Kornimate/medical-research-clean huggingface dataset:
itch relieving effect of botox: a study in healthy subjects

Conditions: Pruritus

Summary: the purpose of this study is to determine if botox is effective in the treatment of an experimentally induced itch that mimics chronic itch in healthy volunteers.

several studies have shown that botulinum toxin type a (bont/a) has an antipruritic effect due to the inhibition of acetylcholine and other pruritic factors, such as substance p and glutamate. for instance, subcutaneous bont/a improves itch accompanied to hand eczema, dermatitis, lichen simplex, and rhinitis. furthermore, a double-blind, placebo-controlled study showed that bont/a reduced histamine itch intensity in healthy men. since acetylcholine has been shown to mediate itch in atopic dermatitis, this study aims to test the itch relieving effect of bont/a on a non-histaminergic model for chronic itch. this non-histaminergic model using the plant cowhage induces itch by activating protease activated receptor 2 (par2) receptors, which play a role in the itch of atopic dermatitis, also making this model better suited to test the efficacy of bont/a to relive chronic itch.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers between 18 and 50 years of age. 2. must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception. 3. no history of chronic itch or pain. 4. must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study. 5. must abstain from the use of moisturizers on the arm. exclusion criteria: 1. individuals under 18 or over 50 years of age. 2. inability to complete the required measures. 3. the presence of an itchy skin disease. 4. diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies). 5. currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy. 6. use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.). 7. use of emollients on the arms a week prior to the study and throughout the study. 8. use of anti-depressants, anti-psychotics, and illicit drugs. 9. known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus. 10. use of botulinum toxin in the last year. 11. known allergies to botox. 12. pregnant women. (women of child bearing potential will undergo an human chorionic gonadotrophin (hcg) pregnancy test before botox application). 13. hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. 14. infection at the injection site. 15. cardiovascular disease. 16. neuromuscular disorder (e.g., amyotrophic lateral sclerosis, myasthenia gravis, or lambert-eaton syndrome). 17. compromised respiratory function. 18. dysphagia. 19. history of urinary tract infection. 20. history of urinary retention.

Keywords: itch botox healthy volunteers
concentration of ertapenem in colorectal tissue

Conditions: Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms

Summary: the purpose of this study is to determine the tissue kinetics of ertapenem in colonic tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem.

the purpose of this study is to determine the tissue kinetics of ertapenem in colorectal tissue from three hours up to six hours (25% of dosing interval) after administration of ertapenem before an elective surgical intervention (open or laparoscopic surgery) at the colon/rectum. subjects are patients. hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study.

Eligibility criteria:
inclusion criteria: * hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at the colon will be eligible for this study. * patients with benignant disorders (e.g. colonic diverticulosis) will be preferred. exclusion criteria: * pregnancy or lactation in women * emergency surgery, history of serious allergy or intolerance to β-lactam antibiotics and other carbapenems * systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry * ongoing intraabdominal infections * terminal illness * chronic immunosuppressive therapy * severe diseases of the liver, e.g. cirrhosis of the liver with alt or ast \> 6 x upper limit of normal (uln) and bilirubin \> 3 x uln, severe renal insufficiency with a creatinine clearance ≤30 ml/min., neutrophil count \ 1.5 x uln, ongoing therapy with valproin acid.
evaluation of dermstream(tm) - an irrigation product for chronic wound management

Conditions: Venous Insufficiency; Diabetes

Summary: the primary purpose of this study is to evaluate the safety of dermastream(tm) in the management of chronic wounds. other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of dermastream(tm) in chronic wound management.

until now no expected or unexpected adverse events were occurred

Eligibility criteria:
inclusion criteria: * diabetic ulcer, or venous insufficiency ulcer * age range: 18-80 years * wound max. diameter range: 1.5 - 10 centimeters * wound san antonio assessment system: grade 1 and 2, stage a and b * palpable pulses in the posterior tibial and the dorsalis pedis arteries * ankle-brachial index \> 0.7 by doppler * wound present for at least 6 weeks * wound location: foot or calf, at a location where the device can be attached properly * lack of purulent discharge from the wound. exclusion criteria: * hypoalbuminemia: albumin \< 2gr/dl * right-side congestive heart failure with edema of legs: +2 or higher * renal insufficiency: cr \> 2 mg/dl * abnormal liver function: alt or ast\>300 * skin disorders adjacent to the wound, unrelated to the pathology of the wound * non-cooperative patient
postprandial walking in obese pregnant women and perinatal outcomes - a multicenter randomized clinical trial

Conditions: Obesity; Gestational Diabetes; Preeclampsia

Summary: the purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years; * gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan; * obesity - body mass index ( bmi ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study; * physically inactive - according to the international physical activity questionnaire (ipac); * single pregnancy. exclusion criteria: * kidney disease or collagen; * previous history of gdm; * diabetes type 1 or type 2; * hypertensive disorders related to pregnancy; * hemodynamic instability; * vaginal bleeding; * visual, auditory or cognitive impairment.

Keywords: perinatal outcomes
study evaluating the impact of the 13-valent pneumococcal conjugate vaccine (13vpnc) in alaskan native children.

Conditions: Pneumococcal Disease; 13-valent Pneumococcal Vaccine

Summary: this study is to evaluate the safety, immunogenicity and impact of 13-valent pneumococcal conjugate vaccine in alaskan native children.


Eligibility criteria:
inclusion criteria: * male or female infants 6 weeks to \< 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures. * infants who have received prevnar are eligible to participate, but this is not required. * infants participating in the blood draws must live in a specific identified area (yukon kuskokwim delta region) exclusion criteria: * contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.

Keywords: 13 valent pneumococcal conjugate vaccine antibody response safety alaskan native children
ministry of child and family development (mcfd) interpersonal psychotherapy for adolescents (ipt-a) training project

Conditions: Education of Therapists Treating Adolescent Depression

Summary: evaluating the effectiveness of different interpersonal psychotherapy for adolescents (ipt-a) therapist training models


Eligibility criteria:
inclusion criteria: -adolescent undergoing psychotherapy exclusion criteria: -

Keywords: depression adolescents ipt knowledge translation psychotherapy
effects of yoghurt consumption on glucose metabolism in prediabetic subjects

Conditions: Prediabetes

Summary: the purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.

study population: the study population will consist of 60 (30 per group) subjects (men and women) at high risk of type 2 diabetes mellitus (t2dm), aged 18-65 years (inclusive), body mass index (bmi) 25.0 (inclusive) - 35.0 kg/m2 (exclusive), diagnosed with prediabetes, defined as fasting plasma glucose levels 100-125 mg/dl (5.6-6.9 mmol/l) (inclusive), randomised in a test and control group. intervention comprises of two study periods: a refrain period from dairy products and pro-, pre- and synbiotic supplements in any form, for 2 weeks, followed by an intervention period of 24 weeks.

Eligibility criteria:
inclusion criteria: 1. signed icf 2. male/female 18-65 years 3. bmi 25-35 kg/m2 4. fpg 100-125 mg/dl 5. at least one relative with t2dm 6. bw maintained (\<3%) 7. female postmenopausal or sterile or using contraceptive method 8. ability to comply with study protocol form 9. access to a refrigerator at home for study products storage 10. ability to collect and store stool samples 11. coverage by french health insurance 12. agreement to be registered in the national database of subjects participating in clinical research 13. ability to complete epro 14. fpg 100-125 mg/dl at randomisation visit exclusion criteria: 1. diagnosis of t2dm, t1dm, or on antidiabetic medications 2. medications or supplements affecting gut microbiota or causing hyperglycemia 3. systemic antibiotic treatment 4. treatment interfering with bw and bariatric surgery 5. liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency 6. chronic gastro-intestinal disorders or recent use of laxatives 7. recent surgery or general anesthesia 8. donation/loss of blood 9. inability to comply with dietary restriction 10. allergy or intolerance to study product ingredients 11. excessive consumption of alcohol 12. smoker 13. pregnancy, breast-feeding or change in contraceptive methods 14. situation interfering with optimal participation 15. participation in other clinical study 16. living in the same home as another participant 17. employees, family members of danone

Keywords: randomized controlled trial prediabetes
endotracheal tube cuff pressure measurement

Conditions: Ventilator Associated Pneumonia; Morality; Trauma, Brain; Endotracheal Aspiration

Summary: the effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia.

aim of this study is to evaluate the effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia of severe traumatic brain injured patients in a tertiary level intensive care unit.

Eligibility criteria:
inclusion criteria: patients with asa classification of 1 - 2- 3 patients patients required mechanical ventilation support for more than 48 hours patients diagnosed with traumatic brain injury exclusion criteria: official patient relatives who rejected to give informed consent for the study patients diagnosed with aspiration pneumonia during icu follow up patients diagnosed with acute respiratory distress syndrome patients diagnosed with cavitary lung lesion primary lung cancer metastatic lung cancer congenitally immune deficiency leukopenia neutropenia tracheostomized patients post cardiopulmonary arrest patients pregnancy

Keywords: pneumonia, cuff pressure, brain injury
a multicenter study to evaluate safety and efficacy of specific immunotherapy with modified allergen extracts

Conditions: Allergic Rhinitis; Allergic Conjunctivitis

Summary: this trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.


Eligibility criteria:
inclusion criteria: * positive history of allergen specific allergic rhinitis/rhinoconjunctivitis * positive screening skin prick test (wheal diameter \> 3 mm) * compliance and ability of the patient to complete a diary card for self-evaluating of the symptoms and antisymptomatic medication * signed and dated patient´s informed consent, exclusion criteria: * previous immunotherapy within the last 3 years, * simultaneous participation in other clinical trials, * other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), * auto-immune disorders, * severe chronic inflammatory diseases, * malignancy, * alcohol abuse, * existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, * treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
agitated patients management: intranasal midazolam vs intramuscular loxapine

Conditions: Emergence Delirium

Summary: this study is a non-inferiority phase iii randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

this study is a prospective, multicenter, open-label randomized, controlled, parallel-group 2-arm phase iii non-inferiority trial. patients with agitation at emergency department will be randomized to two arms of treatment: one experimental arm with intranasal midazolam 5mg (investigational medicinal product), and one control arm with comparator treatment intramuscular loxapine 100mg. the duration of participation for each patient is at least 28 days (+7 days if follow-up not completed on d28). an endpoint adjudication committee will be scheduled.

Eligibility criteria:
inclusion criteria: * age 18 to 60 years; * agitated patient whose somatic or psychiatric aetiology cannot be diagnosed in an emergency situation and who need a sedation in a hospital emergency setting due to the presence of unmanageable agitation with 3 major criteria. major criteria : agitation pain tolerance tachypnea ( fr \> 20) and 1 minor criteria among : sweating tactile hyperthermia medical care non compliance lack of tiring unusual strenght inappropriately clothed, nudity • medical insurance the protocol can start if the three major inclusion criteria and one of the minor inclusion criteria are checked present and all the non-inclusion criteria are checked no. exclusion criteria: subjects who meet any of the following criteria will be excluded from randomization into the study: * pregnancy * prisoners * contraindications to intranasal midazolam or intramuscular loxapine : * hypersensitivity to benzodiazepines or to any of the excipients (sodium chloride, hydrochloric acid, sodium hydroxide, water for injection) * known hypersensitivity to loxapine or to any of the excipients (polysorbate 80, propylene glycol, 20% v/v hydrochloric acid, water for injections, nitrogen (inert gas) * individuals who are in comatose states or have central nervous system (cns) depression due to alcohol or are taking other depressant drugs * individuals with severe depressive states, spastic diseases, and with parkinson's disease, except in the case of dyskinesias due to levodopa treatment * in combination with dopamine agonists except levodopa (amantadine, bromocriptine, lisuride, pergolide, piribedil, ropinirole, cabergoline, pramipexole, apomorphine) outside the patient with parkinson's disease * individuals with a history of cerebrovascular accident or epilepsia * individuals in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension; * individuals with severe cardiac decompensation * patients with severe respiratory failure or acute respiratory depression * individuals with acute narrow angle glaucoma.
safety and efficacy study of kp-1461 to treat art-experienced hiv+ patients

Conditions: HIV Infections

Summary: the primary purpose of the study is to investigate the safety and efficacy of kp-1461 given every 12 hours for 124 days to hiv+ patients who have failed multiple antiretroviral regimens.

kp-1461 is a prodrug of kp-1212 triphosphate, a unique nucleoside that is incorporated into the hiv viral genome resulting in an accumulation of nucleic substitutions that interfere with viral replication. the study is designed to investigate the safety and antiviral activity for 124 days in antiretroviral-experienced hiv-1-infected subjects. by inducing additional mutagenic events in the viral genome, viral decay accelerators such as kp-1212 may force the virus to exceed the threshold of nonviability.

Eligibility criteria:
inclusion criteria: * asymptomatic hiv-1-infected individuals who are treatment-experienced and who have not been on art for at least 16 weeks. * have documented prior non-suppressive art including at least 1 nrti, 1 nnrti and 2 pis; or have documented prior art resistance to at least 1 nrti, 1 nnrti and 1 pi; and in the opinion of the investigator, have few, if any, effective treatment options available. * have \>2,500 copies/ml of hiv-1 rna at screening. * have a stable cd4 cell count while off art and \>250 cells/ml at screening. * have no clinically significant findings on screening evaluations. exclusion criteria: * have a current or recent opportunistic infection that, in the opinion of the investigator, is not being controlled by medication. * have any condition that, in the opinion of the investigator, could compromise subject safety or adherence to the protocol. * have a documented positive test for hepatitis b surface antigen, or have received any antiviral therapy for hepatitis c \<6 weeks prior to study drug administration.

Keywords: hiv viral viral decay acceleration art haart treatment experienced
diabetes in the elderly: prospective study

Conditions: Diabetes; Hyperglycemia

Summary: diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults \>80years of age. it is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing. nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. in addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes. there are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. in addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (ssi) in long-term care facility residents with type 2 diabetes. accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with t2dm.


Eligibility criteria:
inclusion criteria: 1. males or females \> 60 years of age. 2. blood glucose \> 150 mg/dl and a1c \> 7.5%. 3. a known history of t2dm, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin). 4. patients admitted for non-cardiac elective or emergency surgery or trauma. exclusion criteria: 1. subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). 2. subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26). 3. patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl). 4. patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism

Keywords: elderly populations diabetes
impact of covid-19 on family dynamics on bandebereho study participants

Conditions: Gender Relations; Partner Communication; Division of Carework; Couple Conflict; Stress

Summary: this proposed study will assess how covid-19 and the associated 'stay at home' orders are affecting low-income rwandan couples' relationships and family dynamics. the study builds on an existing randomized controlled trial of the bandebereho fathers/couples intervention (nct02694627), which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress.

this proposed study will assess how covid-19 and the associated 'stay at home' orders are affecting low-income rwandan couples' relationships and family dynamics. it will contribute to documenting whether and how this disruptive moment might be changing or influencing relationship dynamics, conflict, and the distribution of care-work. we will build on an existing randomized controlled trial of the bandebereho fathers/couples intervention, which will allow us to assess not only the current conditions in households, but also whether or how the significant impacts of the intervention are sustained under extreme stress. the bandebereho fathers/couples intervention was implemented by the rwanda men's resource center (rwamrec) and promundo-us, in collaboration with the rwanda ministry of health and local authorities in karongi, musanze, nyaruguru and rwamagana districts from 2013-2015. results from a randomized controlled study of bandebereho, a gender transformative intervention for expectant couples originally implemented in 4 districts in 2015, showed positive results across multiple outcomes after 21 months.

Eligibility criteria:
original inclusion criteria in the original rct study included, for men: being between the ages of 21-35, expecting a child or having one or more children under the age of five, living in a stable partnership, and residing in the study site. for women, the criteria were simply being the partner of one of the men selected for the study. inclusion criteria for this study include previous participation in the rct, and that the respondent indicated they or their partner owned a telephone/phone in the 21-month follow up that was conducted in november/december 2016. based on data from the 21-month followup, approximately 80% of respondents reported a cell phone owned by them or their partner.

Keywords: gender, caregiving, covid-19, couple relations