Kornimate/medical-research-clean huggingface dataset:
optimized resting environments in rehabilitation

Conditions: Acquired Brain Injury

Summary: this study investigates whether an individually designed environment can support and improve the quality of daytime resting periods in in-hospital neurorehabilitation of patients suffering severe acquired brain injury. the effect of a individually optimized resting environment will be tested against a standard resting environment.

aim: the aim is to identify differences in quality of rest as reflected by clinical evaluation, pulse rate, motor activity and autonomic balance between the optimized resting environment (ore) and the standard resting environment (sr). method: a randomized controlled time-series study. randomization to either sr or ore for each of the 9 resting periods during a three-day recording session. a period of three days will allow collection of sufficient data. this will also allow the analysis to take the random effects of time and weekday into account. outcome measures will be differences in mean heart rate during daytime resting periods, aggregated measures of heart rate variability and proportion of resting minutes according to accelerometry.

Eligibility criteria:
inclusion criteria: * severe acquired brain injury * \>= 18 years * relatives/surrogate can give informed consent * classified as being ≤ 7 on the level of cognitive functions scale (also known as rancho los amigos scale) exclusion criteria: * admitted due to polyneuropathies e.g. guillain-barré * terminal illness * spinal lesions * expected stay \< 3 weeks * paroxysmal sympathetic hyperactivity

Keywords: quality of rest daytime resting periods accelerometry electrocardiography
the effects of trans venous cardiac pacing on coronary microvascular function and hemodynamics

Conditions: Coronary Microvascular Disease; Cardiac Pacemaker Syndrome

Summary: the study will examine role of transvenous pacing on coronary microcirculation.

to study the role of transvenous pacing on the coronary microcirculation. this will be accomplished by gathering data from invasive fractional flow reserve (ffr) and coronary flow reserve (cfr) with and without ventricular pacing.

Eligibility criteria:
inclusion criteria: all patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker. exclusion criteria: * acute st segment myocardial infarction * known sensitivity or contraindication to the agents planned for administration during coronary angiography * pacemaker dependent patients * pregnancy * hypotension (a systolic blood pressure lower than 90mmhg) that would preclude the administration of adenosine * severe renal dysfunction, defined as a estimated glomerular filtration (egfr) less than 30ml/min, confirmed by recent testing * study subject has any underlying disorder that, in the opinion of the investigator, precludes them from giving informed consent at the time of enrollment

Keywords: coronary microvascular dysfunction
investigation of myotonometer reliability in evaluation of plantar fascia biomechanical properties

Conditions: Diabetes; Diabetes Mellitus; Plantar Fascia

Summary: the study aims to examine the intra-rater, inter-rater, and inter-session reliability of myotonpro in measuring plantar fascia mechanical properties in adults with diabetes.

therefore, changes occur in standing weight-bearing points, loading zones, and gait biomechanics. the thickened plantar fascia increases the risk of developing diabetic foot with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in individuals with diabetes than in healthy individuals. the myotonometer studies showed that chronic diabetes history increases dynamic stiffness, which is one of the mechanical properties of the plantar fascia, and that as the severity of the disease increases, fascial stiffness also increases. the aim of the study is to examine the intra-rater, inter-rater, and inter-session reliability of myotonpro in measuring plantar fascia mechanical properties in adults with diabetes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * body mass index \< 30 kilogram/meter square * willing to participate in the study * diagnosed with type 2 diabetes * hba1c level ≥ 6.5% mmol/mol * fasting plasma glucose ≥126 mg/dl * random plasma glucose ≥ 200 mg/d exclusion criteria: * history of lower extremity injuries * ulceration localized on plantar fascia * age ≥ 65 years * any use of medication that will affect muscle tone

Keywords: diabetes
laparoscopic transabdominal preperitoneal surgical repair of inguinal hernia using sutured repair versus tacker use

Conditions: Inguinal Hernia Unilateral

Summary: background: mesh fixation is a critical step in laparoscopic transabdominal preperitoneal (tapp) hernia repair because fixation is a significant step to prevent the hazard of mesh migration, but is supposed to be associated with a higher risk of acute and chronic pain compared with non-fixation. fixation is more expensive than non-fixation. objective: to compare the efficiency of mesh fixation in laparoscopic tapp surgical repair of inguinal hernia using sutured repair versus tacker use. patients and methods: this prospective randomized comparative study was carried out on 60 patients who presented with a unilateral inguinal hernia and were assigned to laparoscopic tapp hernia repair. patients were randomly allocated into two equal groups (30 patients each); in group a, the mesh was fixed with a titanium tacker, and in group b, the mesh was sutured and fixed with polypropylene 0.


Eligibility criteria:
inclusion criteria: * age ≥ 21 years * american society of anesthesiologists (asa) physical status ≤ ii * patients with body mass index (bmi) of 25 to 35 kg/m² * unilateral inguinal hernia exclusion criteria: * age \< 21 years * asa physical status \> ii * patients with body mass index (bmi) \> 35 kg/m² * pregnant women * bilateral inguinal hernia * large inguinoscrotal hernia * incarcerated hernia * recurrent hernia * strangulated hernia * prostatic diseases * history of; convulsions, cerebrovascular accident, previous neurological diseases * dysrhythmia * hypertension * ischemic heart disease * hyperthyroidism * liver or renal impairment * alcohol or drug abuse

Keywords: inguinal hernia mesh fixation titanium tacker
mhealth biometrics for young people with diabetes

Conditions: Diabetes

Summary: the investigators aim to undertake a feasibility randomised controlled trial (rct) to investigate whether mhealth technology, allowing biometric informed feedback and coaching on exercise and pa, can be effective in children with diabetes. the overall objective is to have an evidence-based exercise and pa intervention ready to evaluate in a future rct.

staff from the children's diabetes team at oxford university hospitals nhs foundation trust will identify patients during routine multidisciplinary team (mdt) clinics. 30 young people with diabetes will be recruited and randomly assigned to one of two groups (active control n=15, intervention n=15). following baseline measures all patients will then complete the 12 week here for health (hfh) healthy lifestyle programme designed by the diabetes team at oxford university hospitals nhs foundation trust. following the initial hfh intervention period assessments will be repeated (t2) before a second 12 week intervention period is completed. active control patients will receive no further input. the intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. the intervention group will also participate in 5 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates. following the second intervention period assessments will be repeated for a final time (t3). testing at baseline and following the 2 interventions will include changes in physical activity, blood pressure, glycaemia control, body composition and diet.

Eligibility criteria:
inclusion criteria: * receiving input from the here for health healthy lifestyle programme * aged 12-18 years * diagnosed with type 1 diabetes * type 1 diabetes diagnosis more than 1 year ago * hypoglycaemic aware or on a continuous glucose monitor (cgm) with alarms * willing to attend additional education on managing blood glucose and exercise * diagnosed with type 2 diabetes and on a stable metformin dose for 3-months or more * bmi centile \> 91st * access to internet-enabled device for video calling exclusion criteria: * severe learning/behaviour difficulties * severe autism * unstable blood glucose levels * glucose lowering medications other than metformin * underlying medical conditions that contraindicate physical activity

Keywords: mobile health technology physical activity exercise exercise prescription/ education exercise adherence
comparative intervention study of stress reduction in corporate health management

Conditions: Stress, Psychological

Summary: aim of the study is the evaluation of the effects (psychological and physiological) of an hrv-biofeedback training, a mindfulness training and a combination of both training methods for stress reduction.


Eligibility criteria:
inclusion criteria: * healthy adults * working in the business in which the study is conducted exclusion criteria: * cardiac disease * thyroid disease (intake of glucocorticoids) * actual psychological illness * intake of psychotropic drugs * intake of other medication changing hrv

Keywords: corporate health management hrv mindfulness
influence of drug-drug interactions on the pharmacokinetics (pk) of voriconazole

Conditions: Invasive Aspergillosis

Summary: to evaluate the drug-drug interaction between rifampicin and voriconazole according to cyp2c19 genotype quantitatively following a single oral administration of 200 mg voriconazole


Eligibility criteria:
inclusion criteria: * 1.healthy male subjects aged 20 - 50 years. * 2.a body mass index (bmi) in the range 17-28 kg/m2. * 3.sufficient ability to understand the nature of the study and any hazards of participating in it. provide written informed consent after being fully informed about the study procedures. exclusion criteria: * 1.presence or history of severe adverse reaction to any drug or a history of severe allergic disease. * 2.clinically relevant abnormal medical history that could interfere with the objectives of the study. * 3.presence or history of eye disease or eye field defect. * 4.a subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug. * 5.a subject whose liver function test (ast, alt, ggt, alp, ldh) result is over 1.25 times of upper limit of normal range. * 6.a subject whose sbp is over 140 mmhg or below 90 mmhg and dbp is over 100 mmhg or below 50 mmhg. * 7.presence or history of drug abuse. * 8.participation in other clinical trial within 2 months. * 9.use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose. * 10.blood donation during 2 months or apheresis during 1 month before the study. * 11.presence or history of alcohol abuse. * 12.smoking of more than 10 cigarettes/day. * 13.use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period. * 14.subject judged not eligible for study participation by investigator.
single ascending dose, first-in-human study on safety, tolerability and pharmacokinetics of bay1161116

Conditions: Polycystic Ovary Syndrome

Summary: this study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of bay1161116.


Eligibility criteria:
inclusion criteria: * healthy female postmenopausal subjects * age: 45 to 65 years (inclusive) * body mass index (bmi) : ≥18 and ≤30 kg/m² * non-smoker for 3 months (former smokers who quit smoking \>3 months before the first study drug administration may be included) exclusion criteria: * incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal * any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible) * any severe disease within the last 4 weeks prior to the first study drug administration * history of orthostatic hypotension, fainting spells, blackouts * any malignant tumor and history thereof * any other medical condition which, at the discretion of the investigator, would make study participation unadvisable * any clinically relevant finding at the physical- and gynecological examinations * allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the imp or reference/interaction product * regular alcohol consumption equivalent to \>20 g alcohol per day * urine screen positive for any drug or cotinine

Keywords: pcos
efficacy and safety of carrimycin tablets in hlh patients with carbapenem-resistant infections

Conditions: Carbapenem Resistant Bacterial Infection; Hemophagocytic Lymphohistiocytoses

Summary: this study aimed to investigate the efficacy and safety of carrimycin tablets in hemophagocytic lymphohistiocytosis patients with carbapenem-resistant infections.

hemophagocytic lymphohistiocytosis (hlh) is a critical condition characterized by the undue activation of cytotoxic t lymphocytes, natural killer cells, and macrophages, resulting in excessive secretion of infammatory cytokines. infection is an important trigger for hlh. this study aimed to investigate the efficacy and safety of carrimycin tablets in hemophagocytic lymphohistiocytosis patients with carbapenem-resistant infections.

Eligibility criteria:
inclusion criteria: * met hlh-2004 diagnostic criteria; * active infection； * empirical treatment with carbapenems did not respond after 72 hours； * age \>18 years old, no gender limitation; * ability and willingness to adhere to the study visit schedule and all protocol requirements. exclusion criteria: * other antibiotics should be selected according to the results of drug sensitivity； * systemic antibiotics other than carbapenems are used with 72 hours； * inability to take oral medications due to disease of gastrointestinal tract； * severe liver insufficiency; * expected survival time \< 1 month; * pregnant or breasting-feeding women; * allergic to carrimycin tablets; * active hepatitis b or hepatitis c infection; * patients with hiv infection; * patients with other contraindications considered unsuitable for participation in this study.
trial of nicotine nasal spray as an aid for smoking cessation in schizophrenia

Conditions: Smoking Cessation; Schizophrenia

Summary: this r01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (nns) as an aid for smoking cessation in 60 individuals with schizophrenia. the objectives of this study are to determine the efficacy of nns with behavioral intervention for smoking cessation in smokers with schizophrenia. it is hypothesized that the quit rate of subjects who receive nns and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (co) less than 10 parts per million during these 4 weeks. the investigators will also assess abstinence rates at study weeks 12 and 20 on the nns and at weeks 26 and 52 after the medication has been stopped. since studies of this group suggest high relapse rates when treatments are discontinued (evins et al., 2005; george et al., 2000; george et al., 2002a), the investigators will continue nns treatment for a total of 20 weeks.


Eligibility criteria:
inclusion criteria: * subjects will be invited to participate in the study if they fulfill the following inclusion criteria: 1. meet dsm-iv diagnostic criteria for schizophrenia 2. be 18 years of age or older 3. be daily smokers of 10 or more cigarettes per day (cpd) 4. have an expired co level \> 9 ppm 5. be motivated to quit smoking 6. be willing to adhere to the study protocol (e.g. provide samples, attend all visits) 7. be able to give informed consent 8. stable on their current atypical antipsychotic medication for at least one month. exclusion criteria: * subjects will be excluded based on any one of the following exclusion criteria: 1. current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days, 2. psychiatric hospitalization in the last 30 days 3. inability to read or understand the questionnaires in english 4. current pregnancy or lactation or plans to become pregnant in the next 12 months 5. regular use of non-cigarette forms of tobacco including cigars, pipes, smokeless tobacco 6. patients with significant cognitive impairment that may interfere with their study participation assessed as a folstein mini-mental status exam score of less than 22.

Keywords: smoking cessation schizophrenia nicotine nasal spray behavioral counseling
dasatinib combination therapy with the smoothened (smo) inhibitor bms-833923 in chronic myeloid leukemia (cml)

Conditions: Leukemia

Summary: the purpose of the study is to determine the safety and tolerability of the combination of bms-833923 plus dasatinib in patients with chronic myeloid leukemia.


Eligibility criteria:
key inclusion criteria * age ≥18 years * diagnosis of chronic myeloid leukemia (cml) and cytogenetic positive for the philadelphia chromosome (ph+), documented ph+ cells on bone marrow assessment (bma) ≤6 weeks prior to treatment * either chronic-phase cml, with \ 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission * resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known t315i/a abl-kinase mutation. key exclusion criteria * known abl-kinase t315i or t315a mutation * ccyr at baseline * any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy * uncontrolled or significant cardiovascular disease * grade 3 or higher peripheral blood counts * serum calcium or phosphate below the lower limit of normal * baseline hypomagnesemia and amylase or lipase at least grade 1 or higher * reduced renal function, defined as serum creatinine level \>3\*upper limit of normal * prior therapies for cml or ph+ all permitted, with the following restriction: * therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study * 6 months or longer after stem cell transplantation * 28 days or longer after any investigational agent * 7 days or longer after any standard chemotherapy agent * concomitant use of medications with a known risk of causing torsades de pointes * concomitant use of strong inhibitors of the cyp3a4 isoenzyme

Keywords: leukemia (chronic myeloid leukemia-chronic phase and advanced)
accessible and inclusive diabetes telecoaching self-management program

Conditions: Diabete Type 2; Disability Physical

Summary: the purpose of this study is to develop and pilot test an accessible and inclusive artificial intelligence (ai)-assisted, individualized, family-focused lifestyle modification intervention (ai4dm) for glycemic control in people with disabilities.

the ai4dm study will use a two-arm randomized control trial design. eligible and consented participants will be assigned to one of two groups: 1) ai4dm intervention group with telecoaching support, and 2) attention-control group. the active intervention period will include six months of weekly and bi-weekly telecoaching calls followed by six months of follow-up and technology access, but no telecoaching calls.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus, * living with a permanent physical disability such as spinal cord injury (sci), spina bifida, multiple sclerosis, stroke, etc. * ability to converse and read in english exclusion criteria: * current enrollment in any diabetes-related intervention * severe untreated depression in the past six months * major cardiac event in the past twelve months * uncontrolled blood pressure * resting tachycardia * renal failure * severe peripheral neuropathy * unavailability of a smartphone
the effect of nsaids after a rotator cuff repair surgery.

Conditions: Rotator Cuff Tear

Summary: the main purpose of the study is to determine the effect of non-steroidal anti-inflammatory drugs (nsaids) on the healing process after a rotator cuff repair procedure.

furthermore, the study will also determine the rate of narcotic medications use and the retear rate after a rotator cuff repair procedure.

Eligibility criteria:
inclusion criteria: * rotator cuff tear * age 45-75 years exclusion criteria: * diabetes * pregnancy * chronic kidney disease * liver cirrhosis * hematologic malignancy * alcohol abusing * drug abusing

Keywords: randomized controlled trial (rct) rct rotator cuff tear nsaids non-steroidal anti-inflammatory drugs rotator cuff repair
eso-sponge registry

Conditions: Leakage After Esophagectomy; Leakage After Gastrectomy; Perforation of the Esophagus

Summary: this international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using eso-sponge® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.

anastomotic leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. for this reason the treatment of this clinical situation is often a challenge for the clinician. besides surgical examination and the endoscopic stent system, good experiences have been obtained with the endo-sponge® therapy for the lower gastrointestinal tract. in the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with eso-sponge®. eso-sponge® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients. the overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. currently only cohort studies including a small number of patients have been performed and published. therefore an international, prospective and multicenter registry was designed to collect clinical evidence for eso-sponge treatment concept in a large population under daily clinical routine.

Eligibility criteria:
inclusion criteria: * endoscopic vacuum therapy (evt) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations * age \> 18 years * written informed consent exclusion criteria: * none

Keywords: esophageal anastomosis leakage endoscopic vacuum therapy esophageal perforation upper gastrointestinal tract esophageal leak endoscopy