili, and survived
* Patients with chest radiography or CT scan at admission to the hospital

Exclusion Criteria:

* Patients who do not sign informed consent.