Kornimate/medical-research-clean huggingface dataset:
a study to monitor long-term treatment with pf-00547659

Conditions: Crohn's Disease

Summary: this study provides open-label drug to eligible patients who have completed a prior study of pf-00547659. the primary endpoint for this study is long-term safety.

the rationale for conducting this open-label extension (ole) study is primarily to evaluate long term safety of pf 00547659. this protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. it also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. this is a multi center phase 2, open label, safety extension study for feeder studies which evaluate pf 00546759 in subjects with moderate to severe crohn's disease. subjects eligible for this study will have completed the 12 week double blind induction period in study a7281006 and will be stratified by responders or non responders based on change in cdai in that study, without unblinding treatment assignment from study a7281006. additionally, subjects who have completed study a7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". all subjects entering this study must have discontinued immunosuppressant therapy. subjects entering this study will be given a 75 mg sc dose at baseline and then every 4 weeks through week 72. after the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). at week 96, subjects will undergo an end of study visit but will continue the every 6 month telephone contacts until week 168.

Eligibility criteria:
inclusion criteria: * subjects between 18 and 76 years of age. * subjects previously enrolled in study a7281006 who have completed the blinded 84 day (12 week) induction period or in study a7281008 who have completed week 12 and have demonstrated a clinical response as defined by that protocol. exclusion criteria: * subjects that have completed day 84 (week 12) of a pf-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study. * subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.

Keywords: active crohn's disease anti-tnf refractory immunosuppressant refractory
clinical outcomes of maitland's mobilization in patients with myofacial chronic neck pain

Conditions: Myofascial Pain Syndrome of Neck

Summary: myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points and local and referred pain patterns. chronic neck pain is responsible for the involvement of joints, ligaments, fascia and connective tissue as well. the objective of this study was to assess the impacts of maitland's mobilization in patients with myofacial chronic neck pain. maitland's mobilization is one of the most common manual therapy approaches used by physiotherapists. maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness. in this randomized, placebo treatment controlled trial, 30 patients consecutively aged 25-45 years meeting inclusion criteria were isolated into two groups. the study group was treated with maitland's mobilization consistently for 8 weeks while the control group got placebo treatment for a similar time frame. visual analog scale (vas), neck disability index (ndi) and cervical range of motion (rom) questionnaire was filled by patients before, intermediate and after the intervention to evaluate the severity of pain, functional ability and range of motion.


Eligibility criteria:
inclusion criteria: * patients age between 25-45 years old, * bilateral pain involving the upper trapezius and elevator muscle of the scapula; * duration of pain of at least 3 months; * a pain intensity corresponding to at least 2 cm on a 10 cm visual analogue scale (vas); -neck pain with symptoms provoked by either neck postures or neck movement; * pain localized at least in the cervical and occipital regions but not in the orofacial region; --neck disability index (ndi) greater than or equal to 15 points; * restricted cervical range of movements (flexion, extension, rotation, and side-bending); ---presence of bilateral mtrps in upper trapezius and levator scapulae muscles were included in this study. exclusion criteria: * a history of traumatic injuries (e.g., contusion, fracture, and whiplash injury); * systemic diseases such as fibromyalgia, systemic erythematous lupus and arthritis; * neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia); * concomitant medical diagnosis of any primary headache (tension type or migraine); * cervical spine surgery; and clinical diagnosis of cervical radiculopathy or myelopathy

Keywords: neck pain manual mobilization isometric exercise triger points visual analog scale
effect of carnitine supplementation and resistance training on skeletal muscle function

Conditions: Sarcopenia

Summary: the primary aim of the current research project is to explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging. a secondary aim of this project is to investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition. the hypothesis is that resistance training combined with nutritional supplementation have a more beneficial effect than resistance training alone in the prevention of muscle loss during aging. leucine stimulates carnitine transport into the muscle cells, which improve mitochondrial capacity. modification in energetic of skeletal muscle affects the body composition and muscle performance.

the study will be included volunteers - women between 60 - 72 years old (n=60). the patients are randomly assigned to two experimental groups (n=20) and control group (n=20). during the 24-weeks intervention period, group a undergoes training procedure supplemented with the carnitine and leucine, whilst group b undergoes training procedure supplemented with leucine. at the same time control group go through only training procedure. measurements are performed before, at the mid-point, and at the end of the intervention period. approximately 1 week prior to the experimental trial day, participants perform a familiarization session during which one-repetition maximum (1rm) strength testing is also performed to determine the experimental exercise load. resistance exercise training is performed twice weekly on non-consecutive days (monday+thursday, or tuesday+friday) for 24-weeks under direct supervision by a research assistant. prior to a training session subjects are required to perform warm - up on the treadmill (walk) and static stretching, after each session - cool down on the cycle ergometer and static stretching. resistance exercise for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row first two weeks of training consist of 3 sets of 10-12 repetitions and are keeping exercises at 65% of 1 repetition maximum (1rm). after this period training consists of 3 sets of 6-8 repetitions and is progressing to 80% of 1rm. the 1rm is re-evaluated every 2 weeks, and the training load is adjusted accordingly. the exercise program follows the recommended guidelines for older adults by the american college of sports medicine and the national strength and conditioning association.

Eligibility criteria:
inclusion criteria: * aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises exclusion criteria: * diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements

Keywords: l-carnitine resistance training magnetic resonance imaging muscle function aging leucine
atomoxetine versus placebo for symptoms of attention-deficit/hyperactivity disorder (adhd) in children and adolescents with autism spectrum disorder

Conditions: Autistic Disorder; Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to determine whether atomoxetine is effective in reducing adhd (attention deficit/hyperactivity disorder) symptoms in children and adolescents with asd (autism spectrum disorder).


Eligibility criteria:
inclusion criteria (most important): * asd (autistic disorder or asperger's disorder or pervasive developmental disorder - not otherwise specified \[pdd nos\]) * criteria a through d for attention-deficit/hyperactivity disorder (adhd) * at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the adhd rating scale-iv-parent version * intelligence quotient (iq) score \> 60 exclusion criteria (most important): * weight under 20 kg * patients who meet diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) criteria for asd other than autistic disorder, pdd-nos or asperger's disorder;history of bipolar i or ii disorder, schizophrenia, another psychotic disorder, substance abuse;have a significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests; patients who have taken (or are currently taking) anticonvulsants for seizure control. * patients at serious suicidal risk. * contraindication to the use of atomoxetine * patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. patients who at any time during study period ii are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during study period iii supportive or educational therapy is permitted.
efficacy of hydrogen peroxide ( h2o2) in controlling placental site bleeding in caesarian delivery for placenta previa / accreta spectrum ( pas)

Conditions: Placenta Accreta

Summary: placenta accreta spectrum (pas), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage (1) . currently, more than 90% of women diagnosed with pas also have a placenta praevia (2), and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases . hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. it is used to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics and burn excisions to induce hemostasis . topical application of hydrogen peroxide was proven to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .

* population of study: a total of 84 pregnant patients with placenta previa / accreta spectrum. * study location: obstetrics and gynecology kasr al-ainy hospital , faculty of medicine , cairo university. the aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling bleeding from placental bed in caesarian section for placenta previa/ accreta spectrum (pas). • this is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (medcalc ®) . group a : hydrogen peroxide group (n=42) group b : control group (normal saline solution) (n=42) .

Eligibility criteria:
inclusion criteria: * age from 18-40 years * bmi \< 35 kg/m2 * pregnant patients with placenta previa . * placenta accrete figo grade 1 . * vitally stable . * candidate for conservative management. * no major intra-operative bleeding. exclusion criteria: * vitally unstable . * massive pre- or intra-operative bleeding. * medical disorders ( e.g. : hypertension , cardiac .... ) * placenta accrete , figo grades 2 or 3 . * not indicated for conservative management.
effects of mental stimulation in patients with mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI)

Summary: the purpose of this study is to learn if activities that challenge the brain (mentally stimulating activities) can improve memory and other types of thinking in patients with mild cognitive impairment. the study will compare the effects of different methods of mental stimulation.


Eligibility criteria:
inclusion criteria: * ≥ 50 years of age * meet criteria for amnestic-mild cognitive impairment (mci) * have capacity to give informed consent * have capacity to complete assessment measures exclusion criteria: * history of drug or alcohol dependence * severe psychiatric conditions associated with psychosis (e.g., schizophrenia) * recent stroke * clinical diagnosis of probable alzheimer's disease * history of seizure disorder, serious head trauma, or other medical, psychiatric, or neurological conditions associated with significant cognitive impairment (e.g., parkinson's disease, korsakoff's, hiv) * current use of alzheimer's disease medications (e.g., cholinesterase inhibitors, memantine)
a safety, tolerability and pharmacokinetics study of r932348 eye drops in patients with dry eye disease

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to determine the safety, tolerability and pharmacokinetics of r348 eye drops in patients with dry eye disease.

this is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of r348 administered in patients with mild to moderate keratoconjunctivitis sicca (kcs).

Eligibility criteria:
inclusion criteria: * mild to moderate keratoconjunctivitis sicca. * a corrected visual acuity in both eyes of 20/40 or better. * an intraocular pressure of \< 21 mm hg with a difference between eyes of \< 6 mm hg. exclusion criteria: * history or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day. * history or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day. * history of herpes simplex keratitis at any time. * current ocular allergy symptoms. * recent use of eye medications such as steroids or cyclosporine * refractive eye surgery within 12 months of the first dosing day. * other eye surgeries within 4 months of the first dosing day. * current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day. * receipt of any blood or blood products within 90 days prior to the first dosing day. * participation in any clinical study within 30 days prior to the first dosing day. * history of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor. * positive for hepatitis b, hepatitis c or hiv. * smoked regularly within 12 months of first dosing day. * history of substance abuse, drug addiction or alcoholism.
biomarker study of previously treated lyme disease volunteers in comparison to healthy volunteers

Conditions: Lyme Disease

Summary: non-interventional study evaluating stool and blood samples collected from individuals previously treated with lyme disease versus healthy volunteers


Eligibility criteria:
inclusion criteria: 1. males and females ≥18 years of age. 2. able to read, understand, and provide signed informed consent. 3. willing to provide blood and stool samples. 4. able to communicate adequately and to comply with the requirements for the entire study. 5. must be willing to discontinue antibiotics 2 weeks prior to sample collection. 6. if participating in the previously treated lyme disease arm, the participants must meet the following criteria: 1) diagnosis of prior lyme disease supported by either an erythema migrans rash (either classic "bull's eye" or irregular) or a cdc-positive western blot, 2) previously treated with antibiotics for lyme disease, 3) remains ill six months or more after receiving preliminary treatment with antibiotics for lyme disease (e.g., fatigue, musculoskeletal pain, or neurocognitive symptoms). 7. if participating in the healthy volunteer arm, the participants must meet the following criteria: 1) must not have had a lyme disease diagnosis, 2) in generally good health exclusion criteria: 1. unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).
effect of physiotherapy in patients presenting to the emergency department after a fall

Conditions: Fear of Falling

Summary: the aim of this monocentric, block-randomized, controlled, open-label, parallel-group study is to assess whether patients presenting to the emergency department (ed) with a fall within the past 7 days would benefit from a physiotherapy intervention, as compared to patients without physiotherapy intervention at the time of ed presentation. primary objective of this study is to assess "fear of falling" 7 days after ed presentation with versus without a physiotherapy intervention.


Eligibility criteria:
inclusion criteria: * written informed consent * age ≥65 * history of falls within the last 7 days * presentation to the ed of the university hospital basel exclusion criteria: * inpatient disposition after ed work-up * immobilizing fractures of the lower extremities * inability or contraindications to undergo the investigated intervention or follow the study procedures, e.g. due to certain neurological disorders (such as parkinsonism, hemiplegia, severe multiple sclerosis), language problems, psychological disorders, cognitive impairment * prior enrolment in this trial

Keywords: fall ground level fall" (glf) physiotherapy intervention short international falls efficacy scale (sfes-i)
feasibility assessment of the blood pressure imager, a continuous blood pressure monitor

Conditions: Blood Pressure; Hypertension

Summary: the investigators are developing blood pressure imager (bpi), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals in underserved, low-resource environments at their own homes or regional care settings. over the last one-year the investigators have developed the bpi prototype, which is ready for testing. bpi is a wrist device that includes a camera, color lights and soft membrane with a reflective coating. in this device feasibility study, the bpi will be placed over the radial artery at the wrist with the help of a wrist strap. the primary purpose of this feasibility study is to compare the bpi with a commercially available cuff-based blood pressure measuring devices.

if the participant volunteers to participate in this study, after signing the informed consent, responses to background data - age, gender, height, weight, wrist circumference of dominant arm, history of high blood pressure, diabetes, high cholesterol and cardiovascular disease - will be collected; the bpi will be strapped to the right or left wrist making sure it is comfortable to the participant and the readings from the bpi will be recorded in a computer. the continuous bpi readings will be recorded for 2 minutes. simultaneously, blood pressure readings will be obtained from a cuff-based, commercially available blood pressure measuring device placed in the same arm. the research team will take a minimum 3 and maximum 6 sets of readings. at the end of the bpi readings, we will place an ultrasound probe of the wrist at the level of the wrist to assess the size of the radial artery and depth of the artery from the skin. participant timeline: the collection of the background data will take 5 to 10 mins. the placement of the bpi and cuff-blood pressure device and the data collection will take about 15 to 20 mins. the ultrasound image collection will 10 to 15 mins. overall, the study procedures will be less than an hour.

Eligibility criteria:
inclusion criteria: * tests will be performed with any adult volunteer who is physically and mentally able to perform the experimental tasks. exclusion criteria: * we will restrict the experiments to adult volunteers who are physically and mentally able to consent.
post-marketing study of lyophilized nasal spray live attenuated influenza vaccine

Conditions: Influenza Prevention

Summary: to evaluate the protective effect 14 days after the live attenuated influenza vaccine; to evaluate the protective effect of vaccination with live attenuated influenza vaccine; to evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; to evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine. to evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

main end point: primary influenza protective effect endpoint protective effect of 14 days on laboratory-confirmed influenza cases. protective effect of 14 days after receiving lyophilized nasal spray live attenuated influenza vaccine on laboratory-confirmed serotype influenza cases. secondary endpoints: secondary point of secondary endpoint protective effect of freeze-dried nasal spray live attenuated influenza vaccine 0 days later on laboratory-confirmed influenza cases. protective effect of freeze-dried nasal spray live attenuated influenza vaccine 14 days later on clinically diagnosed influenza cases. protective effect of live attenuated influenza-like vaccine 14 days against influenza-like cases. safety incidence of adverse events and serious adverse events within 0-30 days after immunization. study on detoxification proproportion of vaccine attenuated proportion and vaccine attenuated content (titer) at different times after vaccination (days 3,7,15). exploration endpoint: 14 days after the freeze-dried nose vaccine, the vaccine was protective for the detection of covid-19 cases.

Eligibility criteria:
inclusion criteria: 1. local residents aged between 3 and 17; 2. people who signed the informed consent form and could actively cooperate with the study； 3. axillary body temperature of 37.0℃. exclusion criteria: 1. subjects who meet the contraindications and precautions specified in the vaccine instructions: 1. those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate; 2. patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever; 3. women in pregnancy; 4. patients with leigh syndrome treated with aspirin or aspirin-containing drugs; 5. immunodeficient, immunocompromised, or under immunosuppressive therapy; 6. patients with uncontrolled epilepsy and other progressive neurological diseases, patients with a history of guillain-barre syndrome; and g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis). 2. have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort. 3. have received any influenza vaccine during this natural year before entering the study 4. those who have been diagnosed with influenza in this natural year before entering the study. 5. any condition that the investigator judged to affect the trial.

Keywords: protection effect