Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and pharmacology of subcutaneous administration of cinryze with recombinant human hyaluronidase

Conditions: Hereditary Angioedema

Summary: the objectives of the study are to: 1. evaluate the safety and tolerability of subcutaneously administered cinryze with recombinant human hyaluronidase (rhuph20) in subjects with hereditary angioedema (hae) who previously participated in cinryze study 0624-200 (nct01095497) 2. characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered cinryze with rhuph20 3. assess the immunogenicity of cinryze following subcutaneous (sc) administration of cinryze with rhuph20


Eligibility criteria:
inclusion criteria: to be eligible for this protocol, a subject must: 1. provide informed consent/assent, as appropriate. 2. have previously participated in cinryze study 0624-200 and completed the subcutaneous therapy period in that study. 3. during the 3 consecutive months prior to screening, have a history of less than 1 hae attack per month (average) that required treatment with c1 inh therapy or other blood products. 4. agree to avoid his/her known hae triggers during the study to the best of his/her ability. exclusion criteria: to be eligible for this protocol, a subject must not: 1. have received c1 inh therapy or any blood products for treatment or prevention of an hae attack within 14 days prior to the first dose of study drug. 2. have received any ecallantide (kalbitor), icatibant (firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug. 3. have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug. 4. if female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug. 5. have a history of abnormal blood clotting. 6. have a history of allergic reaction to products containing c1 inh or other blood products. 7. have a known allergy to hyaluronidase or any other ingredient in rhuph20. 8. be pregnant or breastfeeding. 9. have received an investigational study drug within 30 days prior to the first dose of study drug.

Keywords: hae c1 esterase inhibitor c1 inh subcutaneous hyaluronidase rhuph20
fractional laser therapy and dermabrasion for scar revision

Conditions: Scar

Summary: the goals of this study will be to compare the safety and efficacy of fractional photothermolysis (fraxel) with dermabrasion when used for scar revision.

post traumatic and post surgical scar resurfacing is a common reason for patient visits to dermatologists and plastic surgeons. the fraxel laser is a new fda cleared treatment for textural irregularities of the skin. there have been no studies examining the efficacy of fraxel specifically for scar resurfacing though it is being used in clinical practice as its clearance was given under hte umbrella of "coagulation of soft tissue." dermabrasion is the gold standard for scar resurfacing and provides the criterion against which fraxel therapy should be measured.

Eligibility criteria:
inclusion criteria: * post surgical or post traumatic scar on face or scalp * age 18 or older * able to read and comprehend english * willing to follow treatment schedule and post treatment care requirements * signed informed consent form * fitzpatrick skin type i-iii exclusion criteria: * known photosensitivity * taken any medications known to induce photosensitivity in previous three months * taken accutane within past 12 months * pregnant or nursing * currently on topical or oral antibiotics * immunocompromised status * skin type iv or greater

Keywords: post surgical or post traumatic scar on face or scalp
virtual reality for preoperative anxiety in interventional cardiology

Conditions: Anxiety

Summary: improving the management of perioperative anxiety is important. anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. these findings are also true in interventional cardiology. that is why, for several months, the grenoble university hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). following a survey of the patients of grenoble university hospital, a gray area persists in their care. the room where the patient attends his examination. the investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.


Eligibility criteria:
inclusion criteria: * major male or female patient * coronarography procedure programmed for exploration of coronary artery disease following a positive ischemia test, realized in ambulatory * patient who has given written consent to participate in the study exclusion criteria: * arrhythmia patient and / or patient with a pacemaker * hemodynamic instability * patient who has already had coronarography * prior revascularization by coronary bypass * end-stage renal disease (creatinine clearance \<30 ml / min), * allergy to iodine contrast agent * blind or visually impaired patient (high degree) * deaf or hard of hearing patient * patient with claustrophobia or unable to wear a mask over the eyes * patient whose physical or psychological state could compromise obtaining informed consent and compliance with protocol requirements * patient under administrative or judicial supervision * foreign patient who does not understand french * major patient protected by law (article l1121-8 and l1121-5) * pregnant or lactating patient * patient not affiliated with social security

Keywords: interventional cardiopathy preoperative anxiety virtual reality
expanded controlled study of safety and efficacy of mci-186 in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this is a long-term, double-blind, placebo-controlled study of mci-186 to treat als. this study is the long-term extension of study nct00330681; study nct00330681 is a phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of als. the objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg mci-186 to als patients.


Eligibility criteria:
inclusion criteria: * patients who ware completed drug administration without discontinuation in the preceding confirmatory study nct00330681. exclusion criteria: * patients with such complications as parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone. * patients whose creatinine clearance is 50ml/min or less at the time of completion of drug administration in the study nct00330681. * pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. * patients who are participating in other clinical trials except the study nct00330681. * in addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Keywords: amyotrophic lateral sclerosis (als)
fast food, fatigue, and inflammation

Conditions: Breast Cancer

Summary: this double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).


Eligibility criteria:
inclusion criteria: * we recruited a subset of a larger parent longitudinal observational study to participate in this study. initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis. exclusion criteria: * a history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.

Keywords: breast cancer
neuroimaging study of factors related to exercise

Conditions: Obesity

Summary: this study aims to support the hypothesis that brain processes underlying reward processing and impulse control contribute to obesity and to adherence in a new exercise regimen.

this is a nonrandomized trial with groups being defined by bmi and adherence status to the exercise intervention.

Eligibility criteria:
inclusion criteria: * bmi \>25 to \< 40±1 * must live in the greater kansas city area for at least 1 year * willing to exercise * provide written approval from a licensed physician that they are healthy enough to participate in a program of moderate physical activity and maximum o2 testing * all participants must be sedentary except for casual recreation such as softball, bowling, etc. exclusion criteria: * color-blindness * left-handedness * any diagnosed neurological disorder or conditions that preclude mri scanning (e.g., metal in body) * participation in a research project involving weight loss or physical activity in the previous 6 months * subjects who smoke * subjects use medications that affect metabolism (i.e. thyroid, beta blockers), use medications that affect appetite (i.e. meridia) or cannot exercise (i.e. walk) * participants will be excluded by study personnel following interview if they exhibit eating disorders, binge eating, depression or drug addiction * metabolic disease that would affect energy balance (e.g. diabetes mellitus or hypothyroidism) * pregnant during the previous 6 months, are lactating, or plan pregnancy within 12 months * individuals who are not weight stable (± 4.5kg) within the previous year. * serious medical risks such as type 1-diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.) * high blood pressure * current use of smoking/tobacco products or initiation of the use of smoking/tobacco products during the study and alcohol abuse and any history of dependence * subject iq is less that 80 * reported radiation exposure from ct, pet, fluoroscopic or nuclear medicine studies within the previous year, or other radiation exposure at the discretion of the pi

Keywords: reward processing impulse control obese clinically obese
zenith(r) fenestrated abdominal aortic aneurysm (aaa) endovascular graft clinical study

Conditions: Abdominal Aortic Aneurysms; Aorto-iliac Aneurysms; Juxtarenal Aneurysms

Summary: the zenith(r) fenestrated aaa endovascular graft clinical study is a clinical investigation approved by the us fda to study the safety and effectiveness of the zenith(r) fenestrated aaa endovascular graft in the treatment of abdominal aortic and aorto-iliac aneurysms.


Eligibility criteria:
inclusion criteria: * abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm exclusion criteria: * proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal * renal artery stenosis greater than 50 percent
postoperative acute myocardial ischemic injury

Conditions: Myocardial Infarction

Summary: the investigators propose to estimate the sensitivity and specificity of the vectraplexecg system for detecting acute myocardial ischemic injury, including acute myocardial infarctions after major non-cardiac surgery. a 10 second ceb dynamic sequence recording will be obtained immediately after surgery in the post-anesthesia care unit. on the first, second and third post operative morning a 10 second ceb dynamic sequence will be recorded. blood will be sampled for troponin as well. on the first, second and third post operative afternoons a 10 second ceb dynamic sequence will be recorded. the morning 10 second ceb dynamic sequence and blood draw for troponin will continue as long as the patient remains hospitalized. the afternoon 10 second ceb dynamic sequence will continue as long as the patient remains hospitalized.


Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. ≥ 45 years old. 3. anticipated hospitalization of at least two nights. exclusion criteria: 1. inadequate ecgs, based on an initial 10-second trace, as defined by: * wandering baseline * excessive noise * ventricular ectopy * pacer spikes or * lead placement error 2. atrial fibrillation. 3. average heart rate exceeding 90 beats/minute. 4. evidence of previous myocardial infarction: * pathologic q waves (≥0.04 sec) and/or * pathologic findings of a healed or healing mi and/or * evidence from an imaging study of a region of loss of viable myocardium
a study of apto-253 in patients with relapsed or refractory aml or mds

Conditions: Acute Myelogenous Leukemia in Relapse; Acute Myelogenous Leukemia, Relapsed, Adult; Acute Myelogenous Leukemia, Adult; Acute Myelogenous Leukemia; High Risk Myelodysplasia

Summary: this study is being done to evaluate the safety and effectiveness of apto-253 for the treatment of patients with the condition of acute myelogenous leukemia (aml) or myelodysplastic syndrome (mds) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

this is a multicenter, open-label, phase ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of apto-253 in ascending cohorts (3+3 design) to determine the mtd or recommended dose in patients with relapsed or refractory acute myelogenous leukemia (aml) or high-risk mds patients. this is to be followed by a cohort expansion phase at the mtd or recommended dose.

Eligibility criteria:
inclusion criteria: * patients ≥18 years old * life expectancy of at least 2 months * off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic agents prior to first study treatment administration * patients must have a calculated creatinine clearance \>60 ml/min * acceptable hematologic, renal and liver functions and coagulation status parameters exclusion criteria: * patients with gvhd requiring systemic immunosuppressive therapy * uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder * clinically significant intravascular coagulation * treatment with other investigational drugs within 14 days prior to first study treatment administration

Keywords: aml mds leukemia acute myeloid leukemia aptose apto-253 kinase inhibitor
is the walking velocity an efficient outcome of rehabilitation program in non- specific low back pain patient

Conditions: Non-specific Low Back Pain; Functional Capacities

Summary: despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). however, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. this retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. these patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. in this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of quebec, muscle tests shirado and sorensen).


Eligibility criteria:
inclusion criteria: * female or male * age between 18 and 70 * non-specific low back pain - achieved rehabilitation program exclusion criteria: * inflammatory diseases * cancer * infectious diseases
outcome of conservative management in cases of pre mature rupture of membranes (prom) between 20 and 28 weeks of pregnancy in sohag city hospitals

Conditions: PROM, Preterm (Pregnancy)

Summary: prospective observational study


Eligibility criteria:
inclusion criteria: * pregnant woman 24 weeks to 28 weeks of pregnancy with prom exclusion criteria: * gestational age other than the mentioned before multiple pregnancy cerclage other causes of decreased af
anterior knee pain after tibial nailing

Conditions: Knee Pain

Summary: anterior knee pain (akp) is a common complication following intramedullary (im) nailing of a tibial shaft fracture. the purpose of this prospective study was to determine if there is an association between akp and nail position. the investigators have analyzed postoperative outcome results and the possible relationship between akp according to the visual-analog scale (vas) scale, and nail position marked as a distance from the tip of the nail to the tibial plateau (np) and tuberositas tibiae (nt), measured postoperatively on l-l knee x-rays.

the aim of this study was to determine the possible relationship between anterior knee pain (akp) and nail position marked as a distance from tip of nail to tibial plateau (np) and to the tuberositas tibiae (nt). we evaluated postoperative outcome results of 50 patients in the last 3 years with healed fractures initially treated with intramedullary (im) reamed nails with 2 or 3 interlocking screws on both parts of the nail and with the use of medial peritendinous incision for nail entry portal. patients marked a point on the visual analog scale (vas) that corresponded to the level of postoperative akp felt. two groups of patients were formed on the basis of akp (pain level was neglected): groups a and b, with and without pain, respectively. we found that the difference between the two groups concerning np measurements was statistically significant, but not concerning nt measurements (p \< 0.05). patients were classified by pain with high accuracy (98%) according to a classification tree. we conclude that the symptoms of akp did not appear if the tip of the nail position was more than 6.0 mm from the np and more than 2.6 mm from the nt. however, for better evaluation of these results it will be necessary to examine more postoperative patients with akp.

Eligibility criteria:
inclusion criteria: * tibial shaft fractures * fracture treatment with intramedullary nailing with 2 or 3 interlocking screws on both ends of the nail exclusion criteria: * amputated legs

Keywords: knee tibial fractures pain osteosynthesis intramedullary nailing
adjunctive vaginal progesterone in management of preterm labor

Conditions: Preterm Labor

Summary: this study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.


Eligibility criteria:
inclusion criteria: * singleton pregnancy with gestational age 24-33 weeks 6 days * preterm labor * received treatment with tocolysis and corticosteroids exclusion criteria: * conditions that need immediate delivery such as fetal distress, chorioamnionitis * have medical complications such as heart disease, seizure * fetal anomalies * cervical dilatation more than 5 cm * allergy to progesterone * contraindication to progesterone * contraindication to tocolytic use
pancreatic and gastrointestinal tumor registry and tissue collection

Conditions: Pancreatic Cancer

Summary: the purpose of the study is to collect pancreatic tissue, blood and urine from adults to study pancreatic abnormalities.

the aim of the study is to standardize, collect and share pancreatic cancer related information, to be used for research purposes only by researchers from different participating institutions/centers.

Eligibility criteria:
inclusion criteria: * person over 19 years of age, patient with a tissue-proven diagnosis of pancreatic cancer at the university of alabama at birmingham (uab) university hospital during the period, and cognitive ability to provide informed consent exclusion criteria: * person not 19 or older and have not had a tissue-proven diagnosis of pancreatic cancer.
the transversus abdominis plane block: a prospective randomized clinical trial using exparel.

Conditions: Postoperative Pain

Summary: the purpose of the study is to evaluate the effectiveness of exparel in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.


Eligibility criteria:
inclusion criteria: 1. patients over the age of 18 years w 2. elective laparoscopic colorectal resection. exclusion criteria: 1. patients under 18 years. 2. patients unable to provide informed consent 3. patients undergoing emergency surgery. 4. pregnant women 5. severe liver or kidney disease (gfr 15-29 ml/min)
acceptability study of vaginal films for hiv prevention

Conditions: HIV Infections; Anti-Infective Agents

Summary: this study is being done to find out what women would want in a film vaginal product for human immunodeficiency virus (hiv) prevention, especially what it should look like and how to apply it. the investigators hypothesize that women will prefer a smooth, clear, and rectangular quick-dissolve vaginal film for hiv prevention over a textured, opaque, square quick-dissolve vaginal film.

the lives of 25 million people have ended due to hiv-related causes since the start of the aids epidemic in 1981 (1). each year, aids continues to claim the lives of millions of people, with an estimated two million deaths worldwide in 2008 (2). heterosexual transmission of hiv accounts for the majority of new infections and disproportionately affects women both in the united states and globally (2, 3). there is an urgent need for agents to prevent the sexual transmission of hiv, particularly agents that may be controlled by women. quick dissolve films such as listerene® breath strips have been developed for inexpensive delivery of drugs and vitamins. as products for hiv prevention, quick dissolve films offer a host of potential advantages including low cost, control by the receptive partner, discreet and applicator-free use, low mess, portability, easy storage, stability, targeting to site of exposure, reduction of systemic toxicity by bypassing first-pass metabolism, and the incorporation of multiple active microbicidal compounds (4, 5). in the course of developing agents for hiv prevention, determination of valued characteristics is important for product refinement and for enhancement of future use likelihood. knowledge regarding acceptability can also inform product promotion and educational campaigns (6).

Eligibility criteria:
inclusion criteria: * female 18-30 years old at time of enrollment * able to provide written informed consent exclusion criteria: * not sexually active, defined as no vaginal sex at any time in the past year * pregnant by self-report

Keywords: hiv prevention vaginal film microbicide administration, intravaginal