Kornimate/medical-research-clean huggingface dataset:
effect of motor development, motor function and electrophysiologic findings of iopd under ert

Conditions: Glycogen Storage Disease Type II

Summary: to investigate the motor development, motor function and electrodiagnostics presentation in iopd under ert.

background pompe disease is an autosomal recessive disease, enzyme replacement therapy (ert) and new born screen (nbs) had been initiated in taiwan since 2008. however, residual muscle weakness were noted. decrease in amplitude of nerve compound muscle action potential (cmap) and increase spontaneous activity were reported before the imitation of ert. however, the motor development, motor function and electrodiagnostic presentation which were important in further direction of treatment and rehabilitation program arrangement in infantile pompe disease (iopd) under ert is lacking. aim to investigate the motor development, motor function and electrodiagnostic presentation in iopd under ert. method this is an observational, prospective, longitudinal, follow-up study. motor development was assessed by alberta infant motor scale (aims) and peabody developmental motor scales, second edition (pdms ii); motor function was assessed by pediatric evaluation of disability inventory (pedi) and gross motor function measure (gmfm). electrodiagnosis studies include nerve conduction study (ncs) and electromyography (emg). expect effects obtain the characteristics of motor development, motor function and electrodiagnosis presentation of iopd under ert, and the relation between motor development, motor function and electrodiagnosis presentation.

Eligibility criteria:
inclusion criteria: * all patients with infantile onset pompe disease (iopd) who were diagnosed and follow-up at taipei veteran general hospital (tvgh). exclusion criteria: * patients whose guardian did not provide the inform consent.

Keywords: iopd
high-intensity interval, low volume training in metabolic syndrome

Conditions: Metabolic Syndrome; Insulin Resistance

Summary: the primary objective of the study is to compare the efficacy of an intervention with high-intensity interval, low volume training (hiit-lv) or continuous aerobic exercise (cae) on insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function in adults with metabolic syndrome (ms). the secondary objective is to compare the efficacy of an intervention with hiit-lv or cae on glycosylated hemoglobin, mass and muscle fibre type composition of right thigh and plasma levels of musclin and apelin in adults with ms. the investigators hypothesized that hiit-lv is more effective in decreasing insulin resistance and glycosylated hemoglobin and plasma concentrations of musclin and increasing plasma concentrations of apelin, and both mass and muscle fibre type i percentage in thigh, than cae.

this study is a randomized, controlled, masked (single blind, outcomes assessor) clinical trial, with allocation by the minimization method, with two parallel groups and intention of superiority. it was designed to test the hypothesis that a 12-week program of hiit-lv, yields larger beneficial effects on insulin resistance, skeletal muscle composition and endocrine function than cae. although aerobic exercise increases cardio-respiratory capacity, modifies risk factors and decreases mortality risk, there is currently controversy and gaps in knowledge over the efficacy of more intense and low-volume physical activities on muscle metabolism in patients with metabolic disorders. the primary outcome will be the insulin resistance, insulin sensitivity and percentage of pancreatic β-cell function. the secondary outcomes will be the glycosylated hemoglobin, mass and muscle fibre type composition of thigh and plasma levels of musclin and apelin. assessments will be made before and after the 12-week program. calculations based on previously results (difference mean 10% and sd 15%) suggest that a total number of 60 patients randomized 1:1 (30 in each group) to the two intervention groups is sufficient to detect larger beneficial effects with hiit-lv with a p-value of 0.05 (two-sided test) and statistical power of 0.80 (primary endpoint is insulin sensitivity).

Eligibility criteria:
inclusion criteria: * metabolic syndrome defined according to the international diabetes federation-criteria. * insulin resistance defined according to the homa greater than 2.25 * sedentary lifestyle (less than 60 min of physical activity per week) exclusion criteria: * vegetarian diet * vitamin d3 supplementation * oral contraceptives * musculoskeletal diseases or injuries * physical, sensory or cognitive impairment * history of cardiovascular disease (coronary, cerebrovascular, peripheral arterial disease, uncontrolled cardiac arrhythmias). * pulmonary diseases * acute or chronic inflammatory conditions * cancer * human immunodeficiency virus infection * diabetes mellitus * hyperthyroidism * pregnancy

Keywords: metabolic syndrome exercise training interval training skeletal muscle risk factors insulin resistance
evaluation of an arterial calcification score as a predictive factor of anastomotic leakage in right colectomy

Conditions: Right Colectomy

Summary: anastomotic leakage is the major postoperative complication in right colectomy. evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative ct scan could allow the identification of patient at-risk of postoperative complications. a monocentric retrospective study performed at chd vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage. the aim of this prospective multicentric study is to validate a calcification score based on preoperative ct scan analysis and focussing at coeliac trunk and mesenteric arteries.this study will involve patients operated on with a scheduled right colectomy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * scheduled right colectomy with restoration of digestive continuity * patient who has had or will have a preoperative abdominal-pelvic ct scan with or without contrast injection * patient with the ability to understand the protocol and agree to participate in the study. * affiliated with a social security system exclusion criteria: * patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term corticosteroid therapy * patient with a history of colic resection * patient under guardianship, curatorship, or deprived of liberty * pregnant, postpartum or breastfeeding women * minor patients

Keywords: right colectomy calcification anastomotic leakage
orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(rr fl)

Conditions: Follicular Lymphoma; Relapsed and Refractory Follicular Lymphoma

Summary: this phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(rr fl)


Eligibility criteria:
inclusion criteria: * histologically confirmed grade 1, 2, or 3a fl; * patients received prior anti-lymphoma treatment; * at least one evaluable lesion according to 2014 lugano criteria; * age 18 years or older; * eastern cooperative oncology group (ecog) of 0-2; * life expectancy \> 3 months; * able to participate in all required study procedures; * proper functioning of the major organs: exclusion criteria: * patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease; * histological transformation of follicular lymphoma; * known central nervous system lymphoma; * received a prior allogeneic hematopoietic stem cell transplant. prior autologous hematopoietic stem cell transplant is allowed; * subjects who have received prior treatment with ibrutinib, or other btk inhibitors; * uncontrolled active infection, with the exception of tumor-related b symptom fever; * prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug; * subjects who progressed or become refractory while on treatment with pi3k inhibitors are excluded. however, subjects who were responding to pi3k inhibitors, but had treatment discontinued due to toxicity, are eligible; * patients require treatment with strong cyp3a inhibitors; * clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening; * patients with active hepatitis b or active hepatitis c. patients who are positive for hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies at screening stage must pass further detection of hepatitis b virus (hbv) dna (no more than 1000 iu/ml) and hcv rna (no more than the lower limit of the detection method) in the row. hepatitis b carriers, stable hepatitis b (dna titer should not be higher than 1000 iu/ml) after drug treatment, and cured hepatitis c patients can be enrolled in the group;
safety and efficacy of aqw051 in l-dopa induced dyskinesias in patients with parkinson's disease

Conditions: Dyskinesias; Drug-induced

Summary: this study will assess the safety, tolerability and efficacy of aqw051 in treating moderate to severe l-dopa induced dyskinesias (movement disorders) in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease * patients with dyskinesias for at least 3 months * patients with moderate to severe dyskinesias * patients on l-dopa treatment for at least 3 years exclusion criteria: * patients with atypical parkinson's disease * patients who have had prior surgery for parkinson's disease * patients who are cognitively impaired, have psychosis, have confusional states or hallucinate * patients who received neuroleptics or anti-psychotics within 2 months * women of child-bearing potential other protocol-defined inclusion/exclusion criteria may apply.

Keywords: parkinson's disease dyskinesia movement disorders l-dopa
study on icu patients with nosocomial lower respiratory tract infections

Conditions: Pneumonia

Summary: this is a multicentre, multinational, prospective observational investigation on icu critically ill patients affected by nosocomial pneumonia, defined as: out of icu hospital-acquired pneumonia (hap), non-ventilator icu-acquired pneumonia (nv icuap), ventilator associated pneumonia (vap) ventilator associated tracheobronchitis (vat).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of nosocomial pneumonia * icu and hdu admission (patient may be admitted to the icu with np or may develop pneumonia during icu stay) * informed consent (if required) exclusion criteria: * community acquired infection * absence of microbiological findings
investigate the effectiveness of kefpep® on regulating high blood pressure

Conditions: Prehypertension

Summary: to assess the ability of kefpep® to reduce blood pressure

primary objective- • to assess the ability of kefpep® to reduce blood pressure. secondary objective- 1. to access the effect of kefpep® on vascular inflammation or damage. 2. to access the effect of kefpep® on cardiovascular diseases prevention. 3. to assess the safety of kefpep® .

Eligibility criteria:
inclusion criteria: 1. male or female patient ages 20 years or older. 2. belong to either one of the following categories based on the seventh report of the joint national committee (jnc 7) as measured by office bp at screening visit: * prehypertension (sbp 120 - 139 mmhg or dbp 80 - 89 mmhg) * stage i hypertension (sbp 140 - 159 mmhg or dbp 90 - 99 mmhg) 3. body weight≤90 kg, and bmi≥18.5 kg/m2 or \< 30 kg/m2. 4. not on any antihypertensive treatment at the time of entry into the study. 5. willing to comply with the study procedures and follow-ups. 6. understand the nature of the study, and have signed informed consent forms. exclusion criteria: 1. patients with any of the following conditions within 6 months prior to study participation: * secondary hypertension * uncontrolled diabetes mellitus * renal disease based on the investigator's judgment * severe hepatic disease with child-pugh class c * severe anaemia * any malignant disease or serious disease 2. patients with clinically significant abnormalities in the following laboratory parameters within 2 weeks prior to screening visit or during the screening period: * hba1c \> 9% * ast or alt ≥ 3 x upper limit of normal (uln) * estimated glomerular filtration rate (egfr) \< 50 ml/min/1.73 m2 * serum creatinine ≥ 3 x uln * hemoglobin \< 10 g/dl 3. history of milk allergy and/or lactose intolerance. 4. history of alcohol abuse. 5. constant use of oral medication or supplements affecting blood pressure. 6. female patients who are pregnant, planning to become pregnant, or lactating. 7. male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period. 8. currently participating in any other interventional clinical study within 30 days 9. patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.
the prism adaptation study (pas)

Conditions: Esotropia

Summary: to determine whether the preoperative use of prisms in eyeglasses can improve the outcome of surgery for acquired esotropia, a type of strabismus. to determine whether patients who respond to prism adaptation by developing a new stable angle of -deviation have a better surgical result than do patients who do not respond to prism adaptation. to determine whether patients who respond to prism adaptation are more accurately corrected by operating for the prism-adapted angle or the original angle of deviation. to determine the usefulness of certain input variables (e.g., age at the time of surgery, size of the deviation, visual acuity, binocular function, refractive error) in predicting which patients are more likely to benefit from prism adaptation.

acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months) accounts for 25 percent of all patients with misaligned eyes. surgery to correct esotropia is done primarily to attain functional use of the two eyes together. the cosmetic aspect of the surgery is secondary. in 40 to 50 percent of cases, more than one operation is needed to accomplish the primary goal, and in some cases even three and four operations are needed. preliminary studies from two eye care centers reported that the use of prisms on eyeglasses for about a month before surgery led to good results after a single operation in more than 90 percent of patients. these uncontrolled preliminary studies pointed to the need for a multicenter, randomized, controlled clinical trial designed to prove or disprove scientifically the beneficial effect of prisms. the prism adaptation study was a double randomization trial involving 286 patients. three-fifths of the patients were randomly selected for prism adaptation before surgery. of the patients who responded to the prisms, one-half were randomly selected to have surgery based on the amount of prism required to stabilize the deviation, and the other half had surgery based on the amount of esotropia originally measured. patients who did not respond to the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths of the patients who did not undergo prism adaptation. patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. an independent examiner, masked to the treatment assignment, evaluated the patient at the 6-month followup. the results were analyzed to determine whether the outcome was better in patients who underwent prism adaptation or in those who underwent conventional treatment. because the examiner did not know what type of treatment a patient had received, he or she would have no bias in evaluating the results.

Eligibility criteria:
an eligible male or female must have been age 3 years or older (adults were included) and must have had esotropia that occurred at age 6 months or older, with no history of previous eye muscle surgery.

Keywords: strabismus
efficacy and tolerability of preservative-free 0.0015% tafluprost in glaucoma patients

Conditions: Primary Open-angle Glaucoma

Summary: the aim of this work is to evaluate efficacy and tolerability of preservative containing 0.0015% tafluprost and preservative-free 0.0015% tafluprost. both preservative containing and preservative-free 0.0015% tafluprost will reduce intraocular pressure significantly. in addition, preservative-free 0.0015% tafluprost might improve tolerability of glaucoma patients.


Eligibility criteria:
inclusion criteria: * 1. primary open angle glaucoma and normotensive glaucoma patients who came to the outpatient clinic for regular glaucoma check-ups were enrolled. * 2. glaucoma was defined as the patients who had open angle confirmed by gonioscopy, optic nerve cupping (a vertical cup-disc ratio of \>0.6) and or notching of the neuroretinal rim and or retinal nerve fiber defects characteristics of glaucoma, and visual field defect(i.e., a glaucoma hemi-filed test result outside normal limits, a pattern standard deviation probability of \<5%, or a cluster of three or more non-edge points in location typical of glaucoma, all of which were depressed on a pattern deviation plot at a p level of \<5%, and at least one of which was depressed at a p level of \<1% on two consecutive visual field tests). * 3. normal tension glaucoma included criteria: repeated measurements of untreated iop values of \< 21mmhg. primary open angle glaucoma included criteria: repeated measurements of untreated iop values of ≥ 22mmhg. exclusion criteria: * 1. phakic and pseudophakic eyes. * 2. eyes that had been taken vitrectomy, trabeculectomy, or surgery influenced iop

Keywords: preservative-free, tafluprost
ultrasonography in predicting difficult intubation in obese emergency surgical patients

Conditions: Preoperative Ultrasound Assessment of the Upper Airway Can Predict Difficult Laryngscopy in Obese at Emergency Operations

Summary: validity of ultrasonography in predicting difficult laryngoscopy and confirming endotracheal intubation in obese emergency surgical patients

the aim of the study is to determine whether preoperative ultrasound assessment of of the upper airway can predict difficult laryngscopy in emergency surgical obese patients , by analysis correlations between ultrasound measurements of anterior cervical soft in the upper airway, and the cormack-lehane grade. and evaluate its role in confirming the endotracheal placement the secondary objective was to determine whether clinical screening tests are independent predictors of difficult airway.

Eligibility criteria:
inclusion criteria: * adult obese patients (bmi\>35) of both sex aged from 18 to 60 years undergoing urgent surgeries under general anasthesia with tracheal intubation. exclusion criteria: * . patients with removable upper dentures, upper airway pathology, cervical spine fractures, full stomach, maxillofacial trauma or unstable patients and pregnant women will be excluded from the study

Keywords: ultrasound _difficult intubation _obese _emergency operations
reshaping exercise habits and beliefs (rehab)

Conditions: Cerebrovascular Accident; Stroke

Summary: regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. this study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.


Eligibility criteria:
inclusion criteria: 1. 40-85 years old ischemic stroke patients, 2. stroke onset \<90 days at enrollment, 3. hemiparetic gait disorder, 4. patients able to walk 30ft with or w/out assistive device, 5. sufficient english comprehension to understand instructions, provide consent, and answer questions, 6. lives within 30 miles of the greater baltimore area. exclusion criteria: 1. dementia (extended mmse \<85 or \<80 if education level below 9th grade), 2. untreated major clinical depression (ces-d\>16) and confirmed with clinical interview, 3. heavy alcohol use (\<3 oz liquor, 3, 4-oz glasses of wine, or 3, 12- oz beers daily), 4. active cancer, or any illness with a life expectancy of less than 6 months, 5. any condition in which exercise activity would be contraindicated including, but not limited to: unstable angina, cardiac ischemic event within the past 6 months, congestive heart failure (stage iii or iv), major orthopedic chronic pain or non-stroke neuromuscular disorders restricting exercise, oxygen-dependent copd or peripheral neuropathy.

Keywords: exercise rehabilitation stroke
remote monitoring of interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: as in-clinic pulmonary function testing is greatly restricted due to coronavirus disease 2019 (covid19), alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. this project will evaluate the feasibility of a remote monitoring programme designed for interstitial lung disease (ild) \[including idiopathic pulmonary fibrosis (ipf)\] patients which includes patient-reported spirometry \& pulse oximetry (to estimate lung airflow and oxygen levels in the blood). patients with a confirmed diagnosis of ild will be asked to measure spirometry \& pulse oximetry once/day for approximately three months. each patient will be supplied with a spirometer \& pulse oximeter for home use. there will be no other changes to patients' care. the clinical teams responsible for care of the patients will be able to view all patient-recorded data immediately after data are recorded by the patient. feasibility of remote monitoring will be assessed by determining the proportion of patients who provide measurements at least 3 times/week and on at least 70% of days in the observation period. patient engagement (patient activation measure), changes in spirometry measurements over time and healthcare resource utilisation (e.g. number of in-clinic visits) will also be assessed. other outcomes assessed will include estimation of the proportion of patients with significant decreases in lung function, number of occasions where critical alert values of physiological parameters are reported and number of interventions by healthcare professionals in response to observations or alerts from remote monitoring. feedback from patients and healthcare providers on user experience will also be sought. learnings from this project will be used to assess the wider application of delivery of digitally-based remote monitoring in management of long-term respiratory conditions.


Eligibility criteria:
inclusion criteria: * diagnosis of interstitial lung disease * forced vital capacity ≥50% predicted (at most recent in-clinic spirometry test) * owns a smartphone or tablet device * has a mobile telephone number, email address and access to internet at home * willing to allow home monitoring of their health including spirometry and pulse oximetry data * understands how to use mobile technology (e.g. has downloaded and used other "apps" on their mobile device; uses email) * demonstrates willingness to measure spirometry and pulse oximetry daily for the duration of the study * fluent in english language * written informed consent. exclusion criteria: * serious concomitant conditions which place the patient at high risk of respiratory distress, making them unsuitable to be managed at home * confusion which would limit the patient's understanding of the project or the measurement procedures * current or recent (within last 6 weeks before baseline) participation in another clinical research project.