Kornimate/medical-research-clean huggingface dataset:
canadian orthopaedic foot and ankle society surgical treatment of ankle arthritis outcome study

Conditions: Ankle Arthritis

Summary: the purpose of this study is to see if the clinical outcome success rate of total ankle arthroplasty is similar to that of ankle arthrodesis over a period of 10 years. this will include looking at whether total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to ankle arthrodesis over a period of 10 years.


Eligibility criteria:
inclusion criteria: * eighteen (18) or older * known to have ankle arthritis for more than six (6) months * tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved * patient tests (questionnaires) show that ankle arthritis is severe * patient willing to take part in the study, including signing consent form after carefully reading it exclusion criteria: * dead bone in the ankle * severe foot or ankle deformity * prior ankle fusion or replacement * active or prior infection in the ankle * obesity (greater than 250 lbs) * medical conditions precluding safe surgery * nerve or muscle disease * severe osteoporosis
the british heart foundation senior-rita trial

Conditions: NSTEMI - Non-ST Segment Elevation MI

Summary: senior-rita is a multicentre prospective open-label trial randomizing patients presenting with type 1 nstemi aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal mi

the population is getting older and heart artery disease is the biggest killer in the uk. over recent years, there have been improvements in medications and technologies to treat it, but these have been primarily tested in younger patients. previous research studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients in particular those that are frail and those with co-morbidities are less likely to receive advanced medications and medical procedures. the current study will enrol patients 75 years and over, presenting with a heart attack. if patients agree to participate, they will be randomly allocated to one of two treatment groups. in the first group, patients will receive the latest medications recommended in heart attack. in the second group, in addition to these medications, patients will have coronary angiography. this will show whether they have any blockages in heart arteries. if appropriate, coronary revascularisation by percutaneous coronary intervention (pci) commonly known as coronary angioplasty or coronary artery bypass grafting, sometimes called cabg (a surgical procedure in which a blood vessel from the leg, arm or chest is used to bypass a narrowed section of a coronary artery) will be carried out. during the trial, frailty scores, cognition measures, co-morbidity indices, questionnaires on quality of life, nhs and personal social services utilization will be collected from the participant and in addition proxy quality of life information will be collected from the participant's carers. investigators will evaluate which one of the two treatment groups will do better and live longer. investigators will also collect information on their quality of life and frailty measures for a 5 year period. the trial hopes to recruit 2300 patients from approximately 30 centres across the uk.

Eligibility criteria:
inclusion criteria: * aged ≥ 75 years * type 1 nstemi during index hospitalisation exclusion criteria: * patients presenting with stemi or unstable angina * patients with cardiogenic shock * patients with known life expectancy \<1 year * patients in whom neither the patient nor the consultee are able and willing to provide written informed consent * previous inclusion in the bhf senior-rita trial * inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation

Keywords: acute coronary syndrome
e-stim and achilles tendon repair study

Conditions: Achilles Tendon Rupture

Summary: calf muscle atrophy (muscle degeneration) is common following achilles tendon repair due to the immobilization period necessary to ensure optimal healing. the purpose of this study is to determine if the use of neuromuscular electrical stimulation (nmes) after achilles tendon surgery will reduce calf muscle atrophy.

the specific aims of this study are to evaluate the use of electrical stimulation on muscle cross-sectional area and muscle fascicle length following post-operative achilles tendon surgery. patients will be randomly assigned to receive an electrical stimulation unit (compex®, djo global, san diego, ca). twenty of these units will be experimental and 20 will be sham.

Eligibility criteria:
inclusion criteria: * 1. any patient who is having surgery to treat an acute achilles tendon rupture or any surgery that involves reflecting or repairing the distal achilles tendon. exclusion criteria: 1. body mass index (bmi) greater than or equal to 45 2. inability to consent to participate in clinical research 3. any patient younger than 18 years old 4. any limitations that would interfere with the delivery of electrical stimulation including, but not limited to: 1. presence of an insulin pump 2. pacemaker, defibrillators or other implanted electrical device 3. neurostimulation implants 4. history of epilepsy/seizure 5. current pregnancy. a pregnancy test will be performed for any female prior to surgical intervention per hospital protocol unless she is post-menopausal or has been sterilized. 6. active malignancy 7. peripheral neuropathy 8. diabetes mellitus 9. ischemia of lower limbs 10. active infection 11. following acute trauma or fracture

Keywords: achilles
migraine and homeostasis:what can we learn from glucose

Conditions: Migraine Headache

Summary: patients with migraine often report that stressors such as skipping a meal can bring on a migraine whereas some patients report that their migraine improves with food. few studies to date have looked at the relationship between blood glucose (sugar) and migraine. we are conducting this study to better understand whether or not changes in blood glucose levels can trigger migraine or provide relief during a migraine attack.

the purpose of this pilot and feasibility study is to assess if changes in blood glucose both trigger migraine and can provide analgesia. this information will provide a vital basis for the mechanism of migraine and offer insights into better treatments as well as prevention. this is a pilot unblinded randomized trial with two independent components, aims 1 and 2. it is not possible to blind the current protocol both in terms of the blood sugar readings and the luna bar, non-luna bar intervention.

Eligibility criteria:
inclusion criteria: * male or female participants, age 18-65 with episodic migraine with or without aura (ichd-ii) and/or morning onset and/or patients who self identify that eating reduces their migraine intensity. exclusion criteria: * chronic migraine, use of hypoglycemic medication, dm i or ii, abnormal finger stick glucose, obesity, comorbid eating disorders, pregnancy, seizure disorder, other serious mental or physical condition that would impair participation in the study

Keywords: blood sugar
a ph2b to evaluate clinical efficacy and safety of tildacerfont in adult cah

Conditions: Congenital Adrenal Hyperplasia

Summary: an investigation of the efficacy and safety of up to 70 weeks of treatment with tildacerfont in subjects with classic cah who have elevated biomarkers at baseline on their current gc regimen. optional open label treatment extension period up to 240 weeks with 200mg tildacerfont qd.

this is a study that will test the efficacy and safety of tildacerfont. the first 12-weeks will be a double-blind, placebo controlled, dose ranging study. the following 58-weeks will assess the long term safety of tildacerfont. optional open label treatment extension period up to 240 weeks with 200mg tildacerfont qd.

Eligibility criteria:
inclusion criteria: * male and female subjects over 18 years old, inclusive * has a known childhood diagnosis of classic cah due to 21-hydroxylase deficiency based on genetic mutation in cyp21a2 and/or documented elevated 17-ohp and currently treated with hc, hc acetate, prednisone, prednisolone, methylprednisolone (or a combination of the aforementioned gcs) * has been on a stable supraphysiologic dose of gc replacement ≥15 mg/day and ≤60 mg/day in hc equivalents * for subjects with the salt-wasting form of cah, subject has been on a stable dose of mineralocorticoid replacement for ≥1 month before screening exclusion criteria: * has a known or suspected diagnosis of any other known form of classic cah (not due to 21 hydroxylase deficiency) * has a history that includes bilateral adrenalectomy or hypopituitarism * has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other crf1 receptor antagonist * current treatment with dexamethasone as gc therapy for cah. prior treatment with dexamethasone is allowed as long as the transition to an alternative gc regimen (eg, hc, prednisone, or prednisolone) has resulted in a stable dose of gc replacement for ≥1 month before screening. * shows clinical signs or symptoms of adrenal insufficiency

Keywords: cah adrenal disorder congenital adrenal hyperplasia
lung cancer, exercise and force development

Conditions: Lung Cancer

Summary: this study evaluates the effectiveness of a supervised one-leg resistance training program in patients with inoperable lung cancer with the primary outcome being rate of force development. study design: single center, two-armed, parallel-group, randomized controlled trial. the primary outcome being rate of force development after 12 weeks of progressive resistance training.

muscular dysfunction and sarcopenia are known phenomena in cancer patients, and patients experience reduced muscle function and muscle loss regardless of cancer type or stage. studies indicate that there are a number of cancer-specific and non-cancer-specific factors that influence muscle dysfunction, such as age, poor nutrition, physical inactivity, cancer pathology and treatment preparations. the decreased muscle function can ultimately lead to cachexia, typically seen in stage iii - iv lung cancer patients. previous studies have focused on 1-rm tests, muscle mass and functionality as outcomes. however, a central aspect of functionality in lung cancer patients may be the muscle's ability to develop force in a short time. the present study therefore has rate of force development as a primary outcome with muscle mass and functionality as supporting outcomes. in addition, the patients in this study will perform one-leg resistance exercise with the other leg as the control leg. this will eliminate the interpersonal bias normally seen in randomized controlled trials.

Eligibility criteria:
inclusion criteria: * patients (men and women) from the age of 18 years and above; patients with lung cancer (nsclc stage iii - iv and sclc ed); patients with performance stage 0-2 according to who criteria exclusion criteria: * patients where the doctor has listed contraindications for physical activity in the medical record; documented bone and brain metastases; persistent medullary plasia; patients on anticoagulation treatment; diagnosed symptomatic cardiac disease, including clinical congestive heart disease, arrhythmia requiring treatment or diagnosed myocardial infarction within the last three months; pericardial exudate; patients in terminal treatment; senile dementia and psychotic patients.

Keywords: exercise functionality resistance training muscle, skeletal sarcopenia
can you breathe your way to better health?

Conditions: Cancer; Chronic Stress; Autonomic Dysfunction

Summary: the purpose of this clinical trial is to explore the effects of either a 2-week high-intensity interval training (hiit) or breath training intervention on measures of overall health, circulating biomarkers of stress, and immune function. specific aims include: - does a 2-week hiit or breath training intervention improve measurements of overall health, including heart rate variability, physical activity, sleep quality, and severity of depression, anxiety, and stress? -does a 2-week hiit or breath training intervention improve circulating concentrations of stress-related biomarkers? does a 2-week hiit or breath training intervention improve immune function? researchers will compare hiit and breath training to see if equivalent immune improvements are observed. participants will: -undergo 2 weeks of hiit or breath training interventions at a frequency of 3 times per week for 30 minutes or 5 times per week for 5 minutes if placed into an intervention group. -undergo testing measures at the two pre- and post-intervention time points, if placed in the intervention groups or the healthy control group.


Eligibility criteria:
inclusion criteria: * age, 18-50 years * sex, male and female * informed consent, the capability and willingness to give written informed consent to understand the exclusion criteria and to accept the randomized group assignment is required. * par-q+, the capability and willingness to complete the physical activity readiness questionnaire, with no medical clearance needed. * physical activity: participants must refrain from regular hiit and structured breathing practices for a month before participation * depression, anxiety, and stress scale, subcategory scoring (dass-21) participants must score in the mild or greater category for depression, anxiety, and stress. depression ≥ 10, anxiety ≥ 8, and stress ≥ 14. exclusion criteria: * age: individuals under 18 years and over 50 years * significant respiratory conditions, including but not limited to asthma, chronic obstructive pulmonary disease, * significant cardiovascular disease: participants with a known cardiovascular condition such as a previous myocardial infarction, congestive heart failure, stroke, or transient ischemic attack, cardiomyopathy, serious arrhythmia, peripheral vascular disease, untreated atherosclerosis, or hypertension. * significant musculoskeletal disease, including but not limited to osteopenia, osteoporosis, rheumatoid arthritis, and sarcopenia * cognitive and mental health, including but not limited to untreated anxiety, untreated depression, post-traumatic stress disorder, and thoughts of suicide.

Keywords: high intensity interval training (hiit) cyclic hyperventilation with retention (chr) intervention natural killer cells training stress autonomic nervous system innate immune system natural killer cell cytotoxicity heart rate variability (hrv)
bibw 2992 and bsc versus placebo and bsc in non-small cell lung cancer patients failing erlotinib or gefitinib (lux-lung 1)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this randomized, double-blind, multi-center phase iib/iii trial will be performed in patients with nsclc who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed. the primary objective of this randomized trial is to determine the efficacy of bibw 2992 as a single agent (arm a) as compared to a matching placebo (arm b) in this patient population. patients on both treatment arms will receive best supportive care in addition to study treatment. patients enrolled into the trial will be treated and followed until death or lost to follow-up.


Eligibility criteria:
inclusion criteria: 1. patients with pathologic confirmation of nsclc stage iii-b (with pleural effusion) or stage iv adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). one of the chemotherapy regimens must have been platinum-based. 2. progressive disease following at least 12 weeks of treatment with erlotinib (tarceva®) or gefitinib (iressa®) 3. eastern cooperative oncology group (ecog, r01-0787) performance score 0, 1 or 2 4. patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (mri), or computed tomography (ct) in at least one dimension with longest diameter to be recorded as \>20 mm using conventional techniques or \>10 mm with spiral ct scan 5. male and female patients age \>18 years 6. life expectancy of at least three (3) months 7. written informed consent that is consistent with ich-gcp guidelines exclusion criteria: 1. use of erlotinib (tarceva®) or gefitinib (iressa®) within 14 days of treatment day 1 2. chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks 3. active brain metastases 4. significant or recent acute gastrointestinal disorders with diarrhea 5. patients who have any other life-threatening illness or organ system dysfunction, 6. other malignancies diagnosed within the past five (5) years 7. radiotherapy within the past 2 weeks prior to treatment 8. history of clinically significant or uncontrolled cardiac disease 9. adequate anc and platelet count 10. adequate liver and kidney function 11. patients with any serious active infection including known hiv, active hepatitis b or active hepatitis c
curcumin + aminosalicylic acid (5asa) versus 5asa alone in the treatment of mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is a chronic inflammatory disease resulting in increased morbidity in patients. the current standard treatment for mild to moderate uc (mtmuc) includes 5-aminosalicylic compounds (5asa) such as olsalazine and mesalamine, yet some patients continue to experience disease symptoms and flare-ups. these patients require higher dosages of 5asa medications and in many cases escalate to steroid and/or immunosuppressant therapy which comprises higher risk of hazardous side effects. curcumin, an active ingredient of the indian herb rhizoma curcuma longa, has been extensively studied in the context of inflammatory diseases. in humans, a controlled study using curcumin as an adjusted therapy to 5asa medication has shown it to be superior to placebo in maintaining remission in mtmuc patients . a small, preliminary open label study has also shown efficacy in reducing disease symptoms and inflammatory markers in this group of patients . this data provides bases for investigating an integrative approach to optimize the current standard treatment in mtmuc patients. we speculate that using a combined therapy of 5asa medication and curcumin could benefit this subgroup of patients and reduce morbidity and perhaps need for escalating pharmacological intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of uc as confirmed by endoscopic or histologic criteria as established by romeiii * disease activity score of \>5 and ≤13 according to the simple clinical colitis activity index (sccai) * patient on stable 5 asa medication dose for at least 4 weeks prior to inclusion * patients who receive immunosuppressant or biological therapy (azathioprine, 6-mercaptopurine, infliximab or methotrexate) must be on stable dose for at least 3 months prior to inclusion * patients who receive topical therapy (5asa or steroidal), must be on stable dose for a least 2 weeks prior to inclusion * patient had hemoglobin of \>10 g/dl. * able and willing to give written consent exclusion criteria: * patient with renal or liver disease, sever cardiovascular disease, chronic pancreatitis, diabetes mellitus or gallstone. * patient with laboratory abnormalities indicating anemia (hemoglobin \<10), leucopenia, thrombocytopenia, abnormal coagulation. * patient with infection, sepsis or pneumonia. * pregnant or nursing women. * unable or unwilling to receive curcumin therapy.

Keywords: ulcerative colitis curcumin
to evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.

Conditions: Neuralgia

Summary: to evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.


Eligibility criteria:
inclusion criteria: * must have met the inclusion criteria for preceding double-blind bid study in postherpetic neuralgia * must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks. exclusion criteria: * patients cannot participate if they experienced a serious adverse event during preceding double-blind bid study which was determined to be related to the study medication.
a phase ii/iii trial of human anti-cmv monoclonal antibody msl 109 (macrt)

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to compare the safety and efficacy of sevirumab (msl 109; protovir), human anti-cytomegalovirus (cmv) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in aids patients with newly diagnosed and relapsed cmv retinitis. ganciclovir and foscarnet are used for treatment of cmv retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. studies suggest that msl 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with cmv retinitis.

ganciclovir and foscarnet are used for treatment of cmv retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. studies suggest that msl 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with cmv retinitis. patients are randomized to receive either msl 109 or placebo every 2 weeks as supplemental therapy to primary cmv treatment.

Eligibility criteria:
inclusion criteria concurrent medication: required: * primary cmv treatment. patients must have: * aids. * active cmv retinitis. * at least one photographable lesion of one-quarter or more optic disc area in size. * undergoing primary treatment for cmv retinitis that is not contraindicated with msl 109. * visual acuity in at least one eye of 3 or more letters on early treatment diabetic retinopathy study ( etdrs ) chart at 1 meter distance ( snellen equivalent 5/200 ). note: * exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * retinal detachment not scheduled for surgical repair. * media opacity that precludes visualization of the fundus. * active medical problems sufficient to hinder study compliance. concurrent medication: excluded: * ivig. * cmv immune globulin ( cmvig ). * interferon alpha. * interferon gamma. * interleukin-2 ( il-2 ). drug or alcohol abuse sufficient to hinder study compliance.

Keywords: aids-related opportunistic infections acquired immunodeficiency syndrome antibodies, monoclonal cytomegalovirus retinitis