Kornimate/medical-research-clean huggingface dataset:
a study of danoprevir/ritonavir and copegus with ro5024048 and/or pegasys in patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with copegus plus ro5024048 and/or pegasys in patients with chronic hepatitis c infection. patients will be divided into 2 separate cohorts. cohort a, previous partial responders, will be randomized to groups 1-3 and cohort b, previous null responders, will be randomized to groups 4-6. patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. in addition, groups 1 and 4 will receive ro5024048 1000 mg twice a day and copegus 1000 mg or 1200 mg twice a day for 24 weeks; group 2 will receive pegasys 180 microgram subcutaneously once weekly and copegus 1000 mg or 1200 mg twice a day for 24 weeks; groups 3, 5 and 6 will receive ro5024048 1000 mg twice a day, pegasys 180 microgram subcutaneously once weekly and copegus 1000 mg or 1200 mg twice a day for 24 weeks. in addition, patients in group 6 will receive another 24 weeks of pegasys plus copegus treatment.


Eligibility criteria:
inclusion criteria: * adult patients, age 18 years and older * presence of hepatitis c infection, genotype 1a or 1b * documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks * patients must have discontinued prior hepatitis c treatment at least 12 weeks prior to study start exclusion criteria: * infection with any hepatitis c genotype or subtype other than genotype 1a or 1b * patients with cirrhosis * patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response * co-infection with hepatitis b or human immunodeficiency virus (hiv) * history or evidence of chronic liver disease other than hepatitis c
study to examine the benefits of fabric made with lyocell/chitosan/ceramide in the treatment of children with mild to moderate eczema

Conditions: Atopic Dermatitis

Summary: the study will primarily focus on evaluating the benefits of using a lyocell/chitosan/ceramide fabric as a treatment for young children with mild or moderate eczema. more specifically, the study will focus on the upper limb area in these patients and will examine whether wearing a sleeve made from a lyocell/chitosan/ceramide fabric can improve eczema symptoms compared with wearing a cotton sleeve, no sleeve, or the lyocell / chitosan combination. patients will be evaluated at 3 intervals over a 3-week period using the following four variables: an eczema severity index, amount of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas.

the study will be evaluated using the following four variables: an eczema severity index, amount/severity of itching, bacteria levels in the affected areas of skin, and amount of water loss in the affected areas. the eczema severity will be scored using the easi (upper limb subscale); itch will be assessed with a visual analog scale for itch; the skin will be swabbed for bacterial cultures and results are quantified based on microbiology lab standards to be mild, moderate or heavy growth of the bacteria identified; and transepidermal water loss (tewl) will be measured using a tewameter/capacitive moisture sensor.

Eligibility criteria:
inclusion criteria: * age 3 months to 5 years * mild or moderate atopic dermatitis, as determined by investigator global assessment criteria exclusion criteria: * non-english speaking subjects/families * families unable to complete study requirements

Keywords: atopic dermatitis eczema alternative therapy complementary therapy moisturizer
treatment of steroid dependent idiopathic nephrotic syndrome in children with low doses of interleukin 2: a pilot study

Conditions: Nephrotic Syndrome Steroid-Dependent; Interleukin 2

Summary: nil-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic syndrome in children. recent data suggest that interleukin 2 could be an effective therapy via an increased production of regulatory t cells.

the study will include 10 children (age: 3-15 years old). patients will receive low doses of interleukin 2 (0.5 million ui/m²/ injection, subcutaneously). the treatment will be initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.

Eligibility criteria:
inclusion criteria: * children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome * idiopathic nephrotic syndrome progressing for less than 1 year * steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids \> 15 mg/m² every other day) * steroid dose at inclusion between 15 and 60 mg/m²every other day * patient with a stable dose of steroids within the 8 days before and after the first injection of il2 * patient in remission for more than 15 days * patient affiliated to a french health insurance * signed consent of parental authority exclusion criteria: * hypersensitivity to il2 or to one of its excipients * significant history or presence of cardiopathy * signs of evolving infection requiring an antibiotic treatment * respiratory distress, respiratory infection or chronic respiratory failure * serious dysfunction of one of the vital organs * leukocytes \< 4000/mm3 ; platelets \< 100 000/mm3; hematocrit \<30% * anomaly of serum bilirubin and creatinin levels * history of organ allograft * other pre-existing autoimmune disease * male and female pubescent teenagers under the age of 15 * male and female teenagers whose puberty has begun for more than one year * asthmatic patient * pregnant or breastfeeding female patient * participation in another therapeutic trial concurrently or 30 days prior to inclusion

Keywords: idiopathic nephrotic syndrome-child-steroid dependant-il2 safety efficacy
percutaneous us guided elbow tenotomy with the tenjet hydrosurgery system

Conditions: Elbow, Tennis

Summary: to evaluate the acute and long-term clinical outcomes of tenotomy with the tenjet system in patients with elbow tendinosis.

this is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the tenjet hydrosurgery system to treat elbow tendinosis. patients will be followed for a maximum of 12 months post-procedure.

Eligibility criteria:
inclusion criteria: * patient is \> 18 years of age * chronic lateral or medial elbow pain \> 3 month duration * history and clinical examination consistent with lateral or medial epicondylitis * sonographic evidence of medial or lateral elbow tendinosis as evidenced by * tendon thickening and hypoechogenicity, * with or without hypervascularity on doppler examination and, * with or without cortical irregularities, or mri findings consistent with lateral or medial tendinosis, with or without intrasubstance tear. * \> 3 months of non-operative treatment that included * nonsteroidal anti-inflammatory drugs * activity modification * physical therapy * elbow straps * with or without previous steroid injections, protein rich plasma injections, or stem cell injections * patient is willing and able to provide informed consent and comply with the study protocol exclusion criteria: * documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side) * bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure * use of acetylsalicylic acid (asa) and/or non-steroidal anti-inflammatory drug (nsaid) within 7 days of treatment * steroid injection within 4 weeks of the study procedure * active local or systemic infection * patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament. * patient is known or suspected to be pregnant
pilates exercises v/s yoga on rounded shoulders

Conditions: Weakness, Muscle; Muscle Tightness; Range of Motion; Pain; Heart Rate; SpO2; Sleep Quality

Summary: to compare the effects of pilates exercises an yoga on rounded shoulders

pilates exercises and yoga are two effective treatments for correcting rsp. in pilates each exercise is conducted in more than one times usually three to five hence exposing the body to different and new muscular and kinesthetic challenges. on the other hand yoga is a process in which the joints and muscles operate together in a systematic and automatic manner where each pose is sustained for a period of time. several literatures support the belief that pilates exercises and yoga are effective treatments for rsp correction, as well as improving sleep quality, heart rate and spo2 first, the participants will be divided into two groups, for pilates exercises and yoga. honor wristbands will be distributed and exercises will be demonstrated to each group. explanation of using honor band will be given. measurements will be taken before the intervention including cervical rom. shoulder rom at baseline, 2nd week and 4th week. while heart rate, spo2 immediately after the session. sleep quality prior the intervention, 2nd and 4th week. patients will do the exercises 3 times per week for 4 consecutive weeks.

Eligibility criteria:
inclusion criteria: * patients with rounded shoulders who achieve more than 2.5 cm in table top test. exclusion criteria: * patients with a positive history of trauma, fracture or surgery of the cervical spine or shoulder. * neck pain with radiation to the arm and upper extremity. * diagnosed cases of torticollis and scoliosis. * patient with any serious underlying pathology that influence the mobility of upper limb * history of osteoporosis, any heart disease
deep learning radiomics model for predicting post-cystectomy outcome in muscle invasive bladder cancer

Conditions: Bladder Cancer

Summary: muscle invasive bladder cancer (mibc) has a poor prognosis even after radical cystectomy. postoperative survival stratification based on radiomics and deep learning may be useful for treatment decisions to improve prognosis. this study was aimed to develop and validate a deep learning radiomics model based on preoperative enhanced ct to predict postoperative survival in mibc.


Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed mibc after radical cystectomy; * contrast-ct scan less than two weeks before surgery; * complete ct image data and clinical data. exclusion criteria: * patients who received neoadjuvant therapy; * non-urothelial carcinoma; * poor quality of ct images; * incomplete clinical and follow-up data.

Keywords: tomography, x-ray computed muscle-invasive bladder cancer radiomics deep learning
analgesic effect of intraoperative intravenous s-ketamine during total knee arthroplasty surgery

Conditions: Postoperative Pain, Acute; Anaesthetic

Summary: severe acute pain after total knee arthroplasty surgery has multiple implications for hospitals and patients, monopolising resources and affecting the quality of life. s-ketamine inhibits n-methyl-d-aspartate (nmda) receptor activation and attenuates central sensitization associated with hyperalgesia, opioid tolerance.therefore, the primary aim of this trial was to investigate whether s-ketamine decreases pain and opioid consumption postoperatively in adult individuals undergoing total knee arthroplasty surgery.

total knee arthroplasty surgery is considered a cost-effective therapy for end-stage knee osteoarthritis (koa). with an ageing population and rising rates of obesity in the world, knee joint replacements are estimated to escalate. while joint replacement is a cost effective intervention,approximately 20% of people experience persist pain postoperatively. the surgical injury triggers a myriad of responses in the pain matrix, from sensitization of peripheral and central pain pathways to feelings of fear, anxiety and frustration. opioids are effective for acute postoperative pain but have numerous adverse effects. in addition, postoperative opioid treatment may pose a risk of opioid addiction. numerous publications state that adjuvant s-ketamine reduces pain and opioid consumption postoperatively . whether intraoperative intravenous s-ketamine alleviates postoperative acute pain after total knee arthroplasty surgery still unclear . therefore, a randomized, controlled, clinical study was designed to observed analgesic effect intraoperative intravenous a lower doses of s-ketamine(0.3mg/kg/h) with patients after total knee arthroplasty surgery .

Eligibility criteria:
inclusion criteria: 1. asa physical statusi-iii; 2. patients understood the study in detail and voluntarily signed the informed consent before the study; 3. patients to be treated with total knee arthroplasty surgery under general anesthesia; 4. elderly patients(≥65y),regardless of gender; 5. patients can communicate normally; 6. patients who have no contraindications to drugs such as midazolam,fentanyl,s-ketamine. 7.18 kg/m2 ≤bmi≤30 kg/m2; exclusion criteria: 1. increased intracranial or intraocular pressure; 2. severe hypertension; 3. unwillingness the study; 4. severe psychiatric disease and mental system diseases; 5. severe respiratory diseases; 6. hyperthyroidism; 7. liver and kidney dysfunction; 8. alcohol or drug abuse; 9. allergy to midazolam,fentanyl,s-ketamine.

Keywords: postoperative pain total knee arthroplasty surgery anaesthetic s-ketamine infusion
brown fat activity measurement with infrared imaging thermography andthermogenesis - the bright study

Conditions: Energy Expenditure; Obesity; Adipose Tissue, Brown

Summary: the whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis as a surrogate marker of brown adipose tissue (bat) activation. the infrared (ir) energy flux from activated bat can be accurately imaged and quantified using an ir imaging device, and that this ir energy output may be correlated to the increased energy expenditure quantified by the whole body calorimeter.

the recent rediscovery of functional brown adipose tissue (bat) in healthy adults has opened up the exciting possibility of manipulating bat for obesity management, and it is imperative to develop bat imaging modalities that are non-invasive and safe for repeated use. given that heat is a specific end-product of uncoupling protein-1 (ucp-1)-mediated bat, this study examines whether surface body temperature assessed using infrared (ir) thermography can be a non-invasive measure to accurately and precisely predict brown adipose tissue (bat) activation upon cold stimulation, which involves verifying an semi-automated method for characterizing thermal images. in addition, this study also aims to validate the use of a whole-body calorimeter to pick up changes in energy expenditure upon cold-induced thermogenesis. lean, healthy male volunteers will be recruited. thermal imaging of cervical-supraclavicular bat will be done using an ir camera to assess changes in bat activation. blood samples will also be drawn at regular intervals to track changes in serum metabolites upon bat activation. all in all, this study hopes to provide more supporting evidence that ir thermography is a viable imaging modality that is non-invasive, safe and reproducible of studying bat activity.

Eligibility criteria:
inclusion criteria: * male * ethnic chinese * age between 21 to 35 years * body mass index 18.5 to 22.9 * normal resting blood pressure \~120/80 mmhg * normal fasting blood glucose level \<5.5 mmol/l exclusion criteria: * do not train for or partake in competitive sports * do not have any major diseases * not on any prescribed medication
the greek antiplatelet (grape) registry: a multicenter observational prospective investigation of antiplatelet treatment in patients with acute coronary syndrome subjected to percutaneous coronary intervention

Conditions: Acute Coronary Syndrome

Summary: this is a multicenter, prospective, observational investigation, focusing of antiplatelet treatment in patients with moderate to high risk acute coronary syndrome (timi risk score ≥3)subjected to percutaneous coronary intervention (pci), being conducted in 7 pci capable hospitals in greece. data concerning patients' demographic, clinical/procedural characteristics and contraindications/special warnings and precautions to p2y12 inhibitors are collected during initial hospitalization. study involves 3 follow-up visits after hospital discharge(day 30, at 6 months and at 12 months) where data on major adverse cardiac events (death, myocardial infarction, stroke, urgent revascularization procedure with pci or cabg), bleeding events(according to bleeding academic research consortium criteria)and adherence to antiplatelet treatment are collected. in patients under ticagrelor or prasugrel treatment, platelet reactivity measurement with verifynow assay will be performed at day 30


Eligibility criteria:
inclusion criteria: * age\>18 years * acute coronary syndrome moderate to high risk (timi risk score ≥3) subjected to pci * informed consent exclusion criteria: * pregnancy/breastfeeding * inability to give informed consent * high probability of being unavailable for follow-up visits
advancing equitable access to hiv/hcv testing for people who inject drugs (pwid)

Conditions: HIV Infections

Summary: the purpose of this study is to test the effectiveness of the access strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (ssps) to implement routine, opt-out hiv and hepatitis c (hcv) testing and linkage to care for people who inject drugs (pwid).


Eligibility criteria:
inclusion criteria: * ssps must: 1. be operating in an ending the hiv epidemic (ehe) or centers for disease control and prevention (cdc) determined vulnerable jurisdictions; 2. serve at least 300 unique participants per year; 3. not currently offer opt-out hiv/hcv testing; 4. be capable and willing to prospectively collect aggregated, site-level data on the number of participants who are: i) offered hiv/hcv screening, ii) completed these tests, and iii) linked to care, as well as provide participant demographics; 5. have key staff that consent to participate in study surveys, qualitative interviews and practice facilitation throughout the study. exclusion criteria: * ssps must not: 1. currently receive or have received frontline communities in the united states (focus) funding; 2. have already implemented opt-out hiv/hcv testing.
safety/efficacy of tigan® to control nausea/vomiting experienced during apokyn® initiation and treatment

Conditions: Parkinson's Disease

Summary: the purposes of the study are to determine: i. to assess the efficacy of tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with apokyn® (apomorphine) ii. to determine the optimal duration for continuation of tigan® following initiation of apokyn® therapy iii. to assess the safety of tigan® in combination with apokyn® iv. to characterize the pharmacokinetic (pk) profile of apomorphine in subjects treated concomitantly with and without tigan®

initial randomization is tigan or placebo (3:1) with phased withdrawal of tigan to placebo after 4 and 8 weeks. subjects completing 4 weeks tigan re-randomized to tigan or placebo (2:1) with patients completing 8 weeks tigan re-randomized to receive tigan or placebo (1:1). subjects randomized to placebo over the previous 4 weeks assigned to continue on placebo for the remainder of the study.

Eligibility criteria:
inclusion criteria: * subjects aged 18 years or over * subjects with advanced parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with apokyn® by intermittent subcutaneous injection * able to swallow tigan®/placebo capsules * subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures * women of child bearing potential must have a negative serum pregnancy test (beta hcg) prior to receiving study drug and must be using an appropriate form of contraception * willing and able to provide informed consent exclusion criteria: * hypersensitive to apomorphine hydrochloride or any of the ingredients of apokyn® (notably sodium metabisulfite) * hypersensitive to trimethobenzamide or any of the ingredients of tigan® * previous treatment with apokyn® * participation in any other clinical trial within 14 days of the present trial * contraindications to apokyn® or tigan® * currently taking, or likely to need to take at any time during the course of the study, any 5ht3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron) * malignant melanoma or a history of previously treated malignant melanoma * pregnancy or breast feeding * receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial * any significant medical disorder, condition, concomitant medication or psychiatric disorder according to dsm-iv criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial

Keywords: parkinson's disease anti-emetic nausea vomiting
movement disorder quantification algorithm development

Conditions: Parkinson's Disease; Essential Tremor

Summary: the purpose of this study is to collect kinematic motion data from subjects with movement disorders such as parkinson's disease (pd) and essential tremor (et) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * clinical diagnosis of idiopathic parkinson's disease or essential tremor * able to provide informed consent exclusion criteria: * significant medical or psychiatric illness * not capable of following the required clinical instructions * serious medical conditions that compromise safety

Keywords: motion sensors tremor bradykinesia gait balance dyskinesia
pharmacokinetics and relative bioavailability study of oxycodone

Conditions: Pain

Summary: to estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four pf-00345439 formulations and oxycodone in solution

this study will estimate the pk and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified pf-00345439 formulations b, c, and d compared with the reference formulation a under fed conditions.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive exclusion criteria: * evidence or history of clinically significant diseases

Keywords: pharmacokinetics relative bioavailability oxycodone