Kornimate/medical-research-clean huggingface dataset:
comparing the radial extracorporeal shock waves and botulinum toxin injection for spasticity

Conditions: Post-Stroke Upper Limb Spasticity

Summary: botulinum toxin type a (bont-a) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. however, there were no studies to compare the effect of reswt and bont-a injection for treatment on spasticity.

botulinum toxin type a (bont-a) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. however, the treatments of bont-a injection are associated with high cost and invasive treatment. recent studies have showed that radial extracorporeal shock wave (reswt) is a novel, effective and safety treatment method for the spasticity. however, there were no studies to compare the effect of reswt and bont-a injection for treatment on spasticity.

Eligibility criteria:
inclusion criteria: 1. aged between 18-80 year-old 2. the onset of stroke must be at least 6 months previously 3. spasticity measured as modified asthow scale more(mas) than 1+ 4. signed informed consent form exclusion criteria: 1. patients with marked contractures in the elbow and wrist (mas\>4) 2. resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders 3. prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or bont-a injection within the six months preceding the study

Keywords: extracorporeal shock wave spasticity in stokes botulinum toxin
bloom-dm: behavioral modification and lorcaserin for overweight and obesity management in diabetes mellitus

Conditions: Obesity

Summary: the purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with type ii diabetes mellitus treated with metformin, sulfonylurea (sfu), or either agent in combination with other oral hypoglycemic agents.


Eligibility criteria:
inclusion criteria: * overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s). * body mass index (bmi) 27 to 45 kg/m2, inclusive. * ability to complete a 1 year study exclusion criteria: * pregnancy * use of insulin in any form, exenatide (byetta) or pramlintide (symlin) within 3 months prior to screening * history of symptomatic heart valve disease * serious or unstable current or past medical conditions

Keywords: obesity weight loss lorcaserin apd356 bloom-dm hypertension dyslipidemia sleep apnea glucose tolerance cardiovascular disease arena
a study of gdx012 in adults with relapsed or refractory acute myeloid leukemia

Conditions: Leukemia

Summary: gdx012 is a novel cell therapy developed for the treatment of certain types of cancer, including acute myeloid leukemia (aml). the main aims of the study are to learn how safe gdx012 is, how treatment with gdx012 is tolerated and to determine the best dose of gdx012.

the drug being tested in this study is called gdx012. gdx012 is being tested to evaluate the safety and tolerability in adult participants with aml. the study will enroll approximately 53 patients in two phases, dose escalation and dose expansion. during phase 1 (sequential dose escalation), participants will be assigned to one of the following treatment groups each consisting of 3 to 6 participants to receive gdx012 at one of the three dose levels: 1. gdx012 dose 1 2. gdx012 dose 2 3. gdx012 dose 3 upon completion of phase 1, 1 to 2 dose levels will be selected for phase 2a of the study. at the completion of phase 2a of the study a single dose may be selected by the sponsor and investigators as the recommended phase 2 dose (rp2d) for future study. this multi-center trial will be conducted in the united states. the overall time to participate in the study is approximately 14 months.

Eligibility criteria:
inclusion criteria: 1. total body weight of ≥40 kg. 2. must have pathologically confirmed relapsed or refractory acute myeloid leukemia (r/r aml) including: 1. relapsed aml is defined as ≥5% blasts in the bone marrow (bm) or peripheral blood at any time after achieving a cr, crh, cri, or mlfs. 2. refractory aml is defined as failure to achieve a cr, crh, cri, or mlfs after 1 of the following regimens: i. two courses of intensive induction chemotherapy. ii. at least 2 cycles of hypomethylating agent (hma) or low-dose, cytarabine-based combination regimen. iii. at least 4 cycles of hma monotherapy. 3. during dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (hsct). 4. must have an anticipated life expectancy of \>3 months before lymphodepletion. 5. eastern cooperative oncology group (ecog) performance status of 0 to 1. 6. participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol. exclusion criteria: 1. diagnosis of acute promyelocytic leukemia. 2. has received or plans to receive any of the excluded therapy/treatment within the specified timeframe before lymphodepleting chemotherapy as defined by the protocol. 3. prior allogeneic hsct within 3 months of signing informed consent form (icf) or with ongoing requirement for systemic graft-versus-host therapy. 4. active central nervous system (cns) involvement. 5. history of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg. cervix, bladder, breast) low grade prostate cancer without treatment requirement unless in remission without treatment for ≥2 years.

Keywords: drug therapy aml acute myeloid leukemia cell therapy allogenic gamma delta t cells relapsed/ refractory
cardiomems european monitoring study for heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to characterize the use of the cardiomems™ hf system when used in a real-world setting.


Eligibility criteria:
inclusion criteria: * indicated to receive a cardiomems sensor implant per the cardiomems™ hf system user's manual * ≥ 18 years of age * diagnosis of new york heart association (nyha) class iii heart failure at the time of sensor implantation * hospitalization for worsening hf, as defined in the protocol, within 12 months prior to the cardiomems hf system implant * subjects with reduced left ventricular ejection fraction (lvef) must be on stable guideline directed medical therapy (gdmt) as tolerated * written informed consent obtained from subject exclusion criteria: * known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted * subjects deemed a candidate for transplant, ventricular assist device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
study of dosage individualisation for the treatment of acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the present study is not hypothesis driven but will explore the ability of pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic drugs used in therapy in adult patients with acute myeloid leukemia.


Eligibility criteria:
inclusion criteria: * adult men and women with newly diagnosed acute myeloid leukemia exclusion criteria: * under age 18 years
fazaclo outcomes in the control of schizophrenia (focus) study survey

Conditions: Weight Gain; Sialorrhea

Summary: azur pharma has received several reports from practicing psychiatrists prescribing fazaclo showing that fazaclo patients start losing body weight instead of keep gaining it, after being switched from other clozapine products or other atypical antipsychotics treatments. another important clinical observation reported by doctors is a considerable reduction in hypersalivation when fazaclo administration is compared to other antipsychotic treatments. based on the findings described above, and on the real need for effective and safer treatments for schizophrenia, azur pharma has decided to design and conduct an observational study in a large number of patients taking fazaclo to prove the received clinical reports from physicians. better understanding and evaluation of these beneficial findings are necessary to provide physicians information for improved treatment decision.


Eligibility criteria:
inclusion criteria: * patients with treatment-resistant schizophrenia currently being treated with clozaril or generic clozapine for at least 3 months * patients with treatment-resistant schizophrenia who failed to respond adequately to treatment with at least 2 courses of standard drug treatments for schizophrenia, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs * males and females of 18 years of age or older * females of childbearing potential using a reliable form of contraception * ability to comply with the required wbc/anc monitoring schedule * ability to follow physician's instructions * signed informed consent by patient or legal guardian exclusion criteria: * phenylketonurics * females of childbearing potential not using a reliable form of contraception * women who are pregnant or want to become pregnant * nursing * patients allergic to clozapine or any othe ingredient contained in fazaclo tablets * patients who have previously experienced a severe adverse reaction to clozapine * patients previously excluded from taking clozapine due to a higher risk of developing white blood cell disorders * clinical significant medical condition that the physician believes may increase the patient's risk of participating int he study (e.g., severe cardiac disorder, epilepsy) * concomitant medications that may be contraindicated with fazaclo * patients who have been taking fazaclo within the last three months * patients unable to comply with the required wbc/anc monitoring schedule * patients unable to follow the physician's instructions * patients unable or unwilling to provide informed consent

Keywords: focus weight gain sialorrhea treatment refractory schizophrenia fazaclo treatment resistant schizophrenia clozapine hypersalivation
magnification endoscopy and electronic chromoendoscopy in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: in this study the investigators aim to evaluate the ability of i-scan oe together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (ibd).

in this study the investigators aim to evaluate the ability of i-scan oe together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases. for this purpose, ibd patients will be prospectively enrolled and inflammatory changes will be assessed using optical magnification endoscopy in conjunction with optical chromoendoscopy. endoscopic scoring of inflammatory changes in ibd patients will be done on a newly developed magnification score resulting as a consensus from experts in optical diagnosis and endoscopy in ibd patients. results will be correlated against histopathology.

Eligibility criteria:
inclusion criteria: * patients with established diagnosis of inflammatory bowel diseases * ability to provide written informed consent * age 18 years and older exclusion criteria: * poor bowel preparation * inability to provide written informed consent * minors
am-111 in the treatment of acute inner ear hearing loss

Conditions: Hearing Loss

Summary: the purpose of this research study is to test the effectiveness and safety of the study drug, am-111. am-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

this phase iii study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic am-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (issnhl). the active pharmaceutical ingredient of am-111 is the jnk inhibitor (d-jnki-1), a synthetic peptide consisting of 31 d-amino acids, which acts as a c-jun n-terminal kinase (jnk) ligand.

Eligibility criteria:
inclusion criteria: 1. unilateral issnhl with onset within 72 hours prior to study treatment; 2. mean hearing threshold of equal to or worse than (≥) 60 db averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", pta);\* 3. mean hearing loss of equal to or worse than (≥) 40 db averaged across the air conducted pta frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or iso 7029;2000 norm values in case of asymmetric hearing prior to the issnhl incident; 4. age ≥ 18 and ≤ 65 years on the day of screening; other protocol-defined inclusion criteria may apply. exclusion criteria: 1. bilateral issnhl; 2. acute hearing loss from noise trauma, barotrauma or head trauma; 3. history of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or menière's disease in the affected ear; 4. history of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear; 5. history of acoustic neuroma or other retrocochlear damage in the affected ear; 6. history of otosclerosis in the affected ear; 7. suspected perilymph fistula or membrane rupture in the affected ear; 8. congenital hearing loss; 9. history of issnhl in the past 2 years; 10. otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment; other protocol-defined exclusion criteria may apply.

Keywords: deafness hearing loss, sensorineural ear diseases hearing disorders otorhinolaryngologic diseases sensation disorders signs and symptoms hearing and speech impairment hearing loss, unilateral
a study of incagn01876 in participants with advanced or metastatic solid tumors

Conditions: Advanced Malignancies; Metastatic Cancer

Summary: this was an open-label, non-randomized phase 1/2 safety study of incagn01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. part 2 is dose expansion in which part 1 recommended dose will be evaluated.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * part 1: participants with advanced or metastatic solid tumors. * part 2: participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma. * participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment. * presence of measurable disease based on response evaluation criteria in solid tumors (recist) v1.1. * eastern cooperative oncology group (ecog) performance status 0 to 1. exclusion criteria: * laboratory and medical history parameters not within the protocol-defined range. * receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * has not recovered to ≤ grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy. * receipt of a live vaccine within 30 days of planned start of study therapy. * active autoimmune disease. * prior treatment with any tumor necrosis factor super family agonist. * known active central nervous system metastases and/or carcinomatous meningitis. * evidence of active, non-infectious pneumonitis or history of interstitial lung disease. * evidence of hepatitis b virus or hepatitis c virus infection or risk of reactivation.

Keywords: solid tumor adenocarcinoma of the endometrium melanoma, non-small cell lung cancer (nsclc) renal cell carcinoma (rcc) glucocorticoid-induced tumor necrosis factor receptor (gitr)
safety and efficacy of clopidogrel for cerebral infarction treatment

Conditions: Cerebral Infarction

Summary: the primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.


Eligibility criteria:
inclusion criteria: * patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented * patients with a cerebral infarct confirmed by computed tomography or magnetic resonance image * body weight : \> 50 kg exclusion criteria: * patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement) * patients with transient ischemic attack occuring after the last episode of cerebral infarction * patients with serious impairment that would hinder detection of new ischemic event * patients with bleeding diathesis, coagulopathy, or hemorrhagic disease * patients with history of intracranial hemorrhage * patients with diabetic retinopathy * hypertensive patients with a persistent increase of blood pressure.

Keywords: platelet aggregation inhibitors ischemic cerebrovascular disease
brain mri imaging in patients with sars-cov2 (covid-19) infection with or without anosmia

Conditions: Covid-19; Anosmia

Summary: to date there is no brain imaging and olfactory data available in covid-19 positive patients with anosmia. by describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of covid-19 infection, the study investigators wish to compare the mri aspects obtained in covid-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

brain mapping of covid-19 patients with or without anosmia will allow better understanding of the mechanisms leading to the onset of these symptoms and will provide a pathophysiological basis for the therapeutic interventions to improve the clinical prognosis of affected patients. the study investigators hypothesize that in covid-19 patients witch anosmia the brain mapping objectified by an mri examination is modified and that there are functional abnormalities in the brain in these patients.

Eligibility criteria:
inclusion criteria: * consecutive adult patients consulting the careb or hospitalized at the nîmes teaching hospital due to covid-19 infection (fever, persistent cough, tiredness, shortness of breath, diarrhea, abdominal pain, chest pain, sore throat, loss of smell or taste) * covid-19 confirmed by rt-pcr and / or chest ct or clinical characteristics (i.e an epidemic history and 2 clinical manifestations or at least 3 clinical manifestations) * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan "with anosmia" group: * scoring \< 30 on a vas 0-100 for olfactory ability * responding "yes" to question "have you lost your sense of smell in the last few days?" * negative result to olfactory test with n-butanol diluted to 1/1000. "without anosmia" group: * scoring \< 80 on a vas 0-100 for olfactory ability * responding "no" to question "have you lost your sense of smell in the last few days?" * positive result to olfactory test with n-butanol diluted to 1/16000. exclusion criteria: * patient suffering from serious medical problems or hospitalized in an intensive care unit for invasive ventilation or severe dyspnea. * patient with neurological (motor, sensitive or cognitive), neuropsychiatric or vascular disorders. * patient with a contraindication to mri (pace maker, claustrophobic patient, metallic heart valve, etc.). * patient with a history of rhinological pathology or a sense of smell problem. * patient with known neurological, psychiatric or neuroradiological manifestation.the subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * the subject is unable to express consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient is pregnant, parturient or breastfeeding
the effect of laughter yoga on nurses' perceived stress burnout and life satisfaction during the pandemic period

Conditions: Abdominal Surgery; Hypertension; Done Laughter Yoga Before; Epilepsy

Summary: this study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. a total of 120 nurses, determined by power analysis, were included in the randomized controlled study. the study included 2 groups. (a group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group b: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. laughter yoga; immune system antibodies and endorphin hormone. it has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.

the study data were collected by the researchers using online systems with the snowball method due to the pandemic. the inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) the study consisted of 100 nurses who agreed to participate in the study. introductory features form consisting of 13 questions, maslach burnout scale and life satisfaction scale, perceived stress scale and life satisfaction scale were used to collect data. research data were collected in 3 months. during the study, 9 people from the experimental group (8 people did not attend the sessions regularly, 1 person left voluntarily), 10 people from the control group (he left voluntarily) quit the study. finally, the research was completed with 101 nurses, 51 of whom were in the experimental group and 50 in the control group.

Eligibility criteria:
inclusion criteria: * not have undergone abdominal surgery in the past three months * uncontrollable hypertension * without epilepsy exclusion criteria: * antidepressant etc. nurses using drugs * not attending sessions regularly

Keywords: pandemic, nurse, stress, burnout, life satisfaction, laughter yoga