Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of shr0302 in patients with relapsed/refractory peripheral t/nk cell lymphoma

Conditions: Peripheral T Cell Lymphoma

Summary: this is a non-randomized, open-label, phase 1b clinical study to evaluate the safety, tolerability and anti-tumor efficacy of shr0302 as monotherapy in patients with relapsed/refractory peripheral t/nk cell lymphoma. around 7-18 patients will be subsequently enrolled into 3 different dose ascending cohorts. additional 12-18 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18; 2. pathologically confirmed t or nk cell lymphoma at the enrolling institution; 3. measurable disease; 4. relapse or refractory disease after at least 1 systemic therapy; 5. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 ； 6. with a life expectancy of ≥12 weeks; 7. adequate bone marrow reserve and organ system functions; 8. women of childbearing potential (wobcp) must undergo a serum pregnancy test within seven days before the first medication and the results are negative. wobcp or men and their wobcp partners should agree to take effective contraceptive measures from the signing of icf until 180 days after the last dose of the study drug is used; 9. willing to provide written informed consent. exclusion criteria: 1. patient has undergone an allogeneic stem cell transplant. or patient had autologous stem cell transplant within 6 months; 2. any unsolved toxicity \> common terminology criteria for adverse events (ctcae) grade 1 from previous anti-cancer therapy (except alopecia); 3. central nervous system (cns) or leptomeningeal lymphoma; 4. received any antitumor therapy within 28 days prior to the first drug use, or the first dose was given within five half-lives of the previous antitumor drug, whichever is shorter; 5. major surgical procedures were performed within 28 days before the first dose of study treatment, or surgery was planned during the study period; 6. diagnosed with any other malignancies ≤5 years prior to the first dose, early tumors cured after radical treatment were evaluated by pi and considered for exclusion or not; 7. history of psychotropic substance abuse or drug use; 8. previous history of allergy to the investigational drug or its excipients; 9. severe cardiovascular disease; 10. significant impairment of lung function; 11. active infections; 12. pregnant or lactation; 13. known gi disease or gi procedure that could interfere with the oral absorption of oral medications, including not well controlled refractory nausea, vomiting, chronic gastrointestinal disorders, or capsule swallowing difficulties, or prior surgical resection of intestinal segments; 14. concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
monitoring of lung sounds of patients with pneumonia

Conditions: Pneumonia

Summary: the aim of this study is to investigate if any correlation between lung sounds of pneumonia patients and the clinical development or therapy of the pneumonia exists.


Eligibility criteria:
inclusion criteria: * ambulant aquired pneumonia with typically radiological signs * hospitalisation at medical clinic i, university hospital aachen * age at least \> 18 years * crb-65 score \> 1 * crp\> 60mg/l * fever * lung sounds audible by stethoscope * legal capacity and being able to understand and to follow the instructions of the study staff * being able to consent and being able to understand the importance and the consequence of the study * not being accomondated in an institution exclusion criteria: * pneumonia acquired in a hospital * artificial respiration or other means for supporting respiration * allergic reaction because of skin contact with polymers * pregnancy or breast feeding
chlorhexidine gluconate vs povidone-iodine vaginal cleansing solution prior to cesarean delivery

Conditions: Wound Infection; Complication, Postoperative

Summary: endometritis, an infection of the uterus in the postpartum period, has been shown to complicate the postoperative course of a cesarean delivery in 6% to 27% of cases. vaginal cleansing prior to cesarean delivery has been shown to minimize the presence of micro-organisms and risk of infection. although povidone-iodine is the most commonly used anti-septic for surgical preparation of the vagina, it is not an ideal agent due to it's diminished efficacy in acidic vaginal ph and in the presence of blood. chlorhexidine gluconate, on the other hand, has demonstrated superior disinfectant properties in several clinical trials, as compared to povidone iodine. in this randomized, comparator controlled, study the investigators will be comparing chlorhexidine gluconate vs povidone iodine for intrapartum vaginal preparation in women undergoing non-emergent cesarean delivery.

this is a randomized, comparator controlled, study of intrapartum vaginal preparation with either chlorhexidine gluconate or povidone-iodine solution. women undergoing non-emergent cesarean delivery will be randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% providone-iodine solution. the study will have two arms that will be randomized in a 1:1 ratio. after inclusion criteria have been satisfied, subjects in the comparator control arm will receive vaginal preparation with 10% provodone-iodine solution prior the skin incision. subjects in the study arm will receive vaginal preparation with chlorohexidine gluconate 4% solution. the selected skin preparation will be applied according to the manufacture guidelines with a minimum of four completed minutes of drying time before placement of surgical drapes. a block randomization method will be used to control for variations in care. both groups will receive standard obstetrical care, continuous fetal monitoring, and pre-operative prophylactic antibiotics at least one hour prior to skin incision.

Eligibility criteria:
inclusion criteria: * patients at richmond university medical center that have a non-emergent cesarean delivery exclusion criteria: * emergent cesarean delivery, less than 18 years of age, chorioamnionitis before randomization, intrapartum fever prior to randomization, or known or suspected allergy to chlorhexidine or iodine.

Keywords: caesarean section chlorhexidine gluconate
mastocytosis registry (of zurich)

Conditions: Mastocytosis; Hypertryptasemia

Summary: the study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses. biologic samples are collected from available routine diagnostics (serum, skin tissue, gut mucosa, bone marrow, and others) for further use in experimental research.


Eligibility criteria:
inclusion criteria: * adult patients with mastocytsis/hypertryptasemia which are treated at the university hospital of zurich * available informed consent exclusion criteria: * denied consent

Keywords: mast cell disease
arachidonic acid treatment against schistosomiasis infection in children

Conditions: Schistosomiasis; Bilharzia

Summary: randomized controlled trial: the investigational materials used in this trial were administered to subjects each day by trained clinicians. primary objectives: * assess the effect of dietary supplementation with arachidonic acid on the cure rates for schistosomiasis mansoni with and without concomitant treatment with praziquantel. * assess the safety of dietary supplementation using arachidonic acid in children with clinically confirmed schistosomiasis mansoni infection. secondary objective: * to measure changes in total phospholipids in plasma.


Eligibility criteria:
inclusion criteria: * consent from parent or legal guardian * clinically confirmed schistosomiasis exclusion criteria: * not infected with schistosomiasis * less than 6 or greater than 15 years of age

Keywords: arachidonic acid bilharzia mansoni schistosomiasis polyunsaturated fatty acid
ultrasonic bone scalpel in bsso

Conditions: Maxillofacial Abnormalities

Summary: the conventional saw compared with the piezo surgery in bsso to evaluate cutting time, surgery duration, amount of bleeding. the purpose of this study was to answers following clinical questions: is ultrasonic bonescalpel effective osteotomy like conventional bur in bsso? and 2) does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) does it reduce postoperative morbidity after bsso.

the purpose of this study was to answers following clinical questions: 1) is ultrasonic bonescalpel effective osteotomy like conventional bur in bsso? 2) does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) does it reduce postoperative morbidity after bsso. hypotheses of this study that ultrasonic bone scalpel can improve bsso and its postoperative results due to strong cutting efficiency and soft tissue protective effect. surgical procedure; after removing the full thickness mucoperiosteal flap lingula was localized. in ultrasonic device group, osteotomies one side of the mandible were performed unilaterally using an ultrasonic bone scalpel (bonescalpel; misonix, farmingdale, ny) with a serrated standard blade. in conventional group, contralateral side mandibular osteotomies were performed with lindeman and round bur. groups are selected randomly. c- follow up the predictor variable was the type of instrument used for bone osteotomy. the instruments were ultrasonic bone scalpel and lindeman bur. the main outcome variable are the cutting time and nsd. all patients were followed for 6 months.the authors used the 3dmd imaging system (3dmd, atlanta, ga) and 3dmd vultus software to evaluate the amount of postoperative edema.

Eligibility criteria:
inclusion criteria: * patients are included with older than 18 years old, * normal hemoglobin level, international normalized ratio in the average range, * american society of anesthesiologists status of asa i and ii. exclusion criteria: * the exclusion criteria are neuropathic disease, * recent use of nonsteroidal anti-inflammatory drugs and opioid derivatives, * having preoperative signs of inflammation in the maxillofacial region, * presence of excessive bleeding in the previous surgery, * and allergy to drugs. all patients have given written informed consent.

Keywords: sagittal split osteotomy ultrasonic bone scalpel neurosensory disturbance
intraventricular stasis in non ischemic dilated myocardiopathy

Conditions: Dilated Cardiomyopathy; Thrombosis; Stroke

Summary: this study is designed to quantify the ventricular stasis in patients with non-ischemic dilated cardiomyopathy by post-processing of 2d color doppler echocardiography images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis determined by magnetic resonance.

in patients with left ventricular dysfunction, intraventricular mural thrombosis is a recognized risk factor for cardioembolic events. the flow stasis accompanying ventricular remodeling and myocardial dysfunction could favor the formation of small intracavitary thrombi between lv trabeculae, small enough not be detected by conventional imaging techniques. computational post-processing techniques allow a robust and complete characterization of numerous aspects of fluid dynamics within the heart using the flow field obtained by echo or mri imaging, and it is possible to quantify the stasis and washing of blood in the left ventricular cavity. a cross-sectional study in 80 patients with non-ischemic dcm in sinus rhythm is proposed in which an echocardiogram, cardiac and cerebral mri will be performed. our objective is to quantify the ventricular stasis by post-processing of 2d color doppler echocardiography images in order to establish the relationship between quantifiable intraventricular stasis variables and the prevalence of silent and embolic events and intracavitary thrombosis determined by magnetic resonance (mri).

Eligibility criteria:
inclusion criteria: * diagnosis of nonischemic dilated cardiomyopathy. * sinus rhythm. * lv ejection fraction (ef) less than 45%. * signature of informed consent for the study. exclusion criteria: * implantable defibrillation or stimulation devices not compatible with mri. * hemodynamically significant primary valvular disease or cardiac valve prosthesis. * claustrophobia. * documented history of paroxysmal or persistent atrial fibrillation (af). * previous carotid disease diagnosed with stenosis greater than 50%. * complete oral anticoagulation prior to inclusion in the study or indication of anticoagulation. * known prothrombotic states (active oncological pathology, alteration of the coagulation cascade).

Keywords: non ischemic dilated cardiomyopathy cardiac thrombosis silent brain infarct fluid dynamics intracardiac blood flow echocardiography
a study to evaluate the dosing of amg 827 for subjects with inadequately controlled asthma

Conditions: Asthma

Summary: the purpose of this study is to determine if amg 827 is effective compared to placebo as measured by change in asthma control questionnaire (acq) composite scores.


Eligibility criteria:
inclusion criteria: * men or women 18 to 65 years of age * percent of predicted fev1 ≥ 50% and ≤ 80% * at least 12% reversibility over pre-bronchodilator fev1 * inhaled corticosteroid (ics) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent * ongoing asthma symptoms with acq composite score ≥ 1.5 points exclusion criteria: * respiratory infection within 4 weeks of screening visit or 1 week of baseline visit * history of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma * any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)

Keywords: amgen chronic inflammatory disease wheezing
defining covid-19 infection severity on presentation to hospital

Conditions: COVID-19; Infections; Morality; Death, Assisted

Summary: in the assessment of severity in coronavirus disease 2019 (covid-19), the modified brit_x0002_ish thoracic society (mbts)，curb65 et al. rules identifies patients with severe pneumonia but not patients who might be suitable for home management. a multicentre prospective study was conducted to derive and validate a practical severity assessment model for stratifying adults hospitalised with covid-19 into different management groups.

1. screening interested participants should sign the appropriate informed consent (icf) prior to completion any study procedures. 2. the investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. the following is the general sequence of events during the 30-day evaluation period: 4. completion of baseline procedures participants were assessed for 30 days and completed all safety monitoring.

Eligibility criteria:
inclusion criteria: 1. patients with novel coronavirus infection meeting the criteria of the new coronavirus pneumonia diagnosis and treatment program (ninth edition); 2. participants are willing to participate in this study and follow the research plan; 3. participants or legally authorized representatives can give written informed consent approved by the ethics review committee that manages the website. exclusion criteria: 1. pneumonia was (a) not the primary cause for hospital admission, (b) an expected terminal event,or (c) distal to bronchial obstruction; 2. patients with tuberculosis,bronchiectasis,solid organ and haematological malignancies or human immuno deﬁciency virus (hiv) infection; 3. patients who had been in hospital within the previous 14days, were immunocompromised,or had previously been entered in the study; 4. nursing home residents.participation in other clinical study.
cognitive-motor telerehabilitation in ms

Conditions: Multiple Sclerosis

Summary: the primary goal of this project is providing evidence that a home-based combined cognitive-motor training program improves cognition in persons with multiple sclerosis (ms), compared to single cognitive and motor rehabilitation. secondary goals are to assess the effects on walking performance and to identify the mechanisms of improvement and predictors of treatment response. the main backbone of this project will be a randomized controlled two-centre clinical trial, in which an at-home computerised cognitive-motor rehabilitation program using telemedicine aimed at improving working memory in persons with ms will be evaluated. based on the information gathered during this trial, possible mechanisms of improvement will be identified by analysing anatomical and neurophysiological changes on structural mri and resting-state and task-related eeg before and after rehabilitation. furthermore, factors that can predict treatment response to the rehabilitation program will be identified.


Eligibility criteria:
inclusion criteria: * clinically definite multiple sclerosis (revised mcdonald criteria 2017) * expanded disability status scale (edss) below 6.0 * digit span backwards z-score between \[-3 and -0.5\] standard deviations below the median of the normative values * age between 18 and 65 * able to safely perform motor rehabilitation in the home situation (assessed by rehabilitation physician and/or occupational or physiotherapist) exclusion criteria: * cognitive rehabilitation within six months before inclusion * inpatient multidisciplinary rehabilitation program within three months before inclusion or planned inpatient program during trial * start of or switch in immunomodulator treatment within three months before inclusion * less than one month post-exacerbation * major psychiatric or medical disorder that could influence cognitive functions * combined vision with optimal correction below 0.6 on snellen visual acuity test * unable or unwilling to undergo eeg or mri * refusing informed consent

Keywords: multiple sclerosis cognitive rehabilitation cognitive-motor rehabilitation telerehabilitation
nerve coaptation in diep flap breast reconstruction

Conditions: Breast Cancer

Summary: the sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. a prospective study was conducted of all patients who underwent either innervated or non-innervated diep flap breast reconstruction in maastricht university medical center and returned for follow-up between september 2015 and july 2017. semmes-weinstein monofilaments were used for sensory testing of the breast. this study showed that nerve coaptation in diep flap breast reconstruction resulted in a significantly improved sensation of the reconstructed breast compared to non-innervated flaps.


Eligibility criteria:
inclusion criteria: * female patients 18 years or older * unilateral or bilateral diep flap breast reconstruction * returned for follow-up between september 2015 and july 2017 * informed consent exclusion criteria: * bilateral breast reconstruction with a unilateral innervated diep flap and a contralateral non-innervated flap * flaps that required a take-back

Keywords: breast reconstruction diep flap nerve coaptation sensory recovery
cardiac changes after effective dose carbetocin for elective caesarian section

Conditions: Cardiac Ischemia; Cesarian Section

Summary: the goal of this project is to examine the cardiac symptoms and physiologic changes after administration of a reduced dose of carbetocin in participants undergoing elective cesarian section. * does reduced dose carbetocin (50mcg) have fewer cardiac side effects than usual dose carbetocin (100mcg) when comparing patient reported symptoms, ecg changes and troponin increases? * is there a relationship between patient reported cardiac symptoms after carbetocin administration and subjective measures of cardiac ischemia (ecg changes and troponin increases? researchers will compare 50mcg of carbetocin to the control group of 100mcg of carbetocin in patients undergoing elective cesarian section. participants will: * be given 50mcg or 100mcg of carbetocin during cesarian section * asked to report cardiac symptoms * be assessed for ecg changes and blood loss using standard of practice monitoring * have a troponin i blood test completed after delivery


Eligibility criteria:
inclusion criteria: * undergoing elective cesarian section * primary and repeat cesarian section exclusion criteria: * prior and current cardiovascular co-morbidities including pre-eclampsia * bmi greater than 50 * pre-existing bleeding disorders * allergy to carbetocin * age under 18

Keywords: carbetocin duratocin cardiac symptoms
effect of kinesio taping versus myofascial release on menstrual low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females

: menstrual low back pain is a prevalent condition among women. menstrual low back pain occurrence is affected by hormonal changes. menstrual low back pain incidence more than 40% to 50% during the menstrual phase (days 1-6) of the menstrual cycle, while the range of prevalence was 45 to 95%. it has a high prevalence among females, especially females aged 20 to 25 years old. hormonal changes might play an important role in the formation of menstrual low back pain and is the main cause of feeling of pain during menstrual cycle. kinesio taping and myofascial release technique play an important role in the treatment of menstrual low back pain. this trial has two groups; one will receive kinesio taping three days and the second will receive myofascial release technique for12 sessions through 3 consecutive menstrual cycle

Eligibility criteria:
inclusion criteria: 1. healthy young virgin females suffering from menstrual low back pain diagnosed by the gynecologist. 2. their ages will be ranged from 18-25 years\&#39; old 3. their body mass index will be ranged from 20-25 kg/m2. 4. all females have regular menstruation 5. their pain intensity is scored as \&gt; 4 on vas just before or during the first 3 days of the menstruation - exclusion criteria: females will be excluded from the study if they have: 1. any orthopedic problems such as trauma at lower spine, congenital malformation at spine and scoliosis. 2. any gynecological problem such as irregular menstrual cycle, secondary dysmenorrhea due to endometriosis, ovarian cyst, uterine fibroid and congenital malformation or pelvic inflammation. 3. athletic females 4. allergy to kinesio taping. -

Keywords: kinesio taping myofascial release technique
proof-of-concept lymfif

Conditions: Quality of Life

Summary: this proof-of-concept study was to explore the implementation feasibility to deliver the lymfit intervention to participants remotely during the pandemic.


Eligibility criteria:
inclusion criteria: * 1. previously diagnosed with lymphoma * 2. have completed chemotherapy * 3. had access to a smart phone or an electronic device (e.g., tablet) that allowed them to attend virtual meetings and install the fitbit application exclusion criteria: -1. have any contra-indications to performing physical activities as determined by the hematologist

Keywords: quality of life cancer survivors