Kornimate/medical-research-clean huggingface dataset:
evaluate 4 different formulations of meningococcal serogroups a, c, w-135, y conjugate vaccine when given as 1 dose to healthy subjects aged 15-19 yrs

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the menacwy conjugate vaccine when given to healthy subjects aged 15-19 years. the selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

3 formulations of gsk's menacwy conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. administration of the candidate vaccine or of the active control (mencevax™ acwy) will be done in an open manner. subjects will receive one vaccine dose (gsk's menacwy conjugate vaccine or mencevax™ acwy vaccine), and will have 2 blood samples taken, before and one month after vaccination.

Eligibility criteria:
inclusion criteria: * healthy male or female between, and including, 15 and 19 years of age at the time of vaccination. * written informed consent obtained. subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge. * female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception. exclusion criteria: * previous vaccination against or history of or exposure within previous 12 months to meningococcal serogroup a, c, w-135 or y disease. * administration of a tetanus vaccine within 6 months before study vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of any neurologic disorders or seizures. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
kinesotaping and strengthening exercises in treatment of osgood-schlatter disease

Conditions: Osgood-Schlatter Disease

Summary: the purpose of this study is to investigate the effect of adding kinesotaping to quadriceps strengthening exercises on muscle strength, pain, function and range of motion of knee joint in patients with osgood-schlatter disease (osd).

60 patients will be participated in this study. the patients of both genders with age ranges from 18 -25 years old. the sample will randomly be divided into two groups. group a: will receive strengthening exercise for quadriceps muscle and stretching exercises for hamstring and calf muscles group b: will receive kinesoatping, strengthening exercises for quadriceps muscle and stretching exercises for hamstring and calf muscles . all subject will receive the treatment for 6 weeks, all subjects will assign consent form before starting this study and will be explained the purpose of this study before any application. outcome measurements: 1. quadriceps muscles strength will be assessed by hand held dynamotor. 2. pain intensity will be measured by visual analog scale. 3. disability function of knee will be measured by lower extremity functional scale (lefs-ar). 4. range of motion of knee joint will be measured by smart phone application for range of motion measurement. data will be collected prior to first session as pre-test measure and at the end of last treatment session as post-test treatment.

Eligibility criteria:
inclusion criteria: 1 - age - 18 years to 25 years 2. knee osgood schlatter disease as per diagnosed by orthopaedisit 3. duration of knee pain is 4-5 weeks during 6 months prior to study. 4- patients from both gender 5- bmi from 18 kg/m2 to 25 kg/m2 exclusion criteria: 1. history of low back pain. 2. trauma to the knee joint. 3. loss of joint play in tibiofemoral and patellofemoral articulations. 4. lower extremity fracture and surgery. 5. neurological deficit or movement disorder. 6. if they had meniscal symptoms. 7. if they had rheumatoid. 8. if they had osteoarthritis.

Keywords: osgood-schlatter disease knee function kinesotaping strengthening exercises
study of treatment of thoracic aortic aneurysms and dilatation in combination with tricuspid and bicuspid aortic valves.

Conditions: Ascending Aorta Aneurysm; Dilation of the Ascending Aorta

Summary: clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta

expanding indications for surgical treatment of patients with borderline values of the ascending aorta

Eligibility criteria:
inclusion criteria: 1. extension of the ascending aorta less than 55 mm 2. tricuspid aortic valves. 3. extension of the ascending aorta more than 45 mm exclusion criteria: 1. age less 45 years 2. age more 75 years 3. multiple organ failure 4. oncological disease
effect of anti-inflammatory (itis) diet in knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: to study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis

the investigators would like to evaluate how inflammation occurs in the joints of subjects with osteoarthritis, and identify molecules and bacteria that can predict whether a patients with knee osteoarthritis will have more or less pain . blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. this is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. these studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Eligibility criteria:
inclusion criteria: * patients diagnosed of knee ostoeaarthritis * without changes in treatment in the last 3 months exclusion criteria: * food allergies * pregnancy
training intrinsic foot muscles

Conditions: Muscular Weakness

Summary: the foot intrinsic muscles are increasingly targeted in foot and ankle rehabilitation. the exercises are often difficult to learn initially. the purpose of the proposed study is to examine the effect training the intrinsic foot muscles on performance in selected physical and functional measures such as balance, plantar pressure during gait, vertical jump, and foot posture. in addition,the investigators will compare one group training with traditional exercise instruction methods and one group using an adjunctive modality (neuromuscular electric stimulation) during the introductory phases of exercise instruction. the investigators are interested in how this modality might affect physical and functional outcome measures and if it affects participants' frustration with learning a new exercise.

arm 1: the purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with passive, active-assisted, and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. a frustration index will be employed to assess participant frustration with learning a new exercise. 15 will be enrolled in this arm of the study. arm 2: the purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with neuromuscular electric stimulation (nmes) and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. a frustration index will be employed to assess participant frustration with learning a new exercise.15 will be enrolled in this arm of the study. arm 3: this group will not engage in any training, but will serve as a comparator for the two intervention arms.

Eligibility criteria:
inclusion criteria: * individuals aged 18-30; participate in physical activity 3 times/week; no neurologic injury/condition; no prior experience with study exercises; no injury to lower extremity in past 2 months; inability to selectively extend the great toe while the lesser toes remain quiet (indicating intrinsic foot muscles dysfunction) exclusion criteria: * sedentary; known neurologic injury or condition; current le injury that may affect neuromuscular function; tarsal coalition; absolute contradiction to manual therapy or neuromuscular electrical stimulation (nmes); previous intrinsic foot muscle training protocol

Keywords: therapeutic exercise
effect of open chain versus closed chain segmental control exercises on csa of lumbar multifidus muscle in chronic mlbp

Conditions: Mechanical Low Back Pain

Summary: to investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar rom, and csa of multifidus muscle.

* to investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity. * to investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber rom. * to investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on csa of multifidus muscle. * to investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber function.

Eligibility criteria:
inclusion criteria: 1. patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years. 2. participants with chronic low back pain lasting for more than 6 months. 3. a patient who can follow the command. 4. a patient who can do exercise. exclusion criteria: 1. low back pain patients with a history of severe neurological disease or orthopedic disease. 2. history of psychological disorder. 3. unhealthy patient. 4. pregnant women. 5. patient with a spinal tumor. 6. history of any operation related to spine. ex. vertebral fracture or dislocation.

Keywords: mechanical lbp cross sectional area multifidus muscle
dexpramipexole japanese pk study

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a single and multiple dose, open-label study to evaluate the pharmacokinetics (pk), safety, and tolerability of dexpramipexole administered orally to adult japanese and caucasian healthy subjects.

the study is designed to evaluate the influence of ethnic factors on dexpramipexole safety, tolerability, and pk. subjects will be admitted to the clinical unit on day -1 (the day prior to first dosing) and will remain in the clinical unit under observation until discharge. all subjects will have a final follow up visit. whilst resident in the clinic, subjects will receive 4 treatments: the first 3 treatments comprise part a of the study and the final treatment group comprises part b. part a: treatment 1: dose 1 (reduced) of dexpramipexole; a single dose treatment 2: dose 2 (standard) dexpramipexole; a single dose treatment 3: dose 3 (standard) dexpramipexole; 5 doses administered at 12 hour intervals part b: dose 4 (standard) dexpramipexole; 5 doses administered at 12 hour intervals there will be a minimum washout of 3 days between treatments. for all subjects, prior to proceeding to the next treatment group, safety and tolerability data will be reviewed. caucasian subjects will be matched individually (on a 1:1 basis) to japanese subjects with respect to gender and age and if possible bmi.

Eligibility criteria:
inclusion criteria: * subjects who are able and willing to give written informed consent. * adult japanese and caucasian males/females aged 18 to 60 years inclusive and between 18 and 30 kg/m2 body mass index (bmi), inclusive. * male and female subjects will be enrolled on the study. male subjects and female subjects of childbearing potential, must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment * japanese subjects must be born in japan and have both parents and four grandparents of japanese descent. * japanese subjects must have lived outside of japan for no more than 5 years. * japanese subjects must not have significant changes with regard to diet; i.e., their diet must not have significantly changed since leaving japan. * caucasian subjects will be matched individually (on a 1:1 basis) to japanese subjects with respect to gender and age, and if possible bmi. exclusion criteria: * subjects who do not conform to the above inclusion criteria. * female subjects who are pregnant, trying to become pregnant or lactating. * subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. * subjects who have a clinically relevant surgical history. * subjects who have previously received dexpramipexole or pramipexole.
monitoring of cerebral blood flow in patients on extracorporeal membrane oxygenation

Conditions: Extracorporeal Membrane Oxygenation Complication; Cerebral Circulatory Failure

Summary: venovenous extracorporeal membrane oxygenation (vv-ecmo) is a supportive therapy, indicated in case of severe, possibly reversible pulmonary failure, refractory to conventional therapies. despite advances, morbidity and mortality remain high. severe neurological complications can occur during ecmo, but their exact etiology is not well understood. it is hypothesized that fast correction of severe hypercapnia, a common indication for venovenous ecmo, may be detrimental for the brain. the supposed mechanism is that fast correction of hypercapnia may result in massive cerebral vasoconstriction and impaired cerebral blood flow (cbf). in this prospective, observational study the aim is to quantify change in cbf during routine initial correction of severe hypercapnia during vv-ecmo. furthermore, the investigators will record any other hemodynamic changes during vv-ecmo. the hypothesis is that a larger decline in paco2 will result in a larger decline of cbf.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: * high suspicion of an indication for vv-ecmo; * arterial line present to enable blood sampling; * older than 18 years. exclusion criteria: * subjects will be excluded if the cerebral blood flow cannot be measured using the transcranial doppler * va-ecmo or ecpr; * no possibility for neuromonitoring measurements due to technical difficulties, e.g. post-craniotomy, unsuitable transcranial window; * no possibility for neuromonitoring measurements due to circumstantial difficulties, e.g. ecpr; * contraindications for ecmo; * ecmo is initiated in another center.
an extension study of entacapone in patients with parkinson's disease with end-of-dose wearing-off. this study is not recruiting in the united states

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with parkinson's disease with end-of-dose wearing-off. this study is not recruiting patients in the united states.

the purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with parkinson's disease with end-of-dose wearing-off.

Eligibility criteria:
inclusion criteria: * attended the phase iib study * able to fill out the patient diary exclusion criteria: * serious heart, pulmonary, renal, hepatic or gastrointestinal disease * dementia symptoms * pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply.

Keywords: parkinson's disease, end-of -dose wearing-off, entacapone
can cognitive therapy rating scale (ctrs) be used across cultures? enhancing cultural relevance of ctrs

Conditions: Anxiety; Depression

Summary: translate and adapt the cognitive therapy rating scale (ctrs) into urdu language and establishing the psychometric properties (reliability, validity, and norms) of the translated scale

the purpose of this study is to increase the accessibility and accuracy of clinical assessments, ultimately improving the quality of mental health care delivery and advancing research in the field of clinical psychology within urdu-speaking communities

Eligibility criteria:
inclusion criteria: * individuals aged 18 to 65 years at least 5 years of education score of 8 or higher on hospital anxiety and depression scale-depression or anxiety scales as measured by their primary care clinician exclusion criteria: * substance use disorder according to dsm-5 tr criteria significant cognitive impairment (for example, profound learning disability or dementia) active psychosis as determined by their primary care clinician
the effect of topiramate on etonogestrel concentrations in contraceptive implant users

Conditions: Migraine; Migraine;Menstrual; Contraception

Summary: a prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum etonogestrel (eng) levels in contraceptive implant users.


Eligibility criteria:
inclusion criteria: * healthy women, who have had an eng implant for 12-36 months at the time of enrollment; * will maintain their implant during the study without modifications. exclusion criteria: * women who are taking any medications or supplements known to be 1. cytochrome p-450 enzyme inducers, inhibitors, or substrates, and 2. are not willing to abstain from any of these medications or supplements during the entire course of the study. * women with liver disease (i.e. hepatitis, fatty liver disease), and * women with abnormal liver or renal function, or * women with abnormal electrolytes on their screening blood work.
to compare the pharmacokinetics of traclear 62.5 mg tablets and hgp1206 125mg 1 tablet in healthy male volunteers

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of this study is to compare the pharmacokinetics of two traclear 62.5 mg tablets and one hgp1206 125 mg tablet in healthy male volunteers.

an open-label, randomized, single-dose, 2-way crossover study to compare the pharmacokinetics and safety of traclear 62.5 mg tablets and hgp1206 125mg tablet in healthy male volunteers.

Eligibility criteria:
inclusion criteria: * healthy male * age between 20 and 55 * signed informed consent exclusion criteria: * has a history of primary pulmonary hypertension to investigational product ingredients * hypotension or hypertension
electric blower based ventilator used during procedural sedation

Conditions: Apnea During Procedural Sedation

Summary: conduct human trials in the endoscopy suite of our continuous positive airway pressure (cpap) ventilator approach using an fda approved ventilator.

all study procedures will be performed in adult patients following informed consent at the endoscopy suite of the university of utah health sciences center in salt lake city, utah. a ventilation mask will be placed on the patient's face and connected to the ventilator. supplemental oxygen will be delivered by the ventilator through the mask; the concentration of oxygen delivered will be left to the clinician's discretion. a modified mask with multiple small leaks will be used with a standard elastomeric h-strap to secure it to the patient's face. the endoscopy suite nurse and technicians will attach all clinically necessary standard sensors and connect them to the patient and monitoring system. height, weight, and neck circumference will be measured and recorded digitally on an encrypted laptop. in addition to the standard of care monitors, the investigators will collect data from additional non-invasive modalities and save the data to a laptop using custom software for later analysis. pressure and flow sensors included in the ventilator will be used to monitor the patients' tidal volumes and respiratory rate during the procedure. the data that will be collected and recorded on the laptop will include: rip data, mask pressure, flow, and breath rate. an additional flow sensor will be placed in line with the ventilator. the objective of this study is threefold: demonstrate in patients undergoing procedural sedation (e.g., for colonoscopy) that obstructive apnea can successfully be avoided by stenting the airway open using cpap, demonstrate that we can successfully detect periods of zero ventilation, and demonstrate the functionality of the modified standard mask.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * undergoing a colonoscopy procedure * receiving registered nurse-administered procedural sedation at the university of utah health sciences center * agree to participate * written informed consent exclusion criteria: * inability/refusal of subject to provide informed consent. * standard colonoscopy exclusion criteria used at the gi lab at the university of utah. * pregnant patients and patients with an asa (american society of anesthesiology) physical status of iv or v. * patients with severe medical condition(s) that in the view of the acting physician prohibits participation in the study. * patients with a bmi \> 35 will not be included in the study
purified anthocyanin and nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (nafld). anthocyanins from different plant foods have been shown to improve features of experimental nash, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. the purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of nafld.


Eligibility criteria:
inclusion criteria: * bmi \[body weight divided by height squared (in kg/m2)\] \> 23, * lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and * the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal. exclusion criteria: * overuse of alcohol, * viral hepatitis, * type 1 or 2 diabetes, * gastrointestinal or connective diseases, * chronic pancreatitis, * liver cirrhosis, * kidney stones, or renal failure; * use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation; * supplementation with vitamins or antioxidants

Keywords: oxidative stress dyslipidemia inflammation apoptosis