Kornimate/medical-research-clean huggingface dataset:
tststarr + for treatment of severe prolapsed hemorrhoids --- a multi-center randomized controlled clinical trail

Conditions: Hemorrhoids

Summary: tststarr+ in the treatment of severe hemorrhoids prolapse--a multi center randomized controlled clinical trial.the aim of this stuy is to compare the first year hemorrhoids recurrence rate of tststarr+ and pph in the treatment of severe hemorrhoids.


Eligibility criteria:
inclusion criteria: * severe prolapsed hemorrhoids * no significant anal-malformation before operation * having signed the informed consent. exclusion criteria: * needing emergency operation or having previous history of hemorrhoids operation * with other anal diseases at the same time such as : anal fissure, anal fistula and perianal abscess and so on * diagnosed with inflammatory bowel disease or proctitis * diagnosed with colorectal cancer * associated with cardiovascular and cerebrovascular diseases and other diseases so that can not tolerate surgery or increase the risk of surgery * with chronic or acute renal insufficiency patients * coagulation abnormalities or with anticoagulation treatment at present * diagnosed with diabetes with poor glycemic control * in women with pregnant or menstruation * the intellectual disabilities or mental disorder * had participated in other clinical trial before we selected 4 weeks * other severe complications.

Keywords: hemorrhoids the recurrence rate pph tststarr+
a gene therapy study for hemophilia b

Conditions: Hemophilia B

Summary: a phase 1/2, open-label, non-randomized, dose-escalation study of spk-9001 in subjects with hemophilia b.

hemophilia b, or christmas disease, is a genetic bleeding disorder resulting in the lack of ability to produce blood-clotting factor ix (fix). individuals with hemophilia b suffer repeated bleeding events, which can cause chronic joint disease and sometimes leads to death due to the inability for blood to clot efficiently. this chronic joint disease can have significant physical, psychosocial, and quality-of-life effects, including financial burden. the current treatment is intravenous infusion of fix protein products, either prophylactically or in response to bleeding. the approach being tested in this study uses a novel recombinant adeno-associated virus (aav), which in nature causes no disease, to deliver the human factor ix (hfix) gene to the liver cells where fix is normally made. recent data of a gene therapy study showed preliminary encouraging results with the approach of using an aav vector carrying the factor ix gene. this study will seek to determine the safety and kinetics of a single iv infusion of spk-9001 (a novel aav vector carrying a high specific activity factor ix variant).

Eligibility criteria:
inclusion criteria: * able to provide informed consent and comply with requirements of the study * males ≥18 y.o. with confirmed diagnosis of hemophilia b (≤2 iu/dl or ≤2% endogenous factor ix) * received ≥50 exposure days to factor ix products * a minimum average of 4 bleeding events per year requiring episodic treatment of factor ix infusions or prophylactic factor ix infusions * no measurable factor ix inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor ix protein * agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences exclusion criteria: * evidence of active hepatitis b or c * currently on antiviral therapy for hepatitis b or c * have significant underlying liver disease * have serological evidence\* of hiv-1 or hiv-2 with cd4 counts ≤200/mm3 (\* subjects who are hiv+ and stable with cd4 count \>200/mm3 and undetectable viral load are eligible to enroll) * neutralizing antibodies reactive with aav-spark100 above and/or below a defined titre * participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational drug within the last 12 weeks * unable or unwilling to comply with study assessments

Keywords: hemophilia b blood coagulation disorders gene therapy gene transfer factor ix deficiency factor ix gene factor ix protein vector aav
registry of thrombosis & neoplasia of "sociedad española de oncología médica"

Conditions: Thromboembolism; Cancer

Summary: epidemiological, observational, non-interventional, multicentric study on patients diagnosed with cancer who develop a venous or arterial thromboembolic episode, symptomatic or incidental, within a month prior to cancer diagnosis or at anytime after such diagnosis


Eligibility criteria:
inclusion criteria: * over 18 years of age with a histologically confirmed diagnosis of malignant tumor. * venous or arterial thromboembolism episode, symptomatic or incidental, in the month prior or any time after the cancer diagnosis and in the three previous months to enrollment, confirmed with an imaging technique: doppler echocardiography, computed tomography (ct) angiography, etc. * signing of informed consent. exclusion criteria: * clinical diagnosis of thromboembolic event without radiological confirmation. * presenting a single episode of superficial thrombophlebitis without association with another thromboembolic event. * each patient will be recorded just once, and therefore a second thromboembolic event will be considered a rethrombosis and will be recorded as such. patients with a rethrombosis and a previous thromboembolic event before the start of the study in each center will not be able to be included.
statins to reduce d-dimer levels in patients with venous thrombosis

Conditions: Venous Thromboembolism; Hypercholesterolemia

Summary: elevated levels of d-dimer, a marker of procoagulant state, have been identified as a marker of an increased risk of recurrent vte. statins have proven antithrombotic properties, as suggested by the reduction of several prothrombotic markers, including d-dimer, in patients at high risk of arterial thrombosis. such antithrombotic properties could also be observed in patients at high risk of venous thrombosis. aim of the study is to assess the effect of statins on d-dimer levels in patients with previous vte after oral anticoagulant treatment withdrawal.

patients with a single episode of idiopathic vte (either dvt or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with ldl cholesterol levels of equal to or greater than 130 mg/dl will be randomized to either atorvastatin, 40 mg, 1 tablet daily and lipid lowering diet or lipid lowering diet for 3 months. on the day of oral anticoagulant treatment withdrawal (day 0), enrolled patients will undergo measurement of plasma d-dimer. at 30 days ± 3 (day 30), patients will undergo measurement of d-dimer, ck, ldh, alat e asat and clinical evaluation. at 90 days ± 7 (day 90), patients will undergo measurement of d-dimer, total cholesterol, hdl cholesterol, ldl cholesterol, and triglycerides ed clinical evaluation, ck, ldh, alat e asat. at 6 months ± 1 (day 180), patients will undergo clinical evaluation.

Eligibility criteria:
inclusion criteria: * adult patients with a single episode of idiopathic vte (either dvt or pulmonary embolism) who received at least 6 months of adequate treatment with oral anticoagulants, for whom treatment withdrawal is planned, and with ldl cholesterol levels of equal to or greater than 130 mg/dl. exclusion criteria: * age below 18 years, * pregnancy or puerperium, * active malignancy, * need for other anticoagulant treatments (unfractionated heparin, low molecular weight heparin), * presence of transient risk factors for vte \[recent (\< 3 months) surgery, * trauma, * fractures, * acute medical disease with immobilization, * pregnancy or use of oral contraceptives\], * contraindications to statin therapy, * chronic renal failure (defined by creatinine clearance \< 30 ml/min), * ongoing treatment with statins or fibrates, * major indication to statin therapy \[history of cardiovascular disease, diabetes, elevated cardiovascular risk according to the atp iii criteria(19)\], * life expectancy of less than 6 months, * geographic inaccessibility, * concomitant enrolment in another clinical trial, * refused informed consent.

Keywords: statins secondary prevention venous thromboembolism d-dimer
effectiveness of dry needling of active trigger points in neck muscles in patients with chronic cervical pain

Conditions: Cervical Pain

Summary: randomized single-blind clinical trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain.


Eligibility criteria:
inclusion criteria: * be older than 18 years old * sign informed consent form prior to participating in this study * have chronic cervical pain diagnosis of their primary care doctor. * have one or more active myofascial trigger point in the cervical muscles according to the criteria established by simons et al. exclusion criteria: * major trauma on cervical spine stated from the medical history * inflammatory, hormonal or neurological disorders * have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia) * having received physiotherapy treatment for the condition in the past month
contribution and reproducibility of lung ultrasound in the diagnosis of acute heart failure in the ed

Conditions: Dyspnea; Cardiac

Summary: discrimination between cardiac and non-cardiac causes of dyspnea can be challenging, causing excessive delay before adequate therapy. in clinical practice lung ultrasound (lus) is becoming an easy and reliable noninvasive tool for the evaluation of dyspnea and can shorten the time to diagnosis .however the reproductibility of this test was not extensively studied.

dyspnea is one of the most distressing situations for the patient . emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management. lung ultrasonography is becoming a standard tool in critical cases in the ed. the investigators aim to perform ultrasonography on consecutive patients admitted to the icu with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the icu team. three items were assessed: artifacts (horizontal a lines or vertical b lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles. this study assesses the potential of lung ultrasonography to diagnose heart failure.the second aim of this study was to evaluate the inter-observer reproducibility of lus performed by ed residents in the evaluation of cardiac causes of acute dyspnea. patients presenting to the ed with acute dyspnea will be prospectively enrolled in this study. in each patient, lus was performed by two ed residents blinded to clinical diagnoses. ahf was determined on the base of clinical exam, chest x-ray , brain natriuretic peptide (bnp) and echocardiographic findings. a patient lung comet score (lcs) was obtained by summing the number of comets in each of the scanned spaces. then the probability of ahf was defined as : low probability (lcs\ 30 ).

Eligibility criteria:
inclusion criteria: * non traumatic dyspnea with the final diagnosis of heart failure exclusion criteria: * impossibility to give consent to participate in the study * post traumatic dyspnea * pregnant women * need for endotracheal intubation or inotropic drugs * patients who were deemed too unstable for sonography by the treating team

Keywords: lung ultrasound heart failure diagnosis
activation of the contact system and the immune system in patients with chronic kidney disease.

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: patients with end-stage renal disease undergoing hemodialysis (hd) are burdened with extremely high mortality rates (15% per year) and during the early stage (≤120days) the mortality rate is even higher (27% per year). cardiovascular complications and bloodstream infections (bsis) account for the vast majority of deaths in hd patients. in denmark, bsis occur in 14% of hd patients per year and is most frequently caused by staphylococcus aureus (44%). the most frequent infectious complication is endocarditis that has fatal outcomes in ≈50% of the cases. overall, 10% of hd patients die within 30 days after a positive blood culture for s. aureus. this project aims to answer key questions regarding hd patients' decreased ability to fight s. aureus bsis and in particular the potential exacerbating effect of hd. we hypothesize that hd patients' blood is significantly compromised by the process of hd, to an extend that lowers immunoactivity against s. aureus. moreover, we hypothesize, that contact activation promotes the coagulability of blood thus promoting biofilm formation by s. aureus which increases the overall risk of bsi. we will test these hypotheses by collecting blood and analyzing the inflammation and coagulation status in plasma samples from participants before and after hd. we will compare the level of the inflammatory markers in plasma from participants undergoing hd (n=180) to the level in plasma samples from three control groups: healthy volunteers (n=120), participants with renal disease not in dialysis (n=60) and participants undergoing peritoneal dialysis (n=40).


Eligibility criteria:
participants with chronic kidney disease undergoing hemodialysis inclusion criteria * age \>18 years * chronic kidney disease * hemodialysis exclusion criteria: - acute kidney disease participants with chronic kidney disease, not in dialysis inclusion criteria * age \>18 years * chronic kidney disease (egfr from \<15 to 44) exclusion criteria: * acute kidney disease * hemodialysis * peritoneal dialysis participants with chronic kidney disease undergoing peritoneal dialysis inclusion criteria * age \>18 years * chronic kidney disease * peritoneal dialysis exclusion criteria: - acute kidney disease healthy volunteers inclusion criteria * age \>18 years * blooddonors exclusion criteria: - na

Keywords: contact system infection innate immune system coagulation chronic kidney disease hemodialysis end-stage renal disease
screening and intervention of postextubation dysphagia

Conditions: Oropharyngeal Dysphagia; Swallowing Disorder; Randomized Controlled Trial; Endotracheal Intubation

Summary: this clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the swallowing and oral-care (soc) program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (ped) increasing the risk of penetration, aspiration, and aspiration pneumonia. up to 84% of extubated patients had ped and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. the aims of this three-year, two-stage study are: 1) in the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) in the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day soc program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.

Eligibility criteria:
inclusion criteria: * patient who is over 20 years old. * patient how has received over 48 hours endotracheal intubation and had been successfully extubated. exclusion criteria: * patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities. * patient who has preexisting difficulty swallowing. * patient who has received a tracheostomy. * patient who were unable to follow verbal instructions. * patient who were on contact and droplet precautions (e.g., open tuberculosis) * patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an soc intervention

Keywords: postextubation dysphagia endotracheal intubation randomized controlled trial dysphagia intervention dysphagia screening
an open label study to evaluate the safety and efficacy of bor15001l7 for the treatment of cold sores in patients with recurrent herpes labialis

Conditions: Recurrent Herpes Labialis

Summary: bor15001l7 is a natural product. the primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.

secondary objectives are to: 1. evaluate the efficacy of bor1500l7 on: * the reduction of ulcerative lesions rates following the prodromal stage; * the extension of the delay prior to first ulcerative lesions occurence following the prodromal stage; * the decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages; * the decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages; * the reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis; 2. evaluate the safety and tolerability of bor15001l7 in subjects with recurrent herpes labialis

Eligibility criteria:
inclusion criteria: * provide signed informed consent and willing to comply with study-related procedures; * males and females ≥18 years of age at screening; * diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year; * willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed); * willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region. exclusion criteria: * patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.); * patients with herpes labialis occurring within 14 days prior to screening; * patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions; * treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer. * any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.

Keywords: herpes simplex skin diseases, infectious herpesviridae infections
the mass balance and biotransformation study of [14c] vc005 in chinese healthy adult male volunteers

Conditions: Atopic Dermatitis

Summary: this study was designed to evaluate the mass balance and biotransformation after single-dose of \[14c\]vc005 orally in chinese healthy male volunteers.


Eligibility criteria:
inclusion criteria: * a healthy male adult. * age is between 18 and 45, inclusive. * weight ≥ 50 kg and body mass index is between 19 and 26, inclusive. * voluntarily to provide informed consent form. * willing and able to communicate with investigators and complete the trial according to clinical trial protocol. exclusion criteria: * any abnormal and clinical significant findings to physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood, thyroid function), 12 lead electrocardiogram, chest x-ray (upright position), abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), anal directorial rectum examination, and so on. * tested positive for any one of the following: hbsag/hbeag, anti-hcv igg, hiv-ag/ab or treponema pallidum antibody (syphilis) . * volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal ct, or more than 3 times of different types of x-ray exam. * volunteers are not suitable for this clinical trial, in the opinions of investigators.
campath, rituximab, and myfortic with short-course calcineurin inhibitor therapy in renal transplanation

Conditions: Acute Rejection; Renal Transplantation

Summary: the hypothesis of this study is that lymphocyte depletion by campath-1h and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. however, the advantage of a long term, calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. this is a non-randomized open-label pilot trial in 30 adult renal transplant patients. subjects will receive 2 doses of campath-1h (30mg given on day 0 and day 1) and a single dose of rituximab (375mg/m2) on day 0, given intra-operative. subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (myfortic™). subject will also be given cyclosporine (neoral®) therapy for approximately 2 weeks (10-20 days).


Eligibility criteria:
inclusion criteria: * recipient of cadaver or non hla identical living donor transplantation (tx), re-tx recipient (second tx) allowed, but no organ other than a kidney (ie no prev k/p) * females of cbp must have neg preg test at the time of study enrollment (soc) \& agree to practice birth control for duration of the study, or for 6 weeks after the last dose of myfortic exclusion criteria: * subjects who are pregnant or nursing. * current malignancy or a malignancy in the past 5 years, except for excised skin ca (bcc or sc) * multi-organ tx, abo incompatible and + cm * subjects with a current pra \>50% within the past 30 days pre tx * subjects with active current infection requiring continued use of antibiotics, or the presence of chronic active hepatitis b (surface antigen +) or +hcv. * exclude for subjects who have received an investigational drug within 4 weeks of study entry