Kornimate/medical-research-clean huggingface dataset:
quadriceps strength training on gait parameters and energy expenditure in children with spastic cerebral palsy

Conditions: Cerebral Palsy

Summary: the incidence of cerebral palsy is approximately 2 to 3 cases per 1000 live births around the world. in cerebral palsy the lesion in the central nervous system frequently results in spasticity of various muscle groups. spasticity is defined as a velocity dependent resistance to stretch. spastic cerebral palsy is caused by damage to the pyramidal parts of the brain. the children with spastic cp frequently experience problems with motor control, and balance which may lead to gait abnormalities. because of motor weakness and poor voluntary motor control the children with spastic cerebral palsy develop crouch gait characterized by excessive hip and knee flexion and a slower walking speed, a shorter stride length, and more time spent in double support. this study will help in the quality of life in spastic cerebral palsy children. this will be a randomized controlled trial. approval will be gained from the ethical committee of the riphah international university lahore, pakistan prior to the commencement of study. written informed consent will be taken from all the patients and all information and data will be confidential. subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 children with spastic cp will be randomly distributed into 2 groups. the control group (n=10) will be administered with the baseline treatment that includes 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for relaxation 3 sessions per week for 8 weeks. the experimental group (n=10) will be administered with the strength training intervention along with baseline treatment, 3 sessions per week for 8 weeks. gait parameters will be evaluated physically by measuring stride and step length and cadence. 5-meter stretch test for gait parameters. the energy expenditure will be calculated by measuring the physiological cost index that includes measuring the speed of walking and resulting increase in heart rate. data will be analyzed by using spss version 26.0 and necessary analysis will be done after checking the normality of data.


Eligibility criteria:
inclusion criteria: * diplegic cerebral palsy * (gmfc) level 1 and 2 * able to follow verbal direction for standard testing exclusion criteria: * orthopedic and neurosurgery in last 12 months * children with any associated medical condition * children with botox therapy in last six months
safety, tolerability, and pharmacokinetics of abt-354 in subjects with mild-to-moderate alzheimer's disease on stable doses of acetylcholinesterase inhibitors

Conditions: Alzheimer's Disease

Summary: this study will investigate safety, tolerability and pharmacokinetics of abt-354 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

this is a double-blind, placebo-controlled, randomized, multiple-dose, multicenter study. up to 20 male and female subjects with mild to moderate alzheimer's disease (ad) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. within 28 days prior to study drug administration, subjects will be screened based on national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable ad, mini-mental state examination (mmse) and modified hachinski ischemic scale (mhis) scores, medical history, physical examination, neurological examination, vital signs, ecg, laboratory tests and response to columbia-suicide severity rating scale (c-ssrs). the study will be performed in two groups of 10 subjects each. in each group of 10 subjects, 7 subjects will be randomly assigned to receive abt-354 and 3 subjects to receive matching placebo.

Eligibility criteria:
inclusion criteria: * meets the national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association criteria for probable alzheimer's disease * has a mini-mental state examination total score of 16 to 26, inclusive, at screening * has a modified hachinski ischemia scale score of ≤ 4 at screening * on a stable dose of - donepezil, galantamine or rivastigmine for at least 30 days prior to study drug administration * has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization exclusion criteria: * receipt of any depot drug by injection within 30 days prior to study drug administration * receipt of an investigational product within a time period equal to 10 half-lives, if known, or within 6 weeks prior to study drug administration * history of any significant neurological disease other than alzheimer's disease * history of significant sensitivity or allergy to multiple drugs based on medical records and/or the opinion of the investigator * significant current - suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the columbia-suicide severity rating scale completed at screening or any history of suicide attempts

Keywords: alzheimer's disease
pk/pd and steady state efficacy study of bilastine compared with placebo given orally in the treatment of the symptoms of sar in an eec model (5-arm)

Conditions: Seasonal Allergic Rhinitis; Hay Fever; Rhinoconjunctivitis

Summary: the purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with sar exposed in controlled ragweed pollen using the eec model based on the mean change from baseline in total nasal symptom scores (tnss). study includes male and female subjects, aged 18 and 65 years with clinical history of sar with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.


Eligibility criteria:
inclusion criteria: * clinical history of sar for the last two ragweed allergy seasons. * a positive skin test within 12 months of screening to ragweed allergen. * a minimum qualifying symptom score on both visits, 2 and 3. * females must have a confirmed absence of pregnancy according to a negative urine pregnancy test. exclusion criteria: * women who are pregnant, breastfeeding, or planning a pregnancy. * history of more than mild asthma. * history of clinically significant (as determined by the investigator) active perennial allergic rhinitis to which the subject is regularly exposed. * non-allergic rhinitis (vasomotor or rhinitis medicamentosa). * an anatomic abnormality that interferes with assessment of nasal function. - history of clinically significant recurrent sinusitis or chronic sinusitis. - clinically significant (as determined by the investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject. * a need for use of antihistamines or corticosteroids on a regular basis (systemic or topical). * currently taking monoamine oxidase (mao) inhibitors. * taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within four weeks prior to visit 1. * taken any antihistamine within seven days prior to visit 1 skin testing. * known current alcohol or drug abuse. * current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. - history of generalized anaphylaxis requiring medical attention. * clinically significant abnormality of screening blood chemistry, hematology, or urinalysis.

Keywords: seasonal allergic rhinitis (sar) environmental exposure chamber (eec) therapeutic uses antihistamine drug ragweed pollen
quality of chest compressions after a night shift

Conditions: Cardiac Arrest

Summary: the investigators sought to evaluate the influence of fatigue after a night shift on the quality of chest compressions (cc) in cardiopulmonary resuscitation (cpr), among physicians.

this is a non inferiority cluster randomized trial on three emergency departments (ed) and five intensive care unit (icu) from three urban academic hospital in paris, france. the investigators evaluated the quality of cc with a low-fidelity manikin and its electronic feedback device. the investigators tested subjects on a 6-minutes cc-only cpr scenario, including 2 minutes of pause. physicians were tested either on a control day then after a night shift, or after a night shift then on a control day.

Eligibility criteria:
inclusion criteria: * resident / physicians in emergency departement (ed) or taking night in ed * resident / physicians in intensive care unit (icu) or taking night in ed * nightshift \> 18 hours exclusion criteria: * stop chest compressions before 2 minutes

Keywords: fatigue motor skills cardiopulmonary resuscitation
use of autologous adipose-derived stromal vascular fraction to treat osteoarthritis of hip, knee, ankle, and thumb joints

Conditions: Osteoarthritis

Summary: this study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (svf) cells for treatment of hip, knee and thumb osteoarthritis (oa); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.


Eligibility criteria:
inclusion criteria: 1. grade ii through grade iv hip, knee, ankle osteoarthritis using kellgren-lawrence grading scale (k-l grade) as diagnosed using weight bearing x-ray, physician review, and/or pre-op mri 2. stage ii through iv carpometacarpal (cmc) osteoarthritis using eaton-little's staging of cmc oa as diagnosed by x-ray and physical examination 3. study subjects must be willing to voluntarily give written informed consent to participate in the study and sign the health insurance portability and accountability act (hipaa) authorization before any study procedures are performed 4. subjects with asa grade i, ii, or iii 5. males and females 25-85 years old 6. subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months exclusion criteria: 1. subjects that are allergic to lidocaine, epinephrine or valium 2. subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; thrombolytics and anti-platelet medication including but not limited to coumadin (warfarin) for 3 days, plavix (clopidogrel) for 3 days, acetylsalicylic acid (asa)/nsaids/fish oil supplements for 7 days, xeralta® (rivaroxaban) for 24 hours 3. subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with hiv/viral hepatitis 4. subjects with chondrocalcinosis, paget's disease and villonodular synovitis 5. women that are pregnant or planning to become pregnant during the study 6. subjects on long term use of oral steroids 7. history of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site
a phase iii study of shr-a1811 injection with or without pertuzumab in her2-positive recurrent or metastatic breast cancer

Conditions: HER2-PositiveRecurrent or Metastatic Breast Cancer

Summary: to evaluate the efficacy and safety of shr-a1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in her2-positive recurrent or metastatic breast cancer


Eligibility criteria:
inclusion criteria: 1. women aged 18 to 75 (inclusive) 2. her2 positive (ihc3+ or ish+) unresectable or metastatic breast cancer confirmed by histology or cytology. 3. ecog score is 0 or 1 4. an expected survival of ≥ 12 weeks 5. at least one measurable lesion according to recist v1.1 criteria 6. have adequate renal and hepatic function 7. patients voluntarily joined the study and signed informed consent exclusion criteria: 1. have other malignancies within the past 5 years 2. active central nervous system metastasis without surgery or radiotherapy 3. in (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months 4. presence with uncontrollable third space effusion 5. have undergone other anti-tumor treatment within 4 weeks before the first dose 6. a history of immune deficiency 7. clinically significant cardiovascular disorders 8. known or suspected interstitial lung disease 9. the toxicity from previous anti-tumor treatment has not recovered to ≤ grade i 10. known hereditary or acquired bleeding tendency 11. active hepatitis and liver cirrhosis 12. presence of other serious physical or mental diseases or laboratory abnormalities
platinum diversity

Conditions: Atherosclerosis; Coronary Artery Disease

Summary: to compile acute procedural performance and clinical outcomes data for the promus premier everolimus-eluting coronary stent system in understudied/underserved patient populations including women and minorities.


Eligibility criteria:
inclusion criteria: * patient must be at least 18 years of age * patient must sign informed consent form * patient has received at least one promus premier stent * patient self-identifies as one or more of the following: * female * black of african heritage * hispanic/latino * american indian or alaska native exclusion criteria: * not applicable
effectiveness and safety of therapy based on attenuated ato plus low-dose atra in patients with apl

Conditions: Promyelocytic Leukemia

Summary: atra is the standard of care for all patients with apl. the use of lower doses of atra has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ato demonstrated considerable effectiveness in this disease. more recently, an attenuated regimen has been proven to be effective. in this study we intent to demonstrate the effectiveness of combined therapy of low-dose atra plus attenuated dose ato.

the use of lower doses of atra has been shown since the 1990s to achieve therapeutic plasma concentrations sufficient to achieve therapeutic efficacy with doses of 25mg/m2/day. ato alone demonstrated considerable effectiveness in this disease. more recently, an attenuated regimen has been proven to be effective in inducing similar remission rates and achieving prolonged survival, also demonstrating a reduction in associated toxicities, mainly hepatic and cardiac when using this new scheme. the investigators will conduct a phase 1/2, non-randomized, single center, non-comparative clinical trial to demonstrate the effectiveness of combined therapy of low-dose atra plus attenuated dose ato which is accessible to a population with limited resources while maintaining acceptable efficacy and safety.

Eligibility criteria:
inclusion criteria: * age \>18 years * both genders * new diagnosis of apl * diagnosis of relapsed apl who have not been previously treated with ato * morphological diagnosis of apl confirmed by pcr or fish exclusion criteria: * poor functional status (ecog\>2) * organic dysfunction (marshall score ≥2) * pregnancy * heart failure (nyha iii or iv) * renal failure (gfr \<30 ml/min/1.72m2) * history of ventricular arrhythmias or uncontrolled arrhythmias * acute myocardial infarction, unstable angina, or stable angina in the last six months * uncontrolled active infection * liver disease (child-pugh c)

Keywords: all-trans retinoic acid arsenic trioxide frontline therapy induction chemotherapy
dyslexia, motor control and proprioception

Conditions: Dyslexia

Summary: the investigators hypothesize that children with dyslexia present proprioceptive disorders and the purpose of the present study is to better understand relationships between motor control, proprioception and academic learnings. the investigators compare a group of french students with and without dyslexia aged 10-12.

2 groups of children (dyslexics and control) will be evaluated on 2 tasks: * evaluation of the proprioception: perception of the speed and perception of the position * evaluation of the motor learning: estimation of state in the framework of a motor perturbation

Eligibility criteria:
inclusion criteria for all children * child with a french social security * school child * native french speaker * right-handed * normal or corrected vision * without neurological or psychiatric histories * agree to participate in the study in agreement with parental rights representatives for the dyslexic group : * pluridisciplinary diagnostic * never consulted for proprioception before * without any other leaning disorders like dysphasia * attention deficit hyperactivity disorder (adhd) or developmental coordination disorder (dcd) for the control group : * regular school attendance * never consulted for learning disabilities * no learning disorders known for their parents or siblings. exclusion criteria for all children * genetic disorder * neurological or psychiatric history * delayed psychomotor development * reeducation or current treatment interfering with the evaluation

Keywords: motor control proprioception
comparison of ivr and cati surveys in bangladesh

Conditions: Surveys and Questionnaires; Non Communicable Diseases

Summary: this study focuses on mechanisms to adapt the performance of interactive voice response (ivr) and computer assisted telephone interviews (cati) surveys conducted in low-and middle-income (lmic) setting (bangladesh) and evaluates how the two survey modalities (ivr and cati) affect survey metrics, including response, completion and attrition rates.

using random digit dialing (rdd) sampling technique, participants will be randomized to one of two arms : 1) ivr or 2) cati. participants in the first study arm will receive an ivr survey. participants in the second study arm will receive a cati survey. each questionnaire contains a set of demographic questions and one non-communicable disease (ncd) module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). we will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * in bangladesh, conversant in bengali language exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response
a phase ii/iii study of sep-190 (eszopiclone) in patients with primary insomnia (study 190-126)

Conditions: Primary Insomnia

Summary: the purpose of this study is to investigate and evaluate the efficacy of eszopiclone in japanese participants with primary insomnia.

this is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in japanese participants with primary insomnia. the treatment period consists of two consecutive days (two nights) as one term. patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. participants were randomly assigned to one of 10 prespecified treatment sequence patterns.

Eligibility criteria:
inclusion criteria: 1. participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent 2. participants diagnosed with primary insomnia based on the diagnostic and statistical manual of mental disorders, text revision (dsm-iv-tr) japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period: * sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week * total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week 3. participants who meet both of the following based on polysomnogram (psg) in observation period: * objective sleep latency of more than or equal to 20 minutes for 2 consecutive psg days * objective total sleep time of less than or equal to 420 minutes for 2 consecutive psg days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive psg days exclusion criteria: 1. participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia. 2. participants with insomnia caused by pharmacological actions (drug-induced insomnia). 3. participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s). 4. participants with a complication of psychiatric disorders in axis i or personality disorder in axis ii defined in dsm-iv-tr japanese version. 5. participants with organic mental disorder.

Keywords: primary insomnia
validation of aspiration risk assessment in stroke units

Conditions: Stroke, Acute

Summary: the purpose of the study is to test the validity of a modified daniels swallow test. the original test serves as reference method, the swallow endoscopy (fees) as "gold standard". furthermore, it will be examined whether the modified daniels test can be performed by nursing staff. as a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (fees) by speech therapists and/or physicians.

for each included patient, the standardized daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified daniels test by a second speech therapist who is blinded to the result of the first test. this is immediately followed by the administration of the modified daniels test by a nurse. all investigators are blinded to the results of the preceding water swallow tests. the water swallow tests are not performed by physicians. following the water swallow tests, fees is performed by an examiner (physician or speech therapist) experienced in fees. the examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.

Eligibility criteria:
inclusion criteria: * acute (maximum 7 days old) cerebral infarction detected by cmri or cct * neurological deficits * written informed consent exclusion criteria: * cerebral hemorrhage * pre-existing swallowing disorders of other etiologies * contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - contradictions to fees (lack of alertness as well as lack of compliance)