Kornimate/medical-research-clean huggingface dataset:
dermacell in subjects with chronic wounds of the lower extremities

Conditions: Diabetic Foot Ulcer

Summary: the study will compare treatment with dermacell to conventional care in diabetic foot ulcers (dfu) and venous stasis ulcers (vsu).

this study is designed to demonstrate the effectiveness of dermacell in the treatment of chronic wounds of the lower extremities. dermacell will be compared to conventional care in both subjects with diabetic foot ulcers (dfu) and subjects with venous stasis ulcers (vsu). in addition, dermacell will be compared to an active comparator, graftjacket, in subjects with diabetic foot ulcers. dermacell and graftjacket are both made from donated human skin (dermis). these products have been processed so that cells are removed and bacteria and viruses are destroyed. this processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.

Eligibility criteria:
inclusion criteria: * male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment; * if diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days; * have a dfu that has been present for at least 30 days or have a vsu that has been present for at least 60 days; exclusion criteria: * have a dfu or vsu that is infected; * are pregnant or lactating; * have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin b, or vancomycin; * have a sensitivity to polysorbate 20, n-lauroyl sarcosinate, benzonase or glycerol; * have had a hba1c level greater than 12% within the past 90 days; * have liver function tests or kidney function tests that are very elevated; * have a known or suspected disease of the immune system; * have had surgery in the past 30 days to increase blood flow into your leg or foot; * have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis); * have undergone wound healing treatment with a living skin equivalent (i.e., dermagraft®, apligraf®, theraskin®, oasis®, graftjacket®, integra®, alloderm®) or topical growth factors in the last 4 weeks; * have active charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);

Keywords: diabetic foot ulcer venous stasis ulcer wound of the lower extremity skin substitute acellular dermal matrix
efficacy and safety of ustekinumab in patients with moderate to severe palmar plantar psoriasis

Conditions: Moderate to Severe Palmar Plantar Psoriasis

Summary: the purpose of this study is to determine the short and long term safety and effectiveness of ustekinumab in subjects with moderate to severe chronic palmar plantar psoriasis.


Eligibility criteria:
inclusion criteria: 1. adults between 18 and 85 years of age with palmar plantar psoriasis with well defined psoriatic plaques on the palms and/or soles with a physician global assessment (pga) of 3 or higher who are unresponsive to topical management. pustules, fissures and psoriatic arthritis may be present but are not required. 2. adults in general good health as determined by the investigator based upon the results of medical history, laboratory profile, and physical examination. 3. females of reproductive potential are eligible to participate in the study if they have a negative urine pregnancy test at screening and baseline and who are using 2 forms of effective birth control. 4. palmar/plantar pga of 3 or more exclusion criteria: 1. psoriasis patients without palm and/or sole psoriasis or a palmar/plantar pga score of less than 3 2. patients younger than 18 and older than 85 years old. 3. evidence of skin conditions at the time of the screening visit (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis 4. receipt of any investigational drugs within 4 weeks of study drug initiation 5. psoralens + ultraviolet a (puva) or oral systemic treatments within 4 weeks of study drug initiation. 6. biologics within 3 months of study initiation 7. ultraviolet b (uvb) therapy or topical steroids within 2 weeks of study drug initiation 8. a prior history of tuberculosis, and/or a positive purified protein derivative (ppd) skin test/chest x-ray (cxr) at screening without appropriate treatment. treatment of latent tuberculosis (tb) infections (for those with positive ppd tests) must be initiated prior to therapy. 9. receipt of live vaccines 1 month prior to or while in study 10. chronic hepatitis b or hepatitis c infection 11. history of alcohol or drug abuse one year before and during the study. 12. known human immunodeficiency virus (hiv)-positive status or any other immune-suppressing disease. 13. any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study 14. presence of a grade 3 or 4 infection \<30 days prior to the screening visit, between the screening visit and the first day of treatment on study, or any time during the study that in the opinion of the investigator would preclude participation in the study. 15. any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)

Keywords: palmar plantar psoriasis
prediabetes, exercise, and appetite regulation

Conditions: PreDiabetes; Appetitive Behavior

Summary: the purpose of the study is to learn about how type of exercise influences measures of appetite regulation.

the primary objective of this study is to understand the relationship between exercise modality and appetite regulation in a population with pre-diabetes. the study includes a screening visit to ensure eligibility of participants, baseline assessments, a resistance exercise intervention, and post intervention measurements. the variables of interest include, but are not limited to, hormonal responses to exercise training pertaining to appetite, food cravings, appetite ratings. activity levels, body composition, and ten repetition-max strength. the aim of this study is to better understand the mechanisms involved in the correlation or causation of any improvements in fitness and appetite regulation in a cohort with pre-diabetes.

Eligibility criteria:
inclusion criteria: * age 18-50 years of age * bmi between 27-40 kg/m² * hemoglobin a1c level between 5.7% and 6.4% * physical activity (less than 150 min/week moderate-intensity physical activity, no more than 1 session/week of resistance exercise) exclusion criteria: * unstable cardiovascular disease * uncontrolled hypertension * severe hypertriglyceridemia * history of or active liver disease * uncontrolled thyroid disease * active cancer diagnosis * smoking * engaged in exercise or diet program * history of bariatric surgery * gi malabsorptive disorders * significant diet intolerances * history of major psychiatric disorder * presence of alcohol or substance abuse; * medications affecting weight, * ei or ee in past 6 months; * women currently pregnant, lactating, less than 6 months post-partum, or postmenopausal.

Keywords: resistance exercise pre diabetes appetite
orthostatic, respiratory, balance-intervention

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.


Eligibility criteria:
inclusion criteria: 1. upper/lower/both extremity weakness or paralysis resulting from sci with asia impairment scale (ais) grades a-c who use a wheelchair as primary means of mobility. 2. ≥1 year post-injury 3. willingness to participate in the study and provide consent. exclusion criteria: 1. inability to understand the consent form or consent process 2. reliance on a mechanical ventilator. 3. use of betablockers 4. inability to travel to the miami project for weekly sessions during intervention month 5. any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to: * fracture, dislocation, or malformations affecting supine or sitting tolerance. * spinal instability. * pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine. 6. individuals who are able to stand independently or with a walker 7. unresolved deep vein thrombosis (dvt). 8. hospitalization due to autonomic dysreflexia in the last 3 months. 9. pregnancy determined by urine testing in sexually active females.

Keywords: breathing diaphragm balance blood pressure
determining relationships among maternity stress & sleep

Conditions: Postpartum Depression; Depression

Summary: psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (ppd). biological mechanisms underlying the relationships among these psychosocial risk factors for ppd, and the development of ppd, remain unclear. however, evidence from non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine factors may play a role. the primary objectives of this study are: (1) to assess the feasibility of enrolling second trimester pregnant women, with or without depression histories, into a laboratory-based study protocol which includes a mild psychosocial stressor and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic hormone (acth) and cortisol; (2) to assess the feasibility of retaining participants, for a brief postpartum phone interview, after completion of the second trimester assessments; and (3) to establish proof of concept for measuring group differences, between women with or without depression histories, in second trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.


Eligibility criteria:
inclusion criteria: * nulliparous women in their 2nd trimester of a singleton pregnancy * women between 18-45 years of age * women with a past history of depression * women with no past history of depression exclusion criteria: * under 18 years of age * over 45 years of age * pregnancy gestation \> 22 weeks at study enrollment * multiparity * non-singleton pregnancy * prior termination of pregnancy at \>12 weeks gestation * prior loss of pregnancy \>2 times at \<12 weeks gestation * prior history of stillbirth * current substance use (alcohol and/or elicit drugs) * current chronic steroid use * current use of antidepressants, anti-anxiety medications, mood-stabilizers, psychotropic medications, progesterone treatment, or sleep medications * current tobacco use * diagnosed obstructive sleep apnea, * diagnosed restless legs syndrome (rls) * certain cancers * pre-gestational diabetes * a body mass index (bmi) of \> 40kg/m2 just prior to pregnancy * chronic hypertension (documented or taking medication for hypertension) * gestational hypertension * preeclampsia * current anemia * current or past history of psychosis, schizoaffective disorder,or bipolar disorder * current depression

Keywords: depression postpartum depression pregnancy perinatal depression sleep life stress
effects of hemoperfusion with a polymyxin b membrane in peritonitis with septic shock

Conditions: Peritonitis; Septic Shock

Summary: the purpose of this randomized, comparative, open and multi-centre study is to show that two sessions of hemoperfusion with toraymyxin performed within maximum 36 hours after the surgery of a peritonitis by hollow organ perforation reduce the mortality in patients suffering from septic shock.

the mortality rate due to peritonitis associated to a severe sepsis or a septic shock remains high (between 40 and 60% as per the studies). the recent complementary therapies for severe sepsis have been reassessed (strict glycaemic control, substitutive corticotherapy, activated protein c). early neutralisation of the endotoxaemia related to gram-negative bacilli sepsis in contact with hemoperfusion membrane covered with polymyxin b (toraymyxin™) may enable reduction of the inflammatory reaction caused by sepsis and improve its prognosis. 30 studies, including 10 randomized studies, have compared hemoperfusion with toraymyxin™ to the standard treatment, showing an improvement in the patients' haemodynamic state, oxygenation conditions and reduction in mortality. this treatment is commonly used in japan. however, the studies conducted either include only a limited number of patients or are not randomized prospective studies. the post-hoc analysis of a recent randomized study conducted on a limited number of patients with abdominal septic shock shows a significant reduction in mortality after factor adjustment. though the side effects of such a treatment are limited, its cost is high. hence, extensive prospective studies are necessary to confirm its effectiveness.

Eligibility criteria:
inclusion criteria: * confirmed community or nosocomial acquired peritonitis due to organ perforation * septic shock requiring catecholamine infusion started or maintained 2 hours after surgery exclusion criteria: * pregnancy * no severity criteria within the 8 hours following surgery * neutropenia due to chemotherapy or malignancy * abdominal sepsis without peritonitis * mesenteric ischemia without perforation * peritonitis due to appendicitis * perforation linked to trauma * cirrhosis child c * impossibility to use heparin * prolonged cardiac arrest within 72h before surgery * terminal disease diagnosed during surgery * moribund subjects

Keywords: peritonitis septic shock hemoperfusion polymyxin b endotoxin
assessement of capacity to consent

Conditions: Major Depressive Episode

Summary: any patient can request euthanasia in many of our neighbouring european countries as long as informed consent is given. psychiatric evaluation is not always mandatory. faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in france for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode. this is a social and human sciences study which does not aim to modify the usual management of patients.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 * ability to understand and participate in the interview * french-speaking * presence of a current characterized depressive episode according to dsm-5 diagnostic criteria exclusion criteria: - refusal to participate

Keywords: capacity to consent euthanasia
tgr-1202 alone and in combination with either nab-paclitaxel + gemcitabine or with folfox in patients with select relapsed or refractory solid tumors

Conditions: Pancreatic Cancer; Colorectal Cancer; Rectal Cancer; Gastric Cancer; Esophageal Cancer; Gastrointestinal Stromal Tumor (GIST)

Summary: this is a phase 1 multi-center study to assess the safety and efficacy of tgr-1202 as a single agent or in combination with nab-paclitaxel + gemcitabine or with folfox in patients with select relapsed or refractory solid tumors.

tgr-1202 will be evaluated alone or in combination with nab-paclitaxel + gemcitabine or with folfox in patients with adenocarcinoma of the pancreas, adenocarcinoma of the colon, rectum, gastric and ge junction cancer, and gi stromal tumor (gist) who have relapsed from or are refractory to prior treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed: 1. adenocarcinoma of the pancreas (pancreatic cancer) 2. adenocarcinoma of the colon or rectum (colorectal cancer) 3. adenocarcinoma of the gastric (gastric cancer) 4. esophageal cancer 5. gastrointestinal stromal tumor (gist) * relapsed or refractory disease * measurable lesion by recist 1.1 exclusion criteria: * known hepatitis b, c or hiv infection * previous therapy with any drug that inhibits the pi3k pathway * anti-tumor therapy within 21 days of study day 1
yukon-drug-eluting stent below the knee - randomised double-blind study

Conditions: Arterial Occlusive Diseases

Summary: the purpose of this study is to compare the effectiveness of the treatment with balloon-expandable yukon-btx-sirolimus-eluting stent over the treatment with yukon-btx uncoated stent in patients with ischemic infrapopliteal arterial disease.

based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that yukon-btx-sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. the purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable yukon-btx-sirolimus-eluting stent over the treatment with yukon-btx uncoated stent in patients with ischemic infrapopliteal arterial disease. randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of peripheral arterial occlusive disease as defined by rutherford 2-5 * de-novo stenosis of \> 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery * target lesion length of ≤ 45 mm exclusion criteria: * coagulation disorder * known allergy to contrast medium * contraindications to antiplatelet therapy or heparin

Keywords: arterial occlusive diseases peripheral vascular diseases drug eluting stent restenosis below the knee intervention
observational follow-up study of regatta

Conditions: Urinary Tract Infections

Summary: observational follow-up study of patients included in the clinical trial regatta.

a follow-up telephone interview of the participants of the clinical trial regatta exploring the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three months after inclusion.

Eligibility criteria:
inclusion criteria: * participants of the clinical trial regatta * informed consent to participate in the observational study regatta ii exclusion criteria: - no informed consent granted

Keywords: herbal treatment antibiotics uncomplicated urinary tract infection
effects of photobiomodulation on superficial sensitivity and muscle activity of individuals with myelomeningocele

Conditions: Myelomeningocele Without Hydrocephalus; Sensory Defect; Motor Activity

Summary: myelomeningocele is a neural tube defect that occurs between the third and fourth week of gestation. functional impairment occurs due to dysplasia of the nerve roots, which can lead to flaccid paralysis and sensory-motor dysfunction below the level of the lesion. although advances in the multidisciplinary treatment of myelomeningocele have led to functional improvements in affected children, novel therapeutic modalities, such as photobiomodulation (pbm), could be a promising complement to treatment. objective: evaluate the effectiveness of pbm combined with physiotherapeutic exercises on the sensory-motor response in individuals with myelomeningocele at the lower lumbar and sacral level. participants will be recruited from the integrated health clinic of university nove de julho and randomized into two groups: grupo 1 - treatment with pbm at a wavelength of 808 nm + physical therapy; grupo 2 - sham pbm + physical therapy. evaluations will involve electromyography of the gastrocnemius, tibialis anterior and rectus femoris muscles of both lower limbs. balance will be evaluated using the pediatric balance scale. the sensory evaluation will be performed using the semmes-weinstein monofilament kit (smiles®). bdnf levels will be determined using elisa. the data will be analyzed with the aid of graphpad prism version 7.0. the kolmogorov-smirnov test will be used to determine the normality of the data. variables that fit the gaussian curve will be expressed as mean and standard deviation values. the t-test will be used for the comparisons between groups, with the level of significance set to 95% (p \< 0.05).


Eligibility criteria:
inclusion criteria: * age 5 to 16 years; * diagnosis of myelomeningocele on the lower lumbar and sacral level; * community ambulator; * score above the cutoff point for age on the mini mental state examination. exclusion criteria: * cognitive impairment that compromises the ability to communicate and answer the questions that will be posed; * allergy to latex; - manifestations secondary to mmc, such as hydrocephalus; * congenital club foot; neuromuscular scoliosis; * subluxation or luxation of hip and knee; * other disease of the central nervous system, neoplasms, heart failure, renal, respiratory, hepatic.
post-operative therapy for nausea or vomiting

Conditions: Vomiting; Nausea

Summary: this is a single site, prospective, randomized controlled study designed to evaluate the impact of acupressure when used as an initial treatment before rescue medications in the treatment of post-operative nausea and/or vomiting at ucd.

each individual will only participate in the post anesthetic care unit starting from when the patient's nurse or anesthesiology team deems that the patient needs treatment for ponv. it ends when the patient is discharged from anesthesiology care. patients will be asked to score nausea before randomized treatment of acupressure or medication, and to score nausea after treatment.

Eligibility criteria:
inclusion criteria: - patients scheduled for elective surgery requiring general anesthesia exclusion criteria: * age less than 18 years * adults unable to give primary consent * pregnancy * prisoners * unable to access pericardial 6 acupressure point bilaterally post procedure * allergy to ondansetron

Keywords: ponv nausea vomiting acupressure
a comparison of pr oxycodone/naloxone and pr oxycodone after cardiac surgery

Conditions: Postoperative Pain; Opioid Related Disorders

Summary: the aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. the hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.

opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. these symptoms also limit the use of gastrointestinal tract for nutrition and medication. combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as pr oxycodone. oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy. the aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. during the first three months of the study, all cardiac surgery patients will be treated with pr oxycodone. during the second part of the study (3 months), all cardiac surgery patients will be treated with pr oxycodone/naloxone. the primary end point is the duration of opioid-induced bowel dysfunction. need of laxatives will be recorded.

Eligibility criteria:
inclusion criteria: * adult cardiac surgery patient exclusion criteria: * preoperative continuous use of laxatives * known anatomic or functional gastrointestinal disorder

Keywords: naloxone oxycodone constipation pain, postoperative physiological effects of drugs analgesics, opioid