Kornimate/medical-research-clean huggingface dataset:
irbesartan versus amlodipine: the obi study

Conditions: Obesity; Hypertension

Summary: objective: 1. to study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects 2. to study the drug specific effect in arterial stiffness 3. to study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)

study objectives 1. primary: * reduction of 24h bp in obese hypertensives * reduction in arterial stiffness 2. secondary * drug specific effect on new onset of diabetes * drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio study design study drugs: irbesartan 300mg vs. amlodipine 10mg tx duration and follow-up: 12 months collected data: * 24h sbp and dbp in time 0, 1, 12. * pulse wave velocity in time 0,1,12. * central obesity (total, visceral, abdominal fat) in time 0,1,12. * leptin/adiponectin in time 0,1,12. * bmi, waist/hip ratio in time 0,1, 12. * glu, hba1c, insulin in time 0, 1,12. * k, na, cr, bun, chol, tg, hdl, ldl,alt, ast in time 0, 1,12. number of patients: the reduction in mean sbp expected to be 15 mmhg. previous studies from our group reported an 14mmhg sd for mean sbp. the sample size required at the two sided 5% significance level and 80% power is 40 patients (lehr's formula) number of centers: 1

Eligibility criteria:
inclusion criteria: 1. age between 18 and 60 years. 2. all patients are going to give their informed consent to participate in the study. 3. stage i hypertension. 4. bmi \> 30. exclusion criteria: 1. known oversensitiveness, 2. chronic renal disease (gfr \< 50 ml/min) or esrd, 3. heart or respiratory failure, or 4. recent mi, shock, liver deficiency (alt or ast \> 3 times normal and pregnancy or lactation.

Keywords: irbesartan amlodipine obesity ambulatory blood pressure monitoring new onset diabetes
a study of ninlaro in real world clinical practice in china

Conditions: Multiple Myeloma; Neoplasms, Plasma Cell

Summary: the main purpose of this study is to collect additional safety information of ixazomib citrate (ninlaro) when used to treat multiple myeloma in real world clinical practice in china. participants will be treated with ninlaro according to the normal clinical practice during this study.

this is a prospective, non-interventional study in chinese participants with relapsed refractory multiple myeloma (rrmm), newly diagnosed multiple myeloma (ndmm) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. data will be collected to assess safety information when ninlaro is used in the real world, based on known risks and missing safety information. the study will enroll approximately 3000 patients. the data will be collected prospectively as part of routine clinical visits of participants. participants will be assigned to one of the two observational cohorts: * cohort 1: participants with rrmm * cohort 2: participants with ndmm, rrmm, and non-myeloma the multi-center trial will be conducted in china. the overall duration of study will be approximately 64 months. all participants will be followed up for 21 months unless withdrawal of informed consent form, loss of follow-up or death, whichever comes first.

Eligibility criteria:
inclusion criteria: 1. undergoing treatment with ninlaro (of less than 3 months from initial treatment with ninlaro) or to be prescribed with ninlaro capsule. 2. participants will be able to sign informed consent form to participate. exclusion criteria: 1. currently participates or plans to participate in any interventional clinical trial. 2. any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Keywords: drug therapy
effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated for intermittent claudication (relief)

Conditions: Peripheral Artery Disease With Intermittent Claudication

Summary: to study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated for intermittent claudication.


Eligibility criteria:
inclusion criteria: * aged between 20 and 85 years at visit 1 * patients with ankle-brachial index (abi) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months * patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed) * patients whose blood pressure is more than 140/90 mmhg with/without anti-hypertension treatment exclusion criteria: * blood pressure of more than 180/110 mmhg * patients taking arbs or ace inhibitors treatment for at least 6 months before * patients taking aldosterone receptor antagonists at least 6 months before * patients with serum creatinine of more than 3 mg/dl * serum potassium (k+) \> 5.5mg/dl * history of bilateral renal artery stenosis * history of acute coronary syndrome or heart failure hospitalization within 6 months * peripheral arterial revascularization planned within 1 month * critical limb ischemia * patients with impaired cognition (e.g. dementia) * pregnancy or women at age of childbearing potential
clinical evaluation of t.r.u.e. test allergens in children an adolescents

Conditions: Allergic Contact Dermatitis

Summary: the objective of the study was to evaluate the diagnostic performance and safety of t.r.u.e. test allergens in pediatric subjects aged 6-17 years old. in total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

the evaluation of 7 new allergens on panels 2.2 and 3.2, gold sodium thiosulfate, hydrocortisone-17-butyrate, bacitracin, parthenolide, methyldibromoglutaronitrile, disperse blue 106, and bronopol was the original objective of the study. the protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

Eligibility criteria:
inclusion criteria: * symptoms and history potentially consistent with allergic contact dermatitis * children and adolescents 6-17 years of age, in general good health * adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion * informed consent must be signed and understood by subject. if underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations exclusion criteria: * topical corticosteroid treatment during the last 7 days on or near the test area. * systemic treatment with corticosteroids or other immunosuppressives during the last 7 days. * subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study * treatment with ultraviolet (uv) light (including tanning) during the previous 3 weeks * acute dermatitis outbreak or dermatitis on or near the test area on the back * subjects unable to comply with activity restrictions (e.g. protecting test panels from excess moisture due to showering or vigorous activity) * subjects unable or unwilling to comply with multiple return visits * female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test

Keywords: contact dermatitis eczema
sentinel lymph node mapping using magtrace and mri in healthy subjects for potential use in melanoma patients

Conditions: Melanoma

Summary: sentinel lymph node biopsy (slnb) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with technetium (99mtc) as radioactive tracer. intra-operatively, patent blue (pb) will be injected to improve the visualization of the lymphatic tract. however, current pre-operative sln mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mtc. superparamagnetic iron oxide (spio) is novel, non-radioactive technique using a magnetic tracer (magtrace® (endomagnetics ltd.)) and several studies showed that spio is non-inferior to dual tracing with 99mtc and pb in breast cancer patients. spio is expected to be non-inferior to dual tracing with 99mtc and pb in melanoma patients. however, further research is needed to demonstrate the use of spio in pre-operative magnetic resonance imaging (mri) scanning. guidance on pre-operative mri use is rather limited, though fundamental in the intended research process. hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative mri protocol for melanoma patients. the acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.


Eligibility criteria:
inclusion criteria: * healthy participants; * participants should be ≥18 years of age at the time of consent; * participants should be willing to provide informed consent. exclusion criteria: * known intolerance/hypersensitivity to iron, dextran compounds or magtrace® itself; * standard mri exclusion criteria: * implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator); * any other metal implants; * claustrophobia; * mr-incompatible prosthetic heart valves; * tattoos inked with metallic dye. * participants who refuse to provide informed consent.

Keywords: magnetic tracer sentinel lymph node melanoma mri
ttv viral load in heart transplant recipients

Conditions: Heart Transplant Rejection; Heart Transplant Infection; Virus

Summary: this prospective, multicenter, non-interventional trial aims to study the association between ttv viral load and the occurrence of rejection or infection during the first year after transplantation. the ttv viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.

ttv (torque teno virus) is a ubiquitous virus that is not associated with any disease. a correlation exists between the level of ttv replication and the subject's immunocompetence: weak or non-existent in immunocompetents, very high in immunocompromised patients. in heart transplant patients, pharmacological dosing of immunosuppressants prevents their toxic manifestations but is not correlated with individual immune competence. only clinical manifestations of overdose (infections) or under dosage (rejections) currently allow optimization of immunosuppressants. a predictive biomarker of these clinical manifestations upstream of their appearance would revolutionize the management of these patients. the ttv fulfills the conditions to be an ideal biomarker: classic blood sampling, possible follow-up in all patients, low cost, carrying out the analysis on already existing molecular biology platforms, reproducibility of inter- and intra-laboratory results, defined thresholds for the reliable interpretation of the results. we believe that this marker will provide the clinician with a useful tool for the management of immunosuppressants and the patient with personalized medicine which will allow their management to be individualized. if this study confirms the expected results, then it will allow, secondly, the setting up of interventional studies to validate the ttv viral load as a biomarker, and a tool for piloting immunosuppressive treatment. the ttv viral load of heart transplant patients will be follow during the first year after transplantation. a tube of blood will be taken during the transplant and then once or twice a month. samples will be taken at the same time as those taken as part of standard care. the ttv viral load will be measured at the end of the study. the occurrence of events of interest (infections and rejections) will be collected at each corresponding visit.

Eligibility criteria:
inclusion criteria: * age ≥18 years * heart transplant only * first transplant * patient not having objected to carrying out the research * affiliated to a french health insurance system. exclusion criteria: * patient transplanted from more than one solid organ * patient who has already been transplanted before * patient under guardianship or curatorship * patient under legal protection * pregnant or breastfeeding woman

Keywords: ttv, heart transplant, viral load, rejection, infection
high flow nasal cannula (hfnc) versus nasal intermittent mandatory ventilation (nimv)for respiratory distress syndrome (rds): a randomized, controlled, prospective study

Conditions: Respiratory Distress Syndrome

Summary: the investigators hypothesize that while the extremely low birthweight (elbw) infants (\<1000 g) may need nimv for the treatment of rds, larger infants or the smaller ones post extubation may enjoy the comfort benefits associated with hfnc while getting coparable respiratory support to nimv.


Eligibility criteria:
inclusion criteria: 1. gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight \>1000 g for the initial treatment of rds or \<35 weeks post extubation or for apnea of prematurity 2. infants with rds who will need nrs as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent. exclusion criteria: 1. significant morbidity apart from rds including: cardiac disease (not including patent ductus arteriosus \[pda\]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (ivh), 2. parents refuse consent. 3. unavailability of suitable ventilator.

Keywords: primary treatment of rds and treatment of rds post extubation
fluorine f 18 sodium fluoride pet/ct and whole body and axial mri in finding metastases in patients with recurrent prostate cancer

Conditions: Recurrent Prostate Cancer

Summary: this phase ii trial studies how well fluorine f 18 sodium fluoride positron emission tomography (pet)/computed tomography (ct) and whole body and axial magnetic resonance imaging (mri) work in finding metastases in patients with recurrent prostate cancer. new imaging techniques, such as fluorine f 18 sodium fluoride pet/ct and whole body and axial mri, may be more effective than standard ct and bone scan in finding metastatic prostate cancer.

primary objectives: i. to determine the proportion of patients with biochemically-recurrent prostate cancer (pc) in whom imaging with whole body (wb)/axial mri and f-18 naf (fluorine f 18 sodium fluoride) pet/ct results in detection of metastatic disease not visualized on ct scan and bone scan. secondary objectives: i. to estimate the percent of eligible patients with negative, indeterminate and positive ct scan/bone scan and targeted x-rays if done. ii. to determine the proportion of patients with biochemically-recurrent pc in whom recurrence in the prostate bed can be visualized using mri in the absence of detection using ct scan. iii. to correlate the presence of metastatic disease detected using wb/axial mri and/or f-18 naf pet/ct with the predicted 6-year probability of progression-free survival based on the memorial sloan kettering cancer center salvage radiation therapy (rt) pc nomogram, and with prostate-specific antigen (psa) level at baseline. iv. to compare the role of axial mri of the spine to wb/axial mri with respect to their ability to identify sites of disease. similarly, to evaluate the relative contribution of f-18 naf pet and wb/axial mri. outline: patients first undergo ct scan and bone scan. patients with negative results from the ct and bone scans then undergo wb mri scan using diffusion-weighted mri, axial mri scan using 3-tesla mri, and fluorine f 18 sodium fluoride pet/ct scan. after completion of study, patients are followed up at 4-6 months and periodically until week 52.

Eligibility criteria:
inclusion criteria: * history of prior radical prostatectomy for prostate cancer * two psa values \>= 0.2 ng/ml at least 4 weeks after prostatectomy * patients who have started radiographic evaluation and underwent ct scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (wb/axial mri and f-18 naf pet/ct) can be completed within 8 weeks after ct scan and bone scan exclusion criteria: * patients with known metastatic disease * psa recurrence not verified by elevated psa as discussed in the eligibility section * patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for psa recurrence; nutritional supplements used for treatment of psa recurrence will be allowed
a survey exploring health and screening tests in people treated for hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: a survey of health beliefs and cancer screening behaviour and intentions in hodgkin lymphoma survivors

a survey of hodgkin lymphoma survivors registered in a follow-up database, examining health beliefs (using health belief model) around breast, bowel and lung cancer screening, previous screening uptake and future uptake intentions

Eligibility criteria:
inclusion criteria: * details held in the adapt database at the christie nhs foundation trust * aged 18-80 * previously treated for hodgkin lymphoma without evidence of relapse for at least 5 years * treated with radiotherapy and/or alkylating agent containing chemotherapy exclusion criteria: \* have previously stated they do not wish to be contacted for research
the use of competition in a school-based intervention for increasing cardiorespiratory fitness in adolescents

Conditions: Cardiorespratory Fitness; Mental Health; School-based Intervention

Summary: regular physical activity offers numerous physical, psychological, and cognitive health benefits. however, physical inactivity among adolescents remains a global concern, with 81% of 11- to 17-year-olds failing to meet who's recommendation of at least one hour of moderate- to vigorous-intensity activity daily. this inactivity contributes to immediate and long-term health risks, as many non-communicable diseases (ncds) in adulthood are linked to behaviors established during adolescence. promoting healthy lifestyles early is crucial for lifelong health and disease prevention. one significant barrier to effective school-based physical activity programs, such as high-intensity interval training (hiit), is maintaining student motivation. low engagement often results in poor adherence. integrating competition-focused on effort rather than performance-may enhance student participation and make hiit interventions more effective and easier to implement. this study will evaluate the impact of competition on the burn 2 learn - mallorca (b2l-m) program, targeting adolescents aged 15-18. the intervention aims to determine whether competition improves engagement and outcomes compared to non-competitive groups. the primary outcome is cardiorespiratory fitness (crf), while secondary outcomes include muscular strength, physical activity levels, body composition, mental health (stress and sleep quality), behavior change mediators (self-efficacy, motivation), on-task behavior, blood pressure, and sitting posture. the b2l-m intervention will involve a 16-week, three-arm cluster randomized controlled trial in mallorca, spain, recruiting approximately 360 students from six schools. the program includes teacher-led hiit sessions twice weekly during physical education, supported by information seminars, a dedicated website, and parental e-newsletters. outcomes will be assessed at baseline and after 16 weeks.


Eligibility criteria:
inclusion criteria: * students who belong from "3º eso" to "1º bachillerato" levels exclusion criteria: * students with a health or medical condition that would preclude participation in vigorous physical activity will be excluded from the study but will still participate in normal lessons adapted by the pe teacher
pain in fibrous dysplasia

Conditions: Fibrous Dysplasia/McCune-Albright Syndrome

Summary: pain remains a common and frequently debilitating symptom, particularly during adulthood of fibrous dysplasia/mccune-albright syndrome (fd/mas). for many fd/mas patients, the amount of pain perceived is not commensurate with the level of detectable musculoskeletal pathology. using a combination of clinical and biological assessments, this investigation aims to understand what drives pain in fd/mas.

in fibrous dysplasia/mccune-albright syndrome (fd/mas), healthy bone tissue and marrow is replaced with pre-osteoblastic, fibrous tissue, yielding skeletal deformities and an increased propensity towards fracture, musculoskeletal weakness and bone pain. despite the frequent use of pharmacological and non-pharmacological analgesic strategies, pain in fd remains common and frequently debilitating, particularly during adulthood. moreover, for many patients there is a discordance between perceived pain levels and detectable musculoskeletal pathology. to elucidate the mechanism underlying pain in fd/mas patients, investigators at the national institute of dental and craniofacial research (nidcr), national center for complementary and integrative heath (nccih) and boston children's hospital (bch) aim to probe three inter-related domains that are projected to underlie pain experience(s) in fd/mas patients. these include (i.) the presence of maladaptive central nervous system processes that amplify afferent pain or somatosensory signals, and also facilitate persistent pain; (ii.) aberrant interplay between neurological and musculoskeletal systems; (iii.) a mental health status shaped by the overall burden of living with fd and (iv.) the influence of childhood, fd-related complications on adulthood pain phenotypes. to investigate these four domains hypothesized to underlie fd pain as well as inform on the disconnect between pain and fd disease burden, the investigators will employ methods that complement routine clinical evaluation and diagnostic tests (i.e., 18f-naf pet/ct or 18f-fdg pet/ct) such as neuroimaging, musculoskeletal mri and such as neuroimaging, musculoskeletal mri and assessment of inflammatory and pain mediator expression in blood samples.

Eligibility criteria:
inclusion criteria (fd/mas patients): * male and female subjects * 10-45 years of age * english speaking ability sufficient to comprehend consent (with parental assistance if minor) * diagnosis of fibrous dysplasia exclusion criteria for patients: * younger than 10 or older than 45 years old * weight \> 285 lbs (weight limit of the mri table and \< 36lbs) * surgery leaving implanted material * contraindications to mri scanning and pet scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia, previous significant research related exposure to ionizing radiation) exclusion criteria for healthy controls: same as for the patients, with the addition of the following: • use of recreational or illicit drugs history of chronic pain