Kornimate/medical-research-clean huggingface dataset:
comparison of continuous sternal ecg patch monitors (carnation and zio) trial

Conditions: Syncope; Presyncope; Atrial Fibrillation; Supraventricular Tachycardia

Summary: the purpose of this research is to test the clinical value of a new p-wave sensitive recording vector compared to a standard ecg limb lead ii vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the carnation tm ambulatory monitoring (cam) system and the zio-xt irhythm. the p-wave is a critical aspect of the electrocardiogram. the purpose of this study is to see if the p-wave centric focus of the cam system improves arrhythmia diagnosis.

this study is intended to compare the new carnation patch monitoring system with the zio patch, which represents the current standard for continuous recording of the ecg over extended periods. the primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.

Eligibility criteria:
inclusion criteria: * male or female * written informed consent * patients with one or more of the following: * syncope of uncertain etiology; or * pre-syncope of uncertain etiology; or * palpitations of uncertain etiology; or * management of known af/svt patients exclusion criteria: * any dermatitis or infected skin over the sternum (carnation patch) or left upper anterior thorax (zio patch). * a sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment. * cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing

Keywords: ecg monitoring palpitations
tmqlb versus tpvb for acute pain and quality of recovery after laparoscopic renal surgery

Conditions: Nerve Block, Nephrectomy, Analgesia

Summary: this trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (tmqlb) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral block (tpvb).


Eligibility criteria:
inclusion criteria: * 17\~80 years of age; * american society of anesthesiologists physical status i-iii; * undergoing laparoscopic nephrectomy. exclusion criteria: * have a known allergy to the anesthetics being used; * infection at injection site * coagulopathy or history of anticoagulants use * chronic analgesics consumption or history of substance abuse * inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).

Keywords: quadratus lumborum block, thoracic paravertebral block, nephrectomy
a study of bgm0504 evaluating weight loss in overweight or obese chinese subjects

Conditions: Overweight or Obesity

Summary: to assess the effect of bgm0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * 1. bmi ≥ 28.0 kg/m2 or 24.0 ≤ bmi \< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.controlled by diet and exercise alone for at least 12 weeks prior to screening with \<5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial. exclusion criteria:1.those who have used weight loss drugs within 12 weeks before screening; 2. previous diagnosis of type 1 or type 2 diabetes mellitus; 3. history of acute or chronic pancreatitis, or pancreatic injury; 4. history of thyroid c-cell carcinoma, men (multiple endocrine adenomatosis) 2a or 2b, or relevant family history; 5. subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥ 100 mmhg at screening) or untreated blood pressure meeting the above criteria at screening; 6. concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. at screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at screening; 8. pregnant or breastfeeding women.
first research study of the possible new medicine nnc0113-2023 in healthy men.

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. the study also aims to measure the concentration of the study drug and its breakdown products after a single dose. participants will either get nnc0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. participants will get one dose (can be one or two tablets) of study medicine. the study will last for about 65 days. participants will have 10 scheduled site visits with the study physician or study staff at the study centre. for one of the visits, participants will stay at the research unit for 5 days. at all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. only healthy men are allowed to take part.


Eligibility criteria:
inclusion criteria: * male aged 18 - 45 years (both inclusive) at the time of signing informed consent. * body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * hba1c greater than or equal to 6.5 % (48 mmol/mol) at screening. * use of tobacco and nicotine products, defined as any of the below: 1) smoking more than 1 cigarettes or the equivalent per day or 2) not willing to refrain from smoking and use of nicotine substitute products during the in-house period. * history of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). * presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. * personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. * presence or history of pancreatitis (acute or chronic).
effect mechanism investigation of a non-invasive stimulation device for rapid alleviation of parkinson's disease symptoms

Conditions: Parkinson Disease

Summary: effect mechanism investigation of a wearable electrostimulator for rapid alleviation of parkinson's disease symptoms

activation levels of interested regions of the brain will be measured through fmri technique prior and after the dry needling and active stimulation applications.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * h\&y stage \>= 2 * existing bradykinesia symptoms * existence of one of the symptoms below * resting tremor * rigidity * walking disorder exclusion criteria: * cardiac pacemaker * psychiatric diagnosis * irregular heart/respiration rate * pregnancy * alcohol consumption * cardiovascular disease history * wearing an electro-active prosthesis * brain surgery history * ongoing tens/pens therapy-

Keywords: neurostimulator
effects of chest physiotherapy (cpt) on lung clearance index (lci) in non cystic fibrosis (cf) bronchiectasis

Conditions: Bronchiectasis

Summary: this study will investigate the effects of on technique of chest physiotherapy on pulmonary function. effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.

this is a before-after intervention study. spirometry, body plethysmography and then multiple breath nitrogen washout will be measured before the application of chest physiotherapy. the chest physiotherapy technique used will be autogenic drainage during 30 minutes. a resting period of 5 minutes will be given to the participant before the following tests. spirometry, body plethysmography and then multiple breath nitrogen washout will be measured again, in the same order, after the application of chest physiotherapy.

Eligibility criteria:
inclusion criteria: * non cystic fibrosis bronchiectasis in stable state exclusion criteria: * not in stable state * bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)

Keywords: lung clearance index non cystic fibrosis bronchiectasis multiple breath nitrogen washout
study of human monoclonal antibody to treat mycosis fungoides and sezary syndrome

Conditions: Mycosis Fungoides; Sezary Syndrome

Summary: the purpose of this study is to determine the efficacy of the drug, humax-cd4, in patients with mycosis fungoides(mf) and sezary syndrome who are intolerant to or do not respond to treatment with targretin® and one other standard therapy.


Eligibility criteria:
inclusion criteria: * a biopsy compatible with the diagnosis of mf and sezary syndrome with a cd4 positive phenotype within 6 months of study entry * refractory to or intolerant to at least two prior therapies, one being targretin® (or combinations hereof). * signed informed consent exclusion criteria: * prior treatment with total skin electron beam (tseb) therapy within six months * prior treatment with campath (alemtuzumab) * prior treatment with more than three regimens of single agent chemotherapy * prior treatment with pentostatin within 6 months * treatment within 4 weeks prior to visit 2 with topical targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: targretin® , uv-light therapy, local electron beam therapy (ebt), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin a or etretinate * treatment with topical glucocorticosteroids within 2 weeks prior to visit 2 * unwillingness or inability to avoid prolonged exposure to the sun or uv light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease * concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma * significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease * known or suspected positive serology for hiv * known or suspected positive serology for hepatitis b or c * patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening) * prior treatment with anti-cd4 monoclonal antibodies * breast feeding women or women with a positive pregnancy test at visit 1 * women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period

Keywords: refractory or intolerant to mycosis fungoides and sezary syndrome cutaneous t-cell lymphoma to evaluate the efficacy and safety of zanolimumab in mycosis fungoides and sezary syndrome
use of virtual reality game in rehabilitation of stroke patients in tan tock seng hospital

Conditions: Stroke, Acute

Summary: use of silverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength

either 1 of 3 physiotherapists will recruit the patient from nicu if the gcs is 14 - 15. silverfit 3d will then be used for 20 minutes each day to train the knee and arm strength until the patient's discharge from icu. baseline muscle strength will be measured and graded by the physiotherapist using medical research council grading then followed up by the same physiotherapist on discharge from icu and on discharge from hospital.

Eligibility criteria:
inclusion criteria: * patients 21 - 90 years old * diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the who as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (who 1989), diagnosed by imaging or neurological examination * gcs 14 - 15 * rass -1 to +1 * blood pressure within 20% of patient's baseline * muscle power at least 2 out of 5 on the affected side, as assessed by the physiotherapist or clinician exclusion criteria: * age less than 21 or more than 90 years old * neurological instability * poor prognosis/expected withdrawal of treatment/palliative care patient * visual loss/hearing loss * active delirium with inability to cooperate as determined by cam-icu positivity * severe cognitive impairment/dementia * haemodynamic instability

Keywords: virtual reality silverfit 3d rehabilitation
oc000459 dose finding study in hay fever sufferers.

Conditions: Allergic Rhinitis

Summary: the primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

this will be a randomised, double blind, placebo controlled, parallel group evaluation of oc000459 given orally for eight days. four dose levels will be studied and compared to placebo. they will be studied in treatment groups of 18 to 21 subjects. the placebo group will also consist of 18 to 21 subjects. there will be a screening period of up to six weeks. there will be a follow up one to three weeks after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. * females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening. * acceptable contraception includes the use of two of the following: * oral contraception (i.e. the pill); * intrauterine device (an iud or 'coil'); * barrier contraception (i.e. condoms or diaphragm/cap); * transdermal patch exclusion criteria: * medical conditions likely to affect the outcome of the study. * nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee. * presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as fev1 ≥ 90% predicted for height and age). * immunotherapy treatment course in the past 28 days * use of inhaled or local corticosteroids in the past 28 days.

Keywords: allergic rhinitis human clinical trial efficacy safety challenge test
assessment of impact nutritional program during autologous stem cell transplant

Conditions: Hodgkin's Lymphoma; Multiple Myeloma; Non-Hodgkin's Lymphoma

Summary: nestle impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of nestle impact advanced recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.


Eligibility criteria:
inclusion criteria: * patients receiving an autologous stem cell transplant using the preparative regimens of beam (carmustine, etoposide, cytarabine, melphalan), melphalan 140mg/m2, or melphalan 200mg/m2 * any prior diet or supplement will be allowed. * age \>18 years. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * history of allergic reactions attributed to compounds of similar chemical or biologic composition to nestle impact including fish oil.

Keywords: hodgkin's lymphoma multiple myeloma non-hodgkin's lymphoma
sacroiliac joint injection: comparison of xray versus ultrasound

Conditions: Sacroiliac Joint Arthritis Causing Low Back Pain

Summary: this project involves the assessment of the efficacy of two different image guided techniques in patients with low back pain due to arthritis of the sacroiliac joint (sij). intra-articular injection of local anesthetics and steroids is performed to relieve pain originating from the sij. fluoroscopy has been used traditionally for image guidance for this procedure but there is a growing interest in use of ultrasound (us) for this procedure. us avoids radiation exposure to the patient and the health care team (hct) and is less expensive. we aim to compare procedural efficacy related outcomes for sij injections performed using these image-guided modalities.

the study is a prospective, randomized trial. patients with low back pain which is diagnosed secondary to sij disease will be identified beforehand in clinic and offered a therapeutic joint injection. informed consent will be obtained. patients will be randomized for sij block with 3 ml of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance with ultrasound or fluoroscopy. in both groups, confirmation of needle placement will be obtained using contrast injection imaging before the injection is performed. record will be made of the number of times the needle is correctly placed into the articular space, as well as the number of attempts to do so. the final position of the needle will be recorded. pain scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours, as well as 1 week, 1 month, and 3 months. patients will keep a pain diary and will be followed up at 3 months time in clinic.

Eligibility criteria:
inclusion criteria: * suspicion of sij disease on history: pain below the lumbo-sacral junction; pain with full weight-bearing on one leg; pain worse going down hills or inclines; very low back pain associated with groin pain and absence of lumbar symptoms * two positive responses to the following maneuver: faber (flexion abduction and external rotation of hip), posh (posterior shear test), reab (resisted abduction) * baseline nrs pain score \> or = to 4 * refractory to oral analgesic therapy exclusion criteria: * ongoing litigation issues related to the patient's pain * pregnancy * allergy to steroids or local anesthetics * multiple comorbidities * bmi \> 35

Keywords: sacroiliac joint ultrasound fluoroscopy chronic pain
sirolimus combined with low-dose warfarin for the treatment of refractory pnh

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: classical paroxysmal nocturnal hemoglobinuria(pnh) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(qol) greatly and even lead to death. glucocorticoids and symptomatic supportive therapy are traditional treatments and the response rate is far from satisfactory. eculizumab is an effective therapy but it is expensive and not available in china mainland.the investigators aim to explore the efficacy and safety of sirolimus for refractory classic pnh.

classical paroxysmal nocturnal hemoglobinuria(pnh) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(qol) greatly and even lead to death. there is no ideal therapy except for eculizumab, expensive and not available in china mainland. glucocorticoids and symptomatic supportive therapy are traditional treatments. the response rate is 30%, far from satisfactory. in recent years, t lymphocyte-mediated destruction of normal hematopoietic stem cells have been reported to involve the pathogenesis of pnh, making immunomodulatory drugs be potential effective treatments. sirolimus (rapamycin), produced by the bacterium streptomyces hygroscopicus, is a mammalian target of rapamycin (mtor) inhibitor. mtor is a serine/threonine kinase that regulates cell growth, proliferation, metabolism and survival. it has two interacting complex, mtorc1 and mtorc2. sirolimus primarily inhibits mtorc1, has been demonstrated for its immunomodulatory effects and ability to improve hematopoietic stem cell function. recently, sirolimus has been reported to be effective and well tolerated in the treatment of immune-mediated cytopenias, even in multi-immunosuppressants resistant patients. in addition, classical pnh patients have a higher risk of thrombosis especially in refractory ones and it is reasonable to use low-dose warfarin in the management of patients with classic refractory pnh. in this study, it is anticipated to evaluate the effect of sirolimus combined with low-dose warfarin on patients with refractory classic pnh. the adverse effects and qol on different time points were documented.

Eligibility criteria:
inclusion criteria: * age 18-70 years * diagnosed with pnh and no thrombosis * ineffective, relapsed or intolerant to conventional treatment (eg glucocorticoids, • • iron, folic acid, androgen, etc.) * not available for hematopoietic stem cell transplantation * ecog≤2 * agreed to sign the consent forms exclusion criteria: * severe heart, liver and kidney dysfunction * combined with thrombotic complications * people who are pregnant and breastfeeding * history of other immunosuppressive agents in recent 3 months * patients who are not eligible to participate in this trial due to any reason based • • • on the consideration of investigator
multicenter 12 months clinical study to evaluate efficacy and safety of ranibizumab alone or in combination with laser photocoagulation vs. laser photocoagulation alone in proliferative diabetic retinopathy (pride)

Conditions: Proliferative Diabetic Retinopathy (PDR)

Summary: the purpose of this study was to assess the efficacy and safety of the anti-vascular endothelial growth factor (vegf) agent ranibizumab (0.5 mg) with or without panretinal laser photocoagulation (prp) compared to prp alone in patients with proliferative diabetic retinopathy (pdr).

a 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. a separate informed consent was signed for the 12-month observational follow-up phase. this study was conducted in germany.

Eligibility criteria:
inclusion criteria: * proliferative diabetic retinopathy * best corrected visual acuity (bcva) in study eye of at least 20 early treatment diabetic retinopathy study (etdrs) letters (20/400) * type 1 or type 2 diabetes under medical surveillance / with stabilized treatment exclusion criteria: * proliferative vitreoretinopathy in study eye * clinically significant macular edema (csme) in the study eye * clinically non significant macular edema (cnsme) that is likely to develop to csme in the study eye * uncontrolled glaucoma in either eye * other protocol-specified conditions

Keywords: panretinal photocoagulation ranibizumab