Kornimate/medical-research-clean huggingface dataset:
escape migraine trial

Conditions: Migraine Disorders; Heart Septal Defects, Atrial

Summary: the purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of pfo closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a pfo, compared to medical therapy alone.

migraine headache is a neurological disorder characterized by chronic and disabling headache. approximately 10-12% of humans, comprising some 28 million americans, suffer from this disorder. despite continual advances in medical management of migraine, many sufferers continue to experience frequent and disabling attacks despite appropriate medical therapy. preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers, while effective for many patients, have side-effect profiles that preclude use in many patients. in the past decade, there has been growing evidence that patients with migraine, particularly those with aura, are more likely to have a patent foramen ovale. a patent foramen ovale (pfo) is a persistent, flap-like opening in the wall of the heart, between the right and left atrium. typically, this opening closes shortly after birth, however, in some people, it remains open. while there is currently no proof for cause-effect relationship, several recent studies have confirmed a strong association between the presence of pfo and migraine with aura. comparison: this clinical study will compare pfo closure with medical therapy alone for the treatment of migraine headaches.

Eligibility criteria:
major inclusion criteria: * patient must be between the ages of 18 and 70; * patient must have a migraine history and demonstrate a refractoriness to medical treatment; * patient must have a patent foramen ovale (pfo); * patient must be willing and able to give informed consent and complete required follow-up visits. major exclusion criteria: * patient has any medical condition or receives any medication that would preclude participation in the trial * patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study. * patient is pregnant, or intends to become pregnant during the trial period

Keywords: migraine headache patent foramen ovale patent foramen ovale closure
clinical and magnetic resonance imaging evaluation of micro fragmented adipose tissue injection combined with bone marrow stem cells on healing of temporomandibular joint internal disc derangement without reduction

Conditions: Temporomandibular Joint Disorders

Summary: arthrocentesis of tmj then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of tmj internal disc derangement without reduction.

arthrocentesis of tmj then injection of intra and periarticular of 2 mm of micro fragmented adipose tissue mixed with bone marrow aspirate extracted from 20 mm of bone marrow using gradient separation method in one group and use of bone marrow aspirate injection only in another group and injection of intra and periarticular of 2 mm hyaluronic acid gel in control group on healing of tmj internal disc derangement without reduction.

Eligibility criteria:
inclusion criteria: * patients with tmds not previously surgically treated. * patients with tmj osteoarthritis assessed by clinical examination and magnetic resonance imaging. exclusion criteria: * patients refuse to be enrolled in this study. * patients with uncontrolled systemic disease.
effects of kendall exercises versus kabat exercises in patients with chronic low back pain

Conditions: Low Back Pain

Summary: low back pain (lbp) is pain, muscle tension, or stiffness under the costal border and above the inferior gluteal folds, with or without leg pain.


Eligibility criteria:
inclusion criteria: * both genders * adults aged between 30-65 * low back pain should be persistent for more than 12 weeks * visual analogue scale or vas of 3 or higher * idiopathic pain * ability to engage in physical activity and participate in the intervention program * willingness and ability to provide informed consent to participate in the study exclusion criteria: * low back pain due to other causes 1. fibromyalgia 2. previous spine surgery 3. spondylolisthesis 4. spondylolysis 5. rheumatoid arthritis or ankylosing spondylitis 6. spinal inflammation or tumor 7. spinal or pelvis fracture 8. osteoporosis 9. respiratory or heart diseases 10. stroke 11. pregnancy * persistent use of pain medication * patients who had undergone any other treatments, such as acupuncture or physical therapy, in the last 3 months * anticipated inability to comply with study protocols or attend scheduled."
study of muscle abnormalities in patients with specific genetic mutations

Conditions: Cardiomyopathy, Hypertrophic; Muscular Dystrophy, Oculopharyngeal

Summary: hypertrophic cardiomyopathy (hcm) is a genetically inherited disease affecting the heart. it causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle. this condition can cause patients to experience symptoms of chest pain, shortness of breath, fatigue, and heart beat palpitations. researchers believe the disease may be caused by abnormalities in the genes responsible for producing proteins of the heart muscle. oculopharyngeal muscular dystrophy (opmd) is another genetically inherited disease. this condition affects the muscles of the eyes and throat causing symptoms of weak eye movements, difficulty swallowing and speaking, and weakness of the arms and legs. in previous studies researchers have found that several patients with hypertrophic cardiomyopathy (hcm) also had oculopharyngeal muscular dystrophy (opmd). researchers are interested in learning more about how these two diseases are associated with each other. in this study, researcher plan to collect samples of muscles (skeletal muscle biopsies) from patients belonging to families in which several members have inherited one or both of these diseases. the muscle samples will be used to link the muscle abnormalities with the specific genetic mutations. patients participating in this study may not be directly benefited by it. however, information gathered because of this study may be used to develop better techniques for diagnosing and treating these conditions.

mutations of the fast alpha-tropomyosin gene cause hypertrophic cardiomyopathy (hcm), and are also expressed in skeletal muscle. however, the skeletal phenotype is undetermined. we have identified three families in which hcm is caused by an alpha-tropomyosin mutation. several family members of one of these kindreds have also inherited a distinct skeletal myopathy called oculopharyngeal muscular dystrophy (opmd) which is caused by mutations of the poly(a) binding protein-2 gene (pabp2). the pathologic hallmark of this disease is unique nuclear filament inclusions in skeletal muscle fibers. it is possible that the skeletal muscle phenotype is more severe when the two diseases occur in the same patient. we wish to perform skeletal muscle biopsies to determine the skeletal myopathy in patients with alpha-tropomyosin, in patients with pabp2 gene mutation, and in patients who have inherited both diseases.

Eligibility criteria:
patients will be of either gender, aged 10-80 years old, in whom alpha-tropomyosin and pabp2 genotypes have been determined under protocols 87-h-0057 and 98-h-0100. no bleeding diathesis. negative urine test for pregnancy. no skin infection at site of biopsy.

Keywords: genetic mutations hypertrophic cardiomyopathy oculopharyngeal muscular dystrophy
a study to compare the efficacy and safety of tacrolimus capsules in patient with myasthenia gravis

Conditions: Myasthenia Gravis

Summary: to evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.


Eligibility criteria:
inclusion criteria: * diagnosed as myasthenia gravis (mg) by clinical diagnosis * qmg scores ≥7 at the time of enrollment * basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient exclusion criteria: * receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study * qmg swallowing function score ≥ 2 points or qmg vital capacity = 3 * abnormal hepatic functions * uncontrolled diabetes patients * hyperkalemia patients * immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of hiv infection * patients who are allergic to tacrolimus or macrolide antibiotics * receiving other immuno-inhibitors within 12 weeks

Keywords: prograf immunosuppressant
clinical trial of mesenchymal stem cells in the treatment of severe acute kidney injury

Conditions: Acute Kidney Injury; Mesenchymal Stem Cells

Summary: acute kidney injury(aki) is a common, severe emergency case in clinics,especially severe aki ,which is associated with higher morbidity and mortality. effect of routine therapy is limited and mesenchymal stem cells (msc)are considered a new therapy for treating severe acute kidney injury. patients will be randomized to receive intravenous infusion of msc, or placebo control. this trial is to investigate whether msc can improve renal recovery and mortality of patients with aki.


Eligibility criteria:
inclusion criteria: * have severe aki defined as more than two-fold increase serum creatinine level compared with baseline within 48 hours and/or urinary output consistently\<0.5 ml/kg/h over 12 hours * age between 18 and 65 years * willing or having a legally acceptable representative to give a written informed consent * able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up exclusion criteria: * aki due to post-renal outflow obstruction,glomerulonephritis,lupus nephritis, antineutrophil cytoplasmic antibody (anca) related nephritis, antiglomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and aki caused by purpura nephritis * pregnant or lactating woman * allergic person * organ transplant or hematopoietic stem cell transplant * patients with malignant tumors or those with a history of cancer * life expectancy is less than 3 months * known end-stage liver disease * uncontrollable infection * patients younger than 65 years old ,whose estimated glomerular filtration rate (egfr) were less than 60 * severe pulmonary dysfunction * severe cardiac dysfunction,left ventricular ejection fraction is less than 40%, or severe arrhythmia patients * hemodynamically unstable patients * organ failure affecting more than 2 non-renal organs * acute or chronic vasculitis of any cause * history of chronic systemic infection of any cause * the investigators believe that subjects may need to gradually increase the dose of vasopressor to achieve and / or maintain hemodynamic stability * systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of \>15 mg/day of prednisone or the equivalent within the past 30 days * platelet count \<25,000/ul or other severe hematologic abnormalities, causing the subject to be at risk of death * patients need mechanical ventilation * participate in other clinical trials
evaluation of the gore pv1 device in patients with pulmonary valve dysfunction

Conditions: Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis

Summary: this study will assess the safety and performance of the gore pv1 device for replacement of the pulmonary valve and reconstruction of the right ventricular outflow tract (rvot).


Eligibility criteria:
inclusion criteria: 1. a symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit 2. age ≥5 years at the time of informed consent signature. note: additional inclusion criteria may apply exclusion criteria: 1. an artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years). 2. subjects with previously implanted pacemaker (including defibrillators). 3. major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year. note: additional exclusion criteria may apply
safety and efficacy study of ex vivo immunotherapy for treatment of aplastic anemia

Conditions: Anemia, Aplastic

Summary: our hypothesis is that ex vivo activated immune cells would produce multiple known and unknown potent hematopoietic cytokines, working in concert, these cytokines help stem cell growth and differentiation. additionally, these cells travel and home to bone marrow as well as spleen and liver involved in hematopoietic activities, where direct cell-cell contact may be beneficial.

patients will be required to stay in our hospitals to receive the immunotherapy. allogeneic peripheral blood mononuclear cells from healthy donors and the autologous peripheral mononuclear cells will alternately used for the treatment. patients are expected to spend at least 6 to 12 months in the hospital and won't be released until they have improved significantly.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic aplastic anemia * not eligible for bone marrow transplantation * not responsive to conventional immunosuppressive therapy exclusion criteria: * leukemia or mds or pnh or fanconi's disease * pregnancy * allergic to blood product * severe hypertension or heart disease * liver or kidney disease

Keywords: idiopathic aplastic anemia has failed conventional immunosuppressive therapy not eligible for bone marrow transplantation c15.378.071.085
study of pf-06817024 in healthy subjects, in patients with chronic rhinosinusitis with nasal polyps and in patients with atopic dermatitis

Conditions: Healthy; Chronic Rhinosinusitis With Nasal Polyps; Atopic Dermatitis

Summary: the purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of pf-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe atopic dermatitis

the purpose of the study for part 1 is to evaluate the safety and tolerability of pf-06817024 in healthy subjects. the purpose of the study for part 2 is to evaluate the safety and tolerability of pf-06817024 in patients with chronic rhinosinusitis with nasal polyps. the purpose of the study for part 3 is to evaluate the safety and tolerability of pf-06817024 in patients with moderate-to-severe atopic dermatitis

Eligibility criteria:
inclusion criteria * healthy male subjects, healthy female subjects of non-childbearing potential, 18-55 years of age (part 1) * male subjects, female subjects of non-childbearing potential, female subjects of childbearing potential with documented bilateral tubal ligation (tubes tied) or bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or reduction/loss of smell (part 2) * male or female subjects between the ages of 18 and 75 years, inclusive with moderate-to-severe atopic dermatitis, agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study (part 3) exclusion criteria: * clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.), positive urine drug test, fever within 7 days of dosing, active infections within 28 days of dosing (part 1 and 2 and 3) * history of allergic reaction to topical lidocaine, nasal surgery within 6 months (part 2) * exposure to live or attenuated vaccines, have skin conditions other than atopic dermatitis, use of jak inhibitors and biologics (part 3)

Keywords: fih, pharmacokinetics, pharmacodynamics, safety, tolerability, atopic dermatitis, chronic rhinosinusitis, nasal polyps
a study to compare forms of nemtabrutinib (mk-1026) in healthy adult participants (mk-1026-007)

Conditions: Hematological Malignancy

Summary: the goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.


Eligibility criteria:
inclusion criteria: the key inclusion criteria include but are not limited to the following: * is in good health before randomization * has a body mass index (bmi) ≥18 and ≤32 kg/m\^2, inclusive exclusion criteria: the key exclusion criteria include but are not limited to the following: * has a history of clinically significant endocrine, gastrointestinal (gi), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)
evaluation of three types of dressings after hip surgery

Conditions: Tape Blisters; Hip Surgery

Summary: the purpose of this study is to determine if one of the new types of dressings (mepore pro and/or mepilex border ) will reduce the blister rate compared to the currently used hypafix.


Eligibility criteria:
inclusion criteria: * male or female 45 years old or older * hip surgery at hopital de l'enfant-jesus between 02/2009 and 01/2010 (thr,rthr, dhs, screw fixation, hemiarthroplasty, resurfacing) * signed consent form exclusion criteria: * allergy to dressing * polytrauma / high energy trauma * wound at the surgical site prior to surgery * neurological deficit of operated side (hemiplegia, etc.) * bilateral fracture

Keywords: dressing blisters silicone
effect of nitrate on red blood cell function in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: to investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: type 2 diabetes exclusion criteria: acute coronary syndrome vegetarian diet impaired renal function absolute indication for proton pump inhibitor ongoing treatment with organic nitrate heart failure (ejection fraction \<35%) any condition that interferes with the possibility to fulfill the study protocol
tolerance and growth outcomes in children diagnosed with cow's milk protein allergy and prescribed an extensively hydrolyzed casein formula (damira 2000©) in spain

Conditions: Cow's Milk Protein Allergy

Summary: damira 2000© is a 100% extensive casein hydrolysate (ehcf). it is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (cmpa), to be well tolerated and to help improve symptoms.damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to cmpa, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.the study aimed at evaluating the tolerance of damira 2000 in a cohort of children with cmpa.


Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of allergy to cow's milk protein (cmpa): either confirmed through a placebo-controlled food challenge (dbpcfc) or highly suspected based on specific suggestive symptoms; 2. patients under the age of 1 year at the time of cow's milk protein allergy diagnosis. 3. patients taken damira 2000 for at least 4 months at the time of data extraction. 4. patients with information available on child growth (weight and height) and the following anthropometric indices at diagnosis and for at least 2 follow-up visits after first hospital visit/4 months\*: z-scores for weight-for-age (waz), height-for-age (haz), weight-for-height (whz) and body mass index (bmi)-for-age (baz). exclusion criteria: 1. patients who used other infant formulae or breast milk in addition to the study product of interest during the retrospective study period. 2. premature children with a low birth-weight (\<2.5 kg). 3. patients diagnosed with a metabolic condition that impacts development and growth. 4. patients diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the investigator could potentially interfere with the aim of the study.
chlorhexidine cloths to reduce surgical site infection in cesarean deliveries

Conditions: Surgical Site Infection

Summary: pregnancy-associated infection represents a major cause of maternal morbidity and mortality. cesarean delivery is the most common major surgical procedure and is associated with a rate of surgical site infection (ssi) that is approximately 5-10 times the rate for vaginal delivery. efforts to reduce the risk of ssis in this patient population include the use of preoperative antibiotic prophylaxis in addition to skin and vaginal antiseptic preparations.nevertheless, the rate of ssi in women undergoing non-scheduled cesarean delivery is up to 18%, a significant number that contributes to prolonged hospital stays and increased health care costs. every effort should be made to reduce this major cause of pregnancy-associated morbidity and mortality to aid in the care of patients and reduce the associated prolonged hospital stays, readmission rates and health care costs. studies have shown that preoperative application of chlorhexidine cloths reduces the risk of ssi, however this is based on literature in the orthopedic and intensive care patients. the efficacy of this intervention has not been studied in obstetric patients undergoing cesarean delivery. furthermore, obstetric patients undergoing non-scheduled cesarean delivery represent a target population as it is thought that infectious morbidity is higher in this patient population. therefore, there is a need for this trial to determine if this intervention is effective in reducing the rate of postoperative ssis.

this randomized clinical trial will be investigating the use of preoperative chlorhexidine cloths, a chemical skin antiseptic agent effective on gram positive and gram negative bacteria, as an intervention to reduce the rate of surgical site infections (ssis). the intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths. the control group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care. the impact on women's health is significant, as a reduction in ssis in this prevalent patient population can reduce the number of prolonged hospital stays, outpatient follow-ups for infection, hospital readmissions and health care costs.

Eligibility criteria:
inclusion criteria: * undergoing non-scheduled cesarean delivery \> 23 weeks gestation exclusion criteria: * allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site

Keywords: chlorhexidine cloth surgical site infection non-scheduled cesarean delivery