Kornimate/medical-research-clean huggingface dataset:
to evaluate the pharmacokinetic/pharmacodynamic interactions and safety between id1801 and id1803 in healthy male adults

Conditions: Hypertension; Dyslipidemias

Summary: this study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

an open-label, single or multiple-dose, fixed-sequence, 3-treatment, 3-period phase 1 study to evaluate the pharmacokinetic/pharmacodynamic interactions and safety between id1801 and id1803 in healthy male subjects

Eligibility criteria:
inclusion criteria: * healthy adult male volunteers aged 19 to 45 years * subjects who have over 50kg and bmi more than 18.5kg/m2 and less than 29.9kg/m2 * males must be agree to practice a medically acceptable method\* of birth control and will not donate sperm during the study. * subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period exclusion criteria: * subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease * subject with symptoms of acute disease within 28days prior to study medication dosing * medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug * drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity: * subject with a history of drug abuse or urinalysis positive * subject with clinically significant active chronic disease * subject with genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption. * genetic myopathic disorder or related family history * positive test results for hbs ab, hcv ab, anti hiv(aids), rpr ab * subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) * subject who cannot take standard meal in hospitalization * present history of hypothyroidism or clinically significant assay * subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration. * subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing * smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling. * subjects who judged ineligible by the investigator
a phase ii study to evaluate safety and efficacy of alx-0061 in subjects with systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: primary objective: to assess the efficacy and safety of different dose regimens of alx-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (sle) compared to placebo. secondary objectives: to assess the pharmacokinetics (pk), pharmacodynamics (pd), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of alx-0061.


Eligibility criteria:
inclusion criteria: 1. man or woman ≥ 18 years and \< 65 years of age 2. have a diagnosis of sle for at least 6 months prior to screening and fulfill the 1997 american college of rheumatology (acr) or 2012 systemic lupus international collaborating clinics (slicc) classification criteria 3. have moderate to severe active sle 4. have seropositive disease at screening 5. subject must be at least on one or more of the treatments for sle as listed in the protocol 6. others as defined in the protocol exclusion criteria: 1. have an a score on the revised bilag-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at baseline for the organ systems that can be clinically assessed 2. have a systemic inflammatory disease other than sle 3. clinically significant infection treated or needing treatment 4. any active or recurrent viral infection that based on the investigator´s clinical assessment makes the subject unsuitable for the study 5. have received prior therapy blocking the interleukin-6 (il-6) pathway 6. others as defined in the protocol
adenoma detection rate using ai system in china

Conditions: Colorectal Neoplasms; Colonic Polyp; Adenoma

Summary: the primary aim of this study is - to explore the usefulness of artificial intelligence system in colonoscopy on adenoma detection rate (adr). other aims include to explore the data below when artificial intelligence is used. mean adenomas detected per procedure, map proximal adenoma detection rate, padr polyp detection rate, pdr proximal polyp detection rate, ppdr mean polyps detected per procedure, mpp withdrawal time, wt cecal intubation rate, cir cecal intubation time, cit

colorectal cancer is common in china. most colorectal cancers happen when an adenoma becomes cancerous. doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. removing adenomas is known to reduce the chances of a person developing colorectal cancers. the ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates". a new ai system, called the csk endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. this study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an ai-assisted colonoscopy. the investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. all patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.

Eligibility criteria:
inclusion criteria: * all patients referred for screening, surveillance, or diagnostic colonoscopy * all patients must be able to give informed consent exclusion criteria: * patients with any absolute contraindications to colonoscopy * patients with established or suspicion of large bowel obstruction or pseudo-obstruction * patients with known colon cancer or polyposis syndromes * patients with known colonic strictures * patients with known severe diverticular segments (that is likely to impede colonoscope passage) * patients with active colitis (ulcerative colitis, crohn's colitis, diverticulitis, infective colitis) * patients lacking capacity to give informed consent * pregnancy * patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure. * patients who are attending for a therapeutic procedure or assessment of a known lesion

Keywords: adenoma detection rate
the effects of ankle foot orthoses on gait efficiency in children with acute lymphoblastic leukemia and foot drop

Conditions: Foot Drop; Acute Lymphoblastic Leukemia

Summary: this study is designed to see if children with acute lymphoblastic leukemia who have developed foot drop during treatment for their leukemia consume less oxygen when walking with or without an ankle brace designed to support their foot during walking. in this study children with foot drop are asked to walk for six minutes with and without brace on their ankle. during each walk, the amount of oxygen used is measured. the child wears a face mask which is attached to a device that records how much oxygen they use. the amount of oxygen used during the walk with the brace on will be compared to the amount of oxygen used with the brace off.

1. this study will determine the impact of ankle foot orthoses (afo) wear on gait efficiency in children with all and chemotherapy-induced peripheral neuropathy (cipn). 2. the study hypothesizes that children with cipn will have lower net oxygen consumption during the six minute walk test while wearing afo as compared to their net oxygen consumption during a six minute walk test while not wearing afo. 3. the study will assess whether gait efficiency while using an afo persists after one month of use. 4. the study will hypothesize that the benefits of afo use on gait efficiency persist after one month of wear.

Eligibility criteria:
inclusion criteria: 1. research participant is diagnosed with childhood all and currently being treated on the total xvi protocol at st. jude children's research hospital (sjcrh) 2. research participant is from 6 to 18 years of age at the time of the scheduled evaluation 3. research participant has chemotherapy-induced peripheral neuropathy resulting in foot drop 4. research participant will be receiving afo 5. research participant has a hemoglobin level greater than 8 g/dl and a platelet count above 50 x 109/l exclusion criteria: 1. participant has down syndrome or other known congenital developmental delays 2. participant has a platelet count lower than 50 x 109/l and a hemoglobin level less than 8 g/dl 3. participant has a lower extremity amputation, congenital deformity of the lower limb or an acute fracture of the lower limb 4. participant has symptomatic osteonecrosis in the lower extremities

Keywords: acute lymphoblastic leukemia
mapping for acute transvenous phrenic nerve stimulation study

Conditions: Sleep Apnea

Summary: the mapping for transvenous phrenic nerve stimulation study (maps) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (ep) catheter advanced into the great veins.

purpose the mapping for transvenous phrenic nerve stimulation study (maps) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an ep catheter advanced into the great veins. study design this is a prospective, non-randomized, acute feasibility study.

Eligibility criteria:
inclusion criteria: * subjects older than 18 years of age * subject is undergoing a cardiac catheterization involving right heart catheterization and/or ep procedures and/or device implant. * subjects willing and able to give informed consent exclusion criteria: * subject with a previously implanted transvenous lead, which is still present in the veins under study. * subject with evidence of phrenic nerve palsy. * subject with chronic obstructive pulmonary disease. * subject with a spinal cord stimulator. * subject needs to receive drugs that might interfere with patient perception. * subjects with medical conditions that would prevent study participation * subjects who are pregnant, nursing, or of child bearing potential and are not on a reliable form of birth control * subjects enrolled in concurrent studies which could confound the results of this study * subject is unable or unwilling to participate with study procedures

Keywords: breathing, heart failure, sleep apnea
a study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple doses of abt-333 alone and in combination with pegylated interferon (pegifn) and ribavirin (rbv) in subjects with genotype 1 chronic hepatitis c virus (hcv) infection

Conditions: Chronic Hepatitis C Virus Infection

Summary: the purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of abt-333 (also known as dasabuvir) in treatment-naïve, hepatitis c virus (hcv)-infected participants.

this was a phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis c virus (hcv)-infected adults with 2 planned sequential evaluations, part 1 and part 2. the study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of abt-333 or placebo monotherapy, followed by 26 days of abt-333 or placebo with pegylated interferon a-2a (pegifn) and ribavirin (rbv) combination therapy. review of safety and efficacy in part 1 of the study showed similar response rates across abt-333 doses so part 2 of the study was not performed. the study also assessed emergence of resistant hcv in conjunction with kinetics of viral load decay and rebound in treatment-naïve, hcv-infected participants.

Eligibility criteria:
inclusion criteria: * participant has provided written consent. * if female, participant is postmenopausal or surgically sterile. * if male, must be practicing two effective methods of birth control. * participant is hepatitis c virus (hcv) genotype 1 with hcv ribonucleic acid levels \>50,000 iu/ml. * participants must demonstrate chronic hepatitis c infection for at least 6 months prior to study enrollment. * participants must have a liver biopsy with histology consistent with hcv-induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv. * condition of general good health other then hcv infection. * participants with a history of thyroid disease must have a thyroid stimulating hormone (tsh) value in the normal range. exclusion criteria: * no prior history of receiving therapy for hcv infection. * positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag), or human immunodeficiency virus antibody (hiv ab). * pregnant or breastfeeding females or male partners of women who are pregnant. * history of seizures or cancer. * history of major depressive disorder within 2 years. * any current or past history of cirrhosis. * any cause of liver disease other than chronic hcv infection.
effect of dutasteride on intraprostatic dihydrotestosterone (dht) levels

Conditions: Prostatic Hyperplasia

Summary: this study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to turp. male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. during the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.


Eligibility criteria:
inclusion criteria: * diagnosed with benign prostatic hyperplasia * must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure. * psa (prostate specific antigen) level must be between 1.5 and 15 ng/ml. exclusion criteria: * prostate cancer. * use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication. * previous finasteride use or other investigational 5ari within 6 months prior to screening. * history of chronic utis (urinary tract infections) * presence of acute bacterial prostatitis at screening

Keywords: testosterone dht turp
bone properties following exercise induced changes in insulin sensitivity in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; Bone Diseases, Metabolic; Osteoporosis, Osteopenia; Musculoskeletal Diseases; Metabolic Disease; Glucose Metabolism Disorders

Summary: diabetes mellitus type 2 is associated with low bone turnover and increased risk of bone fractures. bone mineral density, however, is increased and cannot explain the increased fracture risk per se. the pathophysiology is not completely understood, but the decrease in bone turnover is believed to cause an accumulation of microcracks in bone tissue leading to bone fragility. the decrease in bone turnover may arise directly from insulin resistance or indirectly through formation of advanced glycation end-products. the main aim objective is to investigate how increases in insulin sensitivity following 12 weeks of moderate intensity bike exercise affect biochemical bone turnover markers and biomechanical bone properties in individuals with diabetes mellitus type 2.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * age ≥ 45 years * male or female sex * women must be postmenopausal exclusion criteria: * recent substantial changes in diet (within 3 months) * recent substantial changes in activity level (within 3 months) * recent substantial weight changes (within 3 months) * current or previous treatment (within the last 2 years) with non-oral anti-diabetics or oral glp-1 analogs * hba1c ≥ 90 mmol/mol * hba1c \< 48 mmol/mol without anti-diabetic medication * premature menopause (menopause before 40 years of age) * current pregnancy * treatment with one of the following medications: * systemic glucocorticoids (within the last 2 years) * antiresorptive or bone anabolic medication (ever) * lithium (ever) * anticonvulsive medication (current) * menopausal replacement therapy (currently) * estimered glomerular filtrationsrate (egfr) \< 60 ml/minutes * high level of physical activity, assessed by the investigators to interfere with the study results * substantial cardiovascular, endocrine, renal, hepatic, rheumatological, gastrointestinal or other disorders assessed by the investigator * electronic implants * osteoporosis or other bone disease * resent bone fracture (within 6 months) * previous bone fracture in either both tibial bones or both radial bones * parathyroid or calcium metabolism disorder * vitamin d deficiency (\< 50 nmol/l) * other substantial medical disorder in unstable phase or active cancer within the last five years except spino- or basocellular carcinoma * lack of ability to complete the intervention * patients assessed uneligible by the investigator to participate in the study

Keywords: diabetes mellitus, type 2 bone bioelectric impedance diabetic bone disease insulin supression test (ist) bone turnover
mri of the tmj in patients with djd

Conditions: Degenerative Joint Disease; Control Subjects

Summary: this observational research is comparative in design, that is assessing the change in qmri measures in degenerative changes of the tmj in patients diagnosed with djd. these patients will be imaged multiple times over the course of 18 months, using clinical 3t mri scanners located at the center for magnetic resonance research (cmrr), and their findings will be compared to controls; individuals who are not diagnosed with djd. no investigational agents or mri contrast agents will be used.

participants with djd will be recruited during routine examinations at the tmd clinic located at the school of dentistry, umn. they will be approached by their clinicians for potential enrollment in an mri study. eligibility will be assessed based on prior imaging and medical history. if eligible and interested, participants will complete a consent process and a cmrr questionnaire which is a safety screening questionnaire, followed by scheduling for a 2-hour mri session at the cmrr. during the visit, participants will undergo approximately 90 minutes of qmri scans using a 15-channel face coil. afterward, they'll complete an exit questionnaire. additional follow-up scans may occur over 18 months, following the same procedures, while control participants will have two scans 1-4 weeks apart.

Eligibility criteria:
inclusion criteria: 1. to participate in this study, patients (with djd) must: * be 18 years or older * provide written informed consent in english * state willingness to comply with all study procedures and be available for the duration of the study * have clinically confirmed djd diagnoses based on ct and/or radiographs, and /or traditional mri scan obtained by their clinician. * willing to have a separate approximately 2-hour appointment to have an mri at the cmrr * has the ability to manage their own calendar and schedule appointments * does not have a serious medical condition * is not pregnant or is not potentially pregnant 2. to participate in this study, controls (participants without djd) must: * be 18 years or older * provide written informed consent in english * state willingness to comply with all study procedures and be available for the duration of the study * confirm the absence of any pre-existing tmj disease * willing to have a separate approximately 2-hour appointment to have an mri at the cmrr * has the ability to manage their own calendar and schedule appointments * does not have a serious medical condition * is not pregnant or is not potentially pregnant 3. exclusion criteria: participants will be excluded if they: * contraindications to mri. exclusion criteria for mri are: 1. ferromagnetic implants 2. history of shrapnel or shot gun injury 3. too large to fit in the magnet (body mass index \>= 40, approx.) 4. cardiac pacemakers 5. severe claustrophobia 6. large tattoos 7. history of metalwork * are non-english speaking * could be pregnant

Keywords: degenerative joint disease tmj mri controls healthy controls magnetic resounance imaging diagnosis
motexafin gadolinium and radiation therapy in treating young patients with pontine glioma

Conditions: Untreated Childhood Brain Stem Glioma

Summary: this phase ii trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. radiation therapy uses high-energy x-rays to kill tumor cells. drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. giving motexafin gadolinium together with radiation therapy may kill more tumor cells.

primary objectives: i. evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma). secondary objectives: i. evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients. ii. determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients. outline: this is a multicenter study. patients receive motexafin gadolinium iv over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed every 3 months for 3 years and then periodically thereafter.

Eligibility criteria:
inclusion criteria: * diagnosis of intrinsic pontine glioma (brain stem glioma) * clinical and radiographic (mri) evidence of tumors that diffusely involve the brain stem (i.e., tumors that intrinsically \[\> 50% intra-axial\] involve the pons or pons and medulla, pons and midbrain, or entire brain stem) allowed * tumor may contiguously involve the thalamus or upper cervical cord * no more than 1 lesion/mass present at diagnosis * karnofsky performance status (ps) 60-100% (age \> 16 years) or lansky ps 60-100% (age ≤ 16 years) * life expectancy ≥ 8 weeks * absolute neutrophil count ≥ 1,000/mm³ * platelet count ≥ 100,000/mm³ (transfusion independent) * hemoglobin ≥ 10 g/dl (rbc transfusions allowed) * creatinine clearance or radioisotope glomerular filtration rate ≥ 70 ml/min or creatinine normal for age/gender (0.4-1.7 mg/dl) * bilirubin ≤ 1.5 times upper limit of normal (uln) * alt \< 1.5 times uln * no known glucose-6-phosphate dehydrogenase (g6pd) deficiency * if family history suggestive of congenital hemolytic anemia, patient must be screened for g6pd with g6pd activity test prior to study entry * no biliary obstruction * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior definitive therapy for this specific tumor * no prior cranial radiotherapy * concurrent steroids and anticonvulsants allowed * no concurrent proton therapy * no concurrent intensity-modulated radiotherapy * no concurrent anticancer chemotherapy * no concurrent immunomodulating agents