Kornimate/medical-research-clean huggingface dataset:
comparison of nn1250 with insulin glargine in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in south africa, europe and north america. the aim of this trial is to compare efficacy and safety of nn1250 (insulin degludec (ideg)) with insulin glargine (iglar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (dpp-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (oads) qualifying for intensified treatment.


Eligibility criteria:
inclusion criteria: * insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) * current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dpp-4 inhibitor, alpha-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily) -insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -dpp-4 inhibitor: minimum half of the daily maximal dose according to local labelling - alpha-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis * body mass index (bmi) maximum 45.0 kg/m\^2 * type 2 diabetes (diagnosed clinically) for at least 6 months * ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (smpg) profiles according to the protocol exclusion criteria: * use within the last 3 months prior to visit 1 of: thiazoledinediones (tzds), exenatide or liraglutide * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements \[for uk: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods\] * cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
a digital therapeutic solution for cancer patients

Conditions: Cancer; Prostate Cancer; Colorectal Cancer; Lung Cancer

Summary: this is a randomized, controlled trial to assess the feasibility of sidekick health's digital programs for cancer patients. participants will be treated with standard of care (soc) in combination with the digital programs, or soc only. we will compare the effect of the digital programs in addition to soc to soc only, on the cancer-related quality of life (qol), cancer-related fatigue, and side-effect management.

in line with the growing need to support cancer patients with lifestyle modifications, education and disease management, sidekick health developed 14-week digital programs addressing the specific needs of patients with cancers. in this study, the effect of adding the sidekick's digital program to the standard of care (soc) treatment for cancer patients will be assessed, with focus on prostate cancer, colorectal cancer and lung cancer. the digital programs investigated are a general oncology program (sk-411), or specific programs tailored for patients diagnosed with prostate cancer (pc-sk-451), colorectal cancer (crc-sk-441), or lung cancer (lc-sk-431). the study will be a single center feasibility study with an intervention group and a comparison group recruiting 84 cancer patients in active cancer treatment from landspítali university hospital. patients will be randomized to receive either the soc treatment alone or soc with the addition of the digital program. active cancer treatment is defined as chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or radiation therapy according to standard treatment guidelines.

Eligibility criteria:
inclusion criteria: * adults (at least 18 years of age) diagnosed with cancer * has started active cancer treatment (chemotherapy, hormonal therapy, targeted therapy, immunotherapy, radiotherapy) during the study * cancer diagnosis (all stages), with a focus on prostate cancer, lung cancer, or colorectal cancer * understands verbal and written icelandic or english * owning a smartphone compatible with the sidekick health app and capable of using it. * capacity to give informed consent * willing to comply with all scheduled visits, study interventions, and procedures exclusion criteria: * pregnancy * surgeries in the last 4 weeks prior to participation in the study * surgeries planned during the 14-weeks intervention * not able to comply with study intervention or scheduled measures and visits, as assessed by oncologist * current breast cancer diagnosis

Keywords: cancer digital solution lifestyle change prostate cancer quality of life digital intervention side effects medication adherence physical activity colorectal cancer lung cancer
narcotic-free percutaneous nephrolithotomy

Conditions: Nephrolithiasis

Summary: this is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.

this is a randomized control trial comparing oral ketorolac (10mg, q6 prn) and oxycodone (5mg, q6 prn) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (pcnl). primary endpoints are visual analog pain scores (vas) for days 1-5 and day 10 post operatively. secondary endpoints are pill counts, patient-related outcome survey (promis) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.

Eligibility criteria:
inclusion criteria: * undergoing scheduled unilateral standard (24fr), pcnl with at least 2cm stone burden, with expected single access exclusion criteria: * pregnant women * history of chronic opioid abuse * allergy, hypersensitivity, or other contraindication to nsaid usage such as * egfr \< 60 ml/min * peptic ulcer disease or history of gastric bypass * concurrent use of antiplatelet or anticoagulation therapy (including aspirin) * thrombocytopenia * suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding. * concomitant medications: * other nsaids * antiplatelet or anticoagulation medications * probenecid * pentoxifylline * allergy, hypersensitivity, or other contraindication to opioids: * current opioid prescription/usage for any reason, including active treatment with suboxone or methadone * respiratory depression * patients with acute or severe bronchial asthma or hypercarbia * patients who have or is suspected of having paralytic ileus as pcnl done under general anesthesia * patients with hepatic impairment * concomitant medications: * monoamine oxidase inhibitors (maois) * mixed agonist/antagonist and partial agonist opioid analgesics * diagnosis of chronic pain disorder * reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury) * pre-existing stent or nephrostomy tube * urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum) * pulmonary disease * liver disease * seizure disorders * subjects taking nephrotoxic medications * subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)
feasibility study to evaluate the observance rehabilitation of upper limbs by visual-motor simulation associated at transcranial direct current stimulation (tdcs) in hemiparetic patient post-stroke

Conditions: Stroke

Summary: although the mirror therapy is recognized as effective, its practice is difficult, especially with hemiplegic patients. it is difficult for them to understand, control the movements and carry out a double task with the two upper limbs. the implementation of a computerized mirror therapy (cmt) with the intensive visual simulation 3 (ivs3) device makes it possible to limit these problems by proposing pre-recorded sessions, not limited to the right or left hemi-space, and proposing a work on proximal motricity. since the functional prognosis of the upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be proposed. there is currently a consensus to consider the use of transcranial direct current stimulation (tdcs) stimulation in functional recovery after stroke as a method to enhance the effectiveness of training techniques. although all motor therapies can theoretically benefit from increased effectiveness by the addition of transcranial direct current stimulation (tdcs), computerized mirror therapy (cmt) has a high potential for sensitivity to transcranial direct current stimulation (tdcs) due to the intensity of the motor training of the upper limb applied.

the primary objective of this study is to investigate the feasibility of a program combining computerized mirror therapy (cmt) with dual- transcranial direct current stimulation (tdcs) stimulation by evaluating observance to hemiparetic stroke patients.

Eligibility criteria:
inclusion criteria: * patient with first ischemic or hemorrhagic stroke for less than one year, having not recidivated since then and responsible for initially complete left or right hemiplegia * modified frenchay arm test score \<70 (/ 100) * without a neurological history other than stroke * having signed the written consent and affiliated or entitled to a social security scheme exclusion criteria: * patient with contraindications to transcranial direct current stimulation (tdcs) or transcranial magnetic stimulation (tms) (brain metal implant, pacemaker, other implanted active medical device) * patient who didn't have cerebral magnetic resonance imaging (mri) imaging during their stroke * with complete lesion of the primary motor cortex * with alcohol / drug dependence * with psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignant disease, severe renal or pulmonary disease * with a history of disabling associated disease * with cerebellar syndrome * pregnancy

Keywords: transcranial direct current stimulation (tdcs) computerized mirror therapy (cmt) hemiparetic ischemic stroke intensive visual simulation3 (ivs3)
validation of insulin protocol for glucocorticoid-induced hyperglycemia in diabetic oncology patients

Conditions: Lymphoma; Diabetes Mellitus, Type 2; Hyperglycemia

Summary: there are no guidelines for the management of glucocorticoid- (henceforth steroid) induced elevated blood sugars (henceforth hyperglycemia). oncology ward patients have particularly high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. a prior study by muthala et al. (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered. in this pilot study, through an endocrine consult team, a weight-based, steroid dose-based insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.


Eligibility criteria:
for diabetics enrolled on admission: inclusion criteria: * age ≥ 18 years old * type 2 diabetes mellitus treated with insulin secretagogues or insulin prior to hospitalization * diagnosis of lymphoma * plan to treat with steroids of minimum equivalent of 20 mg prednisone per day * hospitalized for at least 48 hours * decision-making capacity to provide own consent exclusion criteria: * type 1 diabetes * any contraindication to insulin therapy * patients only on single agent therapy such as metformin, thiazolidinediones (tzds), dipeptidyl peptidase-4 (dpp4) inhibitors, or exenatide®, for safety concerns * insulin requirement of \>1.5 units of insulin/kg * if a patient required icu stay during the hospitalization, data from 12 hours before, during, and 12 hours after icu stay will be omitted to avoid confounding of the effect of critical illness on glycemic control * pregnancy, confirmed with a urine b-human chorionic gonadotropin (hcg) (for all women between the age of 18 and 60 years old) patients who develop a blood glucose \> 235 mg/dl after admission will be eligible for study enrollment based on the following: inclusion criteria: * age ≥ 18 years old * diagnosis of lymphoma * plan to treat with steroids of minimum equivalent of 20 mg prednisone per day * will be hospitalized for at least an additional 48 hours * decision-making capacity to provide own consent exclusion criteria: * any contraindication to insulin therapy * if a patient required icu stay during the hospitalization, data from 12 hours before, during, and 12 hours after icu stay will be omitted to avoid confounding of the effect of critical illness on glycemic control * pregnancy, confirmed with a urine b-hcg (for all women between the age of 18 and 60 years old)

Keywords: steroid induced hyperglycemia glucocorticoid induced hyperglycemia
a phase ii single-arm study of total body irradiation with linac based vmat and igrt

Conditions: Hematologic Malignancy

Summary: single institution study of safety of linac based vmat tbi for myeloablative treatment in hematologic malignancies.

total body irradiation (tbi) continues to play an important role in myeloablative and non-myeloablative conditioning regimens for allogeneic stem cell transplant (asct). when tbi is used as part of a myeloablative regimen, it is combined with chemotherapy to eradicate malignant cells, as well as to immunosuppress the host to prevent rejection of donor hematopoietic progenitor cells (hpc). this study is a single-institution study to assess the safety of linac based vmat tbi for myeablative sreatment in hematologic malignancies.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. patients undergoing related, unrelated (including cord blood) hematopoietic progenitor cell (hpc) transplant, in which the protocol requires \>12 gray of tbi, as part of the conditioning regimen. a. conditioning regimens outlined per bmt sop: clntx007: selection of conditioning regimens for blood and marrow transplantation - adults. 3. referral from the blood and marrow transplant (bmt) program for full-dose tbi, who meet inclusion and exclusion criterial per bmt sops. 1. bmt program will initiate referral, utilizing form: 170102, radiation oncology consultation. 2. patients undergo pre-transplant testing, as defined in bmt sops:clnal002: related (mrd, haplo) allogeneic recipient evaluation and management or clnal011: unrelated (mud, mmud, cbu) allogeneic recipient evaluation and management, per below. i. bmt sop's include baseline pulmonary function tests (pfts). patient with decreased fvc, fev1 and or dlco (adjusted for hemoglobin) or pulmonary history will have pulmonary consult, at the discretion of the bmt physician prior to undergoing myeloablative radiation. ii. medical history and physical by bmt provider. iii. the following laboratory tests (additional testing may be required for positive results): * abo group and rh type * red blood cell antibody screen. * hla typing and confirmatory typing * hla antibody screen, class i and ii, performed within 30 days of transplant. * complete blood count (cbc) with differential. * basic metabolic panel, including glucose and to include at a minimum electrolyte evaluation of potassium, calcium, magnesium, and phosphorus. * blood urea nitrogen (bun) * creatinine * liver function tests including: total bilirubin, alkaline phosphatase, aspartate aminotransferase (ast), alanine aminotransferase (alt), lactate dehydrogenase (ldh), albumin, total protein, urinalysis exclusion criteria: 1. patient receiving less than 1200 cgy of tbi 2. previous history of thoracic radiation therapy including previous tbi 3. all premenopausal women will require a urine qualitative pregnancy test to exclude pregnancy. pregnant women will be excluded from the study. 4. prisoners 5. patient not meeting transplant criteria per bmt physician.

Keywords: myeloablative treatment total body irradiation
covid-19 active research experience (care)

Conditions: COVID-19

Summary: covid-19 active research experience (care) is an observational, direct-to-participant, web-based, longitudinal study of adults with covid-19 or covid-19 like illness or who were vaccinated against covid-19 to better understand risk factors, symptoms, and treatments for covid-19 illness and vaccine safety and effectiveness.

this is an observational, direct-to-participant, web-based, longitudinal study of adults with covid-19 or covid-19 like illness to better understand risk factors, symptoms, and treatments for covid-19 illness and vaccine safety and effectiveness. upon consent and enrollment, participants will complete an initial baseline survey reporting their demographics, relevant medical history, testing, vaccination, symptoms, use of prescription medications as well as use of supplements and other factors. the study follow-up period is 12 months. during the first month of follow-up participants will be invited to complete a symptom diary weekly to gauge symptom progression and severity and to provide updates on pharmaceutical and non-pharmaceutical interventions as well as healthcare encounters. reporting will then reduce to monthly for month 2 through 12.

Eligibility criteria:
inclusion criteria: * adult (18 years or older) * currently living in the us or uk * have regular access to a computer, smartphone or tablet and sufficient internet to support registry demands (note: this registry is designed to operate well even in regions with low bandwidth) * willing and able to provide informed consent * willing and able to follow the procedures of the study participants must also meet at least one of the following conditions: * have covid-19 or covid-19 like symptoms * received a covid-19 vaccine * potential exposure to covid-19 exclusion criteria: * unable to provide informed consent * unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks
quantifying new heart muscle cells

Conditions: Tetralogy of Fallot With Pulmonary Stenosis; Heart Failure

Summary: regenerative therapies could provide new ways of treating heart failure. unlike many organs in the human body, such as the skin and the gi tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. the investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration. the study has now been registered on clinicaltrials.gov, despite its initiation on july 23, 2015, as registration was not mandated at the original study site, the university of pittsburgh medical center. however, following the transfer of the study to weill cornell medicine, adherence to institutional requirements necessitated its registration on clinicaltrials.gov.


Eligibility criteria:
inclusion criteria: * patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion. * the investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection. * diagnosis of tof/ps or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research exclusion criteria: * patients with low chance of having resection of myocardium as part of their surgical care.
endometrial ablation with non-hysteroscopic methods

Conditions: Dysfunctional Uterine Bleeding

Summary: endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. this study aims to prove that amenorrhoea rates using novasure are higher than those observed in microwave endometrial ablation, one year following intervention.


Eligibility criteria:
inclusion criteria: * women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing) exclusion criteria: * endometrial pathology * fsh \> 20 day 2 -day 3 of the cycle * clotting disorders * thyroid dysfunction
understanding hallucinations (part ii)

Conditions: Hallucinations

Summary: rationale: hallucinations occur in many patients with different kinds of diseases, including psychiatric, neurological and perceptual impairment. the origin of these hallucinations is only partly understood. this prevents correct prediction of treatment response and hampers the development of new, more effective treatment strategies. different subtypes of hallucinations resulting from different neuropathology may exist across diagnostic entities, and be responsive to different treatment strategies. understanding the origin of these subtypes with use of fmri and eeg can help to make rational treatment decisions on an individual basis and enhance the development of innovative treatment paradigms. objective: the primary objective is to find specific abnormalities on resting state fmri related to the pathophysiology of different subtypes of hallucinations. secondary objectives are to find eeg connectivity measures that are related to the pathophysiology of different subtypes of hallucinations, reveal correlating patterns of eeg and fmri that underlie the experience of hallucinations across different disorders, and to examine the frequency of spontaneous synchronized burst activations in auditory and visual cortices using fmri. study design: the investigators intend to examine neural correlates of hallucinations over different disorders using resting state eeg, fmri and smri in an observational study. study population: a total of 140 hallucinating patients will be included, 20 of each of the 7 different diagnostic groups. as a control group, 140 non-hallucinating patients with the same disorder of similar severity will be included. main study parameters/endpoints: the main study endpoint is the difference in resting state correlates as measured with fmri between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes, namely: connectivity within the dmn and connectivity of the dmn to sensory cortices and the hippocampal-amygdala complex. nature and extent of the burden and risks associated with participation, benefit and group relatedness: participation in the study will entail an mri scan of 40 minutes and an eeg measurement of 5 minutes. total visit time, including preparations, will be approximately 2,5 hours. the risks associated with participation and the benefits to the individuals are negligible. the potential benefit to society in the future is considerable if the findings lead to optimization of treatment strategies and treatment response.


Eligibility criteria:
inclusion criteria: * previous participation in the phenomenology/cognition study 13-059. * belong to one of the diagnostic groups as described above in 4.1. * written informed consent exclusion criteria: * \< 18 years of age * any contraindication for a 3tesla mri scan