Kornimate/medical-research-clean huggingface dataset:
lower: lomitapide observational worldwide evaluation registry

Conditions: Homozygous Familial Hypercholesterolemia

Summary: this global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.

to evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.

Eligibility criteria:
inclusion criteria: * patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment. * patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures or paediatric patients with the consent of a parent or legal guardian. patients ≥7 years of age (or above the age determined by the irb/ec and in accordance with the local regulations and requirements) must also provide written informed assent forms. exclusion criteria: * patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol. * patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received market authorization in the country of participation, at time of lomitapide initiation and continuing to receive an investigational agent at time of registry enrolment. these patients may be enrolled if receiving lomitapide when the investigational agent is discontinued..
cost-utility analysis of ambulatory dose escalation of bispecific antibodies in multiple myeloma.

Conditions: Multiple Myeloma in Relapse

Summary: multiple myeloma is the second most common haematological cancer. recent innovations have made it possible for relapsed/refractory patients to benefit from the innovative immunotherapy of bispecific antibodies. these antibodies stimulate the immune system to attack tumour cells. the treatment involves an escalating dose of three subcutaneous injections every 2 to 4 days for a total of about 10 days, followed by a weekly treatment phase. the university hospital of toulouse was the first centre in france to offer outpatient dose escalation for this innovative treatment. this form of treatment depends on clinical and logistical feasibility. where appropriate, patients are treated in a conventional unit. an analysis carried out at toulouse university hospital suggests a response to treatment, with no increased risk of complications in the outpatient setting. patients' quality of life may also be unaffected. in addition, given the increasing demand for care in a context of finite resources, the economic evaluation of healthcare initiatives is becoming essential if we are to maintain a high-quality healthcare system that is accessible to all.

the study has two arms: patients treated in the outpatient unit and patients treated in the conventional unit. the prospective data collection is based on quality of life at three time points during the dose escalation phase. the following questionnaires will be used: eq-5d-5l for utility analysis, qlq-c30 validated in cancer patients and qlq my20 validated in multiple myeloma patients. clinical data will be collected as well as economic data related to hospital stays.

Eligibility criteria:
inclusion criteria: * relapsed and/or refractory multiple myeloma * treated with teclistamab, elranatamab ou talquetamab * more than 18 years old * having received the information from the study and not having objected to participate * day hospital care in case of clinical feasibility (good general condition, no rapid progression or major tumor burden, no current infection) and logistics (accommodated less than 30 minutes from the iuct oncopole for 48 hours after each dose escalation) or in conventional hospitalization at the iuct oncopole exclusion criteria: * illiterate subjects or those with a language barrier

Keywords: multiple myeloma neoplasms plasma cell antineoplastic agents antibodies bispecific outpatient care
impact of active and healthy families

Conditions: Overweight; Obesity

Summary: the purpose of this study is to evaluate the impact of the 10-week active and healthy families (ahf) intervention on body mass index (bmi) in latino youth aged 5-12 years.


Eligibility criteria:
inclusion criteria: * aged 5-12 years * body mass index greater than or equal to the 85th percentile for age and sex * patients seen at contra costa county clinics participating in active and healthy families * spanish speaking * parent of participant exclusion criteria: * previous participation in active and healthy families

Keywords: primary health care pediatrics obesity overweight clinical trial hispanic americans family body mass index
a study evaluating a proprietary amino acid mixture (enterade®)- for maintaining bowel regularity in patients with gi toxicity from any combination of therapy including tyrosine kinase inhibitors (tki)

Conditions: Diarrhea

Summary: this is an open label, randomized investigation of a proprietary blend of amino acids, called enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including tki\*. subjects will be randomized to receive enterade® or continue standard of care. two patients will be enrolled on the treatment arm for each patient on the control arm.


Eligibility criteria:
inclusion criteria: 1. patients with any combination of therapies including radiation therapy alone, chemotherapy alone, tki alone, or any combination are eligible. 2. this includes patients with therapies including xeloda (capecitabine), camptosar (irinotecan) or 5-fu (fluorouracil) with cancer. 3. patients who have been diagnosed with a cid ctcae toxicity of grade 3 or higher 4. patients must be at least 18 years of age. 5. ecog performance status 0-2. 6. patients must have diarrhea symptoms, judged secondary to the systemic therapy, combined systemic therapy, and/or radiation, and must be requiring loperamide or similar (imodium®) for symptom management. for the purposes of this study, diarrhea will be defined as three or more loose or liquid stools per day or loose watery stool (greater volume of stool) that occur more frequently than usual and lasting for more than three days. exclusion criteria: 1. ecog performance status 3 or greater. 2. pregnant and/or breast-feeding women 3. pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an lh-rh agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians 4. post-menopausal status is defined either by: 1. age ≥55 years and one year or more of amenorrhea, 2. age \<55 years and one year or more of amenorrhea with an estradiol assay \<20 pg/ml 3. bilateral oophorectomy 4. cid ctcae grade 1 or 2 (not requiring loperamide or similar)
relationships between tenascin c, smoking and periodontal status

Conditions: Periodontitis; Smoking; Periodontal Diseases

Summary: the goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade b, stage 2 grade c, stage 3 grade b, stage 3 grade c) and the levels of tenascin c, il-1 beta, il-4, and il-6 in saliva samples from smokers and non-smokers. the main questions it aims to answer are: is there a difference in the levels of tenascin c, il-1 beta, il-4, and il-6 between smokers and non-smokers with different periodontal conditions? do these biomarkers correlate with the severity and grade of periodontal disease? researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. participants will: provide saliva samples. be categorized based on their smoking status and periodontal condition.


Eligibility criteria:
inclusion criteria: * the periodontitis groups (non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with stage ii and iii, generalized, grade b, c periodontitis based on the consensus report of the 2017 world workshop on classification of periodontal and peri-implant diseases and conditions. * agreeing to participate in the study exclusion criteria: * use of oral contraceptive drugs * use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study; * history of excessive alcohol use; * pregnancy or breastfeeding status; * periodontal treatment during the last 6 months before the study. * not agreeing to participate in the study * not meeting the inclusion criteria

Keywords: periodontitis cytokines saliva
studies of neuroendocrine and energy metabolism in patients with eating disorders

Conditions: Anorexia Nervosa; Bulimia Nervosa

Summary: this study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients.

the study subjects include female patients with dsm-iv diagnosis of an (n = 30), bn (n = 60) and age-controled normal subjects (n = 30). they will receive a clinical interview and are asked to complete several self-administered questionnaires which included eating-related questionnaires, general psychological functioning scales and personality scales. after overnight fast, each subject undergoes a blood sample collection for neuroendocrine examination, body composition examination using bia method, basal metabolic rate measurement by indirect calorimetry, and ecg in the morning between 0800 and 0900. clinical patients would be asked to repeat filling the self-rating scales, weight and body fat measurement, as well as blood drawing again 2 months after treatment.

Eligibility criteria:
inclusion criteria: * subjects who fulfilled dsm-iv diagnosis of anorexia nervosa or bulimia nervosa * normal controls exclusion criteria: * any major psychiatric disorders * use of psychoactive medications * drug and alcohol abuse * medical problems (cardiovascular condition and endocrine disorders)

Keywords: eating disorders ghrelin leptin bia
a study to assess the cholesterol lowering effect of ezetimibe/simvastatin combination tablet compared to another cholesterol lowering drug in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease (0653a-128)

Conditions: Hypercholesterolemia

Summary: a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.


Eligibility criteria:
inclusion criteria: * patient has a cholesterol level of 130 mg/dl or greater * patient is willing to maintain a cholesterol lowering diet for as long as they are in the study * patient is at moderate high risk or high risk for coronary heart disease per the national cholesterol education program adult treatment panel iii (ncep atpiii) guidelines exclusion criteria: * patient weighs less than 100 lbs * patient has an allergy to ezetimibe, simvastatin or atorvastatin

Keywords: high cholesterol
assessment of lung transplant recipients within the scope of international classification of functioning, disability and health

Conditions: Lung Transplant; Complications; Disability Evaluation

Summary: this study was aimed to evaluate the patients undergoing lung transplantation under the international classification of functionality, disability and health (icf) and to examine the relationships between the age at which lung transplant recipients were transplanted and recipients' comorbidity levels and body structure and functions, activity and participation level.

after lung transplantation, many complications related to various reasons are observed in patients in the long term. in this study, the severity of fatigue, limitation of daily living activities, kinesophobia, impaired sleep quality, anxiety and depression level, fragility level, balance and functional capacity in lung transplant recipients; investigators aimed to examine the relationship between the age at which the patient was transplanted and the level of comorbidity. although there are studies on comorbidities, quality of life, daily living activities and participation level, anxiety and depression level, sleep quality, balance and physical fitness level in lung transplant recipients, kinesiophobia upper extremity functional performance in patients who have undergone lung transplantation surgery, covid-19 infection there are no studies evaluating the anxiety associated with the disease. no study evaluating body structure functions, activity and participation level based on icf in lung transplantation has been encountered. in our study, patients with at least 3 months past lung transplantation and without orthopedic and mental problems will be evaluated. it will be made as a single evaluation. the last pulmonary function test results of the patients, comorbidity conditions, fatigue, respiratory quality of life, coronavirus anxiety status, sleep quality, kinesophobia will be evaluated by questionnaires. lower extremity dynamic balance and mobility will be evaluated with 1 minute sit-to-stand test, timed up and go test. upper extremity functionality will be evaluated with a 6-minute pegboard and ring test.

Eligibility criteria:
inclusion criteria: * at least three months have passed since the lung transplantation, without any complications at the last doctor's control * clinically stable and, if any, accompanying comorbidities are under control * volunteering to participate in research * patients who do not have neurological and orthopedic problems that may prevent them from performing functional tests. exclusion criteria: * single lung transplant recipient * have orthopedic problems * patients who cannot cooperate and adapt.

Keywords: international classification of functioning, disability and health fatigue functional capacity
treatment of screen-detected celiac disease

Conditions: Celiac Disease

Summary: the main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. the investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Eligibility criteria:
inclusion criteria: * positive endomysial antibodies * adults exclusion criteria: * previous celiac disease diagnosis * significant clinical symptoms * suspicion of any serious celiac disease-associated complication * suspected or diagnosed severe illness other than celiac disease * consuming oral corticosteroids or immune suppressants * marked laboratory abnormalities

Keywords: celiac disease endomysial antibodies gluten-free diet screen-detected asymptomatic bone mineral density
clinical trial of bt02 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: a first-in-human, open label, phase i/ii study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary antitumor activity of bt02 in patients with advanced solid tumors

overall study design: this is an open-label, fih, phase i / ii study of bt02 to evaluate the safety, tolerability, pk, immunogenicity, and preliminary antitumor activity of bt02 in adult patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. age ≥18 at the time of signing the informed consent form, male or female; 2. patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor; 3. adequate organ and hematologic function; 4. patients must have at least measurable or evaluable lesion in phase i and measurable lesion in phase ii according to recist 1.1; 5. ecog performance status 0\~1; 6. life expectancy ≥ 3 months; 7. good compliance and be willing to follow-up visit. exclusion criteria: 1. receive treatment before study as below: a) previous systematic anti-cancer therapy; 2. active or prior documented autoimmune disease within past 2 years; 3. history of clinically significant cardiovascular disease; 4. significant acute or chronic infections; 5. prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity; 6. any prior grade≥3 irae while receiving immunotherapy; 7. unstable brain metastasis or meningeal metastasis with clinical symptoms; 8. patients with mental disorders or poor compliance; 9. known alcohol or drug abuse; 10. other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.

Keywords: advanced solid tumors
variability in the measurement of wbct between blood drawn from indwelling catheters and direct venipuncture

Conditions: Healthy

Summary: 1. determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture 2. determine the intra-subject variability in both procedures

no investigational products were administered to any subjects.

Eligibility criteria:
inclusion criteria: 1. signed and dated, written informed consent (institutional review board \[irb\]-approved informed consent form \[icf\]). 2. healthy (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. exclusion criteria: 1. healthy subjects who do not conform to the above inclusion criteria. 2. healthy subjects who cannot communicate reliably with the investigator. 3. history of major bleeding or major trauma within the past 6 months 4. healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids). 5. significant infection or known inflammatory process within 2 weeks of screening. 6. treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening. 7. received non-steroidal anti-inflammatory drug (nsaid) or medications (including aspirin) with a direct effect on hemostasis within 7 days of testing 8. unwillingness or inability to comply with procedures required in this protocol. 9. subjects who are concurrently enrolled in any other clinical study.
effects of early vestibular rehabilitation in patients with dizziness and balance disorders after sport concussion

Conditions: Brain Concussion

Summary: this study examines the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems) and improving the timeline to achieve medical clearance to return to activities such as sports and work activities. half of the participants will receive early vestibular rehabilitation added to standard of care, while the other half will receive standard of care only.

as awareness of concussion and the numbers of reported concussions increase every year in the last few years, so does the need for more effective treatment strategies. concussions can lead to a variety of symptoms that may last from days to weeks after injury.\[1\] dizziness and vestibular impairments are prevalent in up to 81% of patients after concussion.\[2,3\] additionally, dizziness and vestibular impairments are predictive of prolonged recovery times after concussion.\[4\] although there are few studies suggesting that vestibular rehabilitation after concussion is promising,\[5,6\] there continues to be a void in well-controlled studies verifying that vestibular rehabilitation can be used to treat patients with dizziness and balance disorders after concussion. due to the lack of controlled studies and current practice patterns, patients with concussions are not seen for physical therapy until weeks or months after their injury. the purpose of this study is to examine the effect of early vestibular rehabilitation on reducing physical post-concussion symptoms (e.g. dizziness, balance problems), and improving the timeline to achieve medical clearance to return to activities such as sports and work activities, when compared to standard care. the findings of this study are expected to provide medical and sports related professionals with appropriate concussion treatment strategies and improve outcomes of patients suffering from concussion.

Eligibility criteria:
inclusion criteria: * dizziness or balance problems within 10 days of concussion exclusion criteria: * none
safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (mmrv) vaccine made with an alternative manufacturing process (amp)(v221-027)

Conditions: Measles; Mumps; Rubella; Varicella

Summary: this study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (mmrv) vaccine made with an alternative manufacturing process with those of the 2006 process


Eligibility criteria:
inclusion criteria: * negative clinical history for measles, mumps, rubella, varicella, and zoster exclusion criteria: * received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study * received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study * exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination * any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy * received 1) systemic immunomodulatory steroids \[greater than the equivalent of 2 mg/kg total daily dose of prednisone\] within 3 months prior to entering the study, or 2) any dose of systemic immunomodulatory steroids within 7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study * history of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines * received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination * diagnosis of an active neurological disorder. enrollment may be considered when the disease process has been stabilized * history of seizure disorder, including single febrile seizure * diagnosis of active untreated tuberculosis * history of thrombocytopenia * born to a human immunodeficiency virus (hiv) infected mother