Kornimate/medical-research-clean huggingface dataset:
safety of magnetic resonance imaging in non-mri conditional pacemakers and icd devices

Conditions: Arrhythmias, Cardiac

Summary: the primary objective of the study is to determine the safety of mri in patients with non-mri conditional pacemakers. the secondary objective is to determine if there are clinically relevant parameter changes in the devices.


Eligibility criteria:
inclusion criteria. all patients with non-mri conditional pacemakers and icds between the ages of 18-85 will be eligible to participate. medical records will be reviewed to confirm the date and make/model of device implanted. ordering physician discusses the mri request with radiologist, documenting that there is no appropriate alternate imaging test. patient must have an appointment with a cardiologist/electrophysiologist prior to mri. banner health policy for standard of care guidelines involving patients receiving mri's will be followed. exclusion criteria. patients will be excluded from mri based on the department of radiology protocol. additional exclusion criteria include: icd and pacemaker dependent, pacemaker inserted before 2002, epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), patient not awake or unable communicate, battery voltage at elective replacement interval, implanted non-mri conditional device (other than pacemaker/icd).
adapted physical activity program (apa) for effort rehabilitation of children and teenagers with osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: this research study aims to evaluate the effect of a 6-month adapted physical activity program (apa) on the endurance capacities (evaluated as the maximum oxygen consumption \[vo2 peak\]) of children and adolescents with osteogenesis imperfecta.

osteogenesis imperfecta (oi) is a rare genetic disease characterised mainly by bone fragility, decreased bone mass and a susceptibility to fractures of varying severity. different forms have been described according to the severity of the bone manifestations. although it is a genetically heterogeneous disease, approximately 90% of oi patients have a mutation in the gene encoding gene encoding type 1 collagen, a major component of the extracellular matrix. chronic fatigue and decreased physical endurance are almost constant complaints of patients with oi (more than 95% according to some studies), which impacts the activities of daily living and quality of life of these patients. the causes of this decrease in endurance are multifactorial involving prolonged immobilisation secondary to fractures, chronic osteoarticular pain, but also primary muscle damage. mechanography studies carried out in children with oi have shown a significant deficit in muscle function in terms of both strength and power. in healthy adults, physical inactivity is an important predictor of feeling of tired. in addition, in some chronic diseases (such as multiple sclerosis, rheumatoid arthritis or systemic lupus erythematosus), physical activity and training have been shown to be effective in improving muscle strength and functional capacity as well as fatigue and quality of life. in oi, it has been reported that physical activity improves muscle function and bone mass. patients with oi should therefore benefit from a regular exercise programme taking into account their risk of fracture. this study aims to evaluate the effect of a life-skills physical activity (lspa) programme on the endurance capacities and quality of life of children and adolescents with oi. the vo2 peak evolution will be evaluated after 6 months of program. this is a recognized parameter for the evaluation of endurance and has been validated in children. the hypothesis of this study is that the implementation of a physical activity program adapted to the daily life and interests of the child with oi will efficiently improve endurance, prevent deconditioning and promote long term benefits.

Eligibility criteria:
inclusion criteria: * diagnosed osteogenesis imperfecta * informed and written consent signed by at least one of the two holders of parental authority * patient affiliated to a social security scheme or equivalent exclusion criteria: * non-walking children (unable to perform the effort test) * pregnant or breastfeeding * participation in other interventional research

Keywords: osteogenesis imperfecta children adolescents maximum oxygen consumption adapted physical activity effort rehabilitation
survival and reproductive outcomes of malignant ovarian germ cell tumors

Conditions: Fertility Issues

Summary: malignant ovarian germ cell tumor patients conducted fertility-sparing surgery and adjuvant chemotherapy in kasr el-aini hospital - faculty of medicine - cairo university from january 2012 to december 2016 will be retrospectively investigated.

mogct patients conducted fertility-sparing surgery and adjuvant chemotherapy with complete follow up data, younger than 35 years old at first treatment, in kasr el-aini hospital - faculty of medicine - cairo university ( department of obstetrics \& gynecology and center of clinical oncology and nuclear medicine ) from january 2012 to december 2016 will be retrospectively investigated. diagnosis of mogct was revealed by pelvic mass, abdominal pain, and elevated tumor markers like α-fetoprotein (afp), human choionic gonadotophin (hcg) and lactate dehydrogenase (ldh) and confirmed by surgical procedure and pathological diagnosis. pathological diagnosis was confirmed according to the 2014 world health organization classification of tumors of female reproductive organs. tumors were staged according to american joint committee of cancer (ajcc), tnm and figo staging system for ovarian and primary peritoneal cancer. fertility sparing surgery preserves uterus and the contralateral ovary with or without comprehensive staging (omentectomy and lymphadenectomy) by open laparotomy. adjuvant chemotherapy was scheduled based on histopathology, grade and stage. all patients received chemotherapy, but with different schemes and courses the data including: subjects' demographics, clinical and pathological characteristics, treatment received, survival outcome and reproductive outcomes including pregnancy rate ( natural conception ) and live birth rate will be investigated. follow-up data until january 31, 2022 will be collected from hospital records and telephone interview.

Eligibility criteria:
inclusion criteria: * age : younger than 35 years old at first treatment. * fertility-sparing surgery and adjuvant chemotherapy. * pathological diagnosis of malignant ovarian germ cell tumor. exclusion criteria: * patients with benign ovarian germ cell tumors e.g. mature teratoma. * concurrent malignancy. * severe comorbidities that may affect ovarian reproductive function.

Keywords: ovarian germ cell tumors fertility sparing
alcohol consumption and coronary heart disease onset

Conditions: Coronary Heart Disease

Summary: the primary aim of this study is to examine if long-term patterns of alcohol consumption are associated with time-to-onset for incident coronary heart disease (fatal and non-fatal), using data from multiple cohorts.

the relationship between alcohol consumption and coronary heart disease (chd) remains an issue of debate. by capturing drinking trajectories over time, we may be equipped to obtain new insights into this relationship. studies have shown that such trajectories have differential associations for intermediate traits (carotid intima-media thickness, pulse wave velocity and inflammatory markers), but no studies exist that link stability of drinking to actual chd. the current study will employ a longitudinal cohort design to evaluate the association between long-term alcohol consumption trajectories and time-to-event for chd. data will be drawn from six cohorts (five british, one french). the combined participant pool comprises 64,926 individuals (58% male, individual cohort sizes ranging from 1,444 to 25,636 participants); those with a baseline history of chd will be excluded. repeat alcohol intake measurements across a 10-year interval will be the exposure, with participants' intake trajectory defined according to their alcohol consumption volume and its consistency over time. to account for heterogeneity across cohorts, individual participant data meta-analysis methods will be employed in determining chd diagnosis rates and hazard ratios for the different intake trajectories, with adjustment for relevant demographic and clinical characteristics. results from the modelling work illustrating the form and magnitude of the association between the alcohol intake categories and chd will be presented. this work will help further understanding of the role that alcohol intake and its stability over time play in subsequent chd risk, and will have implications for our understanding of alcohol's relationship to cardiovascular health in the general population.

Eligibility criteria:
inclusion criteria: * participated in cohort studies being investigated * provided alcohol intake data at least one time point * was included in coronary heart disease onset tracking exclusion criteria: * left cohort study prior to completion of 10 year exposure window * had history of coronary heart disease before end of 10 year exposure window

Keywords: alcohol coronary heart disease ischemic heart disease cardiovascular health individual participant data meta-analysis longitudinal
perioperative risk factors for intensive care delirium after cardiac surgery

Conditions: Delirium

Summary: the aim of the study is to identify the incidence of early postoperative delirium in intensive care patients after cardiac surgery and detect possible risk factors associated with increased risk for developing delirium after cardiac surgery.

a consecutive series of patients scheduled for elective cardiac surgery is included in the study. delirium screening is performed using intensive care delirium screening checklist. preoperative cognitive state is evaluated with mini-mental state examination. information of possible risk factors is collected from patient's history and chart. the snoring, tiredness, observed apnea, high blood pressure-body mass index (bmi), age, neck circumference and gender questionnaire (stop-bang questionnaire) is used for obstructive sleep apnea screening.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery * patient spends more than 1 day in the intensive care unit after the surgery exclusion criteria: * refusal to participating in the study * documented severe central nervous system, cognitive or psychiatric disorder * unable to be screened with intensive care delirium screening checklist up to 6th postoperative day (e.g. deeply sedated, intubated patients)

Keywords: postoperative cardiac surgery
proof of concept study evaluating rns60 in the treatment of relapsing remitting multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this study is to determine whether rns60 is effective in the treatment of rr-ms compared to interferon beta-1a.


Eligibility criteria:
inclusion criteria: 1. males or females, aged between 18 and 50 years. 2. diagnosis of rr-ms according to mcdonald 2010 diagnostic criteria with a prior brain mri that demonstrates lesions consistent with rrms, both within the past year. 3. no evidence of relapse during the 60 days prior to enrollment. 4. edss score of 0-5 at screening. 5. women of childbearing potential who have a negative pregnancy test (serum hcg) at screening. 6. men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment. 7. subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent. exclusion criteria: 1. diagnosis of secondary progressive ms, primary progressive ms or progressive relapsing ms. 2. normal baseline brain mri. 3. history of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma. 4. current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.) 5. significant organ dysfunction, including cardiac, renal (egfr ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dl; alt or ast ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment. 6. steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or acth for relapse treatment during the course of the study. 7. known allergy to gadolinium-dtpa 8. therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, bg-12, teriflunomide, laquinimod and iv immunoglobulin. 9. treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, tysabri, fingolimod, cytoxan, methotrexate. 10. participation in any investigational therapy within one year prior to enrollment, unless given approval by pi. 11. known or suspected current or past alcohol or drug abuse within one year prior to enrollment. 12. any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.

Keywords: relapsing remitting multiple sclerosis rr-ms
the acute effect of vaping on food intake

Conditions: Energy Intake; Food Intake; E-Cig Use; Appetite

Summary: this study assesses the acute effects of a standardized 20-minute vaping episode compared to a non-vaping control condition on ad libitum food intake during a 30-minute buffet meal, occurring approximately 45 minutes after the vaping episode

weight control is a common motive for cigarette smoking and nicotine has been shown to suppress appetite and increase resting metabolic rate, and also serves as a behavioral alternative to eating or a distraction from hunger or food craving. data on the acute effect of e-cigarette use ('vaping') on ad libitum food intake are non-existent. given that many e-cigarette users report vaping for weight control and that certain e-cigarettes are being actively marketed for weight management and/or suppression of food cravings, addressing this research gap is of the utmost importance.

Eligibility criteria:
inclusion criteria: * 18 - 65 years of age (id card verified) * reports either everyday e-cigarette use with liquid containing at least 0.3% (\~3 mg/ml) nicotine or some day e-cigarette use ( at least 3 days a week) with liquid containing at least 3% (\~30 mg/ml) nicotine for the past 30 days. exclusion criteria: * being unwilling to consume the foods provided due to: a) dietary limitations or preferences or b) allergies to the foods provided. * being unwilling to take 20 puffs from a juul device containing a 5% nicotine pod * self-reported current, diagnosed medical condition(s) will be excluded automatically: heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., hiv/aids, multiple sclerosis), respiratory disorders (e.g., copd, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures * observed high blood pressure at screening (systolic \>140; diastolic \>90) * other self-reported current, diagnosed medical conditions (e.g., specific food allergies, diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the pi and medical monitor * self-reported current, diagnosed psychiatric conditions or who report current psychiatric treatment or psychotropic medication use * past month use of cocaine, opioids, benzodiazepines, methamphetamine, or other (non-cannabis) illicit drugs * self-report of \>25 days out of the past 30 for alcohol use or \>20 days out of the past 30 for cannabis use. * women who are breast-feeding or test positive for pregnancy (by urinalysis at screening) * women using progestin-iuds for birth control * women using birth control injections (e.g., depo-provera) * women who received a hysterectomy and still have ovaries present * self-report intending to quit tobacco/nicotine products in the next 30 days
a study to evaluate geh200520/geh200521 (18f) safety and tolerability when used for pet scans in patients with solid tumour malignancies

Conditions: Malignant Solid Tumor; Oncology

Summary: part a: the purpose of this part is to assess the safety of geh200520 and geh200521 (18f) when administered to patients with solid cancer. subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). the estimated duration of part a is 21 days. part b: the purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of geh200520 and geh200521 (18f) when administered to patients with cancer before and after immunotherapy treatment. subjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ici) treatment visits and 2 additional imaging and 1 follow-up visit . the estimated duration of part b is approximately 64 days.


Eligibility criteria:
inclusion criteria: * the subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed. * the subject is male or female, ≥18 years of age. * subject has a life expectancy ≥12 weeks. * subject has eastern cooperative oncology group (ecog) performance status 0-1. * subject has an irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma. * subject is eligible for ici treatment. * subject is male, or a female who agrees to comply with the protocol contraception method. exclusion criteria: * subject is unable to undergo all procedures in the study and/or is unable to remain still and tolerate the imaging procedure. * subject has 12-lead ecg significant findings during screening, per investigator's assessment. * subject is not stable due to medical condition or therapy that, in the opinion of the investigator, could compromise subject safety or protocol objectives. * subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. * subject has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the investigator, could compromise subject safety or protocol objectives. * subject is pregnant or planning to become pregnant or is lactating. * subject has a history of alcohol or drug abuse within the last year.
a mobile intervention on values in chronic pain patients.

Conditions: Chronic Pain Syndrome

Summary: the study aims to test a mobile intervention on values and goals in chronic pain patients. the cognitive behavioral intervention is a 10-day course in which participants complete a brief intervention each day (about 10-20 minutes a day). the content of the intervention includes the definition of values; development of individualized values and personal value-oriented goals; and implementation of personal goals in every day life. to assess the effectiveness of the intervention, we use a multiple baseline single case design. baseline measurements will be assessed daily between 10 and 17 days (the exact number will be randomized). daily measurements will continue during the intervention. after the intervention, another post measurement will be collected.


Eligibility criteria:
inclusion criteria: * chronic, non-tumor related back pain (pain for at least 6 months) * ownership of a smartphone * numeric rating scale for pain result of ≥ 4 exclusion criteria: * high cognitive impairment (e.g., intellectual disability) * currently in psychotherapeutic treatment * initiation of pain-focused treatment during the study
efficacy study of liquicure™ to treat toe nail fungus

Conditions: Onychomycosis

Summary: there is a major clinical need for an inexpensive topically-applied product that can inhibit the growth of the dermatophytes that cause nail fungus. chesson labs has developed liquicure with a longer drying/curing time that will allow better nail penetration or adsorption. though the product may have inherent antimicrobial activity, the product does not contain a drug or antimicrobial agent. consistent use of liquicure as described will clear fungal nail infection. clearing of nail fungal infection is defined by negative dermatophyte culture and visual improvement in nail characteristics within six months, with few, if any product-related adverse events.


Eligibility criteria:
inclusion criteria: * nail fungal infection of at least one great toe \[per visual assessment, positive koh preparation, and positive dermatophyte culture\] * subjects who have target toenail showing 20-65% involvement as judged by the clinical investigator * 2 mm of clear nail proximally on great toenail / no lunula involvement * subject must be physically able to reach toes to clean them and apply product * subject is willing to discontinue use of other nail fungus treatment products and nail cosmetic products for duration of this study * subject is willing and available to return for study follow up * ability of the subject or legal representative to understand and provide signed consent for participating in the study * negative urine pregnancy test for women of child bearing age * females must be post menopausal or must agree to use approved contraceptives (actions, devices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (note: abstinence is not an accepted form of contraception) exclusion criteria: * known hypersensitivity or allergy to the product materials * negative koh preparation or dermatophyte culture * thickness of nail greater than 3 mm * enrollment in another investigational drug or product protocol that would interfere with this study * continuation or use of other topical or pharmaceutical treatments for the condition; a wash-out period of at least four weeks after discontinuation of a topical product or 180 days after discontinuation of an oral product for treatment of nail fungus is required * chronic disease, including: diabetes, psoriasis, immune deficiency, severe foot injury, chronic vascular disease or any other condition that would decrease circulation to the extremities at the discretion of the investigator pregnant or nursing females * investigators, chesson personnel, or chesson scientific advisory board members or their immediate family

Keywords: toenail fungus onychomycosis dermatophyte