Kornimate/medical-research-clean huggingface dataset:
optimisation and quantification of contrast enhanced computed tomography myocardial fibrosis imaging

Conditions: Myocardial Infarction

Summary: detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart conditions. magnetic resonance imaging (mri) can assess scarred heart muscle but it is time consuming, contraindicated for some patients and not tolerated by others. computed tomography (ct) imaging has the potential to provide a rapid comprehensive assessment of the heart. this study will assess ct imaging of the heart muscle of patients who have previously undergone mri of their heart. using a state of the art ct scanner the investigators will develop a low radiation dose protocol to identify scarred heart muscle. the investigators will use and develop software techniques to analyse these images. this will enable us to develop a new way to identify and measure scarred heart muscle that will benefit patients with heart disease.


Eligibility criteria:
inclusion criteria: * presence of late enhancement on magnetic resonance imaging exclusion criteria: * age less than 40 * inability or unwillingness to undergo ct * renal failure (serum creatinine \>200 umol/l or estimated glomerular filtration rate \<30 ml/min) * hepatic failure * allergy to iodinated contrast * pregnancy * breast feeding * inability to undergo informed consent * fast atrial fibrillation
pain in single incision laparoscopic surgery cholecystectomy

Conditions: Laparoscopic Cholecystectomy

Summary: the attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as natural orifice transluminal endoscopic surgery (notes) and single incision laparoscopic surgery (sils). these new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. in this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.


Eligibility criteria:
inclusion criteria: * body mass index less than 30 * attacks of cholelithiasis exclusion criteria: * body mass index more than 30 * signs of acute cholecystitis

Keywords: minimally invasive surgery scarless cholecystectomy new techniques in laparoscopy invisible scar single port access abdominal pain shoulder pain
rectal spacers use in prostate cancer radiation therapy

Conditions: Prostate Cancer

Summary: this prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for proton beam therapy (pbt). up to 50 subjects will be enrolled in this study. study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.


Eligibility criteria:
inclusion criteria 1. subjects greater than 18 years old with prostate cancer 2. subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. subjects must have clinical stage t1-t3 with no posterior extra capsular extension of the prostate cancer 4. psa less than or equal to 20 ng/ml 5. gleason score less than or equal to 7 6. capacity to comprehend and readiness to sign a written informed consent form exclusion criteria 1. planned pelvic lymph node radiotherapy. 2. metastatic disease. 3. prior local prostate cancer therapy 4. active inflammatory bowel disease requiring treatment with steroids. 5. prior radical prostatectomy. 6. active urinary tract infection. 7. acute or chronic inflammation or infection of the prostate.
a study to investigate bms-986165 and methotrexate in healthy male patients

Conditions: Lupus; Psoriatic Arthritis

Summary: the purpose of this study is to investigate effects of bms-986165 on blood levels of methotrexate given as a single dose in healthy male patients.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * body mass index (bmi): 18.0 - 32.0 kg/m2 * normal renal function at screening exclusion criteria: * any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease * any contraindication indicated in the mtx package insert * history or presence of chronic bacterial or viral infection * history or presence of an autoimmune disorder * any significant acute or chronic medical illness * active tb requiring treatment or documented latent tb within the previous 3 years * current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption other protocol defined inclusion/exclusion criteria could apply
innervation of vascularized iliac transplant avoids resorption in jaw bone reconstruction

Conditions: Bone Resorption; Nerve

Summary: the purpose of this study is to determine the efficacy of simultaneous innervation to prevent graft bone resorption in maxillofacial reconstruction. it may provide basis for future clinical trials and new strategies for improving the functional reconstruction of large jaw bone defects.

the use of autograft is still the main method for reconstructing large defects of jaw bones. however, the spontaneous resorption of the graft bone is still severe, and hinders the success of dental implant(s) and chewing function even after microsurgical vascularization. but till now, there is no effective prevention method for this major problem. based on previous studies, the investigators pioneered a simultaneous innervated vascularized iliac bone graft method, through neurorrhaphy between the nerves innervating iliac bone and recipient site. a clinical retrospective study showed that this new method significantly decreases postoperative osteoporosis, and ensures the success of dental implants (refer to our published article wang l\*, wei j, yang x, yang z, sun m, cheng x, xu l, lei d, zhang c\*. preventing early-stage graft bone resorption by simultaneous innervation: innervated iliac bone flap for mandibular reconstruction. plastic reconstructive surgery, 2017, 139(5):1152e-1161e, cover featured article). the investigators intend to randomly divide the vascularized iliac bone graft cases into traditional group without innervation and simultaneous innervation group (through neurorrhaphy between the nerves innervating iliac bone flap and recipient site). the efficacy of simultaneously innervated maxillofacial reconstruction for preventing graft bone resorption will be assessed using bone mineral density test of grafted bone, as a blinded method. the innervation and sensation of the internal oblique abdominis muscle island will be tested using neuroelectrophysiological examination. the recipient nerve having the best effect on preventing bone resorption, will be determined using hierarchical comparison method.

Eligibility criteria:
inclusion criteria: 1. patients between the age of 17 to 65 years (to avoid possible postmenopause osteoporosis), irrespective of gender. 2. post resection segmental defect of mandible between 5-9 cm long. 3. acceptable systemic conditions like nonmenopausal-related osteoporosis, diabetes mellitus, in controlled normal range. 4. patients agreeing to sign the informed consent form. exclusion criteria: 1. advanced malignant tumors. 2. poor general condition, who can not tolerate vascularized bone flap reconstruction. 3. history of drugs affecting bone metabolism, like bisphosphonates, calcium agents or others.

Keywords: jaw reconstruction innervation bone resorption
immune infiltrate analysis of psoriasis skin during therapy with anti-interleukin 23 (il-23)

Conditions: Psoriasis

Summary: psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques. psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development. although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy. our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-il-23 biologic drug. the immune infiltrate of resistant or relapsed plaques during anti-il-23 therapy will be analysed from skin biopsies.


Eligibility criteria:
inclusion criteria: * moderate-severe psoriasis pasi\>10 * anti il 23 biologic therapy for at least 6 months (for the group under treatment) * during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment) * patients able to express informed consent exclusion criteria: * patients unable to express informed consent * patients with complete response to anti il23, without resistant plaques or disease flare-ups
atorvastatin in relapsing-remitting multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: a phase ii open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (rrms). patients with at least one gadolinium-enhancing lesion (cel) at screening by magnetic resonance imaging (mri) were eligible for the study. patients are screened and enrolled in the outpatient clinic of the cecilie vogt clinic at the charité - university medicine berlin. after a baseline period of 3 monthly mri scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. the primary endpoint is the number of cel in treatment months 6 to 9 compared to baseline. secondary endpoints include other mri-based parameters and changes in clinical scores and immune responses.


Eligibility criteria:
inclusion criteria: * 18 - 55 years old * ms diagnosis according mcdonald criteria * relapsing-remitting ms * edss 0 - 6 * disease activity as occurrence of cel in brain mri * ifn-beta therapy for at least 6 months exclusion criteria: * primary chronic progressive ms * symptoms and signs of clinical disease conditions similar to ms * conditions that can disturb mri measurements * clinically relevant gi diseases eg colitis ulcerosa, crohns disease, history of ulcus pepticum * clinically relevant lung, heart, cns, infectious disease * clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values) * allergies towards gd-dtpa * allergies towards constituents of the therapeutic agent * recruitment to other clinical trials within 6 months prior to or during this study * pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-cd4, campath-1h), mitoxantrone, cyclophosphamide, cyclosporin a, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental ms therapies (6 months prior to study start), glatiramer acetate, azathioprine, ivig (6 months prior to study start) pregnancy or lactation * alcohol or drug abuse * inhibitors of cytochrom p 450 3a (eg. cyclosporin, macrolide antibiotics, azole antimycotics). * medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study
methylphenidate, rivastigmine or haloperidol in hypoactive delirium in intensive care patients

Conditions: Delirium

Summary: the purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive icu-delirium. in addition we will compare duration of delirium, severity of delirium, length of icu/hospital stay and side effects between the different interventions.


Eligibility criteria:
inclusion criteria: * older than 18 years * diagnosed as hypoactive delirium * informed consent given exclusion criteria: * pregnancy * epilepsy * m. parkinson * lewy-body dementia * prolonged qt-time * known allergy to the medicinals used * renal replacement therapy * hepatic encephalopathy * hyperthyroid * glaucoma * previous suicide attempts * syndrome of gilles de la tourette * patients which cannot receive the medication oral or through a nasogastric tube

Keywords: icu delirium hypoactive delirium haloperidol methylphenidate rivastigmine hypoactive icu delirium
television viewing (tvv) & puberty on lunchtime food intake

Conditions: Obesity Prevention

Summary: the investigators hypothesize that television viewing will affect food intake in adolescent girls, and will depend on pubertal stage. food intake will be measured at 30 min following a glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of tv. subjective appetite will be measured as well.


Eligibility criteria:
inclusion criteria: * healthy girls with no emotional, behavioral or learning problems exclusion criteria: * boys

Keywords: girls obesity television viewing puberty
hemodynamic response to angiotensin-ii when used as the second vasopressor agent for septic shock

Conditions: Septic Shock; Shock; Sepsis; Systemic Inflammatory Response Syndrome

Summary: norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. the addition of non-catecholamine vasopressors, including vasopressin and angiotensin-ii may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. uncertainty exists regarding the timing of initiation of these agents and there is a lack of data comparing their safety and efficacy. the current literature suggests that earlier initiation of angiotensin-ii will have a more significant reduction on norepinephrine-equivalent dose compared to later initiation. in addition, approximately half of patients initiated on vasopressin do not have an early hemodynamic response 6 hours after initiation. the purpose of this study is to evaluate the efficacy of angiotensin-ii when used as the second vasopressor agent for septic shock.

objectives: primary objective: 1. to evaluate the efficacy of ang-ii when used as the second vasopressor agent for septic shock secondary objectives: 1. to assess the duration of response to ang-ii 2. to assess overall survival 3. to assess the amount of time spent in the icu 4. to assess the need for renal replacement therapy 5. to assess the overall duration of vasoactive medication use 6. to assess toxicity and tolerability

Eligibility criteria:
inclusion criteria: * patients admitted to the icu within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure \ 2 mmol/l. criteria of systemic inflammatory response syndrome include a temperature \>100.4°f or \ 90/min; respiratory rate \>20/min and a white blood cell count \>12,000/mm3 or \<4,000/mm3. exclusion criteria: * age \<18 years * pregnancy or lactation * known allergic reactions to angiotensin-ii or hydrocortisone sodium succinate * requiring \>25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment * clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism * treatment with another investigational drug or other intervention during study timeframe

Keywords: sepsis angiotensin ii hydrocortisone
spinal muscular atrophy on wheels, using power mobility

Conditions: Spinal Muscular Atrophy

Summary: the group of children diagnosed with spinal muscular atrophy (sma) has serious restrictions on participation. sma is a neuromuscular disease that leads to neuromusculoskeletal disorders that limit functional activities, sometimes making it impossible to sit down autonomously and to walk. scientific evidence has highlighted the importance of implementing physiotherapy interventions in pediatrics that facilitate the integration and participation of children with reduced mobility in their natural environment through the use of different assisted mobility devices that allow the child to acquire a degree of independence and motivation according to their potential and needs. for some time, with the aim of offering independent movement opportunities for children with severe motor impairment, adapted electric cars have been used, as they are simple to use and easy for the child and family to incorporate into daily tasks within natural environments. these low-cost motorized devices can generate a very positive impact on the participation of children diagnosed with sma type i from an early age, after training the family and/or the child himself, guaranteeing the maximum possible safety, comfort, motivation and autonomy. due to the above, there is a need to carry out the research project defined below, to generate opportunities for the inclusion of children diagnosed with sma type i through the use of low-cost electric cars that encourage their participation, motivation and quality of life.

objectives 1. to know the acceptability of an intervention with motorized mobility through electric cars for young children diagnosed with sma type i. 2. to check the effectiveness of the motorized mobility intervention with electric cars with respect to: (a) mobility and (b) participation of young children with sma type i with respect to the control group of children who do not use such devices. 3. to identify the barriers and facilitators of the child's participation in their natural environment of a motorized mobility intervention with electric cars in young children with sma type i.

Eligibility criteria:
inclusion criteria: * diagnosis of sma type i * ages between 10 months to 5 years. * no previous experience with motorized mobility. exclusion criteria: * severe visual problems * associated disorders that do not correspond to the diagnosis of sma type i. * families who do not agree to have training in the use of the electric car and continuous monitoring by the corresponding researcher.

Keywords: home family natural environment participation
mypad - intelligent bladder pre-void alerting system

Conditions: Enuresis, Nocturnal; Enuresis

Summary: development a 'dry alarm' that can help children and adolescents become dry at night.

enuresis / bedwetting is a common problem causing much emotional distress. most children are dry by the age of 5 years, but a significant number of older children still wet their bed. this can be very distressing for child and family. there is also an associated cost due to extra laundry and impact of lost sleep. programmes to help children become dry at night often include the use of a moisture alarm. the alarms sound when the child begins to wet the bed, waking them up to go to the toilet instead. most alarms work by detecting wetness, sounding the alarm when the child starts to pass urine. as such, they still need to change pyjamas and bed sheets. the investigators aim to develop a 'dry alarm' that can help children and adolescents become dry at night. the alarm will sound when the bladder is full, before the child passes urine. this would avoid wet beds. the investigators have engineered parts for this alarm, but need to work on making it ready for use. this device will enable children to have dry nights whilst learning bladder control. this study has several phases. the alarm will consist of a small box worn over the abdomen. the aim is to test this overnight, and adjust it for comfort and ease. the device uses a mini ultrasound machine, which measures how much urine is in the bladder. there will be a series of tests to calibrate the device compared to a clinical ultrasound device. then children with enuresis/ bed wetting will wear it overnight. it will be linked to an alarm which will sound once the bladder is full. this particular study will determine the feasibility of the product, to confirm the design and specifications, including a comfort trial, calibration and comparison with clinical scans, and operating process prior to a future clinical trial. the total number of participants is 25 - however this will be split over the different phases of the trial. comfort trial - 5 calibration trial 3 month testing phase - 10

Eligibility criteria:
inclusion criteria: * age 7 years to 12 years * bedwetting twice a week or more * good understanding of english language * for the initial comfort trials and the calibration trial healthy volunteers may be invited to take part. exclusion criteria: * there is a medical cause for bedwetting * they have significant learning difficulties * they are obese (above 98th centile for body mass index) * they have severe hearing impairment
the web®-it china clinical study

Conditions: Wide Neck Bifurcation Intracranial Aneurysms

Summary: this trial is a prospective, multicenter, single-arm confirmatory clinical trial. the study is to confirm the safety and effectiveness of the web aneurysm embolization system demonstrated in the us web-it study for the treatment of intracranial wide-neck bifurcation aneurysms. the study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. the study device must meet both endpoints. the primary effectiveness endpoint is adjudicated by an independent third party core lab.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 and ≤75 years old * patient must have a single ruptured or unruptured ia(intracranial aneurysm)requiring treatment * patient must sign and date irb/ec approved written informed consent prior to initiate of any study procedures exclusion criteria: * patient has an ia with characteristics unsuitable for endovascular treatment * patient has stroke-in-evolution within the prior 60-days * patient has had an sah(subarachnoid hemorrhage) from a nonindex ia or any other intracranial hemorrhage within 90 days * patient's index ia was previously treated * patient is pregnant
bolt lithotripsy restore atk trial

Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases

Summary: the restore (atk) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the bolt intravascular lithotripsy system.

the restore (atk) above the knee study is a prospective, non- randomized, multi-center study for treatment of stenotic lesions with the bolt intravascular lithotripsy system that was designed to enhance percutaneous transluminal angioplasty by utilizing delivery of intravascular lithotripsy (ivl) to disrupt calcium prior to full balloon dilatation at low pressures.

Eligibility criteria:
inclusion criteria: * age of subject is ≥18. * rutherford clinical category 2, 3, or 4. * target lesion that is located in a native de novo superficial femoral artery (sfa) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery) * calcification is at least moderate. (presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion or absolute length ≥20mm. exclusion criteria: * planned major amputation of the target leg (above the ankle) * the use of chronic total occlusion (cto) re-entry devices * ctos greater than 80 mm in length * lesions within 10 mm of ostium of the sfa * significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g., iliac or common femoral) not successfully treated with percutaneous angioplasty (pta) or stent and without complications

Keywords: pad