Kornimate/medical-research-clean huggingface dataset:
multicenter study of denture adhesive

Conditions: Edentulous

Summary: to establish evidence based guidelines for denture adhesives (powder and cream), multicenter cross over randomized clinical trial will be carried out. the null hypotheses are that there are no difference on improvement from baseline to post application of two adhesives powder and cream, in terms of general satisfaction, oral related quality of life, masticatory function and oral conditions.

this is multicenter study of 10 academic affiliated institutions. the clinical trial will be carried out in randomized allocation at each site, and data will be gathered. the intervention will be 3-arms and center institution (nihon university) will generate each site random numbers for allocation and each site will follow this randomization. research protocol had been published at nihon university and distributed to each site.to survey its protocol compliance, the study meeting will be held periodically (twice an year).

Eligibility criteria:
inclusion criteria: * edentulous exclusion criteria: * cannot answer the questionnaire * deteriorating general conditions * maxillofacial defect * metal denture user * already denture adhesive users * severe xerostomia
safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending oral doses and effect of food on the bioavailability of bi 1060469

Conditions: Healthy

Summary: the objective of the single rising dose part (srd) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of bi 1060469 in healthy male subjects. the objective of the food effect part (fe) is to investigate the relative bioavailability of bi 1060469 tablets in healthy male subjects in fed or fasted state.


Eligibility criteria:
inclusion criteria: 1. healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests 2. age within the range of 18 to 50 years 3. body mass index within the range of 18.5 and 29.9 kg/m2 4. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and local legislation. exclusion criteria: 1. any finding in the medical examination (including blood pressure (bp), pulse rate (pr) or electrocardiogram (ecg)) deviating from normal and judged clinically relevant by the investigator. pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmhg for diastolic blood pressure if confirmed by repeat measurement. 2. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 3. in the srd: serum creatinine laboratory value outside the normal range 4. glomerular filtration rate (gfr) according to ckd-epi (chronic kidney disease - epidemiology collaboration)-formula \< 60 ml/ min 5. current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections) 6. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 7. surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
combining tdcs with vr-based motor training in stroke

Conditions: Virtual Reality Based Therapy; Anodal tDCS; Occupational Therapy; Sham tDCS

Summary: stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. however, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. there is a need to deploy new approaches that advance the current rehabilitation methods and enhance their efficiency. one of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (vr) applications, which combine training scenarios with dedicated interface devices. on the other hand, recent studies have shown the potential of transcranial direct current stimulation (tdcs) to restore motor function in hemiparetic stroke patients. it must be emphasized, however, that so far little work exists on the quantitative assessment of the clinical impact of vr based approaches in combination with tdcs protocols. we hypothesize that the combination of vr-based motor rehabilitation protocols with concurrent anodal tdcs can boost functional recovery, and may achieve superior effects when compared to 3 alternative treatments: 1) vr without tdcs, 2) occupational therapy with tdcs, and 3) occupational therapy without tdcs. the findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke patients. besides the clinical impact, such achievement could have relevant socioeconomic impact.


Eligibility criteria:
inclusion criteria: * patients with hemiparesis secondary to first ever ischemic or hemorrhagic stroke (medical research council score \> 2). * older than 18 years old. * sufficient cognitive capacity to understand and follow the experimental instructions (mini-mental state evaluation \> 20). exclusion criteria: * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * epilepsia and metal implants. a diagnostic eeg will be performed by the department of clinical neurophysiology of the hospital to detect epileptic paroxysmal in order to include or exclude patients in the study. * low cognitive capabilities that prohibits the execution of the experiment arteriovenous malformation * severe associated impairment such as spasticity, communication disabilities (sensorial, mixed or global aphasia or apraxia), major pain or other neuromuscular impairments or orthopaedic devices that would interfere with the correct execution of the experiment (modified ashworth scale \> 3) * history of serious mental-health problems in acute or sub acute phase * refusal to sign the consent form * previous surgeries opening the skull. * active or recent substance abuse or dependence within the past year. * pregnancy, breastfeeding, unwillingness to practice birth control during participation in the study.
bioavailability of abt-333 tablet versus first in human (fih) capsule formulation and safety, tolerability and pk study of single doses of abt-333 in healthy volunteers

Conditions: HCV Infection

Summary: the purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental hepatitis c virus (hcv) polymerase inhibitor in healthy volunteers.


Eligibility criteria:
inclusion criteria: * overall healthy subjects; * non-childbearing potential females included exclusion criteria: * history of significant sensitivity to any drug; * positive test for hav igm, hbsag, anti-hcv ab or anti-hiv ab; * history of gastrointestinal issues or procedures; * history of seizures, diabetes or cancer (except basal cell carcinoma); * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder; * use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration; * donation or loss of 550 ml or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration; * abnormal screening laboratory results that are considered clinically significant by the investigator; * current enrollment in another clinical study; * previous enrollment in this study; * recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol; * pregnant or breastfeeding female; * requirement for any otc and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Keywords: bioavailability (ba) single ascending dose (sad)
an observational study to learn more about the use of androgen receptor inhibitors and how they affect men with nonmetastatic prostate cancer in routine medical care in the united states

Conditions: Non-metastatic Prostate Cancer; Non-metastatic Castration-resistant Prostate Cancer

Summary: this is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmpc) who received their usual treatment with 'androgen receptor inhibitors' (aris) including darolutamide, enzalutamide, and apalutamide. prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. non-metastatic means that cancer has not yet spread to other parts of the body. darolutamide, enzalutamide, and apalutamide are already approved aris for nmpc in the united states (us). they work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. this helps to slow down the growth of the cancer cells. the participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information. researchers want to know more about the use of aris and how they affect men with nmpc in the real world. researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones. the main purpose of this study is to collect and study information from men with nmpc about: * the length of time they continued treatment with an ari as prescribed by their doctors. * the length of time from the start of the treatment with an ari until the cancer spreads to other parts of the body. data will come from the participants' information stored in a database called komodo research dataset (krd) in the us. the data collected will be from may 2019 to june 2023. researchers will only track data of eligible us men with nmpc and will follow them for a minimum of 6 months or until the end of the study.


Eligibility criteria:
inclusion criteria: * men diagnosed with prostate cancer (≥1 claim for prostate cancer). * treatment with apalutamide, darolutamide or enzalutamide initiated for the first time in the nmpc stage during the patient identification period. * age ≥ 18 years at index date * at least 6 months of continuous eligibility in medical and pharmacy benefits prior to the index date * at least 6-months of continuous eligibility only in pharmacy benefits after the index date unless patient died before 6 months. exclusion criteria: * patients with multiple aris recorded at index date * use of an ari agent or abiraterone acetate prior to the index date * other cancer diagnosis (except prostate and skin cancer) during the 6-month baseline period * evidence of metastatic disease any time before or 30 days after index date. * no claim with a diagnosis for hormone sensitive malignancy status (z19.1) during the study period

Keywords: nmpc nmcrpc
pgx study to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy

Conditions: Heart Valve Diseases

Summary: to develop and validate the predictive warfarin dosing algorithm.

this study aims to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy in korean patients.

Eligibility criteria:
inclusion criteria: * the patients taking warfarin exclusion criteria: * noncompliance
single shot fascia iliaca block vs femoral nerve block for analgesia for surgical fixation of hip fractures

Conditions: Hip Fracture

Summary: hip fractures are common in our elderly population and is associated with pain before and after surgery. the current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. as opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. this may enhance their recovery and length of hospital stay


Eligibility criteria:
inclusion criteria: * patients scheduled for surgical fixation of hip fracture * patients with isolated inter-trochantric fracture * american society of anesthesiologists (asa) physical status 1 to 3 * patients who are able to give their own consent exclusion criteria: * patients unable to give consent or inability to communicate/ cooperate * patients with regular consumption of strong opioids (morphine, oxycodone) or steroids * patients with allergy to local anaesthetics or any drugs included in the study * patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection
shortwave diathermy and pilates exercises in patients with chronic non-specific low back

Conditions: Low Back Pain

Summary: the aim of this study is to verify the effectiveness of the association of shortwave diathermy and pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life.

the drawing of the study will be a prospective, randomized controlled trial and double-blind with quantitative approach. study participants 36 subjects diagnosed with non-specific chronic low back pain, which will be divided in two groups with 18 subjects in each: experimental group, which will be submitted to placebo + exercise shortwave diathermy and the control group to do active + exercise shortwave diathermy. there will be 12 one-hour sessions twice a week. the subjects will apply shortwave diathermy for 20 minutes, followed by pilates mat.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with chronic non-specific low back pain for a period of more than 3 months, without irradiation for lower limbs; * who present pain intensity greater than 3 points in the numerical pain scale; * to sign the free and informed consent form. exclusion criteria: * bmi\> 30; * previous surgeries in the spine; * severe spinal affection (tumors, infection, unconsolidated or vicious consolidation fractures, inflammatory diseases); * rheumatic disease; * contraindication to performing the exercises according to the american college of sports medicine guidelines; * degenerative or inflammatory joint and other body segments; * patients who are in labor litigation; * pregnancy; * patients who are undergoing other type of physiotherapeutic or drug treatment.

Keywords: exercise therapy clinical trial diathermy physical therapy modalities
rapidteg ma validation

Conditions: Coagulation; Platelet Function

Summary: during normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. these mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). however, should this homeostatic balance be upset, normal hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding (hemorrhage). in instances that include acquired or congenital abnormalities of the hemostatic system it is clinically important to diagnose, monitor and manage the patient to optimize therapeutic intervention. moreover, it is important to regulate the hemostasis system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain the homeostatic balance. the teg® analyzer, using a small whole blood sample, documents the interaction of platelets with the protein coagulation cascade from the time of placing the blood in the analyzer until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via gpiib/iiia, through eventual clot lysis. it displays both qualitatively and quantitatively the two distinct parts of hemostasis - the part that produces the clot and the part that causes the breakdown of the clot. it shows the balance or degree of imbalance in the patient's hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of the patient's hemostasis condition. if the system is not in balance, one can see where the imbalance lies. if a patient is bleeding, it is crucial to determine the cause of bleeding as soon as possible in order to start the proper treatment. by utilizing a kaolin/tissue factor activator (rapidteg™), the teg® system can measure the interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways which initiate and result in clot formation. this rapidteg™ reagent can deliver results faster than activating with kaolin alone. this protocol will specifically assess one algorithm called ma. ma is a direct function of the maximum dynamic properties of fibrin and platelet bonding via gpiib/iiia that represents the ultimate strength of the fibrin clot. this represents platelet function. the objective of the study is to demonstrate the substantial equivalence of ma rapidteg vs. ma kaolin.


Eligibility criteria:
inclusion criteria: * patient age \> 18 years old * patient is either a trauma patient or is diagnosed with known cardiovascular disease. * samples must be tested within the recommended timeline (4-6 minutes for non-citrated and between 15 minutes and 2 hours for citrated) exclusion criteria: * patients who have been placed on anticoagulation prophylaxis for other conditions (not cpb/pci related). * patients who have established hemostasis system abnormalities (congenital or other). * samples identified as affected by testing errors by lab staff.

Keywords: thromboelastography teg coagulation rapidteg kaolin
comparing speedlyte and iv rehydration treating children with gastroenteritis in a pediatric emergency department (ed)

Conditions: Dehydration; Acute Gastroenteritis

Summary: to compare length of stay (los) of pediatric patients in a pediatric emergency room presenting with gastroenteritis treated with iv rehydration versus oral speedlyte rehydration.

gastroenteritis leading to dehydration is very commonly encountered in the pediatric emergency room setting. oral rehydration therapy (ort) is the first line therapy recommended by the american academy of pediatrics but is seldom used compared to intravenous therapy (ivt). ort has many advantages including less traumatic to the patient, can be administered by mouth, can be administered at home and less costly compared to ivt. furthermore, intravenous fluids may present several complications with iv placement such as infiltration, hematoma, air embolism, phlebitis, extravascular injection, intraarterial injection, etc. speedlyte is a new oral rehydration product with lipophilic absorption which allows for electrolytes to be more readily absorbed compared to other oral rehydration solutions. the liposome encapsulates the salty molecules which is thought to decrease the negative salty taste associated with oral rehydration solutions. in addition, the encapsulation of electrolytes allows for more molecules to be delivered past the stomach acids and absorbed into the body under higher bioavailability due to the lipid shell. participants will be randomized into two rehydration groups. one group will receive oral rehydration with the speedlyte product, the amount will be based on the participant's weight. the other group will receive intravenous rehydration with a normal saline bolus per physician practice, usually in the amount of 20 ml/kg. these interventions can be incorporated into the emergency room practice without undue expense to the setting or placing excessive demands on nursing time as these practices are standard of care in many rehydration cases.

Eligibility criteria:
inclusion criteria: * 6 mths to 18 years; * signs and symptoms of dehydration for less than a week * diagnosis of acute gastroenteritis, dehydration, vomiting, and/or diarrhea; * patient able to drink from bottle and/or cup; * per clinician's judgment, patient needs rehydration with iv solution. exclusion criteria: * chronic disease that includes but not limited to tb, hiv, congenital heart disease with hemodynamic consequences, metabolic disease, cerebral palsy, adrenal hyperplasia, renal tubular acidosis, and nephropathy; * vomiting due to head trauma; * severe hydration; * diabetic ketoacidosis; * bloody diarrhea; * diarrhea for more than a week; * malnutrition; * burns; * pneumonia; * meningitis; * history of seizures; * absent bowel sounds; * not able to drink from bottle or cup; * previous allergic reaction to citrate or other food coloring particles/formulation; * parent/legal guardian refusing to participate.

Keywords: vomiting diarrhea
bonviva(ibandronate) injection pms(post-marketing surveillance)

Conditions: Osteoporosis

Summary: this is an open label, multi-centre, non-interventional post-marketing surveillance

this is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ibandronate injection administered in postmenopausal osteoporosis patients according to the prescribing information

Eligibility criteria:
inclusion criteria: all subjects must satisfy the following criteria at study entry: subjects administered with bonviva(ibandronate) injection following the locally approved prescribing information women diagnosed with postmenopausal osteoporosis. subjects who the investigator believes that they can and will comply with the requirements of the protocol subjects with no experience of treatment using ibandronate injection note: subjects, who have experience of other bisphosphonates treatment, can be included. subjects who are indicated and administered of ibandronate injection according to the prescribing information in normal prescription use exclusion criteria: considering the nature of this non-interventional pms, there is no strict exclusion criteria set up. the doctors participating this study to enrol the subjects prescribed with ibandronate injection following the locally approved prescribing information. the following criteria should be checked at the time of study entry. according to contraindication on the prescribing information, ibandronate injection should not be administered to the following patients: patients with known hypersensitivity to ibandronate injection or to any of its excipients uncorrected hypocalcemia note: ibandronate injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients.

Keywords: osteoporosis ibandronate