Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of tnx-1900 in patients with chronic migraine

Conditions: Chronic Migraine; Chronic Migraine, Headache; Chronic Migraine Without Aura; Aura Migraine

Summary: this is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 iu daily and 60 iu daily) of tnx-1900 in patients with chronic migraine.


Eligibility criteria:
major inclusion criteria: * men and women aged 18 to 65 years, inclusive, at the time of visit 1. * history of migraine with or without aura for at least 1 year and onset at \ 3 months prior to visit 1 as defined by ihs ichd-3 * patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for 90 days prior to screening and during the study. all treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. note: up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. once this category is filled, only patients who are not on any preventative medications can be randomized into the study. major exclusion criteria: * history of cluster headache. * presence of headaches more than 26 days a month on average for the 6 months prior to screening. * failed to benefit from an adequate dose and duration, in the investigator's judgment (eg, one month of β-blocker), of 3 or more migraine preventive medications. * use of opiates or barbiturates more than 4 days per month for more than 3 consecutive months prior to visit 1 and during the study. * use of over-the-counter (otc) nasal products (ie, saline spray, neti-pot, naväge® etc.) during the study. * any use of intranasal corticosteroid medications or conditions in which use of intranasal corticosteroids may be indicated during the study, eg, unstable allergic rhinitis that has previously required intranasal corticosteroids. intranasal corticosteroid use is not allowed within 28 days of baseline/randomization/visit 2 and during the treatment phase or follow-up period of the study. * patients who recently discontinued treatment with an anti-calcitonin-gene-related peptide (cgrp) or participated in anti-cgrp clinical study must be at least 4 months from the last drug administration prior to visit 1.

Keywords: migraine chronic migraine headache chronic migraine without aura aura migraine
canagliflozin-mealtime insulin rescue

Conditions: Diabetes Mellitus, Type 2

Summary: 24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy of canagliflozin as compared with placebo in reducing the need for mealtime insulin in subjects with type 2 diabetes currently using a basal-bolus insulin regimen.

the canagliflozin mealtime insulin rescue study will enroll up to 40 subjects at the atlanta va medical center. subjects will be screened and enter a 2-week run-in period during which they will switch to or continue on a diabetes treatment regimen of basal insulin before supper and aspart insulin before meals. run-in will be useful in evaluating compliance to treatment and self-monitoring. after run-in, subjects will collect one week of baseline glycemic data with regular pre-meal and fasting glycemic levels using both finger stick testing and continuous glucose monitoring. subjects will be randomized at visit 3 to 100 mg of canagliflozin or placebo. if well tolerated, this dose will be increased to 300 mg of canagliflozin or placebo at visit 4. diabetes management will be assured through regular contact with the study team (weekly calls and clinic visits at weeks 4, 8, 16 and 24). management will be facilitated by diabetes management software. self-monitoring and continuous glucose monitoring will be repeated at the end of study participation.

Eligibility criteria:
inclusion criteria: * use of basal-bolus insulin * onset of diabetes after age 30 * bmi less than 35 * egfr at least 60 ml/mn * hb a1c 7.0-10.0% * willingness to perform home glucose monitoring * willingness to transmit glucose and medication information weekly exclusion criteria: * type 1 diabetes * known peripheral artery disease * liver enzymes equal or more than 1.5 times the upper limit of normal * chronic heart failure nyha class iii or iv * current haemodialysis or peritoneal dialysis * end stage liver disease, defined as acute or chronic liver disease and recent history of one of the following: ascites, encephalopathy, variceal bleeding, bilirubin equal or greater than 2.0 mg/dl, albumin equal or less than 3.5 g/ dl, prothrombin time greater or equal to 4 seconds, inr greater than or equal to 1.7 or prior liver transplant * known or suspected hypersensitivity to trial products or related products * female of child-bearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods as required by law or local practice. * expected simultaneous participation in any other clinical trial of an investigational medicinal product. * receipt of any investigational medicinal product within 30 days before randomization * current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) * any condition that in the investigator's opinion would make the subject unable to adhere to the trial visit schedule and procedures * known history of non-compliance to treatment.
reiki/energy healing in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.

120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: reiki, another touch therapy, or guided imagery. subjects in the reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. those in the imagery group have one session prior to their medical intervention.

Eligibility criteria:
inclusion criteria: * newly diagnosed with prostate cancer * scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these exclusion criteria: * already involved in energy healing treatments * any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons * any patient who gets neo-adjuvant therapy or any herbal product that could affect psa

Keywords: prostate cancer reiki energy healing
social media as an information, education and communication tool for rabies prevention: an interventional study

Conditions: Rabies; Health Education; Public Health; Preventive Health Services

Summary: background: rabies is a fatal disease that can be avoided by treating animal bites promptly. hence, post-exposure prophylaxis is critical. as a result, the national rabies control program was approved under the 12th five-year plan in india. one of its strategies is to engage in information, education and communication activities. social media provides an opportunity for the quick and easy dissemination of research but is constrained by a lack of peer review and the risk of misinterpretation. the efficacy of a novel social media-based knowledge dissemination strategy for rabies prevention was tested in this study. methods: an experimental study design was followed, wherein 144 preclinical medical students of maulana azad medical college, delhi, india were included in each control and test group. the test group was administered the intervention, which exposed the participants to health education material via social media across a span of 30 days. participants' knowledge, attitude and practices were observed before and after the study duration.


Eligibility criteria:
inclusion criteria: * adult individuals who have a smartphone, internet access and are whatsapp users * preclinical medical students, i.e., bachelor of medicine, bachelor of surgery (mbbs) 1st and 2nd professional year students exclusion criteria: * individuals who themselves have been a dog bite or rabies victim * individuals who have a dog bite or rabies victim in the household * individuals who developed the above criteria during the study duration were excluded from the data analysis
study of efficacy and safety, tolerability and pharmacokinetics of telbivudine in children and adolescents with compensated chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: the purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d. in compensated pediatric hbeag-positive and negative chb patients aged 2 to \<18 years with the indication of antiviral chb treatment. this study was part of the commitments of the pediatric development plan for telbivudine in europe and us.


Eligibility criteria:
key inclusion criteria: * clinical history compatible with compensated chronic hepatitis b * documented compensated chronic hepatitis b defined by the following: 1. positive serum hbsag at screening and at least one other documentation of hbsag positive at least 6 months prior to screening 2. for hbeag positive patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 5 log10 copies/ml (or 20 000 iu/ml) (cobas taqman®) at screening ; serum alt ≥ 1.5×uln and \< 10×uln (pediatric uln) for two times during the screening period or within 6 months prior to screening 3. for hbeag negative patients at screening, significant biologic and/or histologic signs of disease activity following easl guidelines recommendations for chb pediatric patients (serum hbv dna level ≥ 4 log10 copies/ml (or 2 000 iu/ml) (cobas taqman®) at screening) ; serum alt ≥ 1.0 ×uln and \< 10×uln (pediatric uln) for two times during the screening period or within 12 months prior to screening) key exclusion criteria: * patients with acute or chronic infection of hcv, hdv, hiv, or with acute infection of hav, hev, cmv, ebv, or hsv. * patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-chb treatment (approved or investigational) at any time before screening * patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids, potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy * patient has one or more additional known primary or secondary causes of liver disease, other than chb; has a decompensated liver disease ; is a liver transplant recipient or organ or bone marrow transplant recipient. * history of any other acute or chronic medical condition (that in the opinion of the investigator would make the patient unsuitable for inclusion into the study. * patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum ck levels (≥7×uln), any muscular disease * patient receiving any drugs potentially associated with myopathy within 3 months prior to screening * any other clinical significant disease, condition or abnormality, unrelated to their hbv infection at screening, as assessed by the investigator

Keywords: chronic hepatitis b, pediatrics, antiviral treatment, telbivudine
cr845-100303: study to assess the potential of physical withdrawal from intravenous cr845 (difelikefalin) in hemodialysis patients

Conditions: Hemodialysis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from cr845 upon treatment discontinuation after 3 weeks of iv administration at a dose of 0.5 mcg/kg in hemodialysis patients. the purpose of this study is to determine whether hemodialysis patients who take cr845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. the study will consist of a screening phase, a 3-week open-label phase, a 2-week randomized, placebo-controlled, double-blind phase and a follow-up visit.


Eligibility criteria:
key inclusion criteria: * has esrd and has been on hemodialysis 3 times per week for at least 3 months; * not currently taking opioid medication; * if female, is not pregnant or nursing during any period of the study. key exclusion criteria: • has a concomitant disease or a history of any condition that, in the opinion of the investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements; past or present diseases, which as judged by the investigator, may affect the outcome of this study.

Keywords: difelikefalin cr845 physical withdrawal hemodialysis dialysis ckd esrd (end stage renal disease) chronic kidney disease kidney failure, chronic kidney dysfunction
lumbar assistive exoskeletons in caregiving

Conditions: Healthy; Low Back Pain; Musculoskeletal Pain; Musculoskeletal Injury

Summary: a randomized control trial will be conducted, for evaluating the effectiveness of the implementation of a lower back assistive exoskeleton on the caregivers working in nursing homes.


Eligibility criteria:
inclusion criteria: * nursing home caregivers exclusion criteria: * pregnancy * presence of condition that prevents from the use of a lumbar exoskeleton

Keywords: low back pain exoskeleton caregiver nursing home musculoskeletal disease quality of life
survey of knowledge and attitude of pain in anesthesia residents of thailand

Conditions: Pain

Summary: this study is a prospective descriptive cross-sectional survey using the modified knowledge and attitudes survey regarding pain (kasrp) in english via an online google form.

setting of the study/trial site this study will be conducted via google form survey. target population (provide a complete description of your target population in the study) anesthesia residents of all levels throughout thailand. study population (provide details of your population in the study) anesthesia residents of all levels throughout thailand. inclusion criteria anesthesia residents of all levels throughout thailand. exclusion criteria anesthesia residents who do not want to participate in this study. withdrawal criteria (e.g. research participant withdrawal, adverse outcome during participating the study) anesthesia residents can stop answering the questionnaire survey at any time. termination criteria (e.g. terminating investigational product treatment/trial treatment) not relevant

Eligibility criteria:
inclusion criteria: * anesthesia residents of all levels throughout thailand. exclusion criteria: * anesthesia residents who do not want to participate in this study.
comparison of remimazolam and propofol on emergence in elderly orthopedic patients under general anesthesia

Conditions: Hip Fracture

Summary: purpose: this study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery. background: previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.


Eligibility criteria:
inclusion criteria: * elderly patients (≥65 years old). * scheduled for elective hip replacement surgery. * asa (asa, american society of anesthesiologists) physical status i-iii. * able to provide informed consent. exclusion criteria: * known hypersensitivity to remimazolam, flumazenil, or propofol. * severe hepatic or renal impairment. * history of benzodiazepine or alcohol abuse. * cognitive impairment that may interfere with the ability to provide consent.
concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke

Conditions: Stroke; Physical Disability

Summary: the objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

stroke is a leading cause of disability in the u.s., with more than 4 million stroke survivors in the u.s. who suffer from post-stroke hand disability. post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation. to fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. the objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.

Eligibility criteria:
inclusion criteria: * 18 years old or older * at least 6 months since stroke * wolf motor function test (wmft) total average time \>10 seconds * wfmt hand task average time \<120 s exclusion criteria: * currently undergoing other upper limb therapy * change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment * severe spasticity that limits participation in task practice therapy (e.g., modified ashworth scale=4-5) * comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms * language barrier or cognitive impairment that precludes following instructions and/or providing consent

Keywords: physical stimulation subliminal stimulation stroke rehabilitation physical therapy occupational therapy upper extremity paresis hand function
individualized lung tumor stereotactic ablative radiotherapy (isabr)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: a research study of a procedure to treating lung cancer with focused radiation called stereotactic ablative radiotherapy (sabr). the purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with sabr based on tumor-specific factors. while recent research has identified sabr as a promising method to increase local control (lc) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. this study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, \> 10 cc). this is a study of the procedure stereotactic ablative radiotherapy (sabr). it is not a study of a specific drug or device.


Eligibility criteria:
inclusion criteria * limited primary non-small cell lung cancers (nsclc) (ie, graded as t1an0m0, t1bn0m0, t2an0m0, t2bn0m0, or t3n0m0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases. * up to 4 lesions may be considered. * for a single lesion, the sum of three orthogonal diameters can be no more than 20 cm. * for multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm. * both peripheral and central tumors are accepted for this trial. * age ≥ 18 years old * patients may be enrolled more than once (eg, for a new tumor lesion) exclusion criteria * contraindication for radiotherapy * pregnant and breastfeeding women are excluded * if prior radiation therapy, there is no overlap with the prior high dose regions (exception: by approval of the investigators).
chop and campath-1h in previously untreated aggressive t/nk-cell lymphomas

Conditions: Non-Hodgkin's Lymphoma

Summary: purpose: this study will evaluate the safety of chop plus alemtuzumab in patients with t/nk cell lymphomas and cd-20 negative large b-cell lymphomas who have not had previous treatments. the biological response of lymphoma cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration.

rationale: the drug combination called chop, or cyclophosphamide (cytoxan), doxorubicin (adriamycin), vincristine (oncovin), and prednisone (deltasone), has been used against different types of lymphoma for many years. researchers are investigating what other therapies to combine with the chop regimen to improve outcomes for patients with lymphoma. the current study combines chop with alemtuzumab, a monoclonal antibody used against leukemia. monoclonal antibodies are a type of immunotherapy used against some types of cancer. they are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. alemtuzumab is designed to target leukemia cells that express a specific protein. the specific protein recognized by alemtuzumab is the cd52 antigen. this antigen, or substance that causes the immune system to create a specific response, is expressed on normal b and t cells, as well as on abnormal t cells characteristic of certain cancers. alemtuzumab causes the cd52 antigen to bind with b-cell lymphocytes. this study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the chop regimen. treatment: patients in this study will receive alemtuzumab and chop. alemtuzumab will be given through injections into the skin and chop will be administered through intravenous infusions. patients will receive alemtuzumab alone during the first week of the study. an increasing amount of alemtuzumab will be given during the first week. if patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and chop every three weeks. this schedule will be repeated up to eight times. several tests and exams will be given throughout the study to closely monitor patients. treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility criteria:
inclusion criteria: * cd-20 negative * previous treatment permitted: radiation, electron beam radiotherapy, puva, corticosteroids, ifn, low dose methotrexate, retinoids, ontak * cns disease permitted exclusion criteria: * pregnant or nursing * prior alemtuzumab * history of active hep c

Keywords: untreated cd-20 negative large b-cell lymphomas