Kornimate/medical-research-clean huggingface dataset:
schedule - scandinavian heart transplant everolimus de novo study with early calcineurin inhibitor (cni) avoidance

Conditions: Renal Function and Chronic Allograft Vasculopathy

Summary: a controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy

this was a prospective, multi-center, randomized, controlled, parallel group, open label study in de novo heart transplant recipients. patients eligibility for randomization was assessed 5 days after heart transplant.. patients fulfilling the inclusion and exclusion criteria were randomized to one of two treatment groups: either conventional treatment with cyclosporine a (csa), mycophenolate mofetil (mmf), and corticosteroids (group a), or low-dose csa and everolimus, reduced dose mmf, and corticosteroids (group b). after 7 to 11 weeks, csa was discontinued in group b, while the standard triple-drug immunosuppressive regimen was maintained in group a.

Eligibility criteria:
de novo heart transplant recipients who had received induction therapy with antithomocyte globulin (atg) were eligible for inclusion. recipients of multi-organ transplants or a previous transplant were excluded, as were those with a donor aged \> 70 years, cold ischemia time \>6 hours, patients with severe systemic infection, recipients of abo incompatible transplants, patients with severe hypercholesterolemia (\>350mg/dl) or hypertriglyceridemia (\>750 mg/dl), patients with past (\<5 years). in order to continue in the study after week 7-11 (period 1), patients had to complete first 7-11 weeks on randomized immunosuppression and none of the following criteria should be present: ongoing rejection treatment or experience of one grade 3r rejection or two or more grade 2r rejections during first 7-11 weeks.
the effects of atazanavir-induced hyperbilirubinemia during human endotoxemia

Conditions: Endotoxemia; Inflammation; Multi Organ Dysfunction Syndrome; Sepsis

Summary: excessive inflammation, production of free radicals and vascular injury are considered the main contributors to the development of organ dysfunction in patients with severe infections and sepsis. the endogenously produced unconjugated bilirubin is one of the most powerful anti-oxidants of the human body and the administration of bilirubin in animal experiments has been shown to protect from inflammation-induced death. however, bilirubin for human administration is not yet available. therefore, we wish to exploit one of the side effects of atazanavir, a registered drug currently used as a protease inhibitor in hiv infected patients. atazanavir inhibits the enzyme upd glucuronosyl transferase enzyme (ugt1a1) and therefore increases endogenously produced bilirubin levels moderately. to study the effect of hyperbilirubinemia during inflammation we will apply the human endotoxemia model. the human endotoxemia model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting. we hypothesize that atazanavir-induced hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human endotoxemia.


Eligibility criteria:
inclusion criteria: * healthy male volunteers exclusion criteria: * use of any medication or anti-oxidant vitamin supplements. * history of allergic reaction to atazanavir. * smoking. * previous spontaneous vagal collapse. * history, signs or symptoms of cardiovascular disease. * (family) history of myocardial infarction or stroke under the age of 65 years. * cardiac conduction abnormalities on the ecg consisting of a 2nd degree atrioventricular block or a complex bundle branch block. * hypertension (defined as rr systolic \> 160 or rr diastolic \> 90). * hypotension (defined as rr systolic \< 100 or rr diastolic \< 50). * renal impairment (defined as plasma creatinin \>120 μmol/l). * liver enzyme abnormalities or positive hepatitis serology. * subjects with a total bilirubin level above 15 μmol/l and a normal direct bilirubin level suggesting gilbert syndrome. * positive hiv serology or any other obvious disease associated with immune deficiency. * febrile illness in the week before the lps challenge. * participation in a drug trial or donation of blood 3 months prior to the lps challenge.

Keywords: endotoxin bilirubin inflammation sepsis multi organ dysfunction syndrome oxidative stress heme oxygenase
long-term deferiprone treatment in patients with pantothenate kinase-associated neurodegeneration

Conditions: Pantothenate Kinase-Associated Neurodegeneration

Summary: patients with pkan will be treated with the iron chelator deferiprone for 18 months. only patients who have completed the earlier study tircon2012v1 (nct01741532), a double-blind placebo-controlled trial in which participants were randomized to receive either deferiprone or placebo for 18 months, are eligible to enroll.

tircon2012v1-ext is a multi-center, single-arm, open-label study. all patients who completed the earlier study tircon2012v1 (nct01741532) are eligible to take part. in the initial study, patients were randomized in a 2:1 ratio to receive 18 months of treatment with either the iron chelator deferiprone or placebo, respectively. in this extension study, all participants will receive deferiprone for 18 months. thus, depending on which product was received earlier, patients will be on deferiprone for a total of either 1.5 years or 3 years. as in the earlier study, assessments will be carried out every six months to look at the safety of the drug and to see if patients are showing any improvement in dystonia and other symptoms of pkan.

Eligibility criteria:
inclusion criteria: * completed study tircon2012v1 exclusion criteria: * withdrew from the study tircon2012v1 for reasons of safety * plan to participate in another clinical trial at any time from the day of enrolment until 30 days post-treatment in the current study

Keywords: pantothenate kinase-associated neurodegeneration pkan neurodegeneration with brain iron accumulation nbia deferiprone ferriprox
a nurse led project to introduce hand lettering as a form of creative art expression to patients in an ambulatory oncology setting

Conditions: Anxiety

Summary: the investigators are conducting a project to provide a new type of resource called "hand lettering" to patients receiving chemotherapy. this is a type of art therapy. the goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.

this study is being done to understand if it is feasible to use a form of art-therapy called hand-lettering at dana-farber cancer institute. we would also like to explore the anxiety a person has before and after using hand-lettering.

Eligibility criteria:
inclusion criteria: * adult patients (\>age 18) with a cancer diagnosis receiving oral or iv chemotherapy at dana-farber on yawkey 10. * able to read and speak english * has a minimum appointment time of 60 minutes exclusion criteria: -individuals with visual impairment or blindness will be excluded

Keywords: anxiety
new biopsy needle - evaluation of prostate biopsy quality

Conditions: Prostate Cancer (Diagnosis)

Summary: patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.

prostate biopsy is the golden standard for diagnose of prostate cancer. transrectal prostate biopsy (trusbx) is the most widely used technique. due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. the patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. infections related to transrectal prostate biopsy (trusbx) are increasing in parallel with rising antibiotic resistance. the investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today. this is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.

Eligibility criteria:
inclusion criteria: * eligible for prostate biopsy * signed informed written consent exclusion criteria: * none (other than general contra indications for prostate biopsy or patient not willing to participate)

Keywords: biopsy quality
safety, efficacy and pharmacokinetic study of allegra in pediatric patients with atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: primary objective: to evaluate safety (4 weeks) secondary objectives: * to evaluate the long-term safety (12 weeks) * to evaluate the efficacy * to characterize the pharmacokinetic profile

the study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.

Eligibility criteria:
inclusion criteria: * aged 6 months through 11 years * patients with atopic dermatitis exclusion criteria: * main itching scores are 4 or less than 2 on last three consecutive days before registration. * patients who have itching only on face, head, or diaper area. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
novel serum markers for monitoring response to anti-cancer therapy

Conditions: Carcinomas (Including Squamous Cell and Adenocarcinoma); Neoplasms

Summary: the purpose of this study is to measure the levels of serum proteins and other biomarkers in cancer patients and in patients suspected of having cancer. we believe that some of these markers may be useful for confirming the diagnosis or for selecting patients for specific types of cancer therapies. these markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

this is a blood serum collection study at stanford university for patients with cancer at a variety of disease sites. the purpose of this study is to collect and store blood serum from patients before, during, and after anti-cancer therapy to find new biomarkers that signal disease or response to anti-cancer therapy. the collection and analysis of these biomarkers may lead to improved diagnostic and treatment therapies for certain cancers in the future. we are also interested in collecting blood serum from healthy individuals such as the spouses, relatives, and friends of cancer patients to obtain healthy controls for comparison

Eligibility criteria:
1. age \> or = 18; for the samples collected under the nih grant, no subjects below the age of 20 will be enrolled. 2. prior diagnosis of cancer or suspected of having cancer 3. karnofsky performance status of greater than 70 4. standard pretreatment evaluation 5. signed stanford university human subjects committee consent
trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer

Conditions: Prostate Cancer

Summary: this is a prospective phase ii trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.


Eligibility criteria:
inclusion criteria: * patients older than 18 years and less than 80 years * histologically-proven adenocarcinoma of the prostate * evidence of bone metastases and progressive, hormone-refractory, disease * no previous chemotherapy * no previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion * no previous carcinoma, except basal-cell carcinoma of the skin * adequate renal function: measured or calculated creatinine clearance \> 60 ml/min * absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value * signed informed consent. exclusion criteria: * patients infected by the human immunodeficiency virus (hiv) * patients who do not fit inclusion criteria

Keywords: hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine
crutch use after arthroscopic hip surgery

Conditions: Hip Fractures; Hip Injuries

Summary: the purpose of this study is to determine whether crutch use for 4 weeks following hip arthroscopic surgery is superior to crutch use for 2 weeks following hip arthroscopic surgery. the primary objective of the study is to compare pro scores between patients who have used crutches for 2 weeks and patients who have used crutches for 4 weeks.

this will be a single-center, randomized prospective study. the study will compare post-operative patient reported outcome (pro) scores including the modified harris hip score (mhhs) and the non arthritic hip score (nahs), both are externally-validated surveys for hip function. one cohort will be assigned a rehabilitation regimen that includes 2 weeks of partial weight bearing on crutches, and the other will be assigned a regimen of 4 weeks of partial weight.

Eligibility criteria:
inclusion criteria: * hip arthroscopic surgery exclusion criteria: * any surgery other than hip arthroscopy * age: less than 18 years of age * age: greater than 64 years of age * pregnant patients

Keywords: arthroscopic hip surgery
contribution of the cerebellum in sensory-motor adaptation via gamma oscillations: the case of dystonia

Conditions: Primary Dystonia

Summary: dystonia, a disabling disease with uncontrolled movement disorders was considered to be a manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal and human experiments that the cerebellum plays a prominent role in the pathophysiology of dystonia. our recent results suggest a deficient cerebellar sensory encoding in dystonia, resulting in a decoupling of the motor component from the afferent information flow resulting from changes in the environment. an overall loss of gabaergic-mediated inhibition is at the forefront in dynamic changes in neural circuitry described in dystonia. in the mature brain gabaergic control the generation of temporal synchronies and oscillations in the glutamatergic neurons. taken these all together with the results of a pilot experiment, the investigators hypothesize that deficient synchronies in the fast gamma range are one of the key mechanisms leading to abnormal communication inside the cerebello-cortical network in dystonia. the investigators aim first to demonstrate it by means of meg (magneto encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma oscillations in the nodes of the cerebello-cortical network. the investigators then aim to re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the cerebellum at high gamma frequency a non invasive transcranial alternative current stimulation.


Eligibility criteria:
inclusion criteria: * primary upper limb dystonia * normal physical and neurological examination except for dystonia * no treatment with botulinum toxin during the three months preceding the study exclusion criteria: * writing tremor * current neurological or psychiatric illness other than dystonia * uncontrollable medical problems not related to dystonia * pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control

Keywords: magnetoencephalography non invasive brain stimulation cerebellum gamma rhythms
the inner ear function in psoriatic patients

Conditions: Psoriasis

Summary: psoriasis in a systemic disease that effects many systems of the body. few studies examined the hearing function of these patients but the results were inconclusive. no study, however, investigated the vestibular function of psoriatic patients. in a prospective study, the investigators will compare audiovestibular function between psoriatic patients and healthy volunteers. .

whether psoriatic patients have higher risk for developing inner ear dysfunction (hearing loss and dizziness) is an important issue that needs to be elucidated. awareness to the elevated risk (if there is any) of inner ear impairment, early detection and treatment of the condition may reduce the morbidities resulting from undiagnosed audiovestibular impairment. in a prospective study the investigators will examine the inner ear function (vestibular and auditory) of psoriatic patients and compare it to an healthy, young control group. the study will include 2 groups of participants: psoriatic patients and healthy volunteers. psoriatic patients are recruited from the dermatology clinic while the healthy volunteers are members of the hospital staff. the participants will undergo 2 sets of examinations: 1. auditory function examination: hearing test (that includes pure tone audiometry, speech audiometry and discrimination level), tympanometry and otoacoustic emissions. 2. vestibular function examination: * video head impulse test: a ten-minute, non- invasive test that includes a computer and a set of goggles worn by the participant. the participants is sitting in front of a wall while wearing the goggles, the investigator moves the participant's head sideways with short, rapid movements. the computer calculates the accuracy and the velocity of the eyes movements. * the participants fills a dizziness handicap inventory questionnaire. the participants from the psoriatic group are recruited from the dermatology clinic. the healthy group participants are members of the hospital staff and are recruited from the hospital.

Eligibility criteria:
inclusion criteria: * psoriatic patients that are treated in our institute. exclusion criteria: * patients suffering from cardiovascular diseases (peripheral vascular disease,congestive heart failure, status post cerebrovascular accident). * conditions that are harmful to the inner ear (chronic renal failure,history of noise exposure, usage of ototoxic drugs, chronic otitis media, ear surgery in the past, significant head trauma in the past, ear drum perforation). * participant that complains of vertigo/ dizziness/ unsteadiness. * participant who is/ was suffering from known inner ear disease: meniere disease, acoustic neurinoma, vestibular neuronitis.
secondary central nervous system lymphoma registry - charité

Conditions: Central Nervous System Lymphoma; Non-Hodgkin Lymphoma

Summary: the objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (scnsl) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. in particular, the following questions will be specified: * what therapeutic approaches are being pursued? * what is the clinical outcome of the various treatment options? * what is the frequency of serious adverse events with each therapeutic approach?

the observational study is to be conducted in inpatient clinics, outpatient clinics and by oncology physicians in private practice. the investigators will be invited to participate by the charité - cns lymphoma working group (charité ag znsl) or the competence network malignant lymphomas (kml). when a patient is reported, the personal data of the physician including the patient will be recorded and compiled in the form of a list documentation. all patients with scnsl can and should be included in the study regardless of which therapy options are used and regardless of whether it is a first-line treatment, the treatment of a recurrence or a maintenance therapy for scnsl. no intervention is associated with the conduct of the observational study with regard to the selection and implementation of the specific therapeutic regimen, diagnostics, and examination frequency during and after treatment. the following information should be documented: * patient demographics and medical history * tumor extent at the time of initial diagnosis and cns involvement * prior therapy * general condition * therapy regimen for the cns involvement * response * adverse drug reactions * tolerability of therapy: acute toxicity * chronic therapy toxicity, especially late neurotoxicity * time to treatment failure (relapse or progression) * death from any cause

Eligibility criteria:
inclusion criteria: • all patients with scnsl can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for scnsl. exclusion criteria: • none
postoperative pain management after minimally invasive aortic valve surgery

Conditions: Aortic Valve Surgery; Postoperative; Pain

Summary: the study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. the patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration: 1. group: continous infusion of the local anesthetic plus bolus on demand 2. group: continous infusion of saline plus bolus on demand for all patients metamizol every 12 hours plus bolous of piritramid on demand.

patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent. the study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. patients will then be randomised in two groups according to the protocol: 1. group: continous infusion of the local anesthetic plus bolus on demand 2. group: continous infusion of saline plus bolus on demand all patients will receive metamizol every 12 hours plus bolus of piritramid on demand. analgesia effectivness will be checked hourly according to the visual analogue scale (vas). according to protocol, bolus will be given every time the score of vas scale is \>3. the catheter will be removed 48 hours after the protocols' start.

Eligibility criteria:
inclusion criteria: * patients after minimally invasive aortic valve surgery * patients agreement with the study exclusion criteria: * age under 18 years * allergy to local anesthetic

Keywords: aortic valve surgery postoperative pain
breethe abiomed recovery registry (bart)

Conditions: Cardiopulmonary Bypass; ARDS; Heart Failure

Summary: the bart registry intended to utilize observational data of the abiomed breethe oxy-1 system™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as a resource to inform us on the design of future studies.


Eligibility criteria:
inclusion criteria: * all adult subjects supported with breethe oxy-1 system exclusion criteria: * subjects under 18 years of age

Keywords: breethe oxy-1 system extracorporeal membrane oxygenation cardiopulmonary bypass ards heart failure