Kornimate/medical-research-clean huggingface dataset:
evaluation of a dual action pneumatic compression system: tolerance and comfort in patients with venous leg ulcers (vlus)

Conditions: Venous Leg Ulcer; Chronic Venous Insufficiency; Venous Stasis Ulcer; Venous Ulcer; Venous Insufficiency

Summary: the purpose of the study is to assess treatment tolerance and comfort in chronic vlus after 4 weeks of treatment using a dual action pneumatic compression device.

subjects with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before receiving 4 weeks of treatment using a pneumatic compression device. subjects will be seen in clinic weekly for an evaluation, complete symptom and quality of life questionnaires.

Eligibility criteria:
inclusion criteria: * subject must be ≥ 18 years of age or legal age at the time of enrollment. * chronic venous insufficiency confirmed by ultrasound within previous 12 months. * active ulceration (ceap classification of c6) * ulcer duration: ≥ 2 month but not greater than 24 months - non healing vlu with conservative treatment. * ulcer size ≥ 2cm2 ≤ 50cm2 * leg circumferences within the following range:ankle - 12 to 44cm;calf - 22 to 60cm; below knee - 22 to 68cm exclusion criteria: * target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone. * greater than 3 separate full thickness ulcers on the study limb * target ulcer is of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy). * treatment of the target ulcer with living cellular therapy within 30 days of the time of enrollment. * history of an acute deep vein thrombosis (dvt) or pulmonary embolism (pe) within the last 3 months. * either the dorsalis pedis (dp) or posterior tibial (pt) systolic pressure \< 80mmhg for diabetic patients or \< 60mmhg for non-diabetic patients on study limb or transcutaneous partial pressure oxygen (tcp02) ≤ 30mmhg or great toe systolic pressure ≤ 40mmhg. * acute thrombophlebitis. * history of pulmonary edema or decompensated congestive heart failure. * currently has an active infection of the skin such as cellulitis requiring antibiotics. * history of cancer within the last 5 years with the exception of treated non-melanoma skin cancer or cervical carcinoma in situ. * poorly controlled diabetes with a hemoglobin a1c (hba1c) value of \>12%. * changes to medications that affect edema within the last 30 days * need for current and ongoing therapy with corticosteroids (exception for continued low dose usage) or cytotoxic drugs or the current use of daflon 500. * currently pregnant or trying to become pregnant. * inability or unwillingness to participate in all aspects of study protocol. * currently participating in another clinical trial.
repair of flexor tendon in zone ii using minimal incisions

Conditions: Flexor Tendon Rupture

Summary: repair of the zone ii flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.

flexor tendon laceration in the hand is a common injury with unique characteristics owing to the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical technique as well as strict rehabilitation protocol for regaining function. the hand is divided into 5 zones (verdan's). zone ii is described by bunnel as "no man's land" historically back to the 14th century (an area outside london used for executions) because it was previously believed that primary repair should not be done in this zone. after understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and anesthesia repair is possible with good results. lacerated tendons in zone ii can retract proximally to the pip if the vinculum longus is intact or into the palm if it is disrupted. it will not retract to the level of the wrist because of the origin of the lumbrical insertion into the extensor mechanism. the laceration can be extended in a brunner incision or a mid-lateral exposure but it is better skin incisions are minimal to minimize postoperative finger edema, potential adhesions, and injury of any delicate structures. there are a lot of techniques to retrieve the proximal tendon end as milking, using a hemostat or second incision proximal to the a1 pulley where the tendon is tied to a looped wire of silastic tube and pulled distally through the laceration in the tendon sheath. but little studies discuss the effect of minimal incision on functional outcomes post-operative.

Eligibility criteria:
inclusion criteria: age: between 16-60 years. * flexor tendon injuries of zone ii of any medial four digits in both genders. * within two weeks. * sharp mechanism of injury. * single-level injury * minimal surgical incision. exclusion criteria: * age less than sixteen years old or more than sixty years old. * amputation requiring replantation. * vascular injury requiring revascularization * associated fractures close to the tendon injury. * combined flexor and extensor tendon injury. * multiple-level injury * tendon substance loss * insufficient skin and soft tissue coverage. * surgical incision for whole tendon exposure.
effect of scfos on increase in stool frequency in constipated people

Conditions: Functional Constipation; Healthy

Summary: the study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

this randomized, placebo-controlled, double-blind study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

Eligibility criteria:
inclusion criteria: * functional constipation according to rome iii criteria with 3 or less than 3 stools per week * bmi between 18 and 32kg/m², limits included * subjects who do not usually eat high-fibre foods * subjects who do not usually consume foods siad "reduced in sugars" or "light" * subjects who do not consume regularly pre- and probiotics in the form of dietary supplements exclusion criteria: * subjects presenting irritable bowel syndrome * history of chronic gi disorders: crohn disease, ulcerative colitis,.... * treatments likely to influence gi sensitivity or motility (laxative, neuroleptics,...) * antibiotic therapy in progress or in the past 8 weeks * medical history with impact on the study objectives as defined by investigator * known food allergy to one of the compounds of the study product
drug allergy labels after drug allergy investigation

Conditions: Drug Hypersensitivity

Summary: the aim of this study is to investigate the degree of match between the drug allergy label in the hospital's electronic health record and primary care's electronic health record among patients who previously have been drug allergy tested.

patients who previously have been penicillin allergy tested in 2017 to 2019 at the allergy clinic at gentofte hospital is included in the study. patients are identified through a drug allergy database at the department. a letter describing the study and the data collection process will be sent to the patients' general practice offices (gp). data collection: the patients gp's are contacted by telephone where the information about the drug allergy labels in their electronical medical charts are shared. on the same day as the phone contact to the gp's office, the patient's electronical health record in the hospital system is accessed in order to gain information about the current drug allergy registrations. predictors for the explanatory analysis is collected partly through the phone call to the gp (such as numbers of patients and physicians at each gp and the electronic health system used), from the hospital electronic health record (such as number of hospital admissions since drug allergy testing) and from the drug allergy database.

Eligibility criteria:
inclusion criteria: * penicillin allergy tested at the allergy clinic, copenhagen university hospital - herlev and gentofte, copenhagen, denmark in 2017-2019 exclusion criteria: -

Keywords: drug allergy drug allergy labels penicillin allergy labels
treatment of onychomycosis using a 0.65 millisecond pulsed nd:yag 1064 nm laser

Conditions: Onychomycosis

Summary: the investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. the investigators will compare the success rates of those receiving laser treatments with untreated patients. this study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.

current antifungal treatments have low cure rates and numerous side effects. a new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. while the treatment method has become increasingly popular, studies of its efficacy are few. the investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. this knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.

Eligibility criteria:
inclusion criteria: * have onychomycosis on at least one toe. * age 18 or older. * consent to research use of their toenail clippings. exclusion criteria: * current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs. * pregnant female. * age 75 or older.
innovation of breakfast cereals and snacks for control of appetite and post-prandial glycemia

Conditions: Obesity; Diabetes

Summary: the goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2 exclusion criteria: * smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives * women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy * individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet

Keywords: satiety food intake breakfast cereals/snacks postprandial glycemia
pre-surgery positron emission mammography in patients with newly diagnosed breast cancer

Conditions: Breast Cancer; Breast Cancer Surgery

Summary: the purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for positron emission mammography (pem), and the accuracy and reliability of pem in pre-surgical evaluations for patients with newly diagnosed breast cancer anticipating breast-conserving surgery but identified to have a second unsuspected breast cancer by mri.

the purpose of this research in phase 1 is to determine the lowest dose of radionuclide 18f-fdg that can be used in the diagnostic use of positron emission mammography for the diagnosis of multifocal breast cancer in patients wishing to have breast conservation surgery for newly diagnosed breast cancer. low dose injections (radioactive counts) of 18f-fdg will be compared to the equivalent radioactive counts for the standard higher dose 10 millicuries used in standard pem studies in current clinical practice. images will be post processed by computer aided software and will be placed in two categories: low dose group, and higher dose group. images will be randomly blinded to readers to assess the ability to see positive lesions that warrant further biopsy or to include in current surgical planning prior to breast conservation surgery or mastectomy. images will be assessed for ability to see the pem positive lesions on the lower dose images and this will be compared to the ability to see the pem positive lesions on the standard higher dose images. each of three breast cancer categories will be assessed infiltrating ductal carcinoma, lobular infiltrating carcinoma, and ductal carcinoma insitu. phase 1 will have 30 patients. the purpose of the research in phase 2 is to use the lowest dose identified in phase 1 for imaging primary breast cancer patients who have been identified by breast mri to have an unsuspected second lesion of the breast not expected from mammography or ultrasound that requires biopsy for diagnosis prior to the biopsy to compare the reliability of pem and mri for identifying breast cancer at the 2nd site. parameters assessed will include standard statistical analysis for sensitivity, specificity, positive predictive value and negative predictive value for mri and pem imaging with the new lower radionuclide dose selected by phase 1. phase 2 will have 100 patients.

Eligibility criteria:
inclusion criteria: * must be 18 years of age or older * newly diagnosed primary breast cancer * must have a breast or breast/chest mri ordered as part of standard of care * must meet one or more of the following in part 1: * t1 carcinoma of the breast appropriate for breast conserving surgery diagnosis established by core biopsy * tis (ductal carcinoma in situ) carcinoma \> 2 cm diameter * invasive lobular carcinoma of the breast * must meet the following in part 2: * known invasive or in situ primary breast cancer identified on pre-surgical breast mri to have an unsuspected 2nd lesion recommended for biopsy and biopsy has not yet been performed exclusion criteria: * known diabetes mellitus

Keywords: breast diseases breast neoplasms neoplasms
traditional versus virtual reality for surgical skills for obgyn residents

Conditions: Gynecologic Disease

Summary: this study will verify if a comprehensive laparoscopic curriculum using virtual reality demonstrates skills transfer to the operating room, compared to the traditional teaching method.

second-year residents from different programs of residency in obstetrics and gynecology in porto alegre, rs, brazil, will be invited to participate in this study. they will be randomized to receive a comprehensive training in laparoscopy using modern virtual reality program or the traditional method of training according to their residency program. after 12 weeks of training, they will finish their training and they will perform advanced laparoscopic surgery in the simulator according to their specific needs, for example, salpingectomy, oophorectomy advanced laparoscopic suture or hysterectomy. data generated from the simulator program will be compared between groups.

Eligibility criteria:
inclusion criteria: * residents in obstetrics and gynecology that are about to finish their second-year program exclusion criteria: * refuse to participate

Keywords: competency-based education gynecology laparoscopy resident education simulation surgical curriculum
assessment of bone density and bone turnover markers in patients with down syndrome and comparison to the ts65dn model

Conditions: Down Syndrome

Summary: this study may provide information that may serve as the foundation for a larger research study to address issues regarding the causes, diagnosis, and treatment of osteoporosis in the down syndrome patient population.

osteoporosis is responsible for more than 1.5 million fractures and $14 billion in medical care costs annually (u.s dept of health and human services data, 2006). down syndrome is an independent risk factor for osteopenia/osteoporosis. increases in life expectancy as well as costly morbidity following fracture are reasons for further investigation of osteoporosis and prevention in this population. etiology for low bone density is presently unknown in this population but may be related to unique genes on chromosome 21 which alter the biochemistry of bone metabolism or change the gonadal, thyroid and parathyroid function to alter bone formation and/or resorption. there are no published data on the measurement of bone turnover markers in the down syndrome population; therefore we will measure and accrue this information and compare to our ts65dn data, as described later in this protocol. this pilot study will serve as the foundation for a larger translational research grant which will address multiple issues regarding the pathogenesis, diagnosis and treatment of osteoporosis in the down syndrome patient population and the down syndrome mouse model (ts65dn). the data has the potential to improve our fundamental understanding of osteoporosis pathogenesis and treatment in the down syndrome patient with potential applications to treatment in the general population.

Eligibility criteria:
inclusion criteria: * males and females of all races and ethnicities * age 18 or older and current clinical diagnosis of down syndrome exclusion criteria: * no legally authorized representative (if applicable) willing to provide informed consent. any condition the investigator determines will put the subject at risk by participating in the study.
ima402 t cell-engaging receptor molecule (tcer®) in recurrent and/or refractory solid tumors

Conditions: Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult; Cancer

Summary: the goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of ima402 in patients with recurrent and/or refractory solid tumors. primary objectives: * to determine the maximum tolerated dose and/or recommended dose for extension for ima402 (phase i) * to characterize the safety and tolerability of ima402 (phase i/ii) * to evaluate anti-tumor activity of ima402 (phase ii) secondary objectives: * to evaluate the initial anti-tumor activity of ima402 (phase i) * to evaluate anti-tumor activity of ima402 (phase ii) * to describe the pk of ima402 (phase i/ii)

the study will be conducted in two phases: * phase ia: dose escalation/de-escalation * phase ib: dose extension * phase ii: dose extension in selected indication-specific extension cohort(s) (isec)

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication * patients must have received or not be eligible for all available indicated standard-of-care treatments * measurable disease according to recist 1.1 * confirmed hla status * ecog performance status of 0 to 1 * adequate baseline hematologic, hepatic and renal function, acceptable coagulation status exclusion criteria: * other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) * the patient is pregnant or is breastfeeding * history of hypersensitivity to components of ima402 or rescue medications, if no alternative treatment option is available * the patient has concurrent severe and/or uncontrolled medical disease. any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures * patients with active brain metastases
apremilast in the treatment of uveitis

Conditions: Uveitis

Summary: the purpose of this study is to assess the safety and efficacy of apremilast in the treatment of uveitis.


Eligibility criteria:
inclusion criteria: * patients with vision-threatening autoimmune uveitis * failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects exclusion criteria: * serious concomitant illness that could interfere with the subject's participation * previous or current use of an alkylating agent * use of cyp3a4 inhibitors during the trial * tnf blocker use within the 8 weeks prior to enrollment

Keywords: uveitis apremilast
neuroimaging of pain: changes in regional brain functioning associated with amplified pain and intensive treatment

Conditions: Pain, Chronic

Summary: the proposed study will examine how intensive interdisciplinary pain treatment (iipt, specifically the rehabilitation for amplified pain syndrome, or raps, program at children's mercy hospital) impacts neurofunctional mechanisms of emotional and physical pain processing in patients. there has been recent interest in characterizing the brain regions responsible for processing pain (wager et al., 2013), but little research has included youth. a better understanding of the physiological mechanisms of pain can lead to better treatment outcomes.

youth will be scanned before or during the first week of participation in the rehabilitation for amplified pain syndrome (raps) program, and a second time near or just after program completion (typically 3-5 weeks later). one functional mri task will involve passive viewing of emotional and pain-related images including some that have been widely used in previous neuroimaging research (e.g., the international affective picture set, human facial expressions; alternating positive and negative affect/valence). the other functional mri task, will involve systematic external application of somatosensory stimulation (pressure) to the hand in alternating blocks. the entire imaging procedure will take approximately an hour. mri technicians and/or study staff will administer the scanning protocol. study team will be responsible for the systematic external application of sensory input.

Eligibility criteria:
inclusion criteria: * age 13 to 19 * admitted to the raps program for intensive treatment exclusion criteria: * inability to participate in imaging due to developmental delay * inability or unwillingness to be still during imaging procedures

Keywords: intensive interdisciplinary pain treatment fmri fear of pain
tuberculosis in hiv infected patients in uganda

Conditions: Tuberculosis; HIV Infections

Summary: this was a clinical trial in hiv infected patients with tuberculosis. the study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. the study demonstrated that prednisolone increased the cd4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. therefore, the use of prednisolone for tuberculosis in hiv infected patients is not recommended at this time.

recent observations from retrospective cohort studies indicate that hiv-associated tuberculosis (tb) is associated with reduced survival and increased rate of opportunistic infections compared to cd4-matched controls. mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis, in which cytokines such as tumor necrosis factor alpha (tnf alpha) are over-expressed during the course of tb and stimulate viral replication in latently infected cells, possibly leading to greater viral load. glucocorticoids are potent inhibitors of cytokines, including tnf, and clinicians have extensive experiences with their use in hiv infection. although corticosteroid use in hiv infection has a record of safety, the safety and bioavailability of corticosteroids in hiv/tb coinfection has not been established. this study evaluated the change in viral load and cd4 count in hiv infected patients with tb who were treated with oral prednisolone. the study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly. although there was some benefit to using prednisolone in these patients, the benefit was short-lived and was gone within 4 months of stopping therapy.

Eligibility criteria:
inclusion criteria * pulmonary tb (smear positive) * hiv infected * residence within 20 km of kampala city * allows frequent blood specimens to be drawn

Keywords: tuberculosis hiv infection prednisolone safety immune activation