Kornimate/medical-research-clean huggingface dataset:
umbilical cord mesenchymal stem cells transplantation in the treatment of chronic obstructive pulmonary disease

Conditions: COPD

Summary: this trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived mscs (uc-mscs) as a supplementary intervention in combination with standard copd medication treatments in patients with moderate-to-severe copd based on the global initiative for chronic obstructive lung disease (gold) 2019 and vietnam ministry of health's guidelines

the aim of this trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived mscs (uc-mscs) as a supplementary intervention in combination with standard copd medication treatments in patients with moderate-to-severe copd based on the global initiative for chronic obstructive lung disease (gold) 2019 and vietnam ministry of health's guidelines. this matched case-control phase i/ii trial is conducted at vinmec times city international hospital, hanoi, vietnam between june 2020 and december 2021. in this study, 40 patients will be enrolled and assigned into two age-, gender- and copd condition-matched groups, including a uc-msc group and a control group. both groups will receive standard copd medication treatment based on the gold 2019 guidelines and the vietnam ministry of health protocol. the uc-msc group will receive two doses of thawed uc-msc product with an intervention interval of 3 months. the primary outcome measures will include the incidence of prespecified administrationassociated adverse events (aes) and serious adverse events (saes). the efficacy will be evaluated based on the absolute changes in the number of admissions, arterial blood gas analysis, lung function and lung fibrosis via ct scan and chest x-ray. the clinical evaluation will be conducted at baseline and 3, 6, and 12 months post

Eligibility criteria:
inclusion criteria: * diagnosed with copd with stage b, c, or d according to gold 2019. * age between 40-75 years old. * both genders. exclusion criteria: * smoker or less than 6 months of smoking cessation time. * asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer). * acute and/or active infection. * cancer. * patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome). * liver and kidney failure. * pregnancy. * patients with life expectancy less than 6 months due to concomitant illness. * under immunosuppressive treatment within 8 weeks of the first screening visit. * patient diagnosed diabetes with hba1c\>7%

Keywords: copd umbilical cord mesenchymal stem cells
safety and efficacy of inhaled insulin in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and south america. the aim of this research is to compare the efficacy (reduction in hba1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in type 2 diabetes.

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * currently treated with insulin * body mass index of (bmi) less than or equal to 40.0 kg/m2 * hba1c less than or equal to 11.0% exclusion criteria: * total daily insulin dosage less than or equal to 100 iu or u/day * current smoking or smoking within the last 6 months * cardiac problems * uncontrolled hypertension * current proliferative retinopathy or maculopathy
99mtc-cndg spect/ct in brain tumors

Conditions: Intracranial Tumor

Summary: the goal of this clinical trial is to evaluate the value of 99mtc-cndg for diagnosis of brain tumors by comparing it with 18f-fdg-pet. the main questions it aims to answer are: 1. what is the diagnostic consistency between 99mtc-cndg and 18f-fdg? 2. what is the correlation between the suvmax value of 99mtc-cndg and tumor type? participants will: receive18f-fdg-pet and 99mtc-cndg examination within 2 weeks before surgery. obtain pathological diagnosis by surgery or biopsy as the gold standard.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of brain tumor; * be at least 18 years old; * the final pathological results could be obtained by surgery or biopsy; * informed consent and the ability to be followed up; * those who did not meet the exclusion criteria. exclusion criteria: * insulin-dependent diabetes mellitus or fasting blood glucose \>7 mmol/l before 99mtc-cndg injection; * severe liver or kidney disease (serum creatinine level \>3.0mg/dl or any liver enzyme level ≥ 5 times the upper limit of normal); * severe hypersensitivity or hypersensitivity to radiocontrast agents; * claustrophobia (inability to undergo spect/ct or pet/ct scans); * patients receiving radiotherapy and chemotherapy; * being pregnant or breastfeeding.
a phase 3, placebo-controlled, double-blind study assessing rocatinlimab in prurigo nodularis

Conditions: Prurigo Nodularis

Summary: the main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (pro) measure of pruritus and overall clinical assessment score (us only).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years (or any legal adult age within the country if it is older than 18 years) * clinical diagnosis of prurigo nodularis that has been present for at least 3 months. * patient-reported average daily itch score based on electronic daily diary assessment the last 7 days prior to and including day 1. * has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk. * history of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). exclusion criteria: * skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of ad is allowed). * prurigo nodularis secondary to medications. * prurigo nodularis secondary to neurologic or psychiatric medical conditions. * treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization. * treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.

Keywords: rocatinlimab
substance p-induced migraine attacks without aura

Conditions: Migraine

Summary: substance p is a neuropeptide implicated in the pathogenesis of headache. this study investigates whether its administration can trigger migraine attacks in individuals with migraine without aura.

substance p is a vasoactive neuropeptide of the tachykinin family, expressed in various cell types, including primary afferents of the trigeminal ganglion that innervate the meninges and associated vasculature. its most well-established role is in nociceptive signaling, and accumulating evidence implicates substance p in the pathogenesis of headache. this study investigates whether intravenous infusion of substance p can induce migraine attacks in individuals with a history of migraine without aura. to test this, the investigators will conduct a randomized, double-blind, placebo-controlled, two-way crossover trial.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age upon entry into screening * a body weight of 50 to 100 kg * history of migraine without aura for ≥12 months and in accordance with ichd-3 * between 1-5 monthly migraine days without aura on average across the 3 months prior to screening exclusion criteria: * any history of a primary or secondary headache disorder other than migraine without aura and infrequent episodic tension-type headache * any history of moderate to severe traumatic brain injury * any history of cardiovascular disease, including cerebrovascular diseases * any history of pulmonary disease * any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. this includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * female subjects of childbearing potential with a positive pregnancy test during any study visit * cardiovascular disease of any kind, including cerebrovascular diseases * hypertension (systolic blood pressure of ≥150 mmhg and/or diastolic blood pressure of ≥100 mmhg) prior to the start of infusion on the experimental day * hypotension (systolic blood pressure of ≤90 mmhg and/or diastolic blood pressure of ≤50 mmhg) * daily use of any medication other than contraceptives * intake of any medication other than contraceptives within 48 hours of infusion start * headache of any intensity within 48 hours of infusion start * migraine attack within 5 days of infusion start * aura within 48 hours of infusion start

Keywords: headache migraine pain substance p
oral rinse to reduced expelled severe acute respiratory syndrome coronavirus 2 (sars-cov-2) during covid-19 infection

Conditions: Covid19

Summary: prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled sars-cov-2 viral load using face mask sampling.

the study will consist of a control phase to optimize procedures for measuring expelled/exhaled viral load, and a evaluation phase comparing different commercially available mouthwashes. in the control phase. up to 20 covid-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (cpc) mouthwash. based on outcomes of the control phase, the study will proceed into the evaluation phase, which will randomize approximately 40 covid-19 patients to receive 1 of 4 commercially available colgate mouthwashes following standard package instructions. face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on sars-cov-2 viral load.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. able to provide consent 3. polymerase chain reaction (pcr)-confirmed sars-cov-2 within previous 48 hours. exclusion criteria: 1. clinical contraindication or poor feasibility to complete study procedures 2. unwilling or unable to produce saliva or face mask samples 3. unable to produce at least 500 microliters of saliva. 4. eaten within past 30 minutes 5. known allergy to mouthwash products
improved speech recognition performance in noise by encoding binaural spatial cues to the cochlea implant user

Conditions: Hearing Loss, Cochlear

Summary: the aim of the study is to evaluate the interaural time difference (itd) benefit in patient with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization bilateral cochlear implants certainly restore a part of binaurality

Eligibility criteria:
inclusion criteria: * fluent in local language * normal hearing listener: * pure tone threshold \> 25db from 125hz to 12khz * cochlear implant recipient * bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion * digisonic sp® cochlear implants user exclusion criteria: * binaural sensitivity threshold \< 1000µs

Keywords: iteraural time difference
blood pressure monitoring in postpartum women at risk of hypertension

Conditions: Hypertension in Pregnancy; Preeclampsia; Gestational Hypertension; Chronic Hypertension With Pre-Eclampsia; Hypertension Complicating Pregnancy, Childbirth, and the Puerperium

Summary: cardiovascular disease and hypertensive disorders of pregnancy (hdp) are the leading causes of maternal morbidity and mortality in the united states. postpartum, in office care has demonstrated to be an insufficient model of hypertensive management postpartum, largely due to barriers that women face in accessing in office care, with stark racial disparities in access. the care of postpartum patients with hdp following delivery is made up of either a single postpartum visit at 6 weeks postpartum or a fragmented and non-standardized series of in-person appointments depending on the patients' medical complications and the clinicians' experience. further, current society guidelines outline inpatient thresholds for initiation of antihypertensive medication but do not provide recommendations for titration thereafter. the proposed study will investigate the acceptability and effectiveness of an algorithm-based, outpatient treatment model for the management of postpartum hypertension utilizing an asynchronous text-based platform as compared to the standard of care for postpartum women with a diagnosis of hypertensive disorder of pregnancy at massachusetts general hospital.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of gestational hypertension (systolic blood pressure (sbp)≥140 or diastolic blood pressure (dbp) ≥90 on at least two occasions at least 4 hours apart after 20 weeks gestation in previously normotensive women) and or preeclampsia (sbp≥140 or dbp ≥90, proteinuria with or without symptoms of preeclampsia (headache, vision changes, right upper quadrant pain), and presentation of symptoms/lab abnormalities but no proteinuria) * english and spanish-speaking * delivering at massachusetts general hospital exclusion criteria: * chronic hypertension or underlying cardiovascular disease
postpartum depression prevention trial

Conditions: Postpartum Depression

Summary: the primary objective of this study is to evaluate the effect of peer (mother-to-mother) support on the prevention of postpartum depression among mothers identified as high-risk.

many new mothers from diverse cultures experience postpartum depression (ppd), a serious form of maternal morbidity with well documented health consequences for the mother, child, and family. while the cause of ppd remains unclear, research consistently demonstrates the importance of psychosocial variables. the purpose of this randomized controlled trial is to evaluate the effect of peer (mother-to-mother) support on the prevention of ppd among mothers identified as high-risk. public health nurses using the edinburgh postnatal depression scale (epds) screened mothers who were less than 2 weeks postpartum in the regions of toronto, peel, halton, york, windsor, sudbury, and ottawa. eligible and consenting mothers were randomized to either a control group (usual postpartum care) or experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session). diverse study outcomes, including depressive symptomatology and health service utilization, were assessed at 12 and 24 weeks postpartum. the results from this trial will make substantive contributions in six areas: (1) develop the body of knowledge concerning the effectiveness of peer support in the prevention of ppd among at-risk mothers; (2) advance our understanding of the advantages and disadvantages of using peer volunteers as a complementary form of health care; (3) provide an economic evaluation of a peer support intervention; (4) offer a detailed analysis of peer support interactions including supportive functions provided, types of relationships developed, and health benefits perceived; (5) investigate the utility of screening at-risk mothers using the epds in general public health nursing practice; and (6) present valuable information regarding ppd among a multicultural canadian population.

Eligibility criteria:
inclusion criteria: * live birth * discharged from hospital * \<2 weeks postpartum * scored \>9 on the epds * availability of a peer volunteer who speaks the potential participant's language exclusion criteria: * infant not discharged home with mother * current use of anti-depressant or anti-psychotic medication * prior self-reported mental illness, including prior ppd, will not be an exclusion criterion
acute cholecystitis - early laparoscopic surgery versus antibiotic therapy and delayed elective cholecystectomy

Conditions: Acute Cholecystitis

Summary: acute cholecystitis is frequent in the elderly, or in patients with gall stones. most cases of severe or recurrent cholecystitis need surgery as final therapy. today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. only in some cases an open surgery has to be performed. unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. this study is performed to evaluate if one therapy is superior.


Eligibility criteria:
inclusion criteria: * patients of age \> 18 years * patients with acute cholecystitis based on three of the following signs * abdominal pain in the upper right quadrant * murphy's sign * leucocytosis \> 10 /ml * rectal temperature \> 38 °c or \< 36.5 °c plus * cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall) * immediate antibiotic therapy (400 mg moxifloxacin i.v. once a day) * laparoscopic cholecystectomy possible within 24 hours after presentation of the patient * informed consent exclusion criteria: * asa iv and v (table 2) * septic shock * perforation or abscess of the gall bladder * impossibility of laparoscopic surgery (further surgery, surgeon, ...) * additional need of antibiotics due to secondary disease * known intolerability of moxifloxacin * known or possible pregnancy, breast feeding * life-threatening diseases (life-expectancy \< 48 hours) * end-stage liver disease (child-pugh c) * psychiatric or severe neurologic disease * relevant bradycardia or other symptomatic arrhythmias * significant cardiac disease * known long qt-disorders * electrolyte disorders, especially hypocalcemia * known intolerability of chinolones * earlier participation in this trial

Keywords: acute cholecystitis cholecystectomy antibiotic treatment moxifloxacin intraabdominal infection morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy
mind diet intervention and cognitive performance

Conditions: Obesity

Summary: this single-center, randomized trial examined the effect of mind diet intervention on cognition and brain structure changes of healthy obese women over three months. the intervention group was lea to calorie-restricted modified by the mind diet, and the control group received a calorie-restricted standard diet. the primary end-point was an assessment of cognitive performances measured with a comprehensive cognitive test battery. secondary end-points were voxel-based morphometry to quantify the differences in brain structures. our results revealed mind diet could improve working memory, verbal recognition memory, and attention, more in comparison with the control group. results also suggest that an increase in inferior frontal gyrus in the mind diet group. our study, for the first time, underlined that good adherence to the mind diet as well as calorie restriction could reverse the destructive effect of obesity on cognition.


Eligibility criteria:
inclusion criteria: * middle-aged women (40-60 years), * without any metabolic complication, * bmi 30-35 kg/m2, * mmse ≥ 24, * and no history of severe untreated medical, neurological, and psychiatric diseases which may interfere with the study intervention. exclusion criteria: * have gastrointestinal problems, * participate in weight loss programs, * use weight loss drugs in the last three months, * had not wholly followed the dietary pattern, * became pregnant, * and undergo special medical treatments during a three months study.
coloassist vs. mei

Conditions: Colorectal Cancer; Screening

Summary: colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. we want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (mei) device. the hypothesis is that the performance of the new instrument is non-inferior to the mei system.

the recommended cecal intubation rate in colorectal cancer (crc) screening is 95%. the mei system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. however, the mei system is costly, and trial results are equivocal regarding the actual benefits. a newly designed colonoscope (coloassist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. we want to investigate if we can achieve equal performance results with the coloassist instrument as with the mei system in crc screening. the study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.

Eligibility criteria:
inclusion criteria: * inclusion in an ongoing colorectal cancer screening trial (nct 00883792) exclusion criteria: * excluded from the ongoing screening trial (nct 00883792) * inability or unwilling to provide informed consent

Keywords: colonoscopy colorectal cancer adenoma
observation study of the clinical management of bipolar disorder

Conditions: Bipolar Disorder

Summary: the objective of the ambispective cohort study is to describe clinical management and clinical outcomes related to bipolar disorder in china, and establish the factors associated with different management patterns and clinical outcomes, provide psychiatrists with reliable and up-to-date information on the disease.


Eligibility criteria:
inclusion criteria: * provision of subject informed consent. * diagnosis of bipolar disorder i or ii (dsm-iv tr) in any phase of the disorder. * patients who had at least one mood event( depression, mania, hypomania or mixed) according to dsm-iv tr definition during the 3 and 12 months prior to the beginning of the study. exclusion criteria: * inability to complete patient reported outcomes (pros) questionnaires. * participation in an interventional clinical study in last 12 months.

Keywords: bipolar disorder clinical management clinical outcomes