Kornimate/medical-research-clean huggingface dataset:
randomized clinical trial of posterior retroperitoneoscopic adrenalectomy versus lateral laparoscopic adrenalectomy

Conditions: Adrenal Tumor; Pheochromocytoma; Conn's Syndrome; Cushing's Syndrome

Summary: laparoscopic adrenalectomy has become the gold standard operation for non-malignant adrenal tumors replacing open adrenalectomy. the most popular lateral transperitoneal laparoscopic adrenalectomy (ltla) approach has been recently challenged by an increasing popularity of the posterior retroperitoneoscopic adrenalectomy (pra) approach which is believed by many surgeons as an easy to learn, reproducible and beneficial for patients. however, this belief is not evidence-based, so far. the aim of this study is to clarify if pra is superior to the ltla as minimally invasive approach to small and benign adrenal tumors.

laparoscopic adrenalectomy has replaced open adrenalectomy as the standard operation for non-malignant adrenal tumours. thanks to the popularization of the posterior technique described by walz and co-workers, the posterior retroperitoneal adrenalectomy (pra) is being performed in increasing numbers worldwide. advocates for the laparoscopic and retroperitoneoscopic approaches cite the advantages of each technique, but there is no published evidence that supports the superiority of one over the other. most of the published literature is retrospective, with inadequate or no controls and with potential biases. the aim of this study is to test the hypothesis that pra is superior to the lateral transperitoneal laparoscopic adrenalectomy (ltla) as minimally invasive approach to small and benign adrenal tumors. for a sample size calculation an assumption was made that a 20% reduction in duration of surgery represents clinically relevant difference. to detect this, it was calculated that 24 patients would be required in each treatment arm to give the study a power of 90 per cent. anticipating a 25% loss to follow-up, 32 patients per arm were required in the study.

Eligibility criteria:
inclusion criteria: * unilateral adrenal tumor below 7cm in diameter without suspicion for malignancy exclusion criteria: * active malignancy * pregnancy or lactation * age below 18 years, or above 80 years * high-risk patients according to the american society of anesthesiology (asa 4 grade or higher * inability to comply with the scheduled follow-up protocol

Keywords: lateral transperitoneal laparoscopic adrenalectomy posterior retroperitoneoscopic adrenalectomy
a clinical trial of natalizumab in individuals with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active crohn's disease.

natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for crohn's disease. it is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. these cells are thought to cause damage to the bowel, leading to the symptoms of crohn's disease. elan pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active crohn's disease. individuals with crohn's disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). there will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. for those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.

Eligibility criteria:
* males and females 18 years of age or older * diagnosis of crohn's disease for at least 6 months * females must not be pregnant or breastfeeding * must not have previously taken natalizumab * use of some other crohn's disease medications is permitted, but will be closely supervised

Keywords: crohn's disease inflammatory bowel disease ibd gastroenterology regional enteritis colitis
endocrine dysfunction and quality of life after subarachnoid hemorrhage

Conditions: Endocrine Dysfunction; Cerebral Infarctions; Quality of Life

Summary: investigation of the incidence of endocrine dysfunction following subarachnoid hemorrhage (sah), and to see if this has a relation to cns lesions as evaluated by mri and to common symptoms after sah such as general exhaustion, lack of initiative, increased sleep demand and reduced quality of life.


Eligibility criteria:
inclusion criteria: * acute aneurysmal subarachnoid hemorrhage exclusion criteria: * unable to give informed consent
board game intervention to improve cognitive and daily functioning

Conditions: Mild Cognitive Impairment

Summary: background: with the rapid rise of the aging population, the number of seniors with mild cognitive impairment (mci) has increased, and without timely interventions, participants are at high risk of developing dementia. board games have become a popular tool for cognitive training, but many board games may not be appropriate for seniors and lack the support of empirical research. objectives: to examine the effectiveness of a 12-week board game intervention for mci seniors in improving cognitive functioning and scores on the instrumental activities of daily living (iadl) scale. methods: a single-blind randomized controlled trial was conducted to collect data from a long-term care facility in central taiwan. sixty-eight mci seniors were recruited and randomized into a board game group (trial group) and a health promotion group (control group). participants in both groups received a 2-hour intervention once a week for 12 weeks, with the trial group receiving 12 weeks of board games and the control group receiving 12 weeks of health promotion activities. before and after the intervention, the primary assessment was conducted using the saint louis university mental status exam, contextual memory test, and trail making test part-a; the secondary assessment was conducted using the iadl scale.


Eligibility criteria:
inclusion criteria: * aged 65 years or older without a diagnosis of dementia * mild neurocognitive impairment exclusion criteria: * non-national senior citizens * unable to understand the content and complete the questionnaire * unable to participate in the full 12-week intervention * had an acute illness such as a cold during the trial.
study to evaluate effects of investigational drug on oxygenation in healthy volunteers under hypoxic conditions

Conditions: Cardio-pulmonary Function

Summary: to evaluate the effect of gbt440 on oxygen saturation at rest and exercise, under hypoxic conditions, at day 15 compared to baseline.

this study in healthy subjects will evaluate gbt440 and its effects on cardio-pulmonary function under both normoxic and hypoxic conditions.

Eligibility criteria:
inclusion criteria 1. males or females aged 18 - 50 years inclusive 2. able and willing to provide signed informed consent to participate in this study 3. vo2 max ≥ 40 ml/kg/min for males, and ≥ 35 ml/kg/min for females 4. weight ≥ 40 kg 5. male or female of child bearing potential willing and able to use highly effective methods of contraception during the study to 30 days after the last dose of study drug. exclusion criteria 1. subjects whose exercise regimen at screening is, in the investigator's opinion, expected to change significantly during the study 2. family or personal history of congenital long qt syndrome 3. participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device) 4. clinically significant medical disease that is likely, in the investigator's opinion, to significantly impact the study's efficacy and safety assessments (e.g., history significant cardio-pulmonary disease or arrhythmias) within 6 months of screening. 5. ast, alt or total bilirubin \>2 × uln 6. serum creatinine \>1.5 mg/dl 7. clinical evidence of active infection, within 21 days of screening, which may include but is not limited to bronchitis, pneumonia, urinary tract infection, or cellulitis. 8. female who is breast-feeding or pregnant 9. current smoker or history of smoking within 3 months from screening 10. any condition possibly affecting drug absorption, including but not limited to previous surgery on the stomach or small intestine 11. known hypersensitivity to any component of the study drug
a study assessing rocatinlimab (amg 451) monotherapy in moderate-to-severe atopic dermatitis (ad) (rocket-horizon)

Conditions: Atopic Dermatitis

Summary: the co-primary objectives of the study are to: * evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using validated investigator's global assessment for atopic dermatitis (viga-ad). * evaluate the efficacy of rocatinlimab compared with placebo at week 24, assessed using eczema area and severity index (easi).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) with a diagnosis of ad according to the aad consensus criteria (2014) present for at least 12 months * history of inadequate response to tcs (topical corticosteroid) of medium or higher potency (with or without topical calcineurin inhibitors \[tci\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). * easi score ≥16 * viga-ad score ≥3 * ≥10% body surface area (bsa) of ad involvement * worst pruritus numerical rating scale ≥ 4 exclusion criteria: * treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 * treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1: * systemic corticosteroids * systemic immunosuppressants * phototherapy * oral or topical janus kinase inhibitors * treatment with any of the following medications or therapies within 1 week, prior to day 1: * tcs of any potency * tci * topical phosphodiesterase type 4 (pde4) inhibitors * other topical immunosuppressive agents * combination agents including tcs of any potency or tci, pde4 inhibitors, or other immunosuppressive agents

Keywords: atopic dermatitis amg 451 khk 4083 eczema rocatinlimab
safety and tolerability of xmab®5574 in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is an open-label, multi-dose, single-arm, phase 1, dose-escalation study of xmab5574. the study was conducted to identify the maximum tolerated dose (mtd) and/or recommended dose(s) (rd) for further study, to characterize safety and tolerability, to characterize pk, pd and immunogenicity, and to evaluate preliminary antitumor activity of xmab5574 in patients with relapsed or refractory cll/sll.


Eligibility criteria:
inclusion criteria: * relapsed or refractory cll/sll * at least 18 years of age * able to receive outpatient treatment and follow-up at the treating institution * completed all cll therapies \> 4 weeks prior to first study dose exclusion criteria: * previously treated with an anti-cd19 antibody therapy * undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease * active richter's syndrome * designated class iii or iv by the new york heart association (nyha) criteria * history of myocardial infarction or stroke within the last 6 months * active viral, bacterial, or systemic fungal infection requiring treatment * hiv or hepatitis c positive * hepatitis b infection

Keywords: cll sll cd19
maximal usage pharmacokinetics and safety of arq-151 in children with plaque psoriasis (arq-151-216)

Conditions: Psoriasis; Plaque Psoriasis

Summary: this is a phase 2, open label, maximal usage pk and safety study of arq-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:


Eligibility criteria:
inclusion criteria: * informed consent of parent(s) or legal guardian. * males or females, 2 to 5 years old (inclusive). * clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the investigator or through subject interview. stable disease for the past 3 weeks. * psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of bsa (excluding the scalp, palms, and soles). * an investigator global assessment of disease severity (iga) of at least mild ('2') at baseline. * subject has adequate venous access for pk sampling in areas not involved by plaque psoriasis and not being treated with arq-151 (e.g., back of the hands). * in good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ecg), serum chemistry labs and hematology values. * subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: * subjects with any serious medical or psychiatric condition or clinically significant laboratory, ecg, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the investigator. * planned initiation or changes to concomitant medication that could, in the opinion of the investigator, affect psoriasis vulgaris * current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). current diagnosis of drug-induced psoriasis. * subjects with any condition on the treatment area which, in the opinion of the investigator, could confound efficacy measurements. * subjects who cannot discontinue the use of strong cytochrome p-450 cyp3a4 inducers for 2 weeks prior to baseline/day 1and during the study period. * subjects who cannot discontinue the use of strong cytochrome p-450 cyp3a4 inhibitors for 2 weeks prior to baseline/day 1 and during the study period. * subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (leds) for 4 weeks prior to baseline/day 1 and during the study. * subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the baseline/day 1 and during the study period according to the protocol. * subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to baseline/day 1.
a study of ibi362 in poorly controlled type 2 diabetes patients only through diet and exercise

Conditions: Type 2 Diabetes

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study to evaluate the effectiveness and safety of ibi362 in patients with type 2 diabetes (t2d) with poor glycemia control only through diet and exercise. this study plans to enroll about 300 t2d subjects who still fail to meet the hba1c standard after at least 2 months of simple diet and exercise control. during the whole study, subjects will be required to maintain diet and exercise control. the whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period. subjects who met the randomization criteria will be randomly assigned to the ibi362 4.0 mg group, the ibi362 6.0 mg group and the placebo group at 1:1:1. the randomization stratification factors were (v3) hba1c\<8.5% or hba1c ≥ 8.5% before randomization.


Eligibility criteria:
inclusion criteria: 1. t2d was diagnosed according to who standards in 1999 for at least 2 months 2. age ≥ 18 when signing the informed consent form 3. the blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ hba1c ≤ 10.5% during screening 4. maintain a stable diet and exercise lifestyle during the study 5. subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol exclusion criteria: 1. subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. weight change\>5% within 12 weeks before screening (chief complaint) 3. used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening 4. previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes 5. there are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) 6. mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study 7. pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period 8. the investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
immunosenescence and hepatitis b virus (hbv) vaccine efficacy in chronic renal disease patient

Conditions: Chronic Renal Disease

Summary: the aim of this study is to investigate the role of immunosenescence in the hbv vaccination response in patients with renal insufficiency.

the risk of infection with hepatitis b during exposure to blood is high (30% against 1.8% for hepatitis c virus and hiv 1%) and dialysis patients are a population at risk. vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. however, numerous studies have shown that hbv vaccination was less effective in patients with chronic renal disease than in the general population. the reasons for low vaccine response are poorly understood. however, recent data suggest that renal failure could induce accelerated immunosenescence. the aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. the gradual reduction of the generation of naive t cells in the thymus is the major cause of immunosenescence. but this process is also associated with an accumulation of lymphocytes at the end of differentiation. in this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. the aim of this study is to investigate the role of immunosenescence in the hbv vaccination response in patients with renal insufficiency. vaccination against hbv is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the health authority.

Eligibility criteria:
inclusion criteria: * patient with an indication of hbv vaccination * patient with renal disease, with a creatinine clearance between 15 and 60ml/min * patient who have never been vaccinated against hbv * patient with negative serology for hbv * patient able to understand the reason of the study * patient not opposed to the conservation of biological samples for scientific research exclusion criteria: * patient infected with hepatitis b or with history of vaccination against hbv * patient suffering from psychotic illness * patient with any history of immunosuppressive therapy * patient with infectious and/or cancer diseases in evolution

Keywords: chronic renal disease hepatitis b vaccine biological aging
influence of strength training and protein supplementation on fitness of institutionalized elderly

Conditions: Aging

Summary: the aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune system in elderly institutionalized persons. the participants (n = 120) are recruited from viennese senior residencies (kuratorium wiener pensionistenwohnheime). after a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 intervention groups (cognitive training, strength training, strength training + supplement). study participants are eligible if they are male or female with an age over 65 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. exclusion criteria comprise chronic diseases which contraindicate the medical training therapy, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months. primary outcome measure is the change in isokinetic torque of knee extensors. secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters. the change in muscle signaling pathways will be assessed from muscle biopsies.


Eligibility criteria:
inclusion criteria: * adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (mini-mental-state \>23) * ability to walk 10 meters independently (without orthopaedic devices) * 4 or more points at the short physical performance battery exclusion criteria: * chronic diseases, which contraindicate a medical training therapy * serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias) * diabetic retinopathy * manifest osteoporosis * regular use of cortisone-containing drugs * regular strength training (\> 1x / week) in the last 6 months before inclusion

Keywords: strength training protein supplementation sarcopenia