Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of aeb071 in patients with active, moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study will evaluate the efficacy, safety and tolerability of aeb071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids


Eligibility criteria:
inclusion criteria: * 18-75 years males and females * female subjects of childbearing potential must be using two methods of contraception * active, moderate to severe disease * poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine) * good communication with the investigator, understanding and compliance with the requirements of the study and written informed consent exclusion criteria: * allergy to the drug * very low or high body weight * ongoing treatment with specific other medication (e.g. antibiotics) * diagnosis of primary sclerosing cholangitis * renal impairment * toxic megacolon * presence or history of specific other diseases, cancer, cardiac abnormalities, abnormal laboratory findings * history of alcohol or drug abuse * pregnant or breastfeeding women * positive hiv, hepatitis b or hepatitis c test result other protocol-defined inclusion/exclusion criteria do apply

Keywords: ulcerative colitis immunosuppressive therapy aeb071 modified baron score partial mayo score
using fmri and semg to evaluate the effects and mechanism on abdominal acupuncture combined with upper limb rehabilitation training on brain plasticity of hemiplegic patients with stroke

Conditions: Brain Ischemia; Hemiplegic Patients With Stroke; Image Science; Electrophysiology of Neuromuscular; Abdominal Acupuncture

Summary: using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.the patients were randomly divided into treatment group a(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group b(sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). semg and fmri examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.


Eligibility criteria:
inclusion criteria: 1. first onset stroke, left hemiplegia, right-handed，and diagnosed by brain ct or mri; 2. age 35 to 75 years old; 3. course of disease 0.5 to 3 months with stable vital signs; 4. no cognitive impairment. can understand and execute commands. mmse score more than 7 points. ; 5. can control the sitting balance. brunnstrom stage of hemiplegic upper limb and hand is ⅳ or v ，fugl-meyer motor assessment score of upper limb 20-50 point; 6. agree to sign the informed consent; 7. unilateral neglect. exclusion criteria: 1. recurrent stroke，subarachnoid hemorrhage, brain tumors patients; 2. contraindication to undergo a 3t mr imaging; 3. claustrophobia; 4. have severe heart, hepatic or renal failure; 5. don' t cooperate with the treatment; 6. have participated in other clinical trails recently.

Keywords: functional magnetic resonance imaging（fmri） surface electromyography （semg） abdominal acupuncture brain plasticity effects and mechanism
is therapeutic elastic bandage as effective as corticosteroids following third molar surgery?

Conditions: Third Molar Surgery

Summary: in this study; among the patients randomized because of severe postoperative sequelae expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and therapeutic elastic bandage application considering inflammatory symptoms' severity and health related quality of life following surgical removal of impacted third molars. the study hypothesis was formed stating that corticosteroid injection and elastic bandage application would reduce the inflammatory symptoms more than nsaid.


Eligibility criteria:
inclusion criteria: * age between 18-65 years * american society of anesthesiologists (asa) class 1 physiological status * consistent radiological and clinical data * volunteered to participate in the study * surgical difficulty score above 5 which was determined according to pederson scale. exclusion criteria: * being out of age range * analgesic or antibiotic therapy history in last 30 days due to symptoms of related third molar * smoking cigarette * any pathology associated with impacted third molar * active complaints on preoperative examination on the day of surgery * immunosuppressed or diagnosed with malignancy * diagnosed chronic diseases such as; diabetes mellitus (dm), hypertension, cerebrovascular event, psychiatric diseases, coagulopathies * autoimmune diseases * if total operation time exceeds 45 minutes * patients who could not attend regular follow-up visits * allergy to the medications prescribed or utilized in study protocol * inconsistent clinical and radiological data

Keywords: dexamethasone applied kinesiology non-steroidal anti-inflammatory agents teeth, impacted edema trismus postoperative pain
a new revolutionary 3-injection- protocol in infertile women

Conditions: Infertility, Female

Summary: this is a prospective randomised study of the evaluation of the clinical ivf results after following a new revolutionary 3-injection- protocol for controlled ovarian stimulation in infertile women.

a randomized prospective study focusing on infertile women undergoing ovarian stimulation for ivf, using elonva (corifollitropin alfa) as part of two different stimulation protocols. women assigned to protocol a receive a bolus late luteal dose of degarelix, a new long acting gnrh antagonist, a sole elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (gnrh agonist or hcg a, according to the individual response). women assigned to protocol b are administered a single dose of elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily gnrh antagonist doses, fixed on day 7 of the cycle. ovulation triggering is the same as in group a, with either gnrh agonist or hcg a, accordingly. live birth rates are estimated for both groups of patients. the number of the formed blastocysts in each group is measured, as well.

Eligibility criteria:
inclusion criteria: * primary infertility * age 22-39 years; * body mass index (bmi) 18-29kg/m2; * regular menstrual cycle of 26-35 days, * presumed to be ovulatory; * early follicular- phase serum concentration of fsh within normal limits (1-12 iu/l). exclusion criteria: * women with diabetes and other metabolic disease * women with heart disease, qt prolongation, heart failure * elevated liver enzymes, liver failure, hepatitis * women with inflammatory or autoimmune disease * abnormal karyotype * polycystic ovarian syndrome * endometriosis stage iii/iv

Keywords: ivf infertility long antagonist long acting gonadotropin corifollitropin alfa ovarian stimulation
fast examination during emergency practice

Conditions: Trauma; Ultrasonography

Summary: the study evaluates the knowledge, attitude and practice about focused assessment with sonography in trauma among emergency medicine practitioners in poland.


Eligibility criteria:
inclusion criteria: * paramedics currently practicing in a polish emergency department units and emergency medical services * age ≥ 18 years exclusion criteria: * inability to participate in all aspects of the study prior to study begin

Keywords: trauma examination knowledge paramedic
laparoscopy for primary cytoreductive surgery in advanced ovarian cancer

Conditions: Residual Tumor; Disease-free Survival; Overall Survival

Summary: to assess the feasibility, residual tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with advanced ovarian cancer, compared with abdominal primary cytoreduction in a single-institution, single-surgeon prospective series.

all patients with presumed stage iii-iv ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. a definite protocol was adopted: after radiological preoperative evaluation with pet-ct scan, all patients underwent laparoscopic evaluation with the fagotti score. once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. at the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.

Eligibility criteria:
inclusion criteria: * primary ovarian cancer * epithelial histotype * stage iii-iv disease exclusion criteria: * anesthesiological contraindication to primary cytoreduction * extension of disease contraindicating primary cytoreduction
comparison of the effectiveness of two different squat exercises in healthy individuals

Conditions: Balance; Distorted; Low Back Pain

Summary: the aim of our study is to compare the effects of two different squatting patterns, with and without the knees passing the toes, on low back pain, muscle strength and balance.

a total of 60 volunteer participants between the ages of 18-30, who are in the active category of the international physical activity assessment questionnaire short form, are planned to be included in the study. individuals participating in the study will be divided into 3 groups using a computer randomization system and a closed envelope method. group i (n=20); squatting with the knees passing the toes (pi), group ii (n=20); squatting with the knees not passing the toes (pg) and group iii (n=20); control group (cg). squatting with the knees passing the toes (pi); squatting with the knees not passing the toes (pg) will be applied to the study groups as a home program for 4 weeks and will be checked with an exercise diary. participants will be re-evaluated at the end of the exercise program. no training program will be applied to the control group and they will be asked to continue their daily lives and participants will be evaluated at 4-week intervals. the training program of 1 set; 20 repetitions; 30 seconds active contraction/30 seconds rest is applied to the pi and pg groups 3 days a week, every other day for 6 weeks. the training program of the groups is monitored by a physiotherapist for 6 weeks via telerehabilitation technologies. all participants will be evaluated for back pain, knee pain, muscle thickness, muscle strength, function and balance before and at the end of the program and the data obtained will be recorded.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-30, * according to international physical activity questionnaire - short form being physically active * not having any psychological, neurological, orthopedic and rheumatic disorders, * not having a history of fractures or surgeries affecting the lower extremities in the last year, * being able to do at least one traditional squat exercise * being able to communicate in turkish (written and verbal) exclusion criteria * being pregnant or suspected of being pregnant * knee valgus diagnosis * pes planus or pes cavus diagnosis in the foot * hip rotation diagnosis * strength deficit between two extremities * a history of acute osteoarthritis in the knee * regular medication use or use of nsaids and similar disease-modifying drugs in the last month * intra-articular injection (hyaluronic acid/steroid) application in the last 6 months * having a comorbid disease that contraindicates exercise (advanced osteoporosis, vertigo, neurological diseases, etc.)
the efficacy of transarterial chemoinfusion (tai) combine lenvatinib in advanced hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: evaluation of the efficacy of transarterial chemoinfusion (tai) combine lenvatinib in advanced hepatocelllar carcinoma


Eligibility criteria:
inclusion criteria: older than 18 years old and younger than 75 years; ecog ps≤1; proven hepatocellular carcinoma according patological examination or easl/aasld diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/l; hemoglobin≥100g/l; platelet count≥75×109/l; serum albumin≥35g/l; total bilirubin\<2-times upper limit of normal; alt\<3-times upper limit of normal; ast\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; pt≤upper limit of normal plus 4 seconds; inr≤2.2; sign up consent exclusion criteria: cannot tolerate tai or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of hiv infection; known history of drug or alcohol abuse; have gi hemorrhage or cardiac/brain vascular events within 30 days; pregnancy
long-term lithium treatment for aggressive conduct disorder

Conditions: Conduct Disorder; Aggression

Summary: this study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).

psychotherapeutic agents are often administered without sufficient testing to children and adolescents, often on a long-term basis, to reduce aggression. many pressures, including managed care, will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems. lithium is the most promising agent for the treatment of aggression in children and adolescents. however, it has not been shown that lithium is an effective treatment for these patients in the outpatient (non-hospital) setting, or on a long-term basis. the purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression). the proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder. both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design. phase 1 contains a short-term 8-week controlled trial, with twice as many subjects randomized to lithium as placebo, increasing the pool of potential lithium responders to continue to phase 2. in phase 2, lithium responders from phase 1 enter a 6-month long-term controlled trial. every attempt is made to define responders to lithium.

Eligibility criteria:
inclusion criteria: 1. males and females 2. ages between 9 and 17 years. 3. conduct disorder according to dsm-iv (as rated on the dica-iv). 4. the aggression criterion at screening exclusion criteria: 1. mental retardation. 2. pervasive developmental disorder(s). 3. major depressive disorder or dysthymic disorder. 4. bipolar disorder. 5. psychotic disorder (including schizophreniform disorder and schizophrenia). 6. major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder. 7. history of psychoactive medication in the previous 2 weeks. 8. current pregnancy in females. 9. history of substance dependence in the past month. 10. prior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 meq/l or higher for a cumulative period of greater than 10 days.

Keywords: aggressive conduct disorder adolescence child conduct disorder female lithium male placebos conduct disorder -- *drug therapy lithium -- *therapeutic use
pilot study of the effects of playing golf on people with dementia

Conditions: Dementia

Summary: the research question for this study is whether golf is a suitable physical activity for people with dementia (pwd). it follows a qualitative pilot study in lincoln where pwd enjoyed the activity and caregivers appreciated the service. golf combines many desirable elements in a physical activity programme that include being outdoors, social, cognitively challenging, no reaction-time component, and being a typical everyday activity. the length of time that golf sessions last could also offer a potential respite from care for caregivers. participants will be people with dementia and their caregivers. eligibility criteria will include having been clinically diagnosed with dementia, being able to stand on one leg for at least six seconds to ensure participants are able to balance sufficiently well to be able to play golf. the study will be undertaken at the london shire golf club, with the golf training provided by the golf trust, which is a charitable foundation experienced in providing golf training to people with a range of different disabilities. the randomised controlled trial study will last 16 weeks, with a partial crossover design. the experimental group with have two eight-week periods of golf while the control group will have eight weeks without golf, then the golf intervention. there will be two 150-min sessions each week, starting with 30 minutes socialising, then 90 minutes playing golf, then 30 minutes socialising. the golf sessions will progress from putting, to chipping, and then a full swing, with sessions taking place on a nine-hole golf course. participants will be evaluated before and after each eight-week period for physical function, physical activity level, cognitive function, and quality of life. their caregivers will also provide information related to the pwd in terms of quality of life and psychopathology in dementia, as well as their own quality of life.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with dementia (any dementia) * receiving post-diagnostic support * the capacity to give informed consent * the physical capacity to play golf as determined by a single-leg stance test of balance exclusion criteria: * unable to give informed consent * without the physical capacity to play golf, as determined by a single-leg stance test of balance
autotitrating versus standard non-invasive ventilation (niv) in newly diagnosed patients

Conditions: Nocturnal Hypoventilation; Neuromuscular Disease; Chest Wall Disorder

Summary: the aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (niv) versus standard niv in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home niv.

the aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (niv). niv is standard therapy for patients with nocturnal hypoventilation. the most common type of niv is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. standard bilevel niv (vpap™) has been further developed to create a new automatically adjusting niv (autovpap™). automatically adjusting niv varies the inspiratory air pressure according to the airflow rates generated by the patient. this may improve patient comfort, hours of niv use and recovery time. patients over the age of 18 referred to, or under follow up at, the royal brompton hospital who require domiciliary niv but are inexperienced with use of niv will be considered for entry into this randomised crossover study. if eligible for inclusion and willing to take part patients will be setup on automatically adjusting niv or standard niv, assigned in random order. at the end of one month the patient will be swapped to the alternative niv for a further one month of domiciliary niv treatment. at the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous co2 monitoring and 24 hour holter monitoring.

Eligibility criteria:
inclusion criteria: * new clinical diagnosis of nocturnal hypoventilation * requirement for long-term domiciliary non-invasive ventilation * no previous experience with domiciliary non-invasive ventilation exclusion criteria: * uncontrolled cardiac failure * acute exacerbation of respiratory failure * daytime resting pao2 \< 7.5kpa * moderate or severe bulbar weakness * inability to understand rationale and/or consent form for study

Keywords: respiratory insufficiency hypercapnia hypoventilation sleep polysomnography hypoxia titration non invasive ventilation
evaluation of the course format "nasim25"

Conditions: Emergencies; Trauma Injury

Summary: the investigators intend to evauate the development and professional safety of aspiring prehospital emergency pyhsicians in a cross sectional and longitudinal modality. this compass objecitve and subjective evaluable professional skills essential in prehospital emergency medicine.

in the course format "nasim25" aspiring prehospital emergency physicians are trained in 25 simulation based scenarios dealing about situations being rare on the scene having have a tremendous impact on the patients if not treated adequately. to evaluate the impact of the course format on the skills of the participants (i.e. aspiring prehospital emergency physicians) the investigators quantify the trained skills and professional safety in three dimensions of skills and professional safety: 1. the influence on applying the abcde-approach using the a validated score by peran et al 2020 (abcde cognitive aid tool in patient assessment -development and validation in a multicenter pilot simulation study. bmc emerg med. 2020;20(1)) and non technical skills using a validated score by kim et al 2009 (kim j, neilipovitz d, cardinal p, chiu m.a comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "crm simulator study ib"). simul healthc. 2009;4(1):6-16) 2. the influence on the cource on the self- and external assessement of the participants using school marks 3. the influence on the professional safety using a web based survey in a longitudinal modality throughout the entire qualification curriculum of prehospital emergency medicine.

Eligibility criteria:
inclusion criteria: * physician aspiring the qualification: "prehospital emergency physician" and participating in the course: nasim25 exclusion criteria: * not participating in the course nasim25

Keywords: emergencies trauma pediatric emergencies prehospital emergencies