Kornimate/medical-research-clean huggingface dataset:
efficacy of a new delivery system for beta-hydroxy-beta-methylbutyrate

Conditions: Healthy

Summary: the proposed study will test efficacy of hmb in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. hmb in a free acid gel or in cahmb capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). we hypothesize that hmb in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or cahmb treatment following a bout of acute eccentric exercise. our endpoints will include measurements of: (1) markers for muscle damage (cpk and ldh); (2) indicators of inflammation (crp, tnf-α, il-6, il-1ra and il-18); and (3) muscle strength recovery and soreness.


Eligibility criteria:
inclusion criteria: * must live within 50 miles of ames, iowa * free of cardiac, liver, pulmonary, and kidney disease * free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis * free diabetes mellitus * not classified as morbidly obese (bmi must be less than 40) * free of cardiac, liver, pulmonary, and kidney disease * no other serious medical illness * normal menstrual cycle and not pregnant or lactating * able to consume supplements and perform required exercise testing exclusion criteria: * live more than 50 miles from ames, iowa * presence of cardiac, liver, pulmonary, and kidney disease * presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis * diabetes mellitus * classified as morbidly obese (bmi is greater than 40) * no other serious medical illness * abnormal menstrual cycle, pregnant or lactating * not able to consume supplements and perform required exercise testing

Keywords: acute exercise muscle inflammation cahmb hmb free acid gel healthy subjects
kidney transplantation from donors with hiv: impact on rejection and long-term outcomes (expanding hope kidney)

Conditions: Hiv

Summary: this research is being done to better understand rejection in transplant recipients with hiv who receive kidneys from donors with vs without hiv.

previously, people with hiv in need of a transplant could only receive organs from a donor without hiv. however, in november 2013, the hiv organ policy equity (hope) act made it possible for people with hiv to receive organs from donors with hiv as a part of a research study. over the last two decades, people with hiv have received organs from donors without hiv, and in general, these recipients have done well after transplant and still maintained control of their hiv. over the last several years, people with hiv have received organs from donors with hiv, and in general, these recipients have also done well after transplant and still maintained control of their hiv. this study will look to better understand rejection in transplant recipients with hiv (hivr+) who receive kidneys from donors with hiv (hivd+) vs without hiv (hivd-).

Eligibility criteria:
inclusion criteria: * participant meets local criteria for kidney transplant. * participant is able to understand and provide informed consent. * participant has documented hiv infection by any licensed assay or documented history of detectable hiv-1 rna. * participant is ≥ 18 years old. * hiv-1 rna \ 200 copies/ml. * participant is not suffering from significant wasting (e.g. body mass index \<21) thought to be related to hiv disease. exclusion criteria: * participant has prior progressive multifocal leukoencephalopathy (pml), cryptosporidiosis of \> 1 month, or primary central nervous system (cns) lymphoma. * participant is pregnant or breastfeeding. * past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
adjuvant chemotherapy in patients with lymph node metastasis after radical surgery in cervical cancer

Conditions: Cervical Cancer

Summary: purpose primary endpoint * to evaluate the 3-year disease free survival second endpoints * to evaluate the 3-year \& 5-year overall survival to analyze the toxicity and the quality of life


Eligibility criteria:
inclusion criteria: * cervical cancer stage ia2-iia * histology; squamous, adeno, adenosquamous subtype * age; 20∼70 years * performance status; gog 0∼2 * no medical illness * hematologic, renal, hepatic function; normal * grossly no residual disease * histologically confirmed lymph nodes metastases * no parametrial extension and negative resection margin * number of retrieved lymph nodes; ≥ 20 exclusion criteria: * patients with grade 2 peripheral neuropathy * patients with uncontrolled infection

Keywords: cervical cancer
tracelt hydrogel in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer

Conditions: Bladder Carcinoma

Summary: this pilot clinical trial studies how well tracelt hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer. tracelt hydrogel marks the location of a bladder tumor and makes it more visible during imaging tests. using tracelt hydrogel tissue marker may help doctors learn more about tumor location and altering radiation dosage for bladder cancer.

primary objectives: i. to utilize the traceit hydrogel tissue marker in localizing bladder tumors during transurethral resection of bladder tumors (turbt). ii. to improve identification of gross tumor or tumor bed location in patients receiving chemoradiation treatment for bladder cancers. secondary objectives: i. to report adverse events surrounding the placement of the traceit tissue marker. ii. to calculate the actual dose received by the bladder tumor bed, as delineated by the hydrogel. iii. to compare the dosimetric impact to the tumor bed of daily patient alignment to the pelvic bones, versus alignment to the whole bladder, versus alignment to the hydrogel markers. iv. to calculate the amount of normal tissue radiation dose decrease achievable without losing tumor coverage, with better tumor targeting with hydrogel placement. outline: patients undergo transurethral resection of bladder tumors and receive tracelt hydrogel via injection. patients undergo standard of care radiation therapy within 8 weeks of tracelt hydrogel placement.

Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy of the bladder * no prior cystectomy * treatment plan for bladder must include at least 4 weeks of daily radiation treatment (most patients will receive chemotherapy concurrent with radiation, but this is not required for trial enrollment) * patient must undergo traceit hydrogel placement within 8 weeks prior to starting radiation therapy for bladder cancer * participants must have a complete history and physical examination within 60 days of study entry * participants must be able to provide informed consent for treatment and trial participation * no restrictions on prior treatment to be eligible exclusion criteria: * prior cystectomy * unable to have traceit hydrogel placement \< 8 weeks prior to beginning radiation treatment * treatment for metastatic bladder cancer
effectiveness of handheld ultrasound for diagnosing patients with tmd

Conditions: Temporomandibular Joint Disorders; Magnetic Resonance Image; Handheld Ultrasound

Summary: the aim of this research is to add to the limited body of knowledge comparing the effectiveness of ultrasound (us) to mri diagnoses in patients with tmj disorders. more specifically, we will review the efficacy of handheld us devices, which has not yet been done to the author's knowledge.

currently, patients complaining of temporomandibular joint (tmj) pain are evaluated clinically, which includes measurements of their maximal incisal opening (mio) lateral and protrusive excursions, recording their current pain duration and frequency, and any clicking/popping/grinding of the joints. based on these findings, the patient is sent for an mri if temporomandibular joint disorder is suspected. mri is currently the gold standard of care for imaging of the joint, as it provides valuable information on the position, morphology and signal intensity of the joints and its surrounding structures. magnetic resonance imaging (mri) is currently the gold standard of imaging for diagnosis of internal derangement due to its ability to provide valuable information on the position, morphology and signal intensity of the joints and its surrounding structures. however, using mri is not without its challenges, as patients with severe tmj pain find it difficult to complete a full tmj series and access to mri is often restricted due to limited locations and associated waits, further prolonging time between initial consultation and diagnosis. in addition, mri is contraindicated in patients with metallic implants, coronary and peripheral artery stents, cardiac pacemakers, prosthetic heart valves, intrauterine contraceptive devices, and claustrophobia. for these reasons, the author believes that attempting to find an alternative reliable screening tool for internal derangement is a worthwhile endeavor. for this study, handheld ultrasound would be used at the time of clinical examination to come up with a preliminary diagnosis, and this diagnosis would be compared to the mri findings.

Eligibility criteria:
inclusion criteria: * the patient population will be those patients who meet the criteria for temporomandibular joint disorders based on clinical examination and patient history, including anterior disc displacement with or without reduction, joint effusion, or degenerative joint disease. exclusion criteria: * patients under the age of 18. * patients unable to consent for themselves.
effects of acute aerobic exercise on higher cerebral functions

Conditions: Exercise

Summary: we are comparing higher cerebral functions including cognitive flexibility, inhibitory control and working memory in healthy young adults between a group of acute aerobic exercise and a control group.

the objective of this study is to compare cognitive flexibility, inhibitory control, and working memory in healthy young adults between two groups: a group undergoing acute aerobic exercise and a control group. methodology: study design: a randomized controlled trial study setting: the physiology laboratory at khyber medical college, peshawar study duration: the study will last for three months. sample size: the study will include 19 participants in each group - the exercising group (e-group) and the control group (c-group). healthy young people between 18-25 years who are non-smokers will be included. sampling: the enrollment in the randomised control trial will be conveniently based, wherein all those who meet the inclusion and exclusion criteria will be enrolled as per study numbers. a lottery method will be adopted for randomization. procedure: the first step is to take ethical approval from the institutional research \& ethical review board. following which, after taking informed consent from the participants, the enrolled participants will be randomly allocated to 2 groups. a demographic questionnaire will be filled. this will be followed by a general physical examination. both groups will be familiarized with the executive function tasks, while the e-group will have an additional session regarding the exercise protocol. both groups will have an initial assessment of executive functions using online psytoolkit followed by intervention. the e-group will undergo 30 minutes of treadmill walking at 60-65% of hrmax with continuous recording of heart rate and ecg via the biopac system, while the control group session will consist of sitting idly and quietly in the laboratory doing nothing with continuous recording of heart rate and ecg via the biopac student lab system. in the end, executive function tests will be assessed before and after exercise using online psytoolkit.org. the data will be extracted via a properly designed proforma and on microsoft excel sheet. statistical analysis: statistical package for social sciences (spss)25.0 will be used for statistical analysis.

Eligibility criteria:
inclusion criteria: * healthy young adults exclusion criteria: * smokers * cardiorespiratory disorders * psychiatric disorders
measurement of exhaled nitric oxide (no) and bronchial provocation test with mannitol as a predictor of response to inhaled corticosteroids in chronic cough

Conditions: Cough; Bronchial Hyperreactivity

Summary: chronic cough is defined by its persistence beyond 8 weeks. many conditions can explain the existence of a bronchial inflammation. in the management of chronic cough, the search for bronchial hyperreactivity (hrb) is recommended. the treatment relies primarily on the prescription of inhaled corticosteroids. it has been shown recently that the existence of an hrb with methacholine (bronchial provocation test used in routine) does predict the effectiveness of inhaled corticosteroid treatment in no more than 50% of cases. it is now possible to assess the bronchial inflammation by rapid, non-invasive and reproducible tests such that the fraction of exhaled nitric oxide (feno) and bronchial provocation test with mannitol. in a retrospective study, it was shown that an increased value of feno (cut-off \> 35 ppb) predicts a positive response to treatment with a sensitivity of 90% and a specificity of 80%.

the purpose of this study is to show that the use of the prospective value of exhaled no can predict response to treatment with inhaled corticosteroids in adult with chronic cough. in addition we will assess the interest of the prognosis of bronchial provocation test with mannitol in this indication.

Eligibility criteria:
inclusion criteria: * chronic cough during 2 months * social security regimen affiliated * consent form signed exclusion criteria: * smoking active * treatment with angiotensin converting enzyme inhibitor * clinical signs of obvious gastroesophageal reflux * clinical rhinosinusitis * recent respiratory infection (\< 1 month) * corticosteroid treatment(oral or inhaled) within 2 weeks * vems \< 1 l or \< 80% of the theoretical value * existence of an obstructive ventilatory disorder defined as a report (fev/fvc) \< 90% of the theoretical value

Keywords: chronic cough inhaled corticosteroid treatment bronchial provocation test with mannitol methacholine
the effects of renal function and atrial fibrillation on lipoproteins and clot structure/function

Conditions: Atrial Fibrillation; Chronic Kidney Disease

Summary: this study is designed to investigate the role of lipids/lipoproteins as a potential cause for the harmful changes seen in fibrin clot properties with renal dysfunction and atrial fibrillation

this is a prospective, observational, blinded study that will be conducted in two parts. the first study will assess the relationship between lipids/lipoproteins and fibrin clot properties among anticoagulated atrial fibrillation patients with and without renal dysfunction. the second study will assess the effects of statin therapy on lipids/lipoproteins and fibrin clot properties in anticoagulated atrial fibrillation patients with renal dysfunction. renal dysfunction is defined as an estimated glomerular filtration rate below 50 ml/min/1.73m2 for the purposes for this trial.

Eligibility criteria:
6.1 inclusion criteria wp1: * on anticoagulation therapy * informed consent obtained wp2: * not receiving statins prior to recruitment * diagnosed atrial fibrillation * on anticoagulation therapy * estimated glomerular filtration rate of \<50 ml/min/1.73m2 * informed consent obtained 6.2 exclusion criteria * age \<18 years * severe mitral stenosis or presence of metallic prosthetic valve * active or recent malignancy (\<6 months) * active immunological disease * connective tissue disease * chronic liver disease * recent or chronic serious infection * chronic inflammatory disease * known haemophilia or thrombophilia * active bleeding * untreated hypothyroidism or hyperthyroidism * recent surgery (\<3 months) * familial lipid disorders * concurrent use of steroids * dietary supplements known to influence lipids * contraindications/inability/unwillingness to commence statin (wp2)

Keywords: anticoagulation fibrin clot structure and function lipids lipoproteins statin
efficacy of a web-based lifestyle modification program in obese patients with cardiovascular risk factors

Conditions: Obesity

Summary: to evaluate the effect of a 6-month web-based lifestyle modification program with and without telephone counseling versus usual care in obese patients with cardiovascular risk factors on: * weight loss * waist circumference; blood pressure; total cholesterol, triglycerides, ldl-cholesterol, hdl-cholesterol; glucose and hemoglobin a1c; c-reactive protein. * physical activity and eating habits * quality of life


Eligibility criteria:
inclusion criteria: 1. male or female 25-70 years of age 2. obese (bmi ≥ 30 kg/m2 and \<40 kg/m2) 3. at least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i) hypertension defined by a history of hypertension, treatment of hypertension or bp values \>140/90 mmhg in two consecutive office visits ii) high cholesterol defined by an ldl-c ≥130 mg/dl and/or hdl-c \<40 mg/dl and triglycerides ≥150 mg/dl iii) type 2 diabetes mellitus defined by a history of diabetes, treatment of diabetes or fasting glucose ≥126 mg/dl in two consecutive office visits 4. participant must be willing and able to provide written informed consent 5. participant must be willing and able to comply with study related procedures 6. participant must have access to internet and e-mail exclusion criteria: 1. stage 1 or 2 on patient activation measures tool 2. weight change of more than 5 kg during the 3 months preceding the screening visit 3. history of bariatric surgery 4. fasting plasma glucose at screening \> 250 mg/dl (\> 13.9 mmol/l) 5. hemoglobin a1c at screening \>8.5% 6. treatment of type 2 diabetes with insulin (except for history of intermittent acute use, no more than 2 weeks usage in previous 6 months) 7. uncontrolled or inadequately controlled hypertension at the time of screening with blood pressure \>160/100 mmhg 8. secondary hypertension 9. changes in lipid, blood pressure or diabetes modifying agents including introduction, change in dose or cessation in the 3 months prior to screening visit 10. personal history of coronary heart disease, congestive heart failure, serious arrhythmias and stroke 11. cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease making implementation of the protocol or interpretation of the study results difficult. 12. presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that in the opinion of the investigator would restrict or limit the patient's successful participation for the duration of the study 13. presence of history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer 14. use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening 15. use of any investigational agent (drug, biologic, device) within 3 months prior to screening
a study to assess the effect of capivasertib on midazolam in patients with advanced solid tumours

Conditions: Solid Tumour

Summary: this is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the pharmacokinetics (pk) of midazolam, a sensitive cyp3a substrate. the pk of midazolam will be assessed when administered alone and in combination with repeated doses of capivasertib.

this is 2 part study: part a and part b. part a of the study consists of a screening period and 3 treatment periods (midazolam alone, capivasertib alone, and midazolam + capivasertib). during part a, the pk profile of midazolam will be determined with and without capivasertib.all participants will receive capivasertib treatment (4 days on/3 days off); however, at the investigator's discretion, er positive breast cancer patients may also receive fulvestrant in addition to capivasertib and midazolam. participants completing part a without disease progression or unacceptable toxicity, who are considered likely to continue to benefit from further capivasertib treatment (with or without certain standard of care treatment) in the opinion of the investigator will enter part b. part b of the study consists of an extended treatment period with capivasertib, with or without certain standard of care treatment, followed by a 30-day safety follow-up. part a of the study may be extended to allow the administration of midazolam on a rescheduled cycle 1 day 8(c1d8) and cycle 1 day 12(c1d12 ) visit.

Eligibility criteria:
inclusion criteria: 1. participants with documented evidence of locally advanced inoperable or metastatic solid tumours who may be suitable to receive capivasertib treatment. 2. eastern cooperative oncology group/world health organization performance status 0 to 1 and with minimum life expectancy for 12 weeks. 3. participant should have at least one lesion that can be assessed by computed tomography/magnetic resonance imaging or plain x-ray at baseline. 4. body mass index within the range 18 to 32 kg/m\^2 exclusion criteria: participants are excluded from the study if any of the following criteria apply: 1. radiotherapy with a wide field of radiation within 4 weeks of the first dose of capivasertib and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study intervention initiation. 2. participants with diabetes mellitus type i or participants with diabetes mellitus type ii requiring insulin treatment. 3. undergone a major surgery within 4 weeks of the first dose of capivasertib. 4. any unresolved toxicities from prior therapies higher than ctcae grade 2 or any unresolved toxicity that may interfere with pk assessment at the time of study intervention initiation. 5. participants with spinal cord compression or brain metastases. 6. participants with severe or uncontrolled systemic diseases, active bleeding diatheses, or active infection. 7. previous allogeneic bone marrow transplant or solid organ transplant. 8. known immunodeficiency syndrome.

Keywords: cyp3a inhibitor pharmacokinetics safety
differing levels of positive anti-neutrophil cytoplasm antibody (anca) test and their correlation with vasculitis or malignancy or chronic inflammation

Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Summary: a positive anti-neutrophil cytoplasm antibody (anca) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. a positive anca test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those patients eventually present with malignancy or other inflammatory diseases. the investigators wish to investigate the correlation between the differing levels of positive anca tests and their relationship to vasculitis, malignancy and inflammatory diseases.


Eligibility criteria:
inclusion criteria: * patients with borderline positive anca test results exclusion criteria: * pregnant