Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety and pharmacokinetics of escalating doses of ro7297089 in patients with relapsed or refractory multiple myeloma

Conditions: Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Summary: this is a first-in-human phase i, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of ro7297089 and make a preliminary assessment of anti-tumor activity in patients with r/r mm for whom no established therapy for mm is appropriate and available or who are intolerant to those established therapies.


Eligibility criteria:
inclusion criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 12 weeks * r/r mm for which no established therapy for mm is appropriate and available or be intolerant to those established therapies * measurable disease exclusion criteria: * prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for the treatment of cancer within 4 weeks before first ro7297089 infusion * prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first ro7297089 infusion * prior treatment with car-t therapy within 90 days before first study drug administration * treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first ro7297089 infusion * autologous stem cell transplantation within 100 days prior to first ro7297089 infusion * allogeneic stem cell transplantation within 180 days prior to first ro7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease * primary or secondary plasma cell leukemia * known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with iv anti-microbial therapy within 14 days prior to first ro7297089 infusion * significant cardiovascular disease * current cns involvement by mm
whole transcriptome profiling and metabolic phenotyping in children with rohhad syndrome

Conditions: Childhood Obesity; Morbid Obesity

Summary: rapid onset obesity, hypoventilation, hypothalamic dysfunction and autonomic dysregulation (rohhad) is a syndrome named in 2007. the hallmark of the syndrome is the rapid onset obesity and dysregulation of central ventilation. there is little information about the metabolic changes that lead to the rapid onset obesity in these children. the investigators would like to study the metabolic phenotype of these children to understand the disturbances in energy balance that lead to the rapid onset obesity.

late-onset hypoventilation syndrome with hypothalamic dysfunction was first described in 1965 and renamed to rohhad syndrome in 2007 by ize-ludlow et al. the hallmark of rohhad syndrome is rapid-onset obesity starting at approximately 1.5 years of age with weight gain of 12-20 kg/year, central hypoventilation distinct from the obstructive hypoventilation caused by obesity, hyperphagia, a spectrum of pituitary hormonal dysfunction, and autonomic disturbances including temperature, blood pressure, and nociception abnormalities. some children have been noted with developmental and behavioral abnormalities. tumors of neural crest origin have been identified in 25-33% of the patients. the etiology of rohhad syndrome and the cause of rapid onset obesity is unknown. the aims of this study are to understand the whole transcriptome profiling of patient specific induced pluripotent cell (ipsc) derived hypothalamic neurons to understand the transcriptional level changes that give rise to the manifestations seen in rohhad syndrome. aim 1. generate patient specific ipsc-derived hypothalamic neurons from children with rohhad syndrome and their unaffected first degree relatives. aim 2: compare the whole transcriptome profiling of the patient derived cells compared to those of unaffected relatives and reference datasets to understand the differences in transcriptome that gives rise to rohhad syndrome. aim 3: selected patients may be invited to participate for detailed metabolic phenotyping to understand the mechanisms of excessive weight gain.

Eligibility criteria:
inclusion criteria: * children with rohhad syndrome exclusion criteria: * children with known genetic causes of obesity

Keywords: hypoventilation syndrome hypothalamic dysfunction autonomic dysregulation rapid onsey obesity
clinical study of lipoic acid on ischemic heart failure

Conditions: Ischemic Heart Failure

Summary: the study will evaluate the efficacy of alpha-lipoic acid(α-la) on mortality in patients with ischemic heart failure (nyha class ii - iv and ef =\< 45%).


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age, male or female. * patients with a diagnosis of ami (\>30 days) according to the global definition. ③patients with a diagnosis of chf (nyha class ii-iv) and reduced ejection fraction (ef =\< 45%) and elevated bnp（nt-probnp≥600pg/ml or bnp≥150pg/ml; nt-probnp ≥400 pg/ml or bnp ≥100 pg/ml if patients was hospitalized for heart failure within 12months). * patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks. * patients must give written informed consent before any assessment is performed. exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * allergy to any of the study drugs, drugs of similar chemical classes（vitamin b） as well as known or suspected contraindications to the study drugs. * previous history of intolerance to recommended target doses of α-la. * current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy). ⑤ symptomatic hypotension and/or a sbp \< 100 mmhg. ⑥ severe liver function abnormalities (alt or ast more than 3 times of the normal upper limit). ⑦ estimated gfr \< 30 ml/min/1.73m2 as measured by the simplified mdrd formula. ⑧ serum potassium \> 5.2 mmol/l. ⑨ pregnant women or women preparing for birth.
effectiveness of targeted educational interventions at increasing hpv vaccine acceptability and uptake

Conditions: HPV-Related Cervical Carcinoma

Summary: this study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the hpv vaccine among females ages 12 through 26. subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the hpv vaccine. subject charts will be reviewed to assess for initiation of the hpv vaccine.


Eligibility criteria:
inclusion criteria: 1. females ages greater than or equal to 12 years and less than or equal to 26 years 2. presenting to a gynecology clinic for a routine or problem visit 3. ability to read and write exclusion criteria: 1. women ages less than or greater than 12 years or greater than 26 years 2. women with known cervical cancer 3. known pregnancy 4. prior initiation or completion of the hpv vaccine series
research study to compare three doses of semaglutide tablets taken once daily in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. the final three doses will be randomized (i.e., decided by chance). participants will be administered one tablet per day for 68 weeks. women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. women who can get pregnant will be checked for pregnancy via urine tests. once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the us, in the eu and in some other countries, under the brand name rybelsus®.


Eligibility criteria:
inclusion criteria: * male or female, age above or equal to 18 years at the time of signing informed consent. * diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. * hba1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive). * bmi equal to or above 25 kg/m\^2 * stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens: * no more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*: * metformin (equal to or above1500 mg or maximum tolerated or effective dose). * sulfonylureas (su) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose). * sodium/glucose cotransporter 2 (sglt2) inhibitors (maximum tolerated dose). * dipeptidyl peptidase-4 (dpp-4) inhibitors (maximally indicated dose as per local label). * subjects, on treatment with stable dose of dpp-4 inhibitors at inclusion, must be willing to discontinue dpp-4 inhibitor treatment at randomisation (with no wash-out). exclusion criteria: * treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed. * renal impairment measured as estimated glomerular filtration rate (egfr) value of below 30 ml/min/1.73 m\^2 according to chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation as defined by kidney disease improving global outcomes (kdigo 2012) classification. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
clinical investigation of infections due to leishmanial parasites

Conditions: Leishmaniasis; Leishmaniasis, Visceral

Summary: mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques. both non-specific and antigen-specific humoral and cellular immune responses will be assessed. parasites will be isolated from patients, cultivated in-vitro, and characterized. responses to chemotherapy will be assessed parasitologically, immunologically and clinically.

the main purpose of this protocol is to permit us to see patients who are referred to us for diagnosis and treatment of known or suspected leishmaniasis (from the peace corps, smithsonian institution, tourists, etc.). in the process of working up these patients, we sometimes encounter parasite isolates that are useful for research. we also can perform tests of cell-mediated immune function to evaluate how patients are responding to therapy. in addition, the protocol permits us to observe therapeutic responses to other drugs besides pentavalent antimony, if necessary.

Eligibility criteria:
must be between the ages of 1 and 65 years.

Keywords: chemotherapy cytokines immunology kala-azar leishmaniasis
myovista wavecg clinical validation study versus low e' on echocardiogram

Conditions: Cardiac Disease

Summary: clinical validation study of the myovista wavecg.

this is a multi-center, non-interventional, single arm clinical study of the myovista wavecg for the detection of lv relaxation abnormalities. study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2d transthoracic echocardiogram. the study will be conducted at a minimum of three investigational sites within the united states.

Eligibility criteria:
inclusion criteria: * subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment. * the subject provides written informed consent using an informed consent form that is reviewed and approved by the site's institutional review board (irb). * conventional ecg results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below). * subject is \>/= 22 years of age exclusion criteria: * the subject has current acute coronary syndrome, decompensated heart failure or stroke * the subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (cabg), heart transplant, ablation, coronary stent placement, etc. * conventional ecg results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block * the subject is pregnant at the time of the study testing * the subject has chest deformities that interfere with accurate measurement of ecg (either conventional or wavecg) * subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ecg and/or echocardiogram measurements. * the subject is enrolled in another clinical study that may interfere with myovista or echocardiogram measurements. exceptions to this may be approved by heartsciences.

Keywords: left ventricular diastolic dysfunction electrocardiograph
fredo-odx study: french data on outcomes in hr+/her2- early breast cancer patients with oncotypedx recurrence score-guided therapy

Conditions: Breast Cancer

Summary: the aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer rh+ her2- patients with systemic therapy guided by oncotype dx (odx) breast recurrence score®.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old with invasive breast carcinoma diagnosed on biopsy or surgical sample (histological evidence) operable breast cancer hr+ (at least er+) /her2- tumors with odx assay performed exclusion criteria: * inoperable tumor(s) or inoperable patient (e.g., patient too frail to undergo surgery) synchronous breast cancers with different clinico-pathological features (e.g. : hr+/her2 negative and triple-negative or her2-positive breast cancer patient undergoing neoadjuvant chemotherapy or neoadjuvant hormone therapy nodal involvement in more than 4 lymph nodes (pn2 or higher) metastatic breast cancer at diagnosis other malignancy diagnosed in the past 10 years (except for cutaneous malignancies other than melanoma) the patient participated in the rxponder study in france the patient communicated a refusal to participate in the study (via a refusal letter to the investigator) legal incapacity or limited legal capacity

Keywords: breast cancer early breast cancer
patterned electric dressing effects on open wounds

Conditions: Amputation; Open Wound

Summary: 1. this study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. the secondary objective of this study aims to observe the effect of ped on an open wound and its effects in wound bacteria colonization.

this study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. patients are identified through medical records. the patients will be selected based on inclusion and exclusion criteria through pre-screening through the comprehensive wound center's limb preservation program and wound physicians/providers at indiana university. the decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. the provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. study participation is decided independent of clinical decision. patients enrolled in the study will wear the patterned electric dressing (ped) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Eligibility criteria:
inclusion criteria: * ages 18 years and older * patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment * the affected limb to be amputated must have at least one open wound * wound(s) must be able to be covered by 3x3 dressing * subjects willing and able to provide informed consent exclusion criteria: * pregnant women * prisoners * individuals lacking consent capacity

Keywords: ped wound dressing
myoinositol supplementation, insulin resistance and fetal sonographic parameters in gestational diabetes diet treated

Conditions: Gestational Diabetes

Summary: the aim of this study is to verify the beneficial effects on insulin resistance and fetal sonographic parameters of a diet supplementation of myoinositol taken during the third trimester by pregnant women affected by gestational diabetes. participants should be randomly allocated to take either myoinositol or placebo twice/day for 8 weeks. the effect of myoinositol will be checked in blood samples (insulinemia and homeostasis model assessment - insulin resistance "homa-ir") and in fetal sonographic parameters after 4 and 8 weeks from the beginning of the nutritional supplementation.

background and aim: gestational diabetes mellitus (gdm) is a carbohydrate intolerance diagnosed during pregnancy that is not clearly an overt diabetes. it is characterized by an increase of the physiological insulin resistance of the pregnancy status. myo-inositol is an insulin sensitizing agent that ameliorate the insulin resistance. the investigators have already demonstrated that myoinositol, administered in first half of pregnancy, may reduce insulin resistance and gdm incidence in pregnant women at risk for family history, obesity and overweight . but the experiences in women affected by gdm are few and controversial. so the aim of this study is to test the effectiveness of myoinositol to ameliorate the insulin resistance in gdm patients, diet treated. moreover the investigators would like to verify the impact of this nutritional supplementation on the fetal sonographic parameters. design: the study is a randomized, prospective, placebo-controlled trial, including the first 80 consecutive gestational diabetes patients diagnosed, according to the italian guidelines, from november 2018 to december 2019, in the department of obstetric and gynecology of messina university (italy). after an informed consent participants will be randomly assigned to receive (n. 40) diet and folic acid (400 mcg per day) alone, or (n. 40) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day + 50 mg alfa-lactalbumin) supplementation. multiple pregnancy or known or suspected fetal congenital abnormality had been previously excluded. the insulin sensitivity index (homa-ir) and fetal sonographic profile will be monitor for each patient at gdm diagnosis and after 4 and 8 weeks of treatment. the pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Eligibility criteria:
inclusion criteria: * singleton pregnancy affected by gestational diabetes exclusion criteria: * multiple pregnancy and known or suspected fetal malformations

Keywords: insulin resistance fetal sonographic parameter myoinositol
the use of antimicrobial agents in the inhibition of mutans streptococci in children with dental caries

Conditions: Dental Caries

Summary: the aim of the present study was to compare salivary ms levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. this clinical trial was designed to test two different hypotheses. first, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary ms reduction. secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting ms suppression, dispensing repeated antibacterial treatments.

the present study aimed to compare the effect of sodium fluoride, chlorhexidine and vancomycin on salivary mutans streptococci (ms) levels, on a double-blind, randomized clinical trial. sixty-nine healthy volunteers, aged 4-8 years, with at least one active carious lesion and no previous history of allergies were selected to participate in the study. a gel formulation containing 1.23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin was topically administered to the dentition every 24 hours, during 6 consecutive days. salivary ms levels were measured at baseline (d1), on the 6th (d6), 15th (d15) and 30th day (d30). for microbiological analysis, msb agar medium was used.

Eligibility criteria:
inclusion criteria: * generally healthy children * children with at least one carious cavitated or non-cavitated lesion * must be able to spit * must be able to collaborate during clinical intervention exclusion criteria: * children with history of allergies or allergic diseases, e.g. asthma, urticaria, rhinitis, sinusitis, or intra-oral soft tissue lesions * children who underwent antibiotic treatment during the course of this clinical trial * children with developmental disabilities * children with no clinical signs dental caries

Keywords: dental caries vancomycin chlorhexidine sodium fluoride mutans streptococci
virtual reality for pain control during extracorporeal shock wave lithotripsy: a prospective, comparative, randomized study at a single institution

Conditions: Stone, Kidney; Stone Ureter

Summary: the aim of this study is to prospectively analyze patient satisfaction, pain, delivered energy and clinical effectiveness of using vr as a complimentary treatment modality during swl.

the patients were randomized in two groups swl with vr and swl without vr. when a patient was randomized for a vr session we put on the monitor after adequate patient positioning. we used the oncomfort sedakit. the size and location of stone pre-treatment was measured based on the best available imaging tool (ct\>rx/ultrasonography) using the maximal stone diameter. the locations of the stones were described as upper pole stones, midpolar stones, lower pole stones, renal pelvis stones and proximal ureteric stones. each swl treatment was standardized using diclofenac 100 mg suppository as analgesic and local lidocain/prilocain cream (emla 5g, aspen) to numb the skin. visualization of the stone was done by fluoroscopy of ultrasonography, as these proved to be equivalent (van besien et al. 2017). a specific and standardized ramping protocol was applied. after finishing this protocol, the energy level could be raised further depending on the level of discomfort of the patient. directly after the procedure, the patients were asked to complete a questionnaire where they were asked to write down the experienced amount of pain during the procedure on a vas of 10 cm and the satisfaction level using a likert-scale. the total delivered energy was noted. two weeks after every swl session, follow-up imaging (ultrasound and plain abdominal radiography) was performed by a radiologist. residual stone size was estimated on plain abdominal radiography or ultrasonography. the radiologist was blinded for the randomization process. practitioner and patient were not. after each swl the clinical outcome was noted.

Eligibility criteria:
inclusion criteria: - patients with renal or ureteric stones in need of a shock-wave lithotripsy. the indication was based on the european association of urology guidelines exclusion criteria: * none

Keywords: virtual reality shock-wave lithotripsy pain control