Kornimate/medical-research-clean huggingface dataset:
hiv in orthopaedic skeletal trauma study

Conditions: Fracture Healing in HIV-positive Patients

Summary: adult patients \> 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo im nailing for fracture fixation will be eligible for the study. participants will be recruited over 24 months. participants will undergo a baseline questionnaire, hiv testing and assessment of their bmd. they will be followed up at 6 weeks, and 3, 6 and 12 months. all adult patients who develop delayed bone union at 6 month follow up will be considered cases. adult patients who show evidence of radiological union at 6 months or less will be considered controls.

1. primary research question does human immunodeficiency virus (hiv) alter the fracture repair process? 2. aim to establish whether hiv is a risk factor for the development of delayed bone union or nonunion following a fracture. 3. study 1. setting orthopaedic and trauma department, groote schuur hospital (gsh), cape town, south africa. 2. study design case-cohort study of patients undergoing fracture surgery at gsh, cape town, south africa. 3. study population adult patients \> 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo intramedullary (im) nailing for fracture fixation. 4. study summary adult patients \> 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo intramedullary (im) nailing for fracture fixation will be potentially eligible for inclusion in the study. participants will undergo a baseline questionnaire, assessment of their hiv status and measurement of their bone mineral density (bmd) using a dual energy x-ray absorbometry (dexa) heel scanner. participants will be followed up at 2 weeks, and 3, 6 and 12 months. x-rays will be performed at 3, 6 and 12 months. bone healing will be assessed using a validated x-ray scoring system - the radiological union scoring system for the tibia (rust scoring system).(19), (20) an independent observer blinded to hiv status will assess radiological fracture union. participants will be recruited over 24 months. all adult patients treated at gsh with im nailing of the tibia or femur and develop delayed bone union at 6 month follow up will be considered cases. adult patients who show evidence of radiological union at 6 months or less will be considered controls.

Eligibility criteria:
inclusion criteria; * they are older than 18 years old * present to the gsh within 2 weeks of injury * sustained a closed or open fracture of tibia and femur fractures * undergo im nailing for fracture fixation exclusion criteria: * major head injury * pre-surgical infection at the fracture site * open injury for \>48 hours before the first debridement. * severe burns * pathological fracture * there is evidence that the patient would be unable to adhere to study procedures, complete questionnaires or attend follow up.
a single-arm objective performance criteria trial for intracranial thrombus aspiration catheter

Conditions: Acute Ischemic Stroke

Summary: this is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.

the study is conducted in 15 centers all around china, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * baseline nihss score ≥6; * subject has acute occlusion located in vertebral artery(va) / internal carotid artery (ica) / m1or m2 segment of middle cerebral artery (mca) / basilar artery (ba) diagnosed by dsa; * femoral artery puncture is expected to be completed within 24 hours of onset； * mrs score≤ 2; * subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent. exclusion criteria: * chronic occlusion in the target area; * epilepsy at the time of stroke； * bleeding from the gastrointestinal or urinary system in the past three weeks； * after drug control, systolic blood pressure was greater than 185mmhg and / or diastolic blood pressure was greater than 110mmhg; * international normalized ratio(inr)\>3; * random blood glucose \ 22.2mmol/l; * heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, - systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness); * tortuous lesion / severe stenosis in the starting segment of the carotid artery / carotid dissection / arteritis judged by researchers that is not suitable for the procedure; * acute occlusion of bilateral carotid arteries； * intracranial hemorrhage or massive infarction diagnosed by ct or mr; * history of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents; * expected life \<12 months; * female subjects who are pregnant or planning to become pregnant or lactate within the study period; * subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent; * other circumstances judged by researchers that are not suitable for enrollment .

Keywords: stroke aspiration catheter intracranial
effects of neuromuscular electrical stimulation on glucose variability in patients with type 2 diabetes

Conditions: Type2 Diabetes Mellitus

Summary: in patients with type 2 diabetes mellitus (t2dm) chronic hyperglycemia is the main cause of complications, promoting several micro and macrovascular damages. in order to understand other mechanisms that could have an impact on the development of these diabetic complications, the assessment of glycemic variability have been widely used. glucose control can be achieved with multiple interventions, including exercise training. some individuals, however, especially those with autonomic neuropathy, can have exercise intolerance. in this context, physical therapy proposes neuromuscular electrical stimulation (nmes) as a therapeutic that has been applied in research and clinical practice as an alternative to the training of patients who cannot perform conventional exercise. in patients with t2dm, nmes was shown to improve glycemic control and insulin sensitivity, but quality of these trials is poor. in addition, the effects of nmes on glycemic variability of t2dm patients have not yet been reported. the aim of this study is to evaluate the effects of nmes on glucose levels and glucose variability in patients with t2dm.

patients with t2dm will be recruited from outpatient clinic of the hospital de clinicas de porto alegre. patients will be randomized to nmes session, with maximal intensity tolerance by to induce visible contractions or to nmes-placebo, with minimal intensity to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction. subjects will attend to research facility four times. on the first visit clinical, physical examination and autonomic evaluation (ewing test) will be performed and a blood sample will be collected. on the second visit cgms will be placed for glycemic variability evaluation. on the third visit nmes or nmes-placebo will be performed in a randomized way. on the fourth visit the cgms will be removed. blood pressure and heart rate will be evaluated during the protocol each 5 minutes and oxygenation tissue will be evaluated before, during and immediately after the protocol, through nirs.

Eligibility criteria:
inclusion criteria: * type 2 diabetes; * hba1c from 7,5 to 10%; * fasting plasma glucose lower to 250 mg/dl * drug therapy maintained for at least one month before inclusion in the study. exclusion criteria: * insulin use; * pregnancy; * documented arrhythmia; * unstable angina; * chronic renal failure (gfr lower than 15 ml/min); * varicose vein problems; * clinical musculoskeletal disease.

Keywords: diabetes mellitus diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases endocrine system diseases
study to evaluate the long-term safety of a once-daily omiganan topical gel

Conditions: Rosacea

Summary: this study evaluates the long-term safety of once-daily application of omiganan topical gel in subjects with severe papulopustular rosacea.


Eligibility criteria:
inclusion criteria: 1. healthy, male and nonpregnant female subjects, 18 years of age or older. 2. a diagnosis of severe papulopustular rosacea using the investigator global assessment grading scale at baseline 3. subjects with the presence of telangiectasia at baseline 4. subjects with the presence of facial erythema associated with their rosacea at baseline exclusion criteria: 1. subjects with steroid rosacea or subtype 3 (phymatous rosacea). 2. subjects with nodular rosacea 3. standard exclusion criteria.
sildenafil and stroke recovery

Conditions: Stroke

Summary: this is a small, pilot randomized clinical trial of administering sildenafil citrate to individuals within 10 days of ischemic stroke who have motor impairment and who are undergoing inpatient rehabilitation compared to placebo. the primary outcome is motor recovery at one and three months.

individuals who are within 4-10 days post ischemic stroke with arm hemiparesis or hemiplegia who are admitted to inpatient rehabilitation are randomized to receive either sildenafil citrate (25 mg once per day) or placebo for 14 days. these individuals receive usual rehabilitation and medical care. primary outcomes are motor skills and walking speed at one and three months. if willing and able, participants undergo an mri to measure the integrity of the white matter pathways in the motor system using diffusion tensor imaging. repeat mris are obtained at one and three months. the investigators will examine if such white matter integrity predicts response to the drug and if the drug facilitates changes in white matter.

Eligibility criteria:
inclusion criteria: 1. between 4 and 9 days post-ischemic stroke; 2. admitted to inpatient rehabilitation; 3. cognitively able to provide consent or assent; 4. were living independently in the community prior to their stroke. exclusion criteria: 1. hemorrhagic stroke or subarachnoid hemorrhage; 2. other neurological or psychiatric conditions deemed by the investigator to impair participation; 3. no previous stroke on same side of brain unless that stroke was cerebellar 4. moribound or not expected to live 6 months; 5. contraindications to taking sildenafil in pill or syrup form; 6. other medical conditions that would limit ability to participate in the study, specifically a) currently taking the p450 enzyme inhibitors (erythromycin, ketoconazole, itraconazole, saquinavir), b) currently taking the protease inhibitor ritonavir, c) currently taking nitrates or have a history of requiring nitrates treatment, d) have left ventricular outflow obstruction (i.e., aortic stenosis, idiopathic hypertrophic subaortic stenosis as confirmed by review of standard of care echo received before admission to rehabilitation), e) have severely impaired autonomic control of blood pressure, f) have previous history of symptomatic hypotension, g) have severely impaired hepatic function, h) is pregnant or become pregnant during the course of the study, i) any medical condition which, in the opinion of the investigator, may compromise compliance with the objectives and/or procedures of the protocol. 7. scores \> 50 on the upper extremity section of the fugl-meyer or no walking/gait impairment for the mri portion of the study only: 8. contraindication to mri: ferrous metal in body, lead included body art, claustrophobia, pacemaker 9. allergic to or had previous reaction to gadolinium

Keywords: stroke rehabilitation motor skills sildenafil citrate white matter
field usability study of eclipse mask

Conditions: Obstructive Sleep Apnea

Summary: the study is designed to assess the usability of a novel cpap human interface compared to a traditional nasal mask. human subjects will interact with two different cpap interfaces including a traditional cpap mask and the 2nd generation dreamport-eclipse. subjects will be requested to put on each of the different cpap interface options a total of three times for a total of 6 trials. the order of device will be randomized.


Eligibility criteria:
inclusion criteria: •male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a cpap device. exclusion criteria: * diagnosis of any medical or behavioral conditions that would compromise subject safety. * under the age of 18: target for this current version of the platform is the adult population.
use of haploidentical related donors for patients without matched sibling, unrelated donor or cord blood units

Conditions: Hematologic Neoplasms

Summary: the administration of high-dose chemotherapy followed by the infusion of blood or bone marrow stem cells (stem cell transplantation) from a matched donor has become standard treatment for patients with high-risk or relapsed hematological cancers. currently, donors are found for approximately 80% of people who require such treatment, although the chance of finding a donor is much lower in some ethnic communities. in the current study the investigators will offer patients requiring transplantation, but for whom well matched donors cannot be identified either from within the family or on the donor registry, a transplant from a half-matched (haploidentical) family member. a myeloablative conditioning regimen and un-manipulated peripheral blood stem cells will be used. post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil will be used to prevent graft versus host disease (gvhd). the primary outcome measure will be 6 month survival free from graft failure, relapse and grade 3-4 acute gvhd. other outcomes of interest will include the frequency of cytomegalovirus (cmv) or epstein-barr virus (ebv) requiring treatment, overall survival and progression-free survival.


Eligibility criteria:
inclusion criteria: * a hematological malignancy such as acute leukemia or myelodysplastic syndrome requiring hematopoietic stem cell transplantation. * a haploidentical family member willing to donate. * suitable performance status, organ function (as defined locally) and disease status for transplantation. * patients with acute leukemia must be in morphological complete remission. patients with chronic myelogenous leukemia must be in chronic phase and those with lymphoma must have chemosensitive disease (at least partial remission to most recent chemotherapy regimen). * given written, informed consent to participate in a clinical trial. exclusion criteria: * an 8/8 matched sibling donor or matched unrelated donor (based on high-resolution typing as appropriate), available within a time frame acceptable to the treating physician * patients with an available single allele or single antigen mismatched donor (7/8 or 9/10) or available cord blood donor can be included at the discretion of the treating team, according to local institutional practice. * prior allogeneic transplant * any exclusion criteria for allogeneic stem cell transplant, as defined by the program. examples typically include pregnancy, significant comorbidity, and active uncontrolled infection.

Keywords: hematopoietic stem cell transplantation
tissue repository: ctcl collection protocol

Conditions: Lymphoma, T-Cell, Cutaneous; Lymphomatoid Papulosis; Sézary Syndrome

Summary: this document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in t cells in cutaneous t-cell lymphoma (ctcl). the purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with ctcl for future research studies. collection and storage of tissue samples from control patients will also be carried out.

ctcl is a heterogeneous group of non-hodgkin's lymphomas characterized by chronic inflammation and accumulation of malignant t cells in the skin. in order to carry out research to expand the knowledge and develop more effective treatments, tissue samples from ctcl patients with presumed or known disorders are required and tissue samples from control patients will be required to compare the differences between affected and healthy populations. scientists will be able to test new ideas and new technologies that are not apparent or available at the present moment from this tissue repository in the future. this type of information will thus be of great advantage to future patients with these diseases.

Eligibility criteria:
inclusion criteria: * patients with ctcl or lymphomatoid papulosis (lyp): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed ctcl or lyp who are initiating or changing therapy. * patients with sézary syndrome (ss) or stage iv b ctcl as defined by blood involvement on flow cytometry or morphology: (1) ≥1000/μl sézary cells by morphology; (2) cluster of differentiation 4 (cd4)/cluster of differentiation 8 (cd8) ratio ≥10; (3) cd4+cluster of differentiation 7 (cd7)- cells ≥40 percent; (4) or cd4+cluster of differentiation 26 (cd26)- cells ≥30 percent. * ability to understand and willing to sign a willing informed consent document. * age ≥ 18 years. inclusion criteria for age and sex matched controls: * matched for sex, and age +/- 10 years. * ability to sign informed consent document. * patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents. exclusion criteria: * patients with a history of previous lymphoma other than ctcl or ss or lyp. * medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator. * current, viable pregnancy. * anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months. exclusion criteria for age and sex matched controls: * previous history of ctcl, ss, lyp, or any lymphoma. * previous history of human immunodeficiency virus (hiv) infection. * anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.

Keywords: lymphomatoid papulosis sézary syndrome t-cell lymphoma
clinical trial for the assessment of delayed antibiotic treatment in pediatric (dap-pediatrics)

Conditions: Rhinosinusitis; Acute Bronchitis; Acute Otitis Media; Pharyngotonsillitis

Summary: the general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.

the current project (dap pediatrics) is a study that explores the optimization of antibiotic prescribing in our country by evaluating the delayed prescription of antibiotics. the proposed trial will take place in the context of a prior similar study we conducted in adults. the study currently underway is the dap-adults study (a randomised controlled trial that evaluates several antibiotic prescribing strategies, including de delayed prescription in uncomplicated acute respiratory infections in adults in primary care). the aim of this study dap-pediatrics (randomized, multicenter parallel) to determine the efficacy and safety of delayed prescription of antibiotics compared to direct prescription and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric patients. this 3 arms clinical trial will include 450 children and will evaluate the duration and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived efficacy of antibiotics and the number of visits generated. the project also includes a qualitative study, by means of structured interviews, to assess the perception and attitudes of parents towards the different treatment strategies and carry out a full analysis of economic evaluation.

Eligibility criteria:
general inclusion criteria: in this study can be enrolled children (2 to 14 ages) with non-complicated acute respiratory tract infections, including pharyngotonsillitis, rhinosinusitis, acute bronchitis and acute media otitis. the doctors include children with these infections if they have reasonable doubts if they should treat with antibiotics. general exclusion criteria: * patients not aged between 2 and 14. * patients have participated in the dap-pediatrics previously. * patients are severely affected or patients has been felt severely affected for one week (all time). * patients with symptoms and signs suggestive of serious illness or severely affected and/or complications (particularly pneumonia, mastoiditis, peritonsillar abscess, peritonsillar cellulitis, intraorbital or intracranial complications). * patients at high risk of serious complications due to prior comorbidity. this includes significant heart disease, lung, kidney, liver or neuromuscular, immunosuppression, cystic fibrosis.

Keywords: delayed antibiotic treatment acute respiratory infections pediatrics satisfaction
facilitating shared decisionmaking about prostate cancer screening

Conditions: Prostate Cancer

Summary: due to the disputed efficacy of prostate cancer (cap) screening and treatment, most authorities recommend that providers inform and involve patients in cap screening decisions.

background: due to the disputed efficacy of prostate cancer (cap) screening and treatment, most authorities recommend that providers inform and involve patients in cap screening decisions. objectives: this study evaluated two interventions designed to facilitate this process. methods: 1152 male veterans age 50+ with no cap and primary care appointments at four va medical facilities in visn 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (t1) and one year (t2) after the target appointment. outcomes included: a 10- item validated knowledge index; responses to questions on cap natural history, treatment efficacy, psa accuracy, and expert disagreement about the psa; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and psa testing rates. status: complete

Eligibility criteria:
inclusion criteria: patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 visn 13 medical facilities. patients diagnosed with prostate cancer will be excluded. exclusion criteria: