Kornimate/medical-research-clean huggingface dataset:
eating behaviours in female patients with fibromyalgia

Conditions: Eating Behavior; Fibromyalgia; Health Status

Summary: the relationship between eating behaviours and health status of female patients with fibromyalgia

the purpose of this study is to evaluate the nutritional behaviours of female patients with fibromyalgia according to the healthy population and the relationship of these behaviours with the current health status of the patient. in the investigatgor's clinical practice, eating-related problems (increased or decreased appetite, uncontrolled eating, etc.) are observed in fibromyalgia patients. in this study, it will be investigated whether this situation is different from healthy population and whether it is related with the healt status. patients diagnosed with fibromyalgia according to 2013 american college of rheumatology criteria and healthy volunteers are planned to be included in the study. demographic data (sex, age, level of education, job, socio-economic situation) will be questioned and their body mass indexes (bmi) will be calculated from all participitants all participants' eating behaviour will be questioned with three factor eating questionnaire. in fibromyalgia patients, effect of fibromyalgia on the daily life of the patients will be questioned with fibromyalgia impact questionnaire.

Eligibility criteria:
inclusion criteria: * female patients between the ages of 18-40 * patients diagnosing fibromyalgia for the first time according by 2013 american college of rheumatology (acr) criteria exclusion criteria: * history of eating disorders such as anorexia nervosa, bulimia nevroza * history of hypothyroidism or hyperthyroidism * pregnant or breast feeding * history of central or peripheral nervous system disorders * history of infectious, chronic inflammatory disease, malignant tumors * subjects with active psychiatric illness or who use psychiatric medication * uncooperative subject * history of cardiac pathology such as heart failure, coronary artery disease * history of diabetes, chronic renal insufficiency, chronic liver failure

Keywords: chronic pain eating habits
abi-m201 in adult subjects with mildly-to-moderately active ulcerative colitis

Conditions: Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate

Summary: phase 1b randomized, double-blind, placebo-controlled, two-cohort clinical trial of abi-m201 in adult subjects with mildly-to-moderately active ulcerative colitis(uc) and ongoing treatment with mesalamine.

this multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of abi-m201 and its effects on disease activity measures in men and women with mildly-to-moderately active uc and ongoing treatment with mesalamine. the study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (ia). both cohorts will involve 8-weeks of study drug treatment. interim data from the initial treatment cohort (cohort a) will inform decision to advance to the subsequent second cohort (cohort b) and its dose selection. 20 subjects will be randomized to cohort a (1:1 allocation) and receive treatment with 1 capsule per day of abi-m201 versus placebo. 24 subjects will be randomized to cohort b (3:1 allocation) and receive treatment with up to 5 capsules one time a day of abi-m201 versus placebo.

Eligibility criteria:
inclusion criteria: * established diagnosis of uc for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge * mildly to moderately active uc * inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit exclusion criteria: * possible or confirmed diagnosis of crohn's disease or other forms of inflammatory bowel disorders * ongoing or failed prior treatment for uc with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (fk-506), or biologics (e.g., tnf-alpha-antagonists, anti-integrin therapies, or agents targeting il-12 or il-23, etc.) * any immunosuppressive condition or treatment with immunosuppressive medications * history of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery) * prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the principal investigator might impact the subject's safety or compliance, or the interpretation of results * treatment with any other investigational drugs ≤12 weeks prior to baseline visit * the participant has a condition or is in a situation which, in the principal investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Keywords: phase 1b randomized placebo controlled
optimization of antiviral therapy of chronic hbv infection

Conditions: Australia Antigen Positive; Hepatitis B; Adverse Effects

Summary: along with the improvement of the accuracy of detection of hbv serological markers, the optimization of antiviral therapy for patients with chronic hepatitis b (chb) infection becomes feasible. currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. this study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for hbeag positive chb with inadequate response to 24 weeks interferon treatment.

patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on adv or switch to ldt) for 48weeks. all these patients were followed for 48 weeks and the hbeag seroconversion and hbv dna level were observed. safety and the economic effect of the two optimized therapy methods also were observed.

Eligibility criteria:
inclusion criteria: patients receiving peg interferon α-2a with inadequate response at 24 weeks (hbeag titer ≥ 100paul ehrlich institute unit (peiu)/ml and hbv dna ≥ 5.0 log copies/ml or hbv dna titer decline \<1 log copies/ml) were enrolled into this study. exclusion criteria: * no decompensated cirrhosis, * no hepatitis c, hepatitis d or human immunodeficiency virus (hiv) co-infection, * no hepatocellular carcinoma and other tumors or history of severe hepatitis, * no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).

Keywords: hbeag seroconversion peginterferon alfa-2a chronic hepatitis b(chb optimal therapy response guild treatment(rgt);
nonnarcotic pain control in percutaneous needle tenotomy of elbow

Conditions: Elbow Pain; Chronic Pain

Summary: this study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.

tramadol is currently the standard post-procedure medication. acetaminophen will be prescribed (1000 mg) and should be taken every 8 hours if pain is present. tylenol should be the first taken for pain. if pain persist, the study kit containing the blinded, pain-controlled capsules will be taken second. both diclofenac potassium (50mg) and tramadol (50mg) will be provided in identical-looking capsules and randomly assigned to patients in sealed packets by a physician, ensuring the double-blind nature of the study and be instructed to use every 8 hours as needed for pain if pain is still not adequately controlled an hour after taking the blinded study pack, a rescue medication, consisting of tramadol 50mg capsules, will also be supplied to the nsaid group in sealed packets while rescue medication of oral diclofenac will be provided to the opioid group. these medications will be administered immediately after the tenotomy procedure to all participants. the primary endpoint of the study will be the total count of tramadol doses taken by each group at the 10 day (± 4 days) postoperative follow-up. pill counts from sealed packages and the use of rescue narcotics will be verified during the in-person visit at 10 days (± 4 days) .

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged 18-65 years * percutaneous needle tenotomy of lateral elbow procedure * ability to take oral medication and willingness to participate in a 2-week follow-up pill counts * musculoskeletal ultrasound or mri with diagnosis of tendinosis of the common extensor tendon of the elbow exclusion criteria: * • any full thickness common extensor tendon tear of the elbow * prior history of elbow surgery * symptomatic cervical radiculopathy * concurrent symptoms of the medial elbow * treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control * psychiatric illness that impedes evaluation of pain and/or narcotics use * no history of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia or autoimmune disease * no contraindications to nsaids or opioids

Keywords: tenjet elbow
comparison of inclined backwalk vs kneel walk on genurecurvatum in hemiplegic cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: the 40-68% of ambulating hemiplegic children walk with genu recurvatum and hemiplegic patients shows excessive anterior pelvic tilts (\>4 cm) during the stance phase. the objective of the study is to compare the effects of inclined backward treadmill walk vs kneel walk on genu recurvatum in hemiplegic cerebral palsy. 50 participants will be chosen according to inclusion exclusion criteria of the study which will be randomly allocated into two equal groups . one group will receive treadmill training programme with specifically designed physical therapy program according to child need for one hour for each child. and other group will receive kneel walking programme specifically designed physical therapy program according to child need for one hour for each child. the pre and post assessment of genurecurvatum will be assessed by goniometer.

efficiency of walking and the development of independent gait are often the focus of therapeutic interventions for children with cp. motor learning theory suggests that when encountering a new motor skill or adapting a motor skill to a specific situation, a group of interconnected neurons is selected from a primary neuronal repertoire based on prior experience of the task. generated movement patterns and postural adjustments are then refined via afferent feedback. therefore, it has been argued that to develop and improve a motor skill such as walking, opportunities for repetitive practice of the skill need to be offered. for this reason use of a mechanical treadmill may improve walking in children with cp. treadmill walking provides increased opportunity to repetitively train the whole gait cycle, facilitate an improved gait pattern. improved walking has the potential to increase the mobility and positively influence the societal participation of children with cp at home, at school and in the wider community.

Eligibility criteria:
inclusion criteria: * gmfm level (i \& ii) * knee hyperextension ranged from 10 to 20 degrees exclusion criteria: * children with comorbidities (other knee deformities, surgical intervention or fractures) will not included in this study. * children who recently have botulinum toxin injection.

Keywords: hemiplegic cerebral palsy genu-recurvatum inclined backward walk kneel walk. treadmill training
study comparing cubicin® (daptomycin for injection) with vancomycin in cellulitis or erysipelas

Conditions: Cellulitis

Summary: this study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters: * time to erythema margin cessation to progress * time to defervescence * time to hospital discharge following relief of the presenting cellulitis or erysipelas * degree of improvement of the following signs and symptom of cellulitis or erysipelas including * degree of improvement of cellulitis-related pain and swelling as reported by subjects additionally, the difference in frequency of adverse events between daptomycin and vancomycin will be described.

same as above

Eligibility criteria:
inclusion criteria: 1. read and sign the informed consent form after the nature of the study has been fully explained; 2. male or female \> or = 18 years of age; 3. if female of childbearing potential, a negative pregnancy test is required; 4. primary diagnosis of cellulitis/ erysipelas 1. with onset of signs or symptoms within 3 days of 1st dose of study medication 2. requiring hospitalization, and severe enough to warrant iv antibiotics 3. temperature \>37.5°c (99.5° f) oral or \>38° c (100.2° f) rectal, documented within 48 hours prior to enrollment, and 4. anticipated treatment to be limited to medical (not surgical) interventions 5. at an anatomical location that allows of a clear assessment of the erythema margin exclusion criteria: 1. pregnant or lactating female; 2. conditions where required surgery (in and of itself) constitutes curative treatment of the infection or removal of infected site (e.g., amputation); 3. conditions requiring emergent surgical intervention at the site of infection (e.g., progressive necrotizing infections); 4. previous systemic antimicrobial therapy exceeding 24 hours duration, administered anytime during the 72 hours prior to the first dose of study drug unless on previous antibiotics for at least 72 hours and without any clinical improvement; 5. cellulitis associated with a wound infection or ulcer requiring incision and drainage or debridement 6. perirectal abscess or hidradenitis suppurativa or third degree burn infections 7. buccal cellulitis, facial cellulitis, perianal cellulitis, or periorbital cellulitis; 8. known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection; 9. known to be allergic or intolerant to study medications; 10. subjects with a creatinine clearance (clcr) \<30 ml/min; 11. requirement for non-study systemic antibiotics; 12. requirement for systemic steroids from enrollment through stabilization of cellulitis; 13. rhabdomyolysis; 14. neutropenic subjects with absolute neutrophil count ≤ 500 cells/mm3
a study of tas-205 for duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the objective of this study is to evaluate the safety and pharmacokinetic of tas-205 in patients with duchenne muscular dystrophy.

duchenne muscular dystrophy (dmd) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3500 lives male births. dmd patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and loss of upper body function. the objective of this study is to evaluate the safety and pharmacokinetic of tas-205 after single and multiple doses in dmd patients. it is also evaluated if tas-205 affects the urinary excretion of pharmacodynamic (pd) marker in dmd patients.

Eligibility criteria:
inclusion criteria: * able to give an informed consent. if applicable, able to give an informed assent. * male and \>= 5 years and \< 16 years of age. * bodyweight of \>= 15.0 kg and \< 75.0 kg. * phenotypic evidence of dmd. * able to take tablets. * if taking oral glucocorticosteroids no significant change in total daily dosage or dosing regimen after enrollment. * confirmed the urinary pd marker over its criteria. * able to follow the study protocol. exclusion criteria: * current diagnosis or history of any drug allergy. * a forced vital capacity (fvc) \< 50% of predicted value. * a left ventricular ejection fraction (ef) \< 50% or fractional shortening (fs) \< 25% based on echocardiogram (echo). * ongoing immunosuppressive therapy (other than corticosteroids). * with severe disease such as hepatic disease, kidney disease and others. * with any systemic allergic disease or any chronic inflammatory disease. * treated with any other investigational agents within 90 days. * positive reaction in hepatitis b surface antigen (hbsag), hepatitis c antibody test (hcv), or human immunodeficiency virus (hiv) test.
clinical trial - analyzing participation experiences of amyotrophic lateral sclerosis patients

Conditions: ALS; Amyotrophic Lateral Sclerosis

Summary: clinical trial participation has always been substantially skewed toward certain demographic groups. however, there has been little study on whether trial qualities impact participation in either a positive or negative way. the goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. this data will be analyzed via a number of demographic lenses in order to find trends that could benefit future als sufferers.


Eligibility criteria:
inclusion criteria: * lives in the united states * is 18+ years old * participant has a diagnosis of amyotrophic lateral sclerosis (als) * participant has enrolled in an interventional clinical for als (self-reported) exclusion criteria * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form * no diagnosis of amyotrophic lateral sclerosis (als) confirmed

Keywords: als als clinical trials als diversity studies amyotrophic lateral sclerosis
a study of safety, tolerability, and pharmacokinetics of multiple-ascending doses of php-303 in otherwise healthy overweight or obese subjects

Conditions: Otherwise Healthy Overweight or Obese

Summary: this is a phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (mad) study designed to evaluate the safety, tolerability, and pharmacokinetics (pk) of php-303 in otherwise healthy overweight or obese volunteer subjects. within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive php-303 or placebo. the primary objective is to establish the safety and tolerability and maximum tolerated dose (mtd) of orally-administered php-303.


Eligibility criteria:
inclusion criteria: * male or female subjects, ≥ 18 to ≤ 60 years of age. * in good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ecg at screening, in the opinion of an investigator. * willing to forego other forms of experimental treatment during the study. exclusion criteria: * any clinically significant condition that, in the opinion of an investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements. * major surgery in the 6 months preceding screening. * clinically-significant abnormal laboratory parameters. * positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at screening or on admission to the study site. * electrocardiographic fridericia's corrected qt interval (qtcf) interval \> 450 msec for males and \> 470 msec for females, or any other clinically significant electrocardiographic abnormality. * blood pressure results \> 150 mmhg systolic or \> 95 mmhg diastolic * female subject who is pregnant (positive pregnancy test at the screening visit or on admission to the study site), lactating, or planning to become pregnant during the study period or within 3 months after the final dose of study medication. * history of drug or alcohol abuse or dependence within 1 year prior to screening. * history of cigarette smoking within 3 months of screening. * known intolerance to lactose. * regular use of prescription drugs within 14 days of the first administration of study drug or non-prescription (over-the-counter) drugs within 7 days of the first administration of study drug or unwilling to abstain from prohibited medications through the end of study.
evaluating anatomic versus targeted lead placement for burst stimulation therapy during the trial

Conditions: Chronic, Intractable Pain of the Trunk and/or Lower Limbs

Summary: prospective, multi-center, randomized, single blind study

this clinical investigation compares success rates for anatomically placed leads to conventional, targeted lead placement for burstdr™ during the trial evaluation period with the st jude medical™ invisible trial system. subjects will be blinded to treatment group and randomized in a 1:1 ratio as follows: group 1 (ab): anatomic lead placement followed by burstdr™ stimulation during an initial trial evaluation period group 2 (tb): targeted lead placement followed by burstdr™ stimulation during an initial trial evaluation period if the subject qualifies for permanent system implant according to pre-defined criteria after the initial trial evaluation period, the subject will exit the clinical investigation and continue their treatment per the physician's standard of care. subjects who do not qualify for permanent system implant according to pre-defined criteria after the initial trial evaluation period may participate in an extended trial evaluation period, per physician discretion, during which they will be programmed with tonic stimulation. subjects continuing to an extended trial evaluation period will be followed through the completion of the extended trial period. at the end of the extended trial evaluation period, subjects will exit the clinical investigation.

Eligibility criteria:
inclusion criteria: 1. patient indicated for spinal cord stimulation therapy in accordance with the approved labeling. 2. patient's pain profile indicates appropriate lead placement would be at one or more levels from t7 to t10, to achieve pain coverage. 3. patient has a baseline score on the numerical rating scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation. 4. patient is considered by the study investigator as a candidate for implantation of a spinal cord stimulator system according to the system instructions for use. 5. patient is \>18 years of age at the time of enrollment. 6. patient is willing to adhere to the study requirements, including compliance with and completion of all study visits. 7. patient has signed and received a copy of the ethical committee/independent review board approved informed consent. exclusion criteria: 1. patient currently has a spinal cord stimulation system implanted. 2. patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant). 3. patient has a primary diagnosis of peripheral vascular disease (pvd), angina pectoris, or chronic migraine. 4. patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure) 5. patient is scheduled to be implanted with (a) surgical paddle trial lead(s).