Kornimate/medical-research-clean huggingface dataset:
prospective, randomized clinical investigation of two different postoperative wound dressings

Conditions: Hip Surgery Corrective; Knee Injuries

Summary: the primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit. the secondary objectives are to evaluate: * the performance of the dressing * the comfort, conformability and the acceptability of the dressing * pain before and during dressing removal on the last visit

a prospective, randomized clinical investigation will be conducted at two to three sites in belgium and sweden. male or female, 18 years and older undergoing primary hip or knee arthroplasty with an expected hospital stay of 4 days or longer will be included in to the clinical investigation. 100 evaluable patients (i.e. 50 subjects per arm). the treatment arm (either mepilex border post-op or aquacel surgical) patient eligibility will be established before treatment randomization. patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of surgery (hip or knee), age and skin status. eligible patients will be randomized to receive mepilex border post-op or aquacel surgical in a ratio of 1:1 provided.

Eligibility criteria:
inclusion criteria, enrolment phase 1. age ≥ 18 years 2. have an expected total length of stay of 4 postoperative days or more 3. plan for elective primary arthroplasty of the hip or knee 4. plan for incision size \> 18 cm 5. give their written informed consent to participate inclusion criteria, randomization phase 1. undergoing elective primary arthroplasty of the hip or knee exclusion criteria,enrolment phase 1. known allergy or hypersensitivity to any of the components of the dressings 2. multitrauma 3. undergoing arthroplasty due to tumour 4. wound at the surgical site prior to surgery 5. neurological deficit of operated side ,hemiplegia, etc. 6. documented skin disease at time of enrolment, as judged by the investigator 7. previously enrolled in the present investigation 8. included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator 9. involvement in the planning and conduct of the clinical investigation, applies to all molnlycke health care staff, investigational site staff and third party vendor. exclusion criteria, randomization phase 1. dressing size does not fit the incision area, over 18 cm 2. complications that would increase wound risks if investigation dressing is applied 3. postoperative drain
hemodynamic characteristics of patients with sars-cov-2

Conditions: Coronavirus; SARS-CoV-2; COVID-19; Acute Respiratory Distress Syndrome; Shock; Acute Circulatory Failure; Left Ventricular Dysfunction; Fluid Overload

Summary: the outbreak of coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) has been declared a public health emergency of international concern. hospitalized covid-19-positive patients requiring icu care is increasing along with the course of epidemic. a large number of these patients developed acute respiratory distress syndrome (ards) according to current data. however, the related hemodynamic characteristic has so far been rarely described.

the outbreak of covid-19 is a worldwide concern. to our knowledge, the details of the hemodynamic characteristics of covid-19 patients have not yet been well described. besides, the cardiac injury was reported in about 7-17% of hospitalized patients with covid-19 in previous chinese publications and is much more common in patients admitted to icu and non-survivors. however, no systematic assessment, including echocardiography evaluating the left ventricular function of these patients has been declared. in addition, extravascular lung water (evlw) and pulmonary capillary permeability are two hall markers in ards patient's management, and transpulmonary thermodilution is a validated method to provide these values at the bedside. however, no study has reported the characteristic profile of these variables during ards caused by sars-cov2. a better knowledge of these characteristics would also be helpful in guiding their management.

Eligibility criteria:
inclusion criteria: * confirmed or suspected sars-cov2 cases * patients admitted to icu, defined as a unit in which patients can receive vasopressors. * monitored by a transpulmonary thermodilution system (picco2 (pulsion medical systems, feldkirchen, germany) or ev1000 (edwards lifesciences, irvine, united states of america). exclusion criteria: * sars cov-2 negative * refusal to participate in the study

Keywords: hemodynamic chracteristics transpulmonary thermodilution preload-dependency echocardiography extravascular lung water pulmonary vascular permeability index
pyrotinib in metastatic her2 non-amplified but her2 mutant breast cancer

Conditions: Breast Cancer; HER2 Gene Mutation

Summary: a phase ii study of pyrotinib in metastatic her2 non-amplified but her2 mutant breast cancer


Eligibility criteria:
inclusion criteria: able to understand and willing to sign an institutional review board（irb） approved written informed consent document. at least 18 years of age. histologically or cytologically confirmed her2-negative (0 or 1+ by immuno-histochemical (ihc) or non-amplified by fish) breast cancer that is stage iv. there is no standard therapy. at least one measurable disease by recist 1.1 is required. karnofsky performance status (kps)\>70, life expectancy \> 12 weeks exclusion criteria: lack of adequate organ function as defined below within 2 weeks of registration: absolute neutrophil count (anc)\ 2×upper limit of normal (uln); aspartate aminotransferase (ast) or alanine aminotransferase (alt)\>2.5×uln（or\>5 x uln for patients with liver metastases）; alkaline phosphatase (alp)\>2.5×uln; serum creatinine concentration (scr)\>140umol/l pregnant and/or breastfeeding. history of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias. having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent uncontrolled acute infection currently receiving any other investigational agents or systemic cancer therapy. allergy to any investigational drug ; any other condition that investigator considers inappropriate to participate in this trail
lose 2 win a novel method to motivate weight loss maintenance among college students

Conditions: Overweight; Obese

Summary: investigators are conducting a randomized controlled trial with overweight and obese college students on the university of minnesota campus. the primary outcome will be weight loss measured 12 months after study enrollment (corresponds to 10 months after the end of treatment).

approximately 30% of college students are overweight or obese. intervening on excess weight early may eliminate obesity-related morbidity. evidence supports use of monetary incentives to encourage weight-loss; questions remain about the efficacy of contingency management on weight loss maintenance. "lose 2 win" contests in which participants who achieve weight-loss goals are eligible for cash prizes, appear well-suited for implementation on campuses. our objective in this two-phase trial is to evaluate the feasibility, acceptability and efficacy of lose 2 win for weight-loss maintenance among college students.

Eligibility criteria:
inclusion criteria: * 18-24 years of age * university of minnesota freshman, sophomore, or junior * plan on enrolling at the u of minnesota through spring 2013 * bmi greater than or equal to 26 and less than or equal to 35.5 * have working internet and phone access * ability to read/write english * ability to safely engage in exercise exclusion criteria: * currently pregnant or breastfeeding * prior or planned weight loss surgery * having a special diet or being a member of an "organized weight loss program" * diagnosis of diabetes * have had binge eating disorder * have lost greater than or equal to 10 pounds in the last 3 months

Keywords: weight loss weight maintenance contingency management college students financial incentives
hydroxyurea in primary progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the pathogenesis of ms remain elusive, however some studies have linked the disease with infection by epstein-barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive ms.this study will evaluate treatment with hydroxyurea (hu) in primary progressive ms. hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,hu has recently been used in combination with antiretroviral drugs in hiv and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. furthermore has been demonstrated experimentally that hu suppressed the expression of ebv. for these reasons hu could be useful in primary progressive ms with cytostatic and antiviral action , confirming the role of ebv in the pathogenesis of ms.


Eligibility criteria:
inclusion criteria: * sign written informed consent * 18 to 60 years of age inclusive * diagnosis of pp-ms according to mcdonald criteria * edss score at screening of 2-7 inclusive exclusion criteria: * hypersensitivity to hydroxyurea * patients who were treated with immunosuppressive drugs or steroid three month before * respiratory or urinary infections * history or presence of malignancy * pregnancy or lactation * low compliance to the therapy
the effects of transcranial direct current stimulation (tdcs) and cognitive training in patients with tbi

Conditions: Traumatic Brain Injury; Closed Traumatic Brain Injury; Severe Brain Injury

Summary: long-term sequelae in tbi is a well-recognized burn. we designed a proof of concept study, randomized, double-blind, placebo-controlled to evaluate 36 adult tbi patients. to evaluate the early and late effects of 10 days of 20 minutes applying transcranial direct-current stimulation (tdcs) in the dorsolateral prefrontal cortex (dlpfc), bilateral temporal cortex (ctb) and compare to sham stimulation, and online cognitive training. we expect that the active group will differ from the sham group, showing larger effect sizes in the cognitive assessment.

method: proof of concept study, randomized, double-blind, placebo-controlled. 36 adult patients will be recruited, with closed tbi for at least 6 months, of both sexes. the sequence of randomization will provide the allocation 1: 1: 1 in parallel groups: g1 n = 12 active (ctb), g2 n = 12 active (dlpfc), and g3 n = 12 (sham). the tdcs will be held with the intensity of 2 ma for 20 minutes per session and online cognitive training (concurrent with the etcc). all patients, after the screening and randomization, will make a baseline neuropsychological assessment (t0) and receive 10 sessions of stimulation concomitant to cognitive training. patients will undergo neuropsychological reassessment one week (t1) and two months (t2) after the last tdcs session. we will evaluate performance on episodic memory tests, working memory and attention in the three periods (t0, t1, and t2). the significance adopted is the level of 5% (α = 0.05), analysis of 80% power and bicaudal curve. analysis of the results will be done by intention to treat (itt).

Eligibility criteria:
inclusion criteria: clinical diagnosis closed traumatic brain injury, cognitive complaints reported by the patient or caregiver. exclusion criteria: metal implants in the head, seizures, abnormal eeg, depressive symptoms
treatment of adolescent anorexia nervosa

Conditions: Eating Disorders

Summary: visan is a naturalistic study of family based treatment of anorexia nervosa in adolescnet girls.


Eligibility criteria:
inclusion criteria: * having been diagnosed with f500 or f501 and being planned for family based therapy at the unit. exclusion criteria: * being subjected to care by the social welfare system

Keywords: anorexia nervosa
chemokine (cxcl13) as anew marker in diagnosis of sle

Conditions: Systemic Lupus

Summary: systemic lupus erythematosus (sle) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both t and b lymphocytes with overt production of autoreactive antibodies.the chemokine cxc ligand 13 protein (cxcl13), also known as b cell-attracting chemokine-1 (bac-1) or b lymphocyte chemoattractant (blc), cxcl13 serum levels were correlated with disease activity using the sle disease activity index (sledai) and to lupus nephritis

systemic lupus erythematosus (sle) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both t and b lymphocytes with overt production of autoreactive antibodies . lupus nephritis (ln) is the most common and serious complication in sle patients characterized by proteinuria, hematuria, drop glomerular filtration rate, or renal dysfunction . it is known that b lymphocytes are involved in the pathogenesis of systemic lupus erythematosus in autoantibody-dependent mechanisms . the chemokine cxc ligand 13 protein (cxcl13), also known as b cell-attracting chemokine-1 (bac-1) or b lymphocyte chemoattractant (blc), is a cxc subtype member of the chemokine superfamily. the receptor of cxcl13 is cxcr5, which is normally expressed on mature b cells and follicular t helper cells (tfh). it has been demonstrated that cxcl13 is sufficient to induce secondary lymphoid tissues in peripheral organs. it is well known that different chemokines are involved in the pathogenesis of ln by orchestrating proinflammatory microenvironments, recruiting immune cell subsets into the kidney and by inducing local activation of immune effector cells . local b-cell infiltration and related abnormal expression of ectopic lymphoid tissue (elt) in the renal tissues of ln mice models was related to the severity of renal impairment . of interest, in regions of b cell infiltration a higher expression level of cxcl13 was found. most b cells in this region expressed the corresponding receptor cxcr5, also supporting the hypothesis that cxcl13 induces b cell infiltration into the kidneys via its receptor cxcr5 . in one study on 91caucasian patients, cxcl13 serum levels were correlated with disease activity using the sle disease activity index (sledai) and to lupus nephritis. it was found that serum cxcl13 levels correlated well with sledai and median cxcl13 concentrations were higher in patients with renal involvement .

Eligibility criteria:
inclusion criteria: * sle patients diagnosed according to acr exclusion criteria: * patient with other autoimmune diseases.
safety of bkm120 monotherapy in advanced solid tumor patients

Conditions: Breast Cancer; Colon Cancer; Ovarian Cancer; Endometrium Cancer

Summary: this is a first-in-man, phase i clinical research study with bkm120, a potent and highly specific oral pan-class i phosphatidylinositol-3-kinase (pi3k) inhibitor. the study consists of a dose escalation part followed by a mtd expansion part. once the mtd has been defined, the mtd expansion part will be opened for enrollment.


Eligibility criteria:
inclusion criteria: all patients: * histologically-confirmed advanced solid tumors * progressive, recurrent unresectable disease * world health organization (who) performance status ≤ 2 * no history of primary brain tumor or brain metastases mtd expansion part: * histologically-confirmed advanced solid tumors * progressive, recurrent unresectable disease * world health organization (who) performance status ≤ 2 * no history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months * patients with genetic or molecular alteration of the pi3k pathway exclusion criteria: * prior treatment with a pi3k inhibitor * history of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation * no clinically manifest diabetes mellitus (treated and/or with clinical signs) * no acute or chronic renal disease * no acute or chronic liver disease * no acute or chronic pancreatitis * no unresolved diarrhea * no impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension * no acute myocardial infarction or unstable angina pectoris within the past 3 months * not pregnant or nursing and fertile patients must use barrier contraceptives other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumors breast cancer colon cancer ovarian cancer endometrium cancer
knowledge- attitude- practice (kap) of post exposure prophylaxis for fifth year dental students of a private egyptian university

Conditions: Occupational Exposure

Summary: considering the increase number of occupational injuries, the aim of this study is to assess the current level of knowledge, attitude and practice of fifth year dental students as regards post exposure prophylaxis.

injuries from occupational accidents are associated with agents of biological risk, as they are the gateway to serious and potentially lethal infectious diseases. several studies have demonstrated that dental students are among the most vulnerable to blood-borne exposure due to both their limited and restricted working area and developing skills level. this situation makes the use of post exposure prophylaxis is very important. therefore, this study is conducting to evaluate the awareness level of fifth year dental students regarding post exposure prophylaxis.

Eligibility criteria:
inclusion criteria the fifth year dental students studying at a private egyptian university. dental students who agree to participate. dental students irrespective of age and sex. exclusion criteria: • refusal of participation from the students.

Keywords: knowledge attitude practice questionnaire post exposure prophylaxis
mobile phone detection of atrial fibrillation

Conditions: Atrial Fibrillation; Arrhythmia

Summary: the aim of this study is to evaluate the reliability of smartphone seismocardiographic detection of af in comparison to the gold standard of continuous telemetry ecg recording.

in the this case-control study, 300 patients being treated in the wards of heart center and department of acute internal medicine of turku university hospital in turku, finland between april and september 2017 were included in the study. patients were assigned to two groups according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation). a smartphone equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to obtain a seismocardiographic recording. simultaneous telemetry electrocardiography was obtained to assess the reliability of seismographic rhythm recordings. results will be analyzed to describe the specificity and sensitivity of the method.

Eligibility criteria:
inclusion criteria for patients with fa: * ≥18 years of age * telemetry ecg available * being treated in turku university hospital heart center / acute internal medicine ward * atrial fibrillation inclusion criteria for patients with sinus rhythm: * ≥18 years of age * telemetry ecg available * being treated in turku university hospital heart center / acute internal medicine ward * sinus rhythm * gender and age matching pair in fa group exclusion criteria: * ≤18 years of age * paced rhythm * cardioversion during preceding 7 days * informed consent not signed

Keywords: atrial fibrillation smartphone detection
pain control after orthognathic surgery

Conditions: Postoperative Pain

Summary: this study will assess the efficacy and safety of levobupivacaine for postoperative pain control in patients received orthognathic surgery. in this split-mouth study, each side will be randomized to receive 1) 5ml 0.5% levobupivacine, 2) 2.5ml 0.5% levobupivacaine, or 3) placebo. one shot of these agents will be delivered by nerve block to maxillary and mandibular branches of trigeminal nerve before the incision was made. the degree of postoperative pain will be evaluated daily by visual analog scale for up to 3 days. the anticipated time on study is 1 year, and the target sample size is 40 individuals.

design of intervention vs. control intra-operative injective of (chirocaine) before incision location of injection: inferior alveolar nerve proximal to its entrance to ramus of mandible, maxillary nerve around pterygopalatine ganglion amount of injection on each injection site: (1) experimental group 1: 5mg/ml chirocaine 5cc (2)experimental group 2: 5mg/ml chirocaine 2.5cc (3)control group: normal saline 5cc. there are totally 4 injection sites for two jaw surgery and 2 injection sites for one jaw surgery. the experimental site and control site will be determined randomly before injection. outcome measurement * primary: effectiveness of intra-operative nerve block on post-operative pain control * secondary: 1. whether the pain relieve effect is dose-related 2. how long will this effect last the intensity of post-operative pain will be measured by vas, visual analog scale)daily until patients are discharged. report adverse outcome: * intolerable pain on control group * adverse reaction to local anesthetic agent * injection-related complications (puncture of major vessels, hematoma on -injection site, etc.)

Eligibility criteria:
inclusion criteria: * all patients who will receive orthognathic surgery (one jaw or two jaw, with or without genioplasty) in chang gung memorial hospital since july 2011 exclusion criteria: * more complex (2- or more piece lefort i osteotomy, combined gonial resection in bsso, etc.) or less complex (only wassmund and/or kole osteotomies in upper or lower jaw) orthognathic procedures * unexpected fracture (unilateral) * intra-operative nerve injuries * significant facial asymmetry which demands different procedures (location of osteotomy, extension of muscle stripping, etc.) * cleft patient, post-traumatic patients, patients with craniofacial syndromes or other neurological or systemic problems which might interfere pain evaluation post-operatively

Keywords: orthognathic surgery pain control trigeminal nerve levobupivacaine
hairdx analytical validation study

Conditions: Hair Loss; Hair Loss/Baldness; Female Pattern Baldness; Androgenetic Alopecia

Summary: the hairdx test reports genetic variants associated with the development of fphl.

the hairdx test reports genetic variants associated with the development of fphl. the variants are detected from a saliva sample collected at home. the hairdx test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. the information provided by the hairdx test report is not intended to start, stop or change any course of treatment. the purpose of this study is to collect dna samples from subjects. the dna samples will be used for the analytical validation of the hairdx test. the results of this study will not be shared with the subjects.

Eligibility criteria:
inclusion criteria: * females over the age of 18 * overall good health * able to give informed consent * willing to collect saliva sample exclusion criteria: * xerostomia (dry mouth) * inability to provide informed consent in english * inability to follow instructions for saliva sample collection * non us resident