Kornimate/medical-research-clean huggingface dataset:
evaluation of blood pressure reduction, safety, and tolerability of canagliflozin in patients with hypertension and type 2 diabetes mellitus on stable doses of anti-hyperglycemic and anti-hypertensive agents

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: the purpose of this study is to evaluate the effect of canagliflozin (jnj-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. overall safety and tolerability of canagliflozin will be assessed.

this is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (bp) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (t2dm). the study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. the total duration of participation in this study will be approximately 13 weeks.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of type 2 diabetes mellitus * patients with hypertension (seated office sbp of \>=130 mmhg and \ = 70 mmhg at screening and at week -2 * patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening * patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening exclusion criteria: * a history of diabetic ketoacidosis * type 1 diabetes mellitus (t1dm) * pancreas or beta-cell transplantation * fasting c-peptide \<0.70 ng/ml (0.23 nmol/l) * body mass index \<30 kg/m2 * has ongoing, inadequately controlled thyroid disorder * has a history of cardio-renal disease that required treatment with immunosuppressive therapy.

Keywords: diabetes mellitus, type 2 hypertension canagliflozin jnj 28431754 sodium-glucose transporter 2 blood glucose type 2 diabetes mellitus
bronchial inflammation and hyperresponsiveness after oil supplementation

Conditions: Exercise-induced Asthma

Summary: the purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.

subjects suffering form exercise-induced bronchoconstriction (eib) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. in a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature. it is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators. in this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model. therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation. before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. the investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry. the investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.

Eligibility criteria:
inclusion criteria: * informed consent * patients: age ≥12 and 44 years * known exercise induced asthma * basic lung function fvc ≥ 75%, fev1 ≥ 70% * decrease in fev1 after exercise ≥ 15% exclusion criteria: * lung function forced vital capacity (fvc) \<75% and forced expiratory volume in 1 second (fev1) \<70% * chronic diseases or infections (e.g. hiv, tbc) * pregnancy * systemic corticosteroid-treatment * inhalative corticosteroid therapy or leukotriene antagonists * alcohol, substance or drug abuse * smokers * inability to capture extend and consequences of the study

Keywords: exercise-induced asthma cold chamber exercise challenge cold air challenge oil supplementation middle-chain and polyunsaturated fatty acids
renal sympathetic denervation in mild refractory hypertension

Conditions: Refractory Hypertension

Summary: the purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension


Eligibility criteria:
inclusion criteria: * refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization * systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmhg (abpm mean daytime values) * no change in blood pressure medication within 6 months after randomization * age 18 to 75 years * informed consent exclusion criteria: * blood pressure outside range mentioned above * renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation * estimated glomerular filtration rate \<45 ml/min/1.73 m² (modification of diet in renal disease formula) * unstable angina pectoris * myocardial infarction within 6 months prior to randomization * planned surgery or cardiovascular intervention within 6 months after randomization * severe heart valve disease * severe comorbidities with limited life expectancy * pregnancy * participation in another trial
subcutaneous treatment in randomized subjects to evaluate safety and efficacy in generalized lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the objective of this study is to evaluate and compare efficacy of 3 dose levels of pf-04236921 to placebo in subjects with generalized lupus using a measure called the systemic lupus erythematosus (sle) responder index. the study will evaluate secondary and exploratory measures as well.


Eligibility criteria:
inclusion criteria: * male or female subjects between ages of 18 and 75 years old at time of signing consent. * have a clinical diagnosis of sle according to 1997 update on the revised 1982 american college of rheumatology (acr) criteria. * have a unequivocally positive anti-nuclear antibody (ana) test result. * active disease at screening defined by both: sledai-2k score greater than or equal to 6 and bilag level a disease in more than or equal to 1 organ system (except renal or central nervous system) or bilag b disease in more than or equal to 2 organ systems if no level a disease in present. exclusion criteria: * any prior history of treatment with pf-04236921, or anti-il-6 agent; * have received any of the following within 364 days of day 1: a biologic investigational agent other than b cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with tuberculosis (tb), evidence of prior untreated or currently active tb by chest radiography, residing with or frequent close contact with an individual with active tb.

Keywords: double-blind placebo-controlled multicenter dose-ranging efficacy safety lupus.
effect of dual-task training and cognitive rehabilitation in individuals with multiple sclerosis.

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to examine the effects of dual-task training and cognitive rehabilitation on gait, balance, fatigue and cognitive performance in individuals with multiple sclerosis.

multiple sclerosis (ms) is a complex disease characterized by chronic, inflammatory, demyelinating and neurodegenerative processes of the central nervous system (cns) with heterogeneous clinical symptoms. balance, gait and cognitive impairment are among the biggest problems in individuals with ms and significantly affect their daily lives. dual task (dt); is the process of performing two tasks that can be performed independently and have different purposes simultaneously. walking with dual tasks has recently been shown to resemble typical walking performance in daily life, thus providing clinicians with a realistic walking performance measurement in daily life. although the effects of dual task performance in various neurological diseases have been partially described in the literature, the comparison of dual task training and cognitive rehabilitation on walking, balance, fatigue and cognitive performance has not been made and due to this deficiency in the literature, our study was planned and has originality. the aim of our study is to investigate the effects of dual task training and cognitive rehabilitation on walking, balance, fatigue and cognitive performance in individuals with ms.

Eligibility criteria:
inclusion criteria: * definite ms diagnosis by a neurologist * can walk independently * expanded disability status scale (edss) score below 5 * has not had an attack in the last 3 months, has been medically stable for 6 months * has not received a regular physiotherapy program in the last 6 months volunteer exclusion criteria: * scoring 26 or below on the montreal cognitive assessment scale (moca) * having systemic, orthopedic and neurological problems that may affect walking and balance in the assessments * having additional psychiatric disorders

Keywords: multiple sclerosis balance gait dual task fatigue
ultrasound as a diagnostic tool for occult hip fractures

Conditions: Occult Fractures

Summary: the purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.

introduction: most hip fractures are diagnosed by history, physical examination and confirmed by plain radiographs. when initial x-rays are negative or equivocal, and there is a clinical suspicion of occult hip fracture, additional diagnostic tests are necessary such as mri which is expensive and in many hospitals less available, or bone scan which needs to be delayed 48-72 hours from injury to be indicative. ultrasound examination has been shown to be an accurate measurement to diagnose occult fractures in the ankle and is a relatively easy, available, non-expansive examination. we propose the use of bedside ultrasound examination of the hip as a screening tool for occult hip fractures. objective: to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing or ruling out occult hip fractures. materials and methods: we will include all patients 40 years and older with a painful hip after an injury, and with "normal" hip x-rays. each patient will undergo two hip ultrasounds by two different examiners. afterwards, the patients will undergo mri of the hip. the mri will serve as the gold standard for treatment decisions. the results of the ultrasound will be compared to the mri to evaluate its sensitivity and specificity.

Eligibility criteria:
inclusion criteria: * patients aged 40 years or older, with suspected hip fracture but normal plain x-rays exclusion criteria: * patients younger than 40 years and with contra-indications for mri scan

Keywords: fractures, occult hip ultrasound examination mri sensitivity specificity
trigeminus-evoked somatosensory potentials in patients undergoing carotid surgery

Conditions: Carotid Surgery

Summary: hypothesis: trigeminus-evoked somatosensory potentials (tri-sep) may be used as an alternative technique to medianus-evoked somatosensory potentials (med-sep) in patients undergoing elective carotid surgery.

for cns-monitoring somatosensory-evoked responses ba electrical stimulation of the contralateral median nerve are established: a reduction of amplitude and a delay in latency may represent a sensible marker of imminent cerebral ischemia. this study will evaluate a new concept by using trigeminal nerve evoked somatosensory evoked potentials in comparison to the established med-sep. beside the comparison of two methods of neuromonitoring, this study will investigate the neurological long-term outcome (90-day evaluation) with different neuropsychological tests for the detection of cognitive deficits.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * agreement with study procedure * elective carotid surgery exclusion criteria: * inability to take somatosensory potentials * inability to respond to neuropsychological tests * severe preoperative neurological deficit

Keywords: carotid surgery cerebral ischemia cognitive deficits somatosensory-evoked potentials neuromonitoring
national wilm's tumor study late effects

Conditions: Wilm's Tumor

Summary: the late effects study is being conducted in order to answer scientific questions and to serve as a resource for wilms tumor patients and their families. patients must have been enrolled on the nwts-5 protocol in order to be eligible for this study.

the late effects study is being conducted in order to answer scientific questions and to serve as a resource for wilms tumor patients and their families. although most people in this study enjoy good health, some may be at risk for certain health conditions. we are collecting information from as many participants as possible in order to determine if they or their offspring are at risk for adverse medical conditions. if there is more than one case of wilms tumor in a given family, we plan to work with geneticists to try to estimate heritability and recurrence risks.

Eligibility criteria:
inclusion criteria: previously enrolled in nwts 5.

Keywords: late effects
sitting balance in lower limb amputees

Conditions: Amputation; Traumatic Amputation of Lower Extremity

Summary: the aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

postural stability is important for amputees to perform daily life activities and participate in social activities. the aim of this study is to compare the sitting and standing stability of transfemoral individuals with healthy individuals with similar demographic characteristics. a force platform was used to measure the postural stability of individuals. the sitting limits of stability of the participants were recorded in cm. amputees between the ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with similar demographic characteristics were included in the study. congenital amputees, individuals with bilateral lower extremity amputations, and individuals with central or peripheral vestibular disorders were excluded. our study will reveal the importance of sitting stability limits in the evaluation and treatment of amputees.

Eligibility criteria:
inclusion criteria for amputee: * unilateral transfemoral amputation * using their prosthesis for at least 6 months exclusion criteria: * congenital amputee * bilateral lower extremity amputation * central or peripheral vestibular disorders

Keywords: limits of stability sitting balance standing balance
effects of functional electrical stimulation assisted cycling in patients with hemiparesis after stroke

Conditions: Hemiparesis;Poststroke/CVA

Summary: to determine whether active cycling assisted by functional electrical stimulation (fes) is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

design: in a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive fes-induced cycling training or placebo fes cycling. setting: neurologic rehabilitation unit interventions: 30 minutes of active leg cycling with or without fes applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. during training, participants will be seated on a fes-cycle (hepha bike, kurage): a cyclo-ergometer (technogym) combined with a 8 channel controlled stimulator (motimove-8). in addition to the assigned group treatment, subjects will perform their own standard rehabilitation program. participants will be evaluated before training, after training, and at 3 month follow-up visit

Eligibility criteria:
inclusion criteria: * adults with hemiparesis after an unilateral first ever stroke * able to walk in security * time since stroke within 3 months to 1 year * sufficient cognitive function to understand and perform corresponding tasks exclusion criteria: * any history of neurological disorders or cardiovascular instability * high spasticity on ankle, knee, hip muscles * inability to exercise on a cyclo-ergometer * pacemaker and other contraindications of the use of electrical stimulation

Keywords: cycling exercises functional electrical stimulation
manual t-piece versus ventilator positive pressure ventilation during resuscitation of extremely premature neonates

Conditions: Neonatal Resuscitation; Apnea Neonatal

Summary: many extremely premature infants, born before 28 weeks' gestation age, require immediate help with breathing after birth. positive pressure ventilation (ppv) using a device called a t-piece resuscitator is a common method. ppv is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. however, t-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of ppv. improving ppv effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. a novel approach, that may overcome the above limitations and deliver ppv with precise settings through a nasal mask, is to use a ventilator to deliver ppv (v-ppv) using a respiratory mode called nasal intermittent positive pressure ventilation (nippv). while nippv is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of v-ppv use during immediate post-birth stabilization needs to be studied. preliminary data from our recent single-center study confirmed the feasibility of using v-ppv for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of t-piece. this promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. the research objective is to compare the clinical outcomes of extremely premature infants receiving manual t-piece versus v-ppv during immediate post-birth stabilization. the primary aim is to evaluate the impact of v-ppv on major health complications or death. this study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.


Eligibility criteria:
inclusion criteria:: * ga 25+0 to 28+6 weeks using the best available obstetrical estimate * designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care * received ppv as determined by the resuscitation team during the first 10 minutes of birth exclusion criteria: * outborn birth status * resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward) * known major congenital or chromosomal anomaly * established spontaneous respiration without receipt of ppv

Keywords: premature infant preterm neonates oxygen lung injury respiration, artificial resuscitation ventilator, mechanical
effect of a psycho-educational intervention on psychological outcomes of gynecological cancer patients

Conditions: Psychological

Summary: this study will be conducted to optimize the quality of care rendered for gynecological cancer patients attending the gynecological oncology unit in el-shatby university hospital in alexandria.as well as to assess the effect of implementing a psychoeducational intervention program among gynecological cancer women on the: 1. quality of life with its different domains (physical, emotional, social and functional). "as a primary objective" 2. psychological distress and cancer-specific stress. "as secondary objectives"

cancer is a significant health problem worldwide with wide geographical variation in incidence. additionally it has become an important item in each country's health agenda.it is a prominent cause of mortality in both economically developed and underdeveloped nations.unfortunately, the burden is expected to grow globally due to the development and aging of the population.gynecological cancer, which includes cancers of the cervix, ovary, uterus, vulva, vagina and fallopian tube are among the leading causes of cancer-related mortality worldwide.in egypt, according to the global cancer observatory (globocan) 2020, approximately 2,787 new cases for ovarian cancer were diagnosed and 1,839 women died from the disease,1,694 new cases for uterine cancer and 350 women died from the disease and 1,320 new cases for cervical cancer and 744 women died from the disease. hence, this study will be carried out to develop and implement a psychoeducational intervention program among gynecological cancer patients attending the gynecological oncology unit in el-shatby university hospital in alexandria and evaluate its effect in improving their psychological outcomes and quality of life.

Eligibility criteria:
inclusion criteria: women are eligible to participate if they are: * over 20 years old. * newly diagnosed cases with gynecological cancers (confirmed within 3 months). * scheduled to have surgery as the first-line treatment. * willing to participate in the study. exclusion criteria: women are excluded if they: * are in the late stage (stage iv) as women in this group usually receive palliative/ symptomatic treatment. * have additional cancer diagnosis (including metastasis). * are diagnosed with severe psychiatric or cognitive disorder. * participate in other intervention study.

Keywords: gynecological cancer quality of life