Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of frexalimab, sar442970, or rilzabrutinib in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis or minimal change disease

Conditions: Focal Segmental Glomerulosclerosis; Glomerulonephritis Minimal Lesion

Summary: this is a parallel, phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (fsgs) or primary minimal change disease (mcd). the purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, sar442970, or rilzabrutinib compared with placebo in participants with primary fsgs or primary mcd aged 16 to 75 years. study details for each participant include: the study duration will be up to 76 weeks. the treatment duration will be 24 weeks. there will be up to 18 visits.


Eligibility criteria:
inclusion criteria: * biopsy-proven primary fsgs or primary mcd. * upcr ≥3 g/g at screening. * egfr ≥45 ml/min/1.73 m\^2 at screening. * documented history of upcr reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment upcr was ≥3.5 g/g. * ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization. * on stable dose of raas inhibitors for ≥4 weeks prior to screening (if applicable); starting raas inhibitors treatment will not be allowed during the double-blind or ole treatment period. * on stable dose of sglt2 inhibitor for ≥4 weeks prior to screening (if applicable); starting sglt2 inhibitor treatment will not be allowed during the double-blind or ole treatment periods. * body weight within 45 to 120 kg (inclusive) at screening. exclusion criteria: * genetic or secondary fsgs or mcd. those with apol1 risk alleles are eligible. * collapsing variant of fsgs. * eskd requiring dialysis or transplantation. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
clinical trial of robot-assisted-gait-training (ragt) in stroke patients

Conditions: Stroke

Summary: a clinical trial of robot-assisted-gait-training (ragt) in stroke patients to evaluate its efficacy, safety over conventional gait training.

robot-assisted-gait-training (ragt) in stroke patients to evaluate its efficacy, safety over conventional gait training. experimental group receives robot-assisted-gait-training and conventional gait training. active comparator group receives conventional gait training only as the same number as the experimental group.

Eligibility criteria:
inclusion criteria: * age more than 19 and under 80 * weight under 100kg * height less than 200cm * able to walk independently before onset of stroke * ischemic or hemorrhagic stroke patients * patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment * fac(functional ambulation category) under 3 (0\~2) * subacute stroke patients after 3 days and before 3 months of onset * be informed of the nature of the study and agreed on written consent voluntarily * patients taking medications or scheduled medications due to stroke exclusion criteria: * patients with contraindications to weight bearing such as fractures, etc. * uncontrolled stage 2 hypertension (systolic over 160 mmhg or diastolic more than 100mmhg) or with uncontrolled orthostatic hypotension * patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training * patients with severe skin damage and bedsore on wearing part of the trial device * pregnant or breast-feeding * participation within 30 days of the other clinical trials * patients whom the investigator considers inappropriate to participate in the study

Keywords: stroke
a water-based sequential preparatory approach and stroke

Conditions: Stroke

Summary: many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living. a cochrane review systematically synthesized and compared the effects of aquatic and land-based therapies on the activities of daily living (adl) of patients following stroke and found that water-based exercises improved strength and adl. a recent review indicates that rcts comparing aquatic methods in both environments are lacking. the same movements in water and on dry land that target postural stability and gait require different competences. for example, the postural instability that occurs while squatting in water was enacted on land by sitting on a therapy ball. furthermore, land-based conventional rehabilitation is generally task oriented, customized and challenging and follows a specific preparatory sequence of exercises according to patients' disabilities. therefore, the investigators believe that a sequential preparatory approach (spa), based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex), should also be used in an aquatic environment.


Eligibility criteria:
inclusion criteria: * stroke with unilateral hemiplegia within the previous six months; * ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance (functional ambulation classification ≥ 3); * acclimatization to water. exclusion criteria: * cognitive deficits affecting the ability to understand task instructions (mini-mental state examination \> 24); * severe unilateral spatial neglect (diagnosed with a test battery that included the letter cancellation test, barrage test, sentence reading test and the wundt-jastrow area illusion test); * severe aphasia (diagnosed by means of neuropsychological assessment); * presence of other neurological diseases; * presence of cutaneous and mycosis infections; * presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns; * presence of peg (percutaneous endoscopic gastrostomy); * presence of tracheostomy; * urinary incontinence; * presence of otitis * presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
effects of segmental and pursed lip breathing exercises on upper cross syndrome

Conditions: UPPER CROSS SYNDROME

Summary: upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. the aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome. current study will be randomized controlled trial conducted at ismail medicare jhang, 40 patients according to inclusion criteria will be included in the study. they will be allocated into 2 groups by non-probability purposive sampling technique. group a (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, rom and strengthening exercises) while group b (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. outcome measures are pain numeric scale, quality of life (sf 36) and functional disability (neck disability index). these tools will measure neck function and neck pain intensity. treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. data will be analyzed by spss version 25. after assessing normality of data by shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis. key words: breathing exercises, cervical pain, disability, upper cross


Eligibility criteria:
inclusion criteria: * both gender \>25-40 years * diagnosed with upper cross syndrome, having neck pain intensity more than 5 on numeric pain rating scale and having pain from more than 3 months * positive janda cervical flexion test exclusion criteria: * patient with other musculoskeletal disorder e.g cervicogenic headache excluded * neck pain with whiplash or headache disorder were not included * patients had any history of previous head and neck surgery excluded * any history of infection in the cervical spine were not included * trigger points of trapezius were excluded

Keywords: breathing exercises cervical pain disability upper cross syndrome
emd 640 744 in montanide isa 51 vg administered in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: to compare 3 doses of emd 640744 administered by subcutaneous injection in combination with montanide® isa 51 vg with regard to immunological efficacy. the primary target variable is the immune response as assessed by elispot before and until week 17 after vaccination with emd 640744 in montanide® isa 51 vg.


Eligibility criteria:
inclusion criteria: * male and female subjects ≥18 years of age * signed written informed consent * histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists * disease must be measurable by recist criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity * expressing at least one of the following hla alleles:hla-a1,-a2,-a3,-a24, and -b7 assessed by hlagenotyping * ecog performance status of ≤1, estimated life expectancy of at least 3 months * adequate hematological function defined by wbc ≥3 x 10x9/l, lymphocyte count ≥0.5 x 10x9/l, hemoglobin ≥10 g/dl, platelet count ≥100 x 10x9/l * adequate blood coagulation parameters defined as aptt and inr ≤ 1.5 x uln * adequate renal function defined by a serum creatinine ≤2 x uln * adequate hepatic function defined by total bilirubin ≤2 x uln and ast and alt levels ≤2.5 x uln (in subjects with liver metastases ≤5 x uln) * effective contraception for female and male subjects if the risk of conception exists exclusion criteria: * treatment in another clinical study within the past 30 days prior to the first administration of study treatment * previous treatment with an investigational anticancer vaccine * requirement of concurrent treatment with a nonpermitted drug * active significant autoimmune disease (with the exception of vitiligo) * receipt of allogeneic stem cell transplantation * significant acute or chronic infections (e.g. viral hepatitis, hiv) * primary brain tumors and brain metastases (with the exception of brain metastases that are stable after irradiation or surgically resected brain metastases if subjects have been asymptomatic for ≥6 months) * rapidly progressive disease (e.g. tumor lysis syndrome) * radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy), immunotherapy or any investigational drug within 30 days before the start of study treatment * pregnancy or lactation * active drug or alcohol abuse * known hypersensitivity to the study treatment or any of its components * any significant disease that, in the investigator's opinion, should exclude the subject from the study; for questions about this criterion, the investigator should contact the sponsor. * persisting toxicity related to prior therapy ≥grade 2 national cancer institute-common terminology criteria for adverse events version 3.0 * legal incapacity or limited legal capacity

Keywords: emd 640744 montanide advanced solid tumours
impact of various diets on surgical complications

Conditions: Complication,Postoperative

Summary: the optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. immunomodulating diets were thought to reduce cmplications, hoever recent studies put that opnion in doubt. this study was designed to assess the actual clinical significance of oral immunonutrition.

the optimalisation of the health status of patients scheduled for major surgery has been considered to be the most important point of perioperative care, and nutritional intervention has been perceived a key point of that intervention. italian studies followed by metanalyses demonstrated the superiority of immunomodulating diets (im) over any other preoperative nutrition, hence the surgical guidelines for enteral nutrition published by european society for clinical nutrition and metabolism (espen) in 2006 recommended to use im for 7-14 days preoperatively in all patients undergoing major surgeries. some authors questioned im by showing no benefit of im over standard enteral nutrition. other authors observed similar results.the debate was far from being over - in 2015 a new metanalysis stated that perioperative enteral nutrition is the best option for managing clinical status of patients who underwent selective surgery for gastrointestinal cancer. one year later, espen changed its surgical recommendations and advised to use im preoperatively in malnourished and perioperatively in well-nourished patients. american recommendations remained unchanged and, according to them, it is advised to use im preoperatively in all surgical patients, however, high-protein nutrition could also be an beneficial option. to address those doubts and to assess the actual clinical significance of oral immunonutrition, a randomized, two center, prospective clinical trial was conducted.

Eligibility criteria:
inclusion criteria: * no sign of malnutrition (defined as one of the following unintentional weight loss by at least 10% or body mass index (bmi) \< 18), * good general status (karnofsky performance index \> 80, * eastern cooperative oncology group (ecog) grade 0 or 1); * no confirmed neoplastic dissemination no severe concomitant disease (heart, lung, kidney, liver failure, chronic obstructive pulmonary disease \[copd\], coronary aortic bypass graft \[cabg\], etc.), * no history of known allergies or drug intolerance to analyzed substances. exclusion criteria: * patients malnourished or with metastatic disease, * pregnant, * in poor general status (karnofsky \ 1), * recent history of severe heart, lung, kidney or liver failure, * history of allergies or drug intolerance
treatment of benign thyroid nodules with fastscan hifu

Conditions: Benign Thyroid Nodules

Summary: this study evaluates the efficacy of the hifu for the treatment of benign thyroid nodules with the fastscan version using assessment of patient experience and adverse event reporting.

echopulse is specially designed, manufactured and ce marked for treating benign thyroid nodules. hifu is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°c.this initiates tissue coagulation followed by tissue necrosis ablating the targeted area. in a previous european feasibility study performed at 1 site (bulgaria), 20 benign thyroid nodules were treated. the hifu treatment was well tolerated and showed efficacy.

Eligibility criteria:
inclusion criteria: * male or female patient 18 years or older. * patient presenting with at least one thyroid nodule with no signs of malignancy: 1. non suspect clinically and at ultrasonography imaging 2. benign cytological diagnosis at fnab (fine-needle aspiration biopsy) from the last 6 months 3. normal serum calcitonin 4. no history of neck irradiation * normal tsh (thyroid-stimulating hormone) * targeted nodule accessible and eligible to hifu * absence of abnormal vocal cord mobility at laryngoscopy * nodule diameter ≥ 10mm measured by ultrasound * composition of the targeted nodule(s) : predominantly solid * patient has signed a written informed consent. exclusion criteria: * head and/or neck disease that prevents hyperextension of neck * known history of thyroid cancer or other neoplasias in the neck region * history of neck irradiation * macrocalcification inducing a shadow in the thyroid significant enough to preclude the hifu treatment * posterior position of the nodule if the thickness of the nodule is \<15mm * pregnant or lactating woman * any contraindication to the assigned analgesia/anaesthesia.
dialysis training therapy: the diatt trial

Conditions: Chronic Kidney Diseases; Hemodialysis

Summary: diatt is an interventional, cluster-randomized (1:1), multicenter trial for patients with chronic kidney disease undergoing hemodialysis (n=1,100). this trial will test the effectiveness (by change of sit-to-stand test between baseline and 12 months) of intradialytic exercise training (et) and health literacy counseling (hlc) for 12 months (intervention group) in comparison to control group (usual care, uc; no et, no hlc).

the primary objective of this trial is to assess the effectiveness of intradialytic exercise training (et) and health literacy counselling (hlc) over 12 months intervention in patients undergoing chronic outpatient hemodialysis as compared to usual care (uc). the primary endpoint is change in sit-to-stand (sts60) test, from baseline to after 12 months intervention. the et consists of both resistance and endurance training, focusing on improving patients' health status and physical functioning. health literacy counseling aims at improving education, proficiency and self-awareness of the patient. all patients undergoing hemodialysis in participating centers (clusters) for at least four weeks are eligible to participate in the study. irrespective of randomized center (cluster) group assignment, all dialysis and overall medical treatments will remain unchanged and follow standard of care and center routine without adaptations to the training intervention.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * chronic ambulatory hemodialysis for \> 4 weeks * written and signed confirmation by the treating dialysis physician that the patient is able to exercise * signed informed consent to participation in qin registry * signed informed consent obtained according to confidentiality and data protection regulation, international guidelines and local laws exclusion criteria: * unstable angina pectoris * uncontrolled arterial hypertension (systolic blood pressure \> 180 mmhg or diastolic bp \> 105 mmhg on repeated measurements) * uncontrolled tachycardia * acute severe infection * planned live kidney transplantation within the next 12 months * planned conversion to home-hemodialysis or peritoneal dialysis within the next 12 months * dialyzing in long overnight dialysis shift * participation in a regular exercise program during hemodialysis sessions (≥ 1/week) in the last 6 months

Keywords: chronic kidney disease hemodialysis intradialytic exercise physical activity safety health economics health literacy training therapy
an additional confirmatory study of kps-0373 in patients with spinocerebellar degeneration (scd)

Conditions: Spinocerebellar Degeneration

Summary: the purpose of this study is to investigate the superiority of kps-0373 to placebo, and evaluate the safety of kps-0373 in scd patients.


Eligibility criteria:
inclusion criteria: * japanese scd patients with mild to moderate ataxia exclusion criteria: * patients with secondary ataxia * patients with clinically significant hepatic, renal, or cardiovascular dysfunction
medical clowning in the nicu (neonatal intensive care unit and their effects on parents and staff

Conditions: Premature Neonate

Summary: the study will compare intervention by infant aquatics to infant massage. the intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. development will be assessed and compared at 3, 8 and 18 months using infant motor pattern method, griffith developmental scales and vineland adaptive behavior scales.

preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (mnd) to cerebral palsy (cp), mainly due to developmental brain injury. infant aquatics have been found to benefit and promote infant development. the support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

Eligibility criteria:
inclusion criteria: * neonates wherein their parents have expressed consent to participate in trail * neonates with parents who are able to understand and fill in questioners * neonates with no chromosomal deficiencies and no genetic deficiency exclusion criteria: * neonates with parents who are unable to understand and fill in questioners * neonates with intraventricular bleeding ivh/pvh * neonates with periventricular hemorrhage * neonates with known chromosomal deficiencies or genetic deficiency

Keywords: clown neonate premature
cbt4cbt for office based buprenorphine

Conditions: Opioid-use Disorder

Summary: in this phase ii sbir/sttr project, our specific aim will be to determine if the use of cbt4cbt-buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a larger and diverse population of individuals seeking buprenorphine treatment in primary care (n=100).

in this phase, 100 individuals entering buprenorphine maintenance at the primary care clinic (central medical unit, cmu) will be randomized to either (1) standard buprenorphine maintenance in which counseling is offered on site, or (2) standard buprenorphine maintenance with cbt4cbt-buprenorphine substituting for on-site counseling. this will be a 12-week trial.

Eligibility criteria:
inclusion criteria: * meets current diagnostic statistical manual (dsm-5) criteria for opioid use disorder * requesting buprenorphine maintenance treatment at central medical unit of the apt foundation exclusion criteria: * unstabilized psychotic disorder * currently suicidal or homicidal * current cocaine, benzodiazepine, or alcohol use disorder. * any history of pcp (phencyclidine) use. * pregnant or lactating * any other physical or mental condition that would contraindicate office-based buprenorphine maintenance treatment.