Kornimate/medical-research-clean huggingface dataset:
clinical outcomes and patient satisfaction with use of the amma system

Conditions: Breast Cancer

Summary: the primary goal is to conduct a pilot evaluation of the amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the ph\&s system.

a novel cold capping device, named amma™, is now commercially available for use and fda approved. the amma system has the potential to be as effective as the penguin cold cap system, but with key innovations that make it more efficient and feasible in the clinic. innovations include: * portable and battery powered unit, not requiring dry ice * form-fitting scalp cap that eliminates the need for frequent cap exchanges the amma system has not been evaluated for efficacy, and no clinical trials are published. because of the ease of use and the self-directed administration of the amma scalp cooling device, we wish to explore this as an option for patients treated within the ph\&s system. to do this, we propose an observational study that evaluates clinical outcomes and patient-reported satisfaction amongst a cohort of patients who undergo self-directed scalp cooling using the amma system.

Eligibility criteria:
inclusion criteria: - women with stage i-iii breast cancer are eligible to participate if: * they consent to conduct baseline (week 0) and follow-up (week 4 post-chemo) surveys/interviews * they consent to be photographed at baseline (week 0) and follow-up (week 4 post-chemo), to document hair retention outcomes * curative-intent chemotherapy is planned with a taxane-based, anthracycline-sparing chemotherapy regimen (which includes but may not be limited to: tc x 4, t x 12, tchp x6)

Keywords: amma, cooler heads
a study of different dosing schedules of selumetinib with cisplatin/gemcitabine (cis/gem) versus cis/gem alone in biliary cancer

Conditions: Biliary Tract Carcinoma; Gallbladder Carcinoma

Summary: this is a phase ii study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer. selumetinib, an oral drug which plays an important role in the regulation of cell growth (mek 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. cisplatin and gemcitabine are intravenous drugs that work by damaging dna in tumor cells so that they are unable to grow and divide.


Eligibility criteria:
inclusion criteria: * unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer * no prior systemic therapy * performance status 0, 1, or 2 * age 18 years or older * estimated life expectancy \> 3 months * adequate hematological, liver, renal function * no evidence of active uncontrolled infection * capable of giving written consent * acceptable recovery of previous side effects exclusion criteria: * progressing within 3 or 6 months of receiving certain treatments * prior chemotherapy for non-resectable or metastatic disease or a mek inhibitor * progressing within 6 months of adjuvant treatment. * may not have received prior chemotherapy for non-resectable/metastatic disease. * prior mek, ras, or raf inhibitors or history of hypersensitivity to study drugs. * ampullary carcinoma * incomplete recovery from previous surgery * undergoing treatment with curative intent * prior malignancy that could interfere with the response evaluation * severe or uncontrolled systemic diseases or lab finding that makes it undesirable for patient to participate * any psychiatric or other disorder likely to impact consent * pregnant or breastfeeding * patients with significant cardiac-related issues * history of eye-related issues. * systemic disease, active infection, bleeding diatheses or renal transplant, including hep b, hep c or hiv * receiving potent inhibitors or inducers of cyp3a4/5, cyp2c19 and cyp1a2 can continue with caution

Keywords: randomized selumetinib tablets cisplatin gemcitabine non-resectable recurrent metstatic
hydrotherapy with hydrogen-rich water vs. rice protocol following acute ankle sprain

Conditions: Ankle Injuries

Summary: the traditional treatment of soft tissue injuries consists of the rice protocol - rest, ice, compression, and elevation, followed for up to 72 hours after a trauma. although designed as an immediate therapy to reduce inflammation that occurs after an acute injury, the rice might not be the best way to promote healing due to limiting blood flow. molecular hydrogen (h2) has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine, yet limited data are available concerning its effectiveness as a first-aid intervention.

experimental protocol * randomized controlled parallel-group trial * acute (24 h) post-injury intervention: * hydrogen-rich water hydrotherapy * rice protocol * first sessions given immediately after an initial examination (\~ 60 min after the injury). * source of hydrogen-rich water = hrw natural health products inc. (new westminster, bc, canada) o formulation (7g/ tablets, 800mg magnesium) dissolved into a 3-l stationary whirlpool with water (20°c) * no other interventions during the period of evaluation outcomes assessed at baseline (pre-intervention) and at 24-h follow up: * figure-of-eight method of measuring ankle joint swelling * visual analogue score (vas) score for pain at rest and during movement * weight-bearing lunge test (wblt) * single leg balance test (slbt) with eyes open and closed * serum inflammatory biomarkers (il-1ß, tnf-α, crp) • early termination criteria: serious subjective side effects (e.g. tingling, discoloration of skin, burning, itching, rash)

Eligibility criteria:
inclusion criteria: * age 18 - 35 years * body mass index 19 - 25 kg/m2 * free of major chronic diseases or acute disorders * acute ankle sprain incurred during sport-related activity exclusion criteria: * history of a previous ankle sprain during the past 6 months * unwillingness to return for follow-up analysis
efficacy of once-weekly exenatide versus once or twice daily insulin detemir in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the effects of exenatide once weekly (qw) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.


Eligibility criteria:
inclusion criteria: * have suboptimal glycaemic control as evidenced by an hba1c 7.1% to 10.0%, inclusive * have a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive * are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start or are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start exclusion criteria: * have any contraindication for the oad that they have been using * have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents * have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (iv) or intramuscular (im) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. addison disease) * have been treated with drugs that promote weight loss, within 3 months of screening * have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, byetta® (exenatide bid formulation), thiazolidinediones (tzd), dipeptidyl peptidase (dpp)-4 inhibitors * have previously completed or withdrawn from this study or any other study investigating exenatide qw * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Keywords: diabetes exenatide once weekly byetta insulin detemir levemir amylin lilly
promotion of self-help strategies for depression

Conditions: Depressive Disorder; Depression

Summary: the purpose of this study is to investigate the effectiveness of health promotion emails for depression. it is hypothesised that emails containing self-help advice will improve depression symptoms more than emails containing information about depression.

depression symptoms are commonly experienced and disrupt day-to-day life. increasing depression literacy and the use of effective self-help methods could improve depression across the community. the internet is an ideal promotional medium for health messages, because it is often used to search for information about mental health issues, and health messages can be widely disseminated at little cost. an email campaign could be a low-cost approach to improving self-help behavior and knowledge about depression in adults with depression symptoms.

Eligibility criteria:
inclusion criteria: * access to the internet at least once per week * resident of australia, new zealand, canada, ireland, united kingdom, usa exclusion criteria:

Keywords: depression self care
intervention for sustained testing and retention among hiv-infected patients

Conditions: HIV

Summary: the purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with hiv.

using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of istar, a community-based social network intervention that combines trained church-based health advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (intervention group; ig) versus a clinic-based approach (control group; cg) on linkage, engagement, retention and viral suppression among hiv-infected women and children. eighteen health facilities in identified local government areas in benue state, north-central nigeria will be randomly assigned to either the ig (n=9 health facilities) or the cg (n=9 health facilities). a total of 10,000 pregnant women will be screened and 400 hiv-infected participants will be enrolled over a 24-month period. the primary outcome will be the difference in the rate of linkage and engagement between the groups. the secondary outcome will be the difference in rate of retention and viral suppression among participants. additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on istar implementation and sustainment.

Eligibility criteria:
inclusion criteria: * hiv-infected pregnant women identified during baby showers programs at participating worship centers. exclusion criteria: * hiv-infected women already on treatment

Keywords: hiv, pmtct
unique electroencephalography (eeg) markers of habit behaviors in obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: this study focuses on explaining the occurrence and development of compulsive behaviors from habit hypothesis. investigators will study both ocd patients and healthy individuals using hardwick's forced-response time task(2019), the habit go/no-go task, and the intra-extra dimensional set shift task. investigators aim to explore the cognitive abilities and differences between ocd patients and healthy controls in these three tasks. control variables will include participants' levels of anxiety, depression, and stress, as well as sense of incompleteness and intolerance of uncertainty levels. by examining the differences in habit formation and expression abilities between ocd patients and healthy controls, and exploring the specific brain electroencephalographic activity processes in ocd patients, investigators hope to reveal the abnormal neural activity in habit-related circuits in ocd patients. this could provide new insights for the diagnosis and treatment of ocd.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 50; 2. y-bocs score greater than or equal to 16; 3. meet dsm-5 diagnostic criteria with no medication changes in the past two weeks; 4. right-handed. exclusion criteria: 1. diagnosed with any dsm-5 disorder other than ocd; 2. have a major physical illness; 3. have strong suicidal ideation.

Keywords: habit cognitive flexibility response inhibition
effects of ezetimibe with simvastatin in the therapy of adolescents with hefh (study p02579)

Conditions: Hypercholesterolemia

Summary: this is a randomized, double-blind, controlled, parallel-group, multicenter, phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with heterozygous familial hypercholesterolemia.

this study consisted of 3 distinct periods. in period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. the primary and key secondary efficacy analysis were based on the evaluations performed during period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups. in period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in period 1. in period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 weeks.

Eligibility criteria:
inclusion criteria: * adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg). * subjects must have high cholesterol (low density lipoprotein cholesterol \[ldl-c\] more than 159 mg/dl or 4.1 mmol/l) and a family history of high cholesterol. exclusion criteria: * subjects diagnosed with delayed puberty. * subjects who are sensitive to simvastatin and/or ezetimibe. * subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years. * subjects who are known to be hiv positive, are undergoing ldl apheresis or plasma apheresis, or have had a partial ileal bypass.

Keywords: cholesterol drugs hypercholesterolemia adolescent randomized controlled trials
identification of predictors for the evolution of covid-19 related pneumonia by transcriptomic and seroproteomic

Conditions: Covid19; Interstitial Pneumonia

Summary: the investigating group aims at performing an observational, prospective study that involves the evaluation of circulating biomarkers predictive of clinical evolution in patients suffering from covid-19 disease. in particular, the aim will be to verify whether there are transcripts or cytokines / chemokines in peripheral blood, modulated differently in patients with covid-19, distinguished on the basis of the evolution towards more severe clinical pictures that require patient intubation or that show signs of cardiovascular damage. the study will be based on the transcriptional analysis of the entire genome and serum protein to evaluate the expression of a broad spectrum of cytokines and chemokines. genome analysis will allow the genotype to be correlated to the identified gene expression profiles.

study design this observational, prospective, monocentric study will make use of the recruitment of consecutive patients with covid-19. enrollment will last 6 months or, considering the desirable drop in infections in the next few weeks, until exhaustion of enrolled patients. enrollment will be followed by 18 months dedicated to transcriptomics and seroproteomics investigations, for a total duration of the study of 24 months. all patients will receive optimal medical therapy, and will undergo laboratory or instrumental examinations (chest x-ray, ct, echocardiography) as needed. blood samples will be taken at the entrance and then twice a week for the duration of the hospitalization (generally 2-3 weeks). anamnesis will be noted for all patients. in addition, at all times, patients will undergo clinical evaluation and the following laboratory tests, which include: * blood count * biochemistry * standard coagulation and thrombin generation, fibrin generation and fibrinolysis (inr, ptt, d-dimer, tissue plasminogen activator tpa, plasminogen activator inhibitor pai-2, plasmin-antiplasmin complex pap, thrombin activated fibrinolysis inhibitor tafi, thrombin-antithrombin complex tat, prothrombin fragment pf 1+2, fibrinopeptide a) * inflammation/infection (il-6, procalcitonin, ferritin, pcr, scd14, tlr3 and 4, rantes, ccr3 and 4 * other (troponin i, nt-pro-bnp, hb1ac). a subgroup of patients will undergo a microcirculation analysis with sdf (sidestream dark field imaging).

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. positivity to the test for sars-cov-2 3. informed consent to enrollment in the study. 4. for intensive care patients: entry into the intensive unit and / or endotracheal intubation for no more than 4 days. 5. for patients in the covid19 wards: home hospitalization or emergency room for no more than 4 days. exclusion criteria: 1. age less than 18 years 2. pregnant women 3. patients with malignant neoplasm, autoimmune diseases. 4. hospitalization as transfer from another hospital or other similar facility.

Keywords: inflammation thrombin generation fibrinogenesis fibrinolysis
chinese herbal therapy combined with acupuncture for female mixed urinary incontinence

Conditions: Urinary Incontinence

Summary: the purpose of this study is to determine whether combination therapy with chinese herbal formula, yiqi suoquan granule, and acupuncture is effective in the treatment of female mixed urinary incontinence.

this factorial, randomized, controlled trial is aimed to assess the effectiveness of combination therapy with chinese herbal formula, yiqi suoquan granule, and acupuncture in the treatment of female mixed urinary incontinence (mui). eligible participants will be randomly allocated to receiving combination therapy with yiqi suoquan granule and acupuncture, yiqi suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham acupuncture. to minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Eligibility criteria:
inclusion criteria: * (1) female, leaking with urgency and with physical activity, coughing or sneezing (mui) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary exclusion criteria: * (1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 ml.

Keywords: urinary incontinence, chinese herb, acupuncture
prophylaxis of thrombosis with implantable devices for central venous access in cancer patients

Conditions: Cancer

Summary: this is a phase iii open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients). study period (date of first inclusion/last inclusion): 3 years treatment period : 3 months


Eligibility criteria:
inclusion criteria: * first line chemotherapy for solid tumor with: * metastatic disease or * involved nodes or * unresectable tumor * indication for implantable device for central venous access * potential survival \> 3 months * ecog performance status 0 to 2 (who) * age between 18 and 75 years. * social security guaranteed * normal laboratory assessments (platelets\> 100000/mm3, tp 60%, spontaneous tca with m/t\<1.5, tgo and tgp \< 2xn, serum creatinin\<120µmol/l) * informed consent signed exclusion criteria: * inability to understand informed consent or interfering with compliance for treatment or protocol anti-coagulant treatment -related criteria * acute infectious endocarditis * history related with heparin allergy or thrombopenia due to heparin * uncontrolled high blood pressure (systolic blood pressure \>180 mm hg and/or diastolic blood pressure \>110 mm hg) * hemorrhagic syndrome ongoing * patient with platelet inhibitors treatment * chronic, daily treatment with anti-coagulant therapy (lmwh or avk), use as preventive or curative level * patient with liver failure (tp\<60%) or renal insufficiency (creatinin clearance\< 20 ml/mn) * women with pregnancy and lactating pathology-related criteria * deep venous thrombosis history or pulmonary embolism (\< 6 months) * clinical suspicious of brain metastasis
a first in human study in healthy people to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of pf-05212372.

Conditions: Phase 1; Single Dose; Safety; Toleration; Pharmacokinetics

Summary: the purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of pf-05212372.


Eligibility criteria:
inclusion criteria: healthy subjects. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * a positive urine drug screen. * treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.