Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of sp-02l in relapsed or refractory patients with peripheral t-cell lymphoma (ptcl)

Conditions: Peripheral T-cell Lymphoma

Summary: the purpose of this study is to evaluate the safety and tolerability of sp-02l monotherapy in japanese patients with relapsed or refractory peripheral t-cell lymphoma (ptcl).


Eligibility criteria:
inclusion criteria: * japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent * patients with histologically confirmed diagnosis of the following: * peripheral t-cell lymphoma, not otherwise specified (ptcl-nos) * anaplastic large cell lymphoma (alcl alk-positive/negative) * angioimmunoblastic t-cell lymphoma (aitl) * have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy) * have at least 1 evaluable lesion * eastern cooperative oncology group (ecog) performance status of 0 to 2 * life expectancy of at least 3 months
a human in-vivo model for the detection of inflammatory and nociceptive biomarkers

Conditions: Skin Diseases

Summary: this study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. in a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. we wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.


Eligibility criteria:
inclusion criteria:1. age between 21-60. 2. skin type ii or iii according to the classification of fitzpatrick (ii: fair skin, always burns, sometimes tans, iii: medium skin, sometimes burns, always tans).\&#xa; exclusion criteria:1. history of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain. 2. consumption of analgesic drugs. 3. hypersensitivity to sunlight.
treatment of attention deficit hyperactivity disorder in preschool-age children (pats)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this research focuses on the treatment of attention deficit hyperactivity disorder (adhd) in very young children. the medication being used is methylphenidate (ritalin); it is being studied to determine its safety and how well it works to treat adhd in preschool-age children (3-5.5 year olds).

young children age 3-5.5 years will be studied. the study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study. prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week). throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects. participants will be monitored by regular visits with a study physician. most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring

Eligibility criteria:
boys and girls who are: * between the ages of 3-5.5 years * qualified as having adhd by our diagnostic evaluations and clinical staff * otherwise generally healthy * willing, and have parents that are willing, to attend all visits required by the study * enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week * in classrooms with teachers that are willing to participate by completing rating scale

Keywords: adhd
bowel sounds analysis in paediatric inflammatory bowel disease: relationship with wpcdai

Conditions: Bowel Sounds; Intestinal Inflammation; Crohn Disease

Summary: the precise and noninvasive evaluation of disease activity among patients with crohn's disease is not easy, especially for children. it deals with clinical, biological, histological and radiological parameters. bowel sounds (bs) when evaluated by a stethoscope are modified by several factors including surgery, infection, drugs or intestinal inflammation. these factors can interact on intestinal motricity. there is a direct relationship between gastrointestinal motility and characteristics of bw. the study of bs using a stethoscope is a simple method, although operator dependent and subjective,with a wide inter and intraindividual variability. some studies among adults showed interest in the spectral analysis of bs to assess gastrointestinal motility. this more precise and reproducible method is not operator dependent. to date, no such study has evaluated the correlation between disease activity and the spectral pattern of bs. of this project is to assess the correlation between disease activity and the spectral pattern of bs in pediatric crohn's disease.


Eligibility criteria:
inclusion criteria: * crohn's disease * age between 4 and 17 years * follow-up at chu amiens-picardie exclusion criteria: * other diseases than crohn's or treatments affecting the gastrointestinal tract, recent (\< 3 months) surgery or refusal to participate (parents or children)

Keywords: bowel sounds intestinal inflammation crohn disease
gender, obesity, c-reactive protein, and oxidative stress

Conditions: Cardiovascular Disease

Summary: this randomized placebo-controlled trial will test whether supplementing with vitamins c and e can lower markers of inflammation and oxidative stress in healthy adults. we will examine whether one antioxidant vitamin is more effective than another, and whether gender or body fat influence the treatment effects. we will also determine whether gender, body fat, or menopausal status are associated with baseline concentrations of inflammation and oxidative stress markers.

participants will be given 1000 mg vitamin c or 800 iu vitamin e daily for 60 days.

Eligibility criteria:
inclusion criteria: * nonsmoker and not passively exposed * males and females 18 year and older * able to take vitamin supplements * able to take acetominophen instead of aspirin or nsaids during the study exclusion criteria: * pregnancy or lactation * history of ever smoking or passive smoke exposure in the last year * active liver disease; history of hiv/aids, diabetes, kidney stones, hemochromatosis, or autoimmune diseases; heart disease, stroke, or cancer in the last 5 years * user of prescribed anti-inflammatory or lipid-lowering medications, oral contraceptives, hormone replacement therapy, or blood-thinning drugs * user of iron supplements or vitamin e at 600 iu per day or more * consumption of more than 2 alcoholic beverages per day
effectiveness of routine sterile gloving in blood culture

Conditions: Bacteremia

Summary: the purpose of this study is to determine whether routine sterile gloving can lower contamination rates in blood culture.

because contamination during sampling for blood culture may interfere in interpreting the results of blood culture, lowering the contamination rates in blood culture is very important. according to current guideline, routine sterile gloving is not recommended. we hypothesized that routine sterile gloving can lower contamination rates in blood culture.

Eligibility criteria:
inclusion criteria: * the patients in whom blood culture is medically needed exclusion criteria: * blood sample is obtained through central venous catheter or arterial line * no consent to this study

Keywords: bacteremia blood culture contamination
comparison of simulated standard versus modified jaw thrust i-gel insertion technique in novice anesthesiologists

Conditions: Training Group, Sensitivity; Igel

Summary: the primary objective of study was to compare insertion ease by modified i-gel jaw thrust insertion technique and standard i-gel insertion technique on the basis of i-gel insertion attempts and i-gel insertion time duration. the secondary objective of study was to analyse the impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques. and, tertiary objective of study was to analyse the trainee's preference insertion technique at the basis of learning method and practical adaptability. hypothesis: the modified i-gel jaw thrust insertion technique is easy to understand and practice than the standard i-gel insertion technique at the beginning of airway management training among the novice anesthesiologists.

* i-gel insertion attempts are the number of i-gel insertion attempts with each study's insertion technique. the 10 insertion attempts allowed to performed with each insertion technique by trainees. * i-gel insertion time duration was the time taken to complete i-gel insertion; from the holding of device till the confirmation of chest movement (artificial lung inflation in manikin). * the correlation of previous information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques were assessed by asking from participant's questionnaire based at the start of study. * the trainees were asked at the end of study for preferred insertion method at novice level on the basis of learning method and practical conduct (user friendly).

Eligibility criteria:
inclusion criteria: * first year anaesthesia residents * using adult mannequin exclusion criteria: * pediatric mannequin * participant's refusal

Keywords: i-gel technique standard modified simulation
transcranial doppler ultrasonography and brain death

Conditions: Brain Dead

Summary: in france the diagnosis of brain death relies on electroencephalography (eeg) or cerebral angiography. concerning the latter a time of 6 hours is mandatory between the clinical diagnosis and the realization of the cerebral computed tomography (ct) angiography. transcranial doppler (tcd) is not recommended in the french guidelines for the diagnosis of brain death. in other countries, some flow patterns allow to confirm the diagnosis of brain death. the hypothesis of our study is that tcd could shorten the time between the clinical diagnosis of brain death and the realization of the ct angiography.


Eligibility criteria:
inclusion criteria: * brain death patients exclusion criteria: * craniectomy * post anoxia encephalopathy * no tcd performed before the clinical diagnosis of brain death * transtemporal approach impossible

Keywords: brain death ct angiography ultrasonography, doppler, transcranial
the evaluation and management of patients with acute chest pain in china

Conditions: Chest Pain; Acute Coronary Syndrome

Summary: the purpose of this study is to describe the characteristics, evaluation, management and outcomes of acute chest pain, and to provide opportunities for future initiatives to improve the emergency care for patients experiencing acute chest pain in china.


Eligibility criteria:
inclusion criteria: * acute chest pain(pain in the area inferior to the clavicle, superior to the rib arch, and anterior to the bilateral posterior axillary line）; * possible acute coronary syndrome; * symptoms occurring within last 24 hours; * informed consent from patient or next of kin. exclusion criteria: * arrhythmia or heart failure not cause by myocardial ischemia; * confirmed lung disease without chest pain; * no onset of symptoms within last 24 hours; * no written consensus.

Keywords: chest pain acute coronary syndrome cardiac emergency department cardiac testing healthcare utilization patient centered outcomes shared decision making unnecessary hospital admissions decision aid
ema and mhealth in preventing postpartum depression

Conditions: Postpartum Depression (PPD); Ecological Momentary Assessment; mHealth Intervention

Summary: this proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, ecological momentary assessment (ema), mhealth-based psychological support, and cbt-guided telephone counselling to prevent postpartum depression (ppd).

the target participants are pregnant women between 20 and 28 weeks of gestation with a total epds-10 score of ≥7. sixty participants will be actively recruited from the department of obstetrics and gynaecology at queen mary hospital (qmh), a major acute hospital in hong kong. recruitment will extend to other public hospitals if needed. this study will be a three-arm (allocation ratio:1:1:1; permutated block size of 3, 6, and 9), single-blinded, parallel, pilot randomised controlled trial (rct) with follow-ups at 2, 4, 6, and 8 weeks post-enrollment using standard methodology (consort) to evaluate the effectiveness of the intervention. the ema+im group (group a) will receive an evidence-based intervention composed of brief psychological counselling and health education, 2-week ema, mhealth-based psychological support, and cbt-guided telephone counselling, guided by comprehensive assessment. the ema group (group b) will only receive a 2-week ema, and the control group (group c) will receive only brief psychological counselling and health education. surveys will be collected via telephone after childbirth. semi-structured individual interviews will be conducted with the participants in the intervention group to understand the experience and the perceptions towards the ema data collection and mhealth-based intervention on mental health. the primary clinical outcome of this study will be the difference in the epds scores between the two groups at 2 weeks postpartum. secondary clinical outcomes will include differences in anxiety levels, stress levels, and insomnia symptoms at 2, 4, 6 and 8 weeks postpartum. differences in participants' self-rated health, family functioning, family well-being and perceived happiness will also be analyzed.

Eligibility criteria:
inclusion criteria: 1. pregnant women who are in their 20 to 28 weeks of gestation, 2. receiving regular antenatal care service in hong kong, 3. had a total score ≥7 in epds-10 (suggesting potential distress symptoms), 4. able to read and understand chinese and use an instant messaging app weekly exclusion criteria: 1) pregnant women who are undergoing psychiatric/psychological treatment.

Keywords: postpartum depression ecological momentary assessment mhealth-based intervention pregnant women
a longitudinal observational follow-up of the precept study cohort

Conditions: Parkinson Disease

Summary: the purpose of this study is to longitudinally follow consenting clinical trial participants who participated in precept (a randomized, double blind, placebo controlled, dose finding study to assess the efficacy and safety of cep 1347 in patients with early parkinson's disease). the study will assess the clinical and imaging outcomes relevant to the natural history of parkinson's disease (pd), as well as determine early biomarkers of the disease.


Eligibility criteria:
inclusion criteria: * participation in the precept study * willing and able to give informed consent exclusion criteria: * patients will be excluded from participating in the the study if either of the criteria stated above is not met

Keywords: parkinson disease, observational, longitudinal
bridge-enhanced acl repair (bear) in meniscus repair

Conditions: Meniscus Tear

Summary: the bridge-enhanced acl repair (bear) implant is a collagen-based scaffold loaded with whole blood. it is designed to promote healing in the setting of intraarticular knee pathology. this study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the bear implant.


Eligibility criteria:
inclusion criteria: • history of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy. exclusion criteria: * patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears * patients with a history of blood-borne diseases including hiv, hepatitis b virus, hepatitis c virus, human t-lymphotropic virus, and syphilis
anxiety associated with the use of the electrocardiogram function in smart watches

Conditions: Mental Health Wellness 1; Anxiety Disorders; Depression

Summary: the integration of electrocardiography (ecg) functionality into smartwatches is primarily intended to screen for atrial fibrillation, a frequent cause of ischemic stroke, among people aged 50 years and older. however, it should be noted that recommendations for atrial fibrillation screening are controversial, and several organizations and communities do not recommend screening outside of at-risk groups. some smart device manufacturers do not recommend using the ecg function for anyone under the age of 22. however, young people are frequent users of wearable devices. one of the most common cardiologic diseases at the age of 18-30 is benign heart rhythm disorder, which often does not require diagnosis or treatment and can be considered normal. that said, notification of the detection of atrial fibrillation can affect psycho-emotional well-being, particularly anxiety. this study will assess the level of psycho-emotional health (anxiety level) of the study participants. participant observation will provide an opportunity to identify associations between the use of the ecg recording function on wearable devices and levels of anxiety and depression. it is hypothesized that the use of smartwatches with the ecg function activated will not lead to a change in anxiety levels on the gad-7 scale among the study participants. this assumes that after 30 days of use, the mean value of the gad-7 scale in the intervention group and the control group will be the same.


Eligibility criteria:
inclusion criteria: * status of a student or employee of itmo university; * availability of a smart watch with ecg function (apple watch series 4 and newer, galaxy watch active2, samsung galaxy watch series 3 and newer or similar with ecg function); * availability of a galaxy smartphone running android 7.0 or newer or availability of an iphone 8 and newer smartphone with the latest version of ios. * signed informed consent and consent for data processing of personal data; * absence of previously diagnosed clinically significant cardiovascular pathology. exclusion criteria: * participants under the age of 22 cannot be included in the study; * participants in the acute phase of any disease or in the exacerbation of chronic diseases are excluded from the study.

Keywords: anxiety depression ecg smartwatch randomized trial
acupuncture therapy for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (koa), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. it was estimated to affect more than 9 million individuals in the united states in 2005 and is a leading cause of disability and medical costs. most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. koa is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability. acupuncture is a popular treatment taken from ancient chinese medicine, in which fine needles are placed into the body at specific points. studies have shown that acupuncture can stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). however the evidences of acupuncture for koa are contradictory. according to the review, intensive acupuncture with three sessions a week is more effective for koa than sparse acupuncture with one session a week. moreover, the papers published in the past years suggest that manual acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the treatment of knee osteoarthritis. the aim of this study is to evaluate the efficacy of intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain and improving function in patients with koa.


Eligibility criteria:
inclusion criteria: 1. age 45-75 years old, male or female 2. single / bilateral knee pain, duration of more than 6 months 3. kl (kellgren-lawrence) grade ⅱ or ⅲ 4. nrs ≥ 4 exclusion criteria: 1. surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy) 2. knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, fracture, gout, lumbosacral vertebrae disease, etc.) 3. history of arthroscopy within 1 year or intra-articular injection within 4 months 4. history of receiving acupuncture or massage treatment within 3 months 5. severe acute/chronic organic or mental diseases 6. coagulation disorders (such as hemophilia, etc.) 7. cardiac pacemaker, metal allergy or needle phobia 8. pregnant women, pregnant and lactating women 9. participation in another clinical study in the past 3 months

Keywords: knee osteoarthritis acupuncture electroacupuncture sham acupuncture
study to evaluate efficacy and safety of ropanicant in mdd patients

Conditions: Major Depressive Disorder (MDD)

Summary: the primary objective is to evaluate the efficacy of ropanicant at two different dosage levels compared to placebo in patients with major depressive disorder (mdd).

this is a phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of ropanicant versus placebo in patients with mdd. the study will be conducted at multiple centers located in the us. this study consists of a 4-weeks screening period, 6-weeks treatment period, and a 2-weeks follow-up period. approximately 195 patients will be randomly assigned to receive ropanicant either 30 mg bid or 45 mg bid, or placebo bid for 6 weeks in a ratio of 1:1:1 (65 patients in each treatment group).

Eligibility criteria:
inclusion criteria: * patients must meet the diagnostic and statistical manual of mental disorders, fifth edition, text revision (dsm-5-tr) criteria for mdd without psychotic features based on the mini international neuropsychiatric interview (mini) with a current major depressive episode of at least 4 weeks of duration but no longer than 12 months. * patients must have a clinical global impression-severity (cgi-s) score of ≥4. * patients must have a structured interview guide for the hamilton depression rating scale (sigh-d) score of ≥20. * patients must have a snaith-hamilton pleasure scale (shaps) score of ≥20. * patients must have vision and hearing (corrected if needed) sufficient to comply with the testing procedures. exclusion criteria: * patients who meet criteria for treatment-resistant depression (trd) during the current major depressive episode, which is defined as being nonresponders (\<50% of symptom improvement) to 2 or more depression treatment periods of adequate dose and duration. * patients not in good general health with clinically significant abnormalities as assessed by the investigator and determined by physical examination results, neurological examination results, ecg results, or laboratory assessments. * female patients who are pregnant, planning to become pregnant during the study or within 30 days after the last administration of study drug, or breastfeeding. * patients with bradycardia (\ 100 bpm) on the ecg results.

Keywords: suvn-911 α4β2 ropanicant mdd