cyrilzakka/clinical-trials huggingface dataset:
Mindful Movement for Breast Cancer Survivors

The purpose of this study is to determine if participating in a Mindful Movement Program (MMP) (learning how to be mindful in one's movement), positively affects the body's immune functions improves mindfulness and reduces worries about cancer returning. All participants will be in this study about three months.

Breast cancer survivors (BCS) may experience psychological and physical effects long after treatment is over. Some research shows that practicing mindfulness, and movement types of activities such as qi gong or yoga may lead to improvements in emotional and physical well-being, including improved immune function. Immune function can be negatively affected by stress and worry, and this has an unknown effect on the risk of cancer recurrence. Psychological and physical interventions that help enhance an individual's wellbeing and reduce stress and worry may have a positive influence on immune function and in turn, reduce the risk of cancer recurrence. While there is limited research in this area, and none with dance therapy, little attention has been given to older BCS. However, understanding of immune function suggests that older women may be the best group to target for such interventions. Previous research with BCS age 50 or older who participated in a 12-week program combining mindfulness practice with dance/movement therapy (Mindful Movement Program) demonstrated positive effects: participants were more mindful in their day-to-day living and had less worry about the cancer coming back. Participants also reported through focus groups that the Mindful Movement Program (MMP) had improved their overall well-being. No laboratory tests of the body's immune response to MMP were included.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed at age 50 or older with stage 0-III disease
* 6 months or more since completion of primary breast cancer treatment
* have a medical release from their physician
* English-speaking
* not pregnant
* no weekly practice of yoga, qi gong, tai chi, dance/movement therapy, or mindfulness meditation practice

Exclusion Criteria:

* Males with breast cancer
Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease

The aim of the protocol is to study the resting brain activation profile of 3 groups of people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25 Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy controls. The first analysis of the data will search differences of brain activation profiles between the 3 groups. In the second step, the investigators will study the predictive value of fMRI-SAM to detect MCI patients who will later convert to AD.


Eligibility Criteria:
Inclusion criteria:

* Alzheimer's disease of mild to moderate severity (25 patients)
* Amnestic MCI patients (25 patients)
* 55-75 year-old patients

Exclusion criteria:

* Any other cause of dementia for AD patients
* Any stroke
* Any disease with a negative vital prognosis
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study).
2. Subjects with constipation caused or aggravated by opioids
3. Subjects must be willing to discontinue their current opioid analgesic routine, and .
4. current laxative regimen

Exclusion Criteria:

1. Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
2. Subjects presently taking, or who have taken, naloxone \<=30 days prior to the start of the Screening Period.
3. Subjects suffering from diarrhoea.
4. Abnormal liver or kidney function.
Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.

This randomized, double-blind, placebo-controlled trial will evaluate the impact of methylfolate, pyridoxal-5'-phosphate (P5P), and methylcobalamin supplementation on homocysteine and LDL-C levels in individuals with low to medium cardiac risk and MTHFR, MTR, and MTRR gene polymorphisms. The study aims to explore the efficacy of these vitamins in reducing homocysteine levels, a critical risk factor for cardiovascular disease (CVD), while also monitoring LDL-C levels. The findings will offer valuable insights into personalized CVD prevention and management, emphasizing the significance of genetic factors in nutritional therapy.

Design: Participants with specific genetic polymorphisms and homocysteine levels above 15 µmol/L, without a history of severe CVD or other exclusion criteria, will be enrolled and randomized into two groups: one receiving methylfolate, P5P, and methylcobalamin, and the other a placebo. The study, adhering to ethical standards and informed consent, will involve 54 patients divided equally between the treatment and placebo groups. The primary endpoint will be the percent change in homocysteine levels over six months, with secondary endpoints including changes in LDL-C and other lipid profile components.

Intervention: Participants will receive either the active treatment (L-methylfolate, P5P, and Methylcobalamin) or a placebo, with both groups taking two capsules daily for 180 days. Fasting measurements of lipid profiles and homocysteine levels will be conducted at the start, midpoint, and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75.
* Homocysteine levels greater than 15 µmol/L and LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.
* Presence of at least one minor allele in any of the following genetic polymorphisms: rs1801133 (MTHFR C677T), rs1801131 (MTHFR A1298C), rs1805087 (MTR A2756G), and rs1801394 (MTRR A66G).

Exclusion Criteria:

* Personal history of cardiovascular disease or high risk (≥ 20%).
* Triglycerides (TG) ≥ 400 mg/dL.
* Obesity (Body Mass Index \> 32 kg/m\^2).
* Assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months.
* Use of medications or supplements known to affect homocysteine levels, such as B-vitamins and certain antihypertensives, within the last three months.
* Diabetes mellitus.
* Known severe or uncontrolled thyroid, liver, renal, or muscle diseases.
Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma

The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed mantle cell lymphoma
* Relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents
* ECOG performance status 2 or less
* Adequate hematologic, hepatic, and renal function i. White blood cells ≥ 3,000 /ul ii. Absolute neutrophil count ≥ 1,000 /ul iii. Platelets ≥ 50,000 /ul iv. Hemoglobin ≥ 9.0 g/dL v. Total bilirubin \< 2 times upper limit of normal vi. AST, ALT \< 2.5 times upper limit of normal vii. Serum creatinine \< 1.5 times upper limit of normal

Exclusion Criteria:

* Previously treated with 4 or more lines of chemotherapy with or without immunologic agents
* Previously treated with bortezomib
* Treated with a cytarabine-containing regimen as the last line and within 6 months before registration
* Other cancer diagnosed within 5 years before registration
* Uncontrolled symptomatic CNS involvement of mantle cell lymphoma
* Uncontrolled systemic infection
* Inherited immunodeficiency disease or AIDS
* Pregnancy
* Breast-feeding
* Peripheral neuropathy of grade 3 or higher
* Other health conditions considered to be inappropriate for this trial in the primary physician's opinion
A Study to Evaluate the Efficacy and Safety of SYHX1901 Tablet in Non-segmental Vitiligo Patients

A 52-Week Study of SYHX1901 tablet in Adults with non-segmental vitiligo.

SYHX1901 tablet is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 144 participants aged 18-65 with non-segmental vitiligo in 4 treatment arms. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign an ICF, able to comprehend and comply with the study procedures.
2. Male or female subjects aged 18 to 65，inclusive.
3. Subjects with a clinical diagnosis of non-segmental vitiligo.
4. Agree to stop all other treatments for vitiligo during the study period.
5. Women of child-bearing potential must have a negative serum pregnancy test within 3 days prior to the first study agent administration.

Exclusion Criteria:

1. Diagnosed as other active depigmentation disease.
2. At screening or baseline visits, subject exhibits active inflammatory dermatologic disease or symptoms that in the opinion of investigators would interfere of vitiligo evaluation or response to treatment.
3. Uncontrolled thyroid function at screening as determined by the investigator.
4. Use of permanent depigmentation treatment or skin grafts.
5. Use of phototherapy, topical or systemic treatments within certain time frame prior to Day1.
6. Have active bacterial/virus/other pathogens infection or infestation that require medical intervention.
7. Have progressive or uncontrolled systemic disease, or other concomitant chronic disease that the investigators believe unsuitable to participate the study.
8. History of alcohol and drug abuse within one year prior to screening; History of neurological or mental disorders with diagnosis records, such as severe depression, suicidal tendencies, epilepsy, dementia, etc.
9. Have any other reasons determined by the investigator that the subject is not eligible for the study.
Dexamethasone in Cryptococcal Meningitis

To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with cryptococcal meningitis and intracranial hypertension.

In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.

In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis.

Patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). Additionally, standard antifungal therapy with amphotericin B and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. Lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine or systemic chemoprophylaxis for PCP.
* Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin).

Patients must have:

* Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.)
* Acute cryptococcal meningitis with cerebrospinal fluid opening pressure \>= 250 mm H2O prior to receipt of antifungal therapy for this episode.
* Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection.
* Ability to begin therapy within 8 hours after the pre-entry lumbar puncture.
* Consent of parent or guardian if less than 18 years of age.

NOTE:

* Comatose patients eligible provided informed consent can be provided by guardian or next of kin.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response.
* Prison incarceration.

Concurrent Medication:

Excluded:

* Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study.
* Treatment or prophylaxis with other systemic antifungal agents at any time.
* Antiretroviral therapy during the first 72 hours of the study.

Prior Medication:

Excluded within 7 days prior to study entry:

* Corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin.
A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With Tocilizumab (RoActemra/Actemra)

This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of tocilizumab in patients with rheumatoid arthritis. Patients initiated on treatment with tocilizumab according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to revised (1987) American college of rheumatology (ACR) criteria
* Initiated on tocilizumab treatment by the treating physician in accordance with the Canadian product monograph
* Informed consent to data being subject to computerized data processing
* Participant must fulfill the reimbursement criteria for treatment with tocilizumab under provincial or private health insurance coverage

Exclusion Criteria:

* Received tocilizumab prior to enrolment visit
* Previously received tocilizumab in a clinical trial or for compassionate use
* Enrolled in an ongoing clinical trial and/or received treatment with any investigational agent within 4 weeks, or 5 half-lives of the investigational agent, whichever is longer, before starting treatment with tocilizumab
* Participation in another clinical trial or industry sponsored observational study
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome
Intra-parotid Facial Nerve Tractography

The aim of the study is to evaluate concordance between the facial nerve's path in the parotid evaluated by radiologist in preoperatively and the facial nerve's path in the parotid evaluated by surgeon in peroperatively.

Surgery is the main treatment for parotid tumol, benign or malignant pathologies. The procedure requires a trunk search and a facial nerve dissection along its intraparotid length. This intervention entails a risk of facial paralysis.

MRI tractography is a new imaging technique that can characterize nerve fibers and their path.

The interest would be to allow the surgeon to best prepare the parotidectomy by locating the tumor in relation to the trunk and all the branches of the facial nerve.

Eligibility Criteria:
inclusion criteria :

* Major patient
* Patient with initial parotid mass or recurrent
* Parotidian mass with surgical indication
* Benign or malignant
* With or without preoperative facial paralysis
* Patients consenting the protocol

exclusion criteria :

* Parotidian masses without surgical indication
* Patient with a classic contraindication to MRI
Physiological Impact of Cloth Mask During Exercise

Mask wearing during the Covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. However, cloth masks may be uncomfortable and have physiological repercussion during exercise. This study aims to investigate the impact of cloth masks during exercise.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* active, non-active and athletic individuals;

Exclusion Criteria:

* preexisting chronic conditions
* obesity
* physical limitation precluding exercise.
Distal Radial Access for Primary PCI in STEMI Patients to Prevent RAO

Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.

Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ST-segment elevation myocardial infarction for primary percuteous coronary intervention
* Palpable pulses on both access sites of the radial artery
* Informed consent

Exclusion Criteria:

* Thrombolysis before primary percutaneous coronary intervention
* Previous CABG or radio-cephalic fistula using radial artery
* Cardiogenic shock
* Severe arrhythmias
* Severe liver and kidney dysfunction
* Pregnancy
* Enrolment in another study within 1 month
* Inability to obtain written informed consent
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).


Eligibility Criteria:
Inclusion Criteria:

* Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b). Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503) OR (c). Participants who completed through Week 24 of the phase 3b durability study (NCT05052983) or who exit the study due to relapse may be eligible to re-enter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites)
* Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
* Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study
* Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

Exclusion Criteria:

* Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
* Body weight \< 30 kg
* Pregnant women (positive pregnancy test result at screening or baseline visit or re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during the clinical study
* Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia)
* Planning or expected to have a major surgical procedure during the clinical study
* Participants unwilling to refrain from using prohibited medications during the clinical study
* History of alcohol or substance abuse within 6 months prior to the screening visit or re-entry Week R0 visit
Eplerenone for the Treatment of Central Serous Chorioretinopathy

To test the effect oral eplerenone versus placebo in patients with central serious chorioretinopathy .

To evaluate the effect of oral eplerenone compared to placebo in patients with central serous chorioretinopathy (CSCR) on sub-foveal (small part of retina) fluid using optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Ability to give written informed consent
* Sub-retinal fluid under fovea seen on OCT
* Diagnosis of central serous chorioretinopathy (CSCR): classification is at the discretion of the investigator, but general guidelines are

  1. Acute- first episode or symptoms less than one month prior to presentation
  2. Chronic- previously documented sub-foveal fluid, any prior treatment, symptoms for over 3 months, or \<50% reduction in fluid thickness on OCT after 3 months.

Exclusion Criteria:

* Age under 18
* Impaired decision-making ability
* At initial laboratory screening serum potassium \>5.5 milliequivalent (mEq)/L
* At initial laboratory screening serum creatinine \>2 mg/dL in men and \>1.8 mg/dL in women or decreased renal function by creatinine clearance less than 50 mL/min
* Absence of sub-foveal fluid
* Any patient with prior treatment for CSCR within 3 months of enrollment
* Patients taking potassium supplements or potassium-sparing diuretics spironolactone, amiloride, and triamterene and/or potent CYP3A4 (cytochrome) inhibitors (amifostine, cyclosporine, fluconazole, itraconazole, ketoconazole, mifepristone, posaconazole, potassium salts, rituximab, tacrolimus, voriconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)
* Women who are pregnant or are actively trying to conceive
* Patients with type 1 or type 2 diabetes