Kornimate/medical-research-clean huggingface dataset:
feasibility study of a new fistula pouching system

Conditions: Cutaneous Fistula

Summary: the purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.


Eligibility criteria:
inclusion criteria: * 18 years or older * capable of giving informed consent * have to be hospitalized * have a fistula with the opening on the skin in the abdominal area exclusion criteria: * pregnant and/or breast-feeding * receiving radiation- or chemotherapy during the investigation period
safety study of trk-820 for patient with hemodialysis

Conditions: Chronic Renal Failure

Summary: the purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions * patients aged 20 years or older * patients whose post-dialysis bmi measured at the nearest time before the singing day is in the range of 70 \~ 130 % * patients who can understand and follow instructions and participate in the study during the entire study period * patients who signed the informed consent form before participating in the study exclusion criteria: * patients who have confirmed malignant tumor * patients with cognitive impairment including depression, schizophrenia and dementia * patients with hepatic cirrhosis as a complication * patients with drug allergy to opioids * patients with drug dependency or allergic disease (including skin response to uv radiation) * patients who participated in other study and received the investigational drug within 1 month before the signing day * patients who participated in other trk-820 study within 4 weeks before the signing day * pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception * patients who received any of the following drugs within 2 weeks before day 1 1. azole antifungal agents 1. ketoconazole 2. fluconazole 3. itraconazole 4. clotrimazole 2. macrolide antibiotics 1. erythromycin 2. midecamycin 3. josamycin 4. roxithromycin 5. clarithromycin 6. triacetyloleandomycin 3. ritonavir 4. cyclosporine 5. nifedipine 6. cimetidine 7. amiodarone * patients who had the following drinks and foods within 2 weeks before day 1 1. foods and drinks containing grape fruit juice 2. food and drinks containing st. john's wort * patients who participated in other clinical study during the period between the singing day and hospitalization (day 1) * patients who smoked and drank from three months before the signing day * patients who are ineligible for the clinical study for other reasons at the investigator's discretion

Keywords: safety evaluation pharmacokinetic analysis
prasugrel 5mg versus high dose clopidogrel in clopidogrel resistant patients aged ≥75 years and/or weighing <60 kg post percutaneous coronary intervention (pci)

Conditions: Platelet Reactivity

Summary: the use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (pci) with stenting. however, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. the aim of the study is to define in consecutive patients with acute coronary syndrome (acs) undergoing pci, those aged\>75years and/or weighted\<60 kg with high on-clopidogrel platelet reactivity (platelet reactivity units-pru≥235) as estimated 24 hours post pci with the verifynow assay. those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. at day 30 platelet reactivity will be determined as well.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. patients having pci with stenting 24 hours prior randomization, meeting the following criteria : * acute coronary syndrome (unstable angina or myocardial infarction) * timi risk score\>2 3. platelet reactivity in pru ≥235 24 hours post-pci 4. age≥75 years and/or weight\<60 kg 4. informed consent obtained in writing exclusion criteria: * a history of bleeding diathesis * chronic oral anticoagulation treatment * contraindications to antiplatelet therapy * known platelet function disorders * pci or coronary artery bypass surgery \< 3 months * unsuccessful pci (residual stenosis \> 30% or flow \< thrombolysis in myocardial infarction flow 3) * planned staged pci in the next 30 days * hemodynamic instability * hemodialysis * creatinine clearance \<25 ml/min * inability to give informed consent * high likelihood of being unavailable for the day 30 * history of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months. * other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy. * any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm). * thrombocytopenia (\<100.000 / μl) at randomization * anaemia (hct \<30%) at randomization * polycythaemia (hct \> 52%) at randomization * periprocedural iib/iiia inhibitor administration

Keywords: platelet reactivity clopidogrel prasugrel
ddi study with multiple-dose lx4211 and single dose digoxin

Conditions: Healthy

Summary: this study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple dose lx4211 (400 mg administered as 2 × 200-mg tablets qd × 12 days) on the pk of single-dose digoxin (2 × 0.25-mg tablets) in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * adult subjects ≥18 to ≤55 years of age * vital signs at screening in the following ranges: systolic blood pressure, 90-140 mmhg; diastolic blood pressure, 50-90 mmhg; heart rate, 45-100 bpm * body mass index (bmi) ≥18 and ≤32 kg/sq m * willing and able to provide written informed consent exclusion criteria: * presence of clinically significant physical, laboratory, or ecg findings that, in the opinion of the investigator and/or sponsor, may interfere with any aspect of study conduct or interpretation of results * history of clinically significant arrhythmias * history of cardiac arrhythmias or palpitations associated with presyncope, syncope, or a family history of sudden cardiac death * use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study * receipt of any investigational agent or study drug within 30 days prior to screening * receipt of any protein- or antibody-based therapeutic agents within 3 months prior to screening * prior exposure to lx4211 * use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to screening and for the duration of the study * history of any serious adverse reaction or hypersensitivity to any inactive component of lx4211 or digoxin * existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of lx4211 or digoxin * history of any major surgery within 6 months or anticipated surgery prior to day 1 * history of any clinically significant hypoglycemia or hyperglycemia * history of renal disease, or significantly abnormal kidney function test at screening * history of hepatic disease, or significantly abnormal liver function tests at screening * history of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or gi abnormality * history of any active infection within 14 days prior to day 1 * history of alcohol or substance abuse within 2 years prior to screening * positive hepatitis panel * donation or loss of \>500 ml of blood or blood product within 3 months prior to screening * women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test * positive urine glucose at screening * positive urine screen for drugs of abuse and cotinine at screening, day -1, or day 13 * inability or difficulty swallowing whole tablets * unable or unwilling to cooperate with the investigator for any reason
observational study evaluating outcomes of hip arthroplasty using tornier dual mobility acetabular cup

Conditions: Primary Osteoarthritis; Post-traumatic Osteoarthritis of Hip Nos; Femur Head Necrosis; Femur Neck Fracture; Congenital Dislocations

Summary: the purpose of this study is to demonstrate the performance and reliability of tornier "dual mobility cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.

the purpose of this study is to demonstrate the performance and reliability of the tornier "dual mobility cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. the primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. the secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed

Eligibility criteria:
inclusion criteria: * men and women aged over 18, undergoing total hip replacement with insertion of a dual mobility acetabular cup between october 2010 and october 2011, * capable of attending the 2-year follow-up visit; * capable of understanding the information about the study and agreeing to take part in it. exclusion criteria: * patients with tumoral pathology.

Keywords: arthroplasty hip replacement acetabular cup dual mobility hip revision surgery
frequency of functional gastrointestinal disorders in children

Conditions: Functional Abdominal Pain Syndrome

Summary: cross sectional study to detect frequency of functional gastrointestinal disorders among schhol aged children complaining of recurrent abdominal pain

school aged children from age of 5 to age of 15 who are complaining of recurrent abdominal pain will be included in the study , detailed history , examination and investigations will be done

Eligibility criteria:
inclusion criteria: * clinical diagnosis of recurrent abdominal pain * the child can express and locate site of the pain exclusion criteria: * children less than 5 and adolescents more than 14 * mentally retarded children

Keywords: abdominal pain recurrent
mental health engagement network (mhen)

Conditions: Mood Disorder; Psychotic Disorder

Summary: patients with mood disorder or psychotic disorder will be given handheld devices with personal health records to educate, monitor and deliver customizable healthcare tools based on their personal needs. the use of technology has great potential to deliver care more effectively and efficiently. no actual information is on the handheld device - it is accessed from a secure site behind hospital firewalls.


Eligibility criteria:
inclusion criteria: * must be diagnosed with mood disorder or psychotic disorder for a minimum one year * able to make informed consent to participate in the study * able to understand and speak english to the degree necessary to participate in interviews/focus groups exclusion criteria: * younger than 18 or older than 80

Keywords: mental health smart technology mood disorder psychotic disorder
a prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of convafoam™ dressings in the management of indicated chronic wound types.

Conditions: Chronic Ulcer of Leg or Foot; Pressure Injury

Summary: a prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of convafoam™ dressings in the management of indicated chronic wound types.

a prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of convafoam™ silicone, convafoam™ border and convafoam™ non-adhesive dressings in the management of chronic leg ulcers (including diabetic foot ulcers) and pressure injuries (grade ii and above)

Eligibility criteria:
inclusion criteria: * patients aged 18 years and over * patients able and willing to provide informed consent * patients with wounds with a duration of no less than 2 months and no more than 12 months * patients must be willing to complete the qol (quality of life) questionnaires via a valid email address * patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound: * chronic ulcers (venous, arterial, mixed aetiology or diabetic foot ulcers) * pressure injury stage ii or greater * patients must be willing to attend visits as per schedule in protocol exclusion criteria: * patients with known allergies to any of the materials used in the dressing * patients with known malignant wounds * patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions * patients, who in the opinion of the investigator, are considered as unsuitable for any other reason * patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
the foot and ankle ability measure (faam) is translated from english to turkish and assess the validity and reliability in athletic population who have foot and ankle disorders.

Conditions: Ankle; Injury, Superficial, Multiple (With Foot)

Summary: sport activity induces a relevant risk for lower extremities especially ankle and foot structures. athletes who participate in basketball, volleyball and soccer are predisposed. self-reported outcome instruments have been used by clinicians to assess the treatment interventions effectiveness directed at patients with pathologies and identify impairments, disabilities and quality of life. the assessment of musculoskeletal injuries can be problem without clinical, radiological examination and on scores from patient-based questionnaires. the information from these questionnaires provides us good evidence if there is not interpretation of obtained scores. the foot and ankle ability measure (faam) is a self-reported outcome instrument for patients with foot and ankle disorders available in english, german, and french. the faam has a sports subscale and activity of daily living (adl) subscale that can assess the activities that requires higher level. the aim of this study is to translate the faam into turkish language, perform a cross-cultural adaptation, and investigate the reliability, validity of the translated version in athletic population


Eligibility criteria:
inclusion criteria: 1. participants should be professional athletes 2. age ranges must be 18-40 years old 3. clinical diagnosis of ankle and foot injury 1. acute condition 2. chronic condition 4. injuries must to happened in sport activities. exclusion criteria: 1. if athletes had injuries to hip, knee, lower leg within the previous 6 months before the study. 2. the history of surgery to the above-mentioned areas. 3. coexisting musculoskeletal injuries in other body parts, or chronic conditions. 1. systematic diseases 2. neurological or vascular conditions. 3. alcohol abuse 4. psychiatric disorders

Keywords: self-reported outcome instrument sport ankle and foot injury
a new model to reach vulnerable older adults with pain self-management support

Conditions: Chronic Pain

Summary: learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. community health workers (chws) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. the goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by chws, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in detroit, michigan. this study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.


Eligibility criteria:
inclusion criteria: * english-proficient * age \>= 60 years * ambulatory with or without assistive device * community-living * have a cell or landline phone * have internet access (home or elsewhere) * self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities * ability to attend a one-time study orientation session exclusion criteria: * serious acute illness or hospitalization in last month * planned surgery in next three months * significant cognitive impairment as indicated by affirmative response to question: "do you have significant difficulties with your memory that get in the way of your usual daily activities?" * other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.
the effect of coenzyme q10 on hearing and tinnitus characteristics of chronic tinnitus patients

Conditions: Tinnitus

Summary: the study is a randomised double-blinded trial. a group of 40 tinnitus patients with a naturally low q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ent-consultation. the 40 patients with the lowest level will be asked to take 2 months q10 (n=20) or the placebo (n=20). to evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.


Eligibility criteria:
inclusion criteria: * chronic non-pulsatile tinnitus \> 3 months * tinnitus has a clear otological cause * age \> 18 years exclusion criteria: * pulsatile tinnitus * persons who take already q10 * pregnancy * cervical tinnitus * holocranial tinnitus * depression * mental of neurological disorders * history of chemotherapy * middle ear diseases

Keywords: q10 ubiquinol
efficacy, safety and tolerability of vs-01 in adult patients with acute-on-chronic liver failure and ascites (unveil-it)®

Conditions: Acute-On-Chronic Liver Failure; Ascites

Summary: a phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation vs-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (acute-on-chronic liver failure, aclf) and accumulation of fluid in the abdominal cavity (ascites)


Eligibility criteria:
inclusion criteria: 1. patients with aclf grade 1, 2, or 3a according to european association for the study of the liver (easl)-clif criteria; 2. onset of aclf not more than 14 days before baseline (bl); 3. presence of ascites requiring diagnostic or therapeutic paracentesis; 4. patients with dry body weight ≥40 and \<140 kg; 5. written informed consent obtained prior to the start of any study-related procedures. exclusion criteria: 1. presence of any of the following organ failure(s) as per the easl-clif criteria and/or adapted from clif-c organ failure (clif-c of)/clif- sequential organ failure assessment (clif-sofa) scores: 1. respiratory failure necessitating invasive mechanical ventilation; 2. coagulation failure (inr \> 3.2 or platelet count ≤20 x 109/l); 3. severe cardiovascular failure requiring the use of high dose vasopressors; 2. aclf grade 3b: presence of four or more organ failures as per easl clif criteria; 3. presence of spontaneous or secondary bacterial peritonitis; 4. presence of uncontrolled severe infection(with hemodynamic instability or shock); 5. poorly controlled seizure disorder; 6. patients with history of upper gastro-intestinal bleeding over the past 7 days prior to bl, acute bleeding or bleeding upon paracentesis at screening (scr) or bl; 7. contraindication for paracentesis; 8. coagulation disorders such as disseminated intravascular coagulation or hemophilia; 9. potential or known hypersensitivity to liposomes; 10. potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities; 11. patients after organ transplantation receiving immunosuppressive medication; 12. any severe disease considered to be potentially detrimental at the discretion of the principal investigator. this includes but is not limited to hepatocellular carcinoma outside milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years or people who inject drugs; 13. need for renal replacement therapy or any extracorporeal liver support device (e.g., mars®, prometheus®, plasmapheresis); 14. alfapump® in place to manage ascites; 15. pregnancy and lactation; 16. women of child-bearing potential who are not willing to use adequate contraception; 17. patients who participate in another clinical trial at the time of scr or within 4 weeks prior to scr.

Keywords: chronic liver diseases hepatic dysfunction extrahepatic organ dysfunction liver failure renal disease hepatic impairment renal impairment hepatic decompensation cirrhosis
usefulness of non epi-dwi-mri / ct 3d static co-registration prior to surgery of cholesteatomas

Conditions: Cholesteatoma

Summary: cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl arising from a squamous epithelium in the middle ear and/or mastoid process. evolution consists in a destruction of the ossicles as well as their possible spread through the base of the skull into the brain. surgical treatment is required to prevent infectious or functional complications. a recurrence after surgery occurs in approximately 10% of patients and rarely affects initial site. surgical treatment is the only care option for recurrent cholesteatoma. various locations such as surgical approach cavity, mastoid, hypotympanum are seen. temporal bone ct is performed prior to surgery for added information on bone erosions especially of ossicules, tegmen tympani, facial nerve canal of internal ear. due high anatomical resolution and complex anatomy, temporal bone ct is usually displayed with magnetic resonance imaging (mri) in operating room to help surgical guidance . imaging especially using mri is the cornerstone for diagnosis in asymptomatic patients. since 2006, non echo planar imaging (epi) diffusion weighted imaging (dwi) magnetic resonance imaging (mri) (sequences has shown high accuracy to depict recurrent cholesteatoma. if epi sequences had a high rate of diffeomorphic atefacts whereas non epi sequences using either half-fourier acquisition single-shot turbo spin-echo (haste) or fast-spin-echo demonstrates less magnetic susceptibility artifacts. multimodality fusion between nonepi-dwi-mri and computerized tomography (ct) is a rational promising tool to rise the performance for cholesteatomas delineation. the performances of nonepi-dwi-mri in assessing lesion spread and volume are still unknown and needs further investigations. the aim of the study is to assess the dwi-mri/ct fusion feasibility, reproducibility and the accuracy prior to surgery propectively compared to surgical findings.


Eligibility criteria:
inclusion criteria: - adult woman or man who had surgery and suspicion of cholesteatoma recurrence exclusion criteria: * chronic renal failure * contraindications to mri