Kornimate/medical-research-clean huggingface dataset:
adalimumab in combination with ciprofloxacin/placebo treatment of perianal fistulas in crohn's

Conditions: Crohn's Disease With Perianal Fistulas

Summary: to assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in crohn's disease

dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.

Eligibility criteria:
inclusion criteria: * proven crohn's disease * single or multiple draining perianal fistulas exclusion criteria: * abscesses * infliximab, cyclosporine, tacrolimus and antibiotics for crohn's disease within past 3 months * active viral infection * significate cardiovascular dysfunction * pregnancy, lactation * surgical bowel resection to be expected within 6 months * positive stool culture for enteric pathogens * total parental nutrition

Keywords: perianal fistulas crohn's disease
microincision versus smallincision combined surgery

Conditions: Cataract Extraction

Summary: the purpose of this study is to compare refractive outcomes after two different types of combined cataract surgery, namely microinscision cataract surgery and smallincision cataract surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal disorders and coexisting cataracts.

purpose: to compare refractive outcomes after combined cataract and vitreoretinal surgery. methods: patients with a diagnosis of vitreoretinal disorder and a coexisting significant cataract were randomly assigned to be treated with a microincision cataract surgery and a 23-gauge vitrectomy (treatment group 1) or with a smallincision cataract surgery and a 23-gauge vitrectomy (treatment group 2). main outcome measures: refractive outcomes, stability of the intraocular lens (iol), intraocular pressure (iop) and functional outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis vitreoretinal disorder with coexisting cataract * combined surgery * age over 60 years * iol master for preoperative intraocularlens (iol) calculation exclusion criteria: * ultrasound for iol calculation due to hazy media (dense cataract,vitreous hemorrhage) * macular edema, proliferative diabetic retinopathy * myopia or hyperopia more than 5 diopters, astigmatism more than 2 diopters * previous refractive surgery, retinal detachment surgery, glaucoma surgery and vitrectomy

Keywords: refraction refractive error combined surgery microincision smallincision cataract surgery vitrectomy
plasma transfusion in liver transplantation

Conditions: Bleeding in Liver Transplantation

Summary: the aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

three types of plasma are transfused in bleeding patients undergoing liver transplantation: * quarantined plasma, * methylene blue treated plasma, * solvent/detergent plasma. the main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma. in addition, the correction of coagulation abnormalities are studied.

Eligibility criteria:
inclusion criteria: * age 18 yo and above * consent is signed, * liver transplantation is indicated, * plasma is transfused exclusion criteria: * multiorgan transplantation (except combined kidney and liver transplantation) * allergy to methylene blue.

Keywords: plasma bleeding liver transplantation
systems support mapping in guiding self-management in stage i-iii colorectal cancer survivors

Conditions: Cancer Survivor; Stage I Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8

Summary: this pilot trial studies how well systems support mapping works in guiding self-management in stage i-iii colorectal cancer survivors. systems support mapping helps participants to see complex self-management activities on paper, which makes them more actionable. behavioral interventions, such as systems support mapping, may help colorectal cancer survivors facilitate self-awareness, create motivation for behavior change, and guide self-management.

primary objectives: i. to evaluate the feasibility of the systems support mapping (map) intervention in colorectal cancer survivors, as characterized by enrollment, intervention adherence, and retention rates. secondary objectives: i. to evaluate intervention acceptability as characterized by participant ratings. ii. to describe outcome variability to inform future studies. iii. to identify multi-level contextual factors influencing self-management (sm). iv. to qualitatively assess feasibility, acceptability using semi-structured interviews. v. to examine how study results vary by rural-urban context. outline: participants complete map in-clinic over 60-90 minutes. after completion of study, participants are followed-up for up to 2 weeks.

Eligibility criteria:
inclusion criteria: * diagnosed with stage i-iii colorectal cancer * within 2 years of completing active treatment for colorectal cancer * cognitively able to complete interviews as judged by the study team * able to understand, read and write english exclusion criteria: * declined participation in the study
financial incentives for medication adherence

Conditions: Diabetes Mellitus; Hypertension; Hyperlipidemia

Summary: this study is a pilot study. the investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. prior work has shown that many patients do not take their medications as prescribed by their doctors. this contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. the investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases. the investigators plan to identify patients who get primary care at boston medical center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. subjects will be approached at the time of a regularly-scheduled appointment with their primary care doctor and offered the opportunity to participate in the study. all subjects who agree to participate in the study will meet with a clinical pharmacologist to review their medications in detail, and then undergo randomization. subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin a1c decrease. the investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients. all patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. the observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients. at the end of eight months, all subjects will meet with a visiting nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. outcomes to be evaluated include hemoglobin a1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * speaks english, spanish, or haitian creole * established patient in boston medical center section of general internal medicine primary care practice * uses boston medical center pharmacy * diagnosed with diabetes for more than one year * prescribed medications for diabetes * last hemoglobin a1c \> 7.9 exclusion criteria: * pregnant * history of brittle diabetes * meets april, 2012 american diabetes association criteria for an increased goal hemoglobin a1c
the relationship between magnetic resonance imaging (mri) scores and sensory testing in axial spondyloarthritis

Conditions: Central Sensitisation; Axial Spondyloarthritis; Inflammation

Summary: axial spondyloarthritis is one of the most common rheumatic diseases and chronic pain and morning stiffness are the main complaints of these patients. central sensitization is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies. there is no method for the diagnosis of central sensitization is accepted as a gold standard. the clinical scales and quantitative sensory testing (qst) widely is used for this purpose widely. the most commonly used qst types include pressure pain threshold (ppt), temporal summation (ts) and conditioned pain modulation (cpm). the well-known scale used for the evaluation of central sensitization is the central sensitization inventory (csi) , developed in 2011 for detect central sensitization in chronic pain patients. in this study, it was aimed to investigate the relationship between qst and csi and sacroiliac mri changes.

central sensitization is hypersensitivity and increased response to normal/painless stimuli due to dysfunction in endogenous pain pathways. quantitative sensory testing is frequently used to detect pain sensitization, and pressure pain threshold (ppt) and temporal summation (ts) are often preferred for this purpose. recently, in addition to these methods, conditional pain modulation (cpm), in which descending pain pathways are tested, is also preferred. with ppt and ts measurement, local/generalized sensitivity increase can be detected in patients who develop pain sensitization. observation of increased nociceptor response and decrease in pressure pain threshold in the tissue damaged area is interpreted in favor of peripheral sensitization, while obtaining a similar response in adjacent or distant areas is defined as generalized increased sensitivity. although it is known that local hyperalgesia is one of the main findings of inflammation, studies that have shown this quantitatively are limited. inflammatory lesions are observed in patients with axial spondyloarthritis, especially in the active stages of the disease, and the relationship of these lesions with ppt, ts and cpm values and pain sensitization is unknown. therefore, in this study, it was planned to investigate the relationship of inflammatory and structural lesions detected by sacroiliac mri with regional ppt,ts, cpm and pain sensitization in patients diagnosed with axspa.

Eligibility criteria:
inclusion criteria: * diagnosed with axspa according to the assessment of spondyloarthritis international society (asas) criteria * aged between 18-65 years exclusion criteria: * had an other rheumatic diseases, peripheral vascular disease, peripheral neuropathy and spine disease (e.g., symptomatic herniated disc, spinal stenosis), * using centrally acting pain medications (e.g., pregabaline, duloxetine, opioids) or glucocorticoids (\>10 mg prednisone or its equivalent) within 3 months of study enrollment
ventilation-perfusion matching in early-stage prone position ventilation

Conditions: Acute Respiratory Distress Syndrome

Summary: prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ards). this study aimed to compare the effect of pronation on lung ventilation-perfusion matching between covid19-associated acute respiratory distress syndrome (cards) and ards from other etiologies (non-cards) using electrical impedance tomography (eit).

in this prospective study, both covid19-associated ards (cards) patients and patients with ards from other etiologies (non-cards) were enrolled. electrical impedance tomography (eit) was used to evaluate the changes in ventilation and perfusion between supine and prone positions. baseline values of the area of deadspace, shunt, ventilation-perfusion matching (vqmatch) were identified at the time of enrollment. within the defined vqmatch region, the global inhomogeneity index (vqmatch-gi) was calculated to assess the degree of uniformity within the region. prone position was applied immediately after the baseline data were collected. after 2 hours of proning, another eit examination was conducted. parameters such as deadspace, shunt, vqmatch, and other common measurements before and after pronation were taken and compared to evaluate the effect of prone positioning on cards and non-cards patients.

Eligibility criteria:
inclusion criteria: * above the age of 18 * diagnosed with ards based on the berlin definition of ards * under mechanical ventilation exclusion criteria: * contraindications to eit examination and prone position * refusal of signing the informed consent

Keywords: acute respiratory distress syndrome icu covid19 electrical impedance tomography
efficacy of tap block in cesarean section patients

Conditions: Pain Control

Summary: tap block done with 2 different concentrations of bupivacaine and placebo

tap block was done using 2 different concentrations of bupivacaine (0.5% and 0.25%) and placebo and the post operative sedation was measured in each arm and compared together.

Eligibility criteria:
inclusion criteria: * healthy pregnant women exclusion criteria: * allergy to local anesthetics
study of dose escalation versus no dose escalation of imatinib in metastatic gastrointestinal stromal tumors (gist) patients

Conditions: Gastrointestinal Stromal Tumors

Summary: the purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * unresectable and/or metastatic gist * currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. this must be the first time that the patient has been treated for metastatic and/or unresectable gist * for patients who received imatinib following surgery at the time of an initial diagnosis of gist, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic gist * good physical functioning (ecog performance status of 0 or 1) * generally, good function of organ such as liver and kidneys exclusion criteria: * disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for gist) * known intolerance of imatinib at a dose of 400 mg/day or higher * prior systemic therapy for advanced gist with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease * major surgery within 2 weeks prior to day 1 of study or who have not yet recovered from prior surgery * use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon) * patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks or who have not recovered from side effects of this therapy

Keywords: gist gastrointestinal stromal tumors exon 9 gleevec imatinib blood levels
a multicenter, observational study to evaluate clinical manifestation, diagnosis and treatment of primary hemifacial spasm in chinese patients

Conditions: Hemifacial Spasm

Summary: to determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in chinese outpatient subjects

about 1000 outpatient subjects will be recruited. the inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. the exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. the outcome measures include the percentage of the treatment methods of hfs in outpatient subjects, aggrevated and relieved factors of hfs symptom, concomitant symptoms of hfs and adverse events of botulinum toxin treatment in hfs patients.

Eligibility criteria:
inclusion criteria: 1.clinically diagnosed primary hemifacial spasm 1. tonic and clonic contractions of muscles innervated by the unilateral facial nerve. 2. no other neurological disorder. 2.male or female 18 to 80 years old 3.informed consent has been obtained exclusion criteria: 1. secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on. 2. other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures. 3. history of surgery of microvascular decompression of the facial nerve. 4. participation in another clinical study currently. 5. not able to understand and answer questionnaire. 6. investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.

Keywords: hemifacial spasm observational study clinical manifestation treatment chinese
a study of the safety, effectiveness and clinical use of maviret in adolescent patients with chronic hepatitis c virus

Conditions: Hepatitis C Virus (HCV)

Summary: this study will assess the safety and effectiveness of maviret (glecaprevir plus pibrentasvir (gle/pib)) in adolescent participants diagnosed with chronic hepatitis c (chc) in a real world setting across clinical practice in japan.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c virus (hcv) infection treated in daily practice with maviret * enrolled after maviret treatment begins * prior treatment with maviret exclusion criteria: none

Keywords: hepatitis c virus (hcv) chronic hepatitis c (chc) maviret mavyret
remote ischemic conditioning for treatment of chronic wounds

Conditions: Leg Ulcer; Varicose Ulcer

Summary: the goals of this series of studies is to test the effect of ric on chronic leg ulcers (diabetic ulcers and venous ulcers) - and to improve the understanding of its biological mechanism. this is a prospective, double-blind, randomized, shame procedure-controlled study.

after getting patients informed consent. initial evaluation that includes: venous and arterial vascular evaluation, medical past history including medications and surgeries documentation of the chronic wounds by description and photography with scale. base line blood test for cbc, hba1c, electrolytes, urea, cr, liver enzymes. il 1 il 6 vegf no cd34 adenosine all patients will received the standard wound care in use by the staff of the chronic wound clinic. care givers will be blinded as to the study allocation of each patient. patients will be divided randomly into two equal groups. pressure cuffs will be applied to both arms of all subjects. the cuffs will be inflated and deflated intermittently for three cycles of 5 minutes each. in the study group, the cuffs will be inflated to 50 mmhg above systolic blood pressure while the performing investigator examines the radial pulse to ensure complete blood flow obstruction. in the control group, inflation will be up to 10 mmhg only. the patients will be followed for 10 weeks. during this period, they will be examined every 2 weeks (5 follow-up visits); and in each of these visits the above procedure will be repeated including blood collection before intervention and 24-48h after intervention. in each visit a "blinded" physician will photograph with scale the wound and grade the granulation tissue covering the wound on a scale from 0 to 5. the primary end point of the study is the number of healed wounds and wound area change among the two groups. secondary outcomes will be the degree of granulation tissue and levels of il 1 il 6 vegf no cd34 adenosine

Eligibility criteria:
inclusion criteria:all patients presented to chronic/hard to heal wound clinic at soroka university medical center and sherutei briut clalit regional clinic. wound that did not heal under proper medical care for over two months. exclusion criteria:ulcers suspected or proven to be malignant tumors. patients that are planned for vascular intervention within the next month patients that are planned for amputation within the next month

Keywords: chronic ulcer diabetic ulcer venous ulcer remote ischemic conditioning
epidiolex in obsessive compulsive disorder and related disorders

Conditions: Obsessive-Compulsive Disorder; Trichotillomania (Hair-Pulling Disorder); Tourette Syndrome; Hoarding Disorder

Summary: the primary objective of the proposed study is to evaluate the safety and efficacy of epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (ocrds). subjects will be treated in an open-label fashion with epidiolex for two weeks.

the primary objective of the proposed study is to evaluate the safety and efficacy of epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (ocrds). ocrds include obsessive compulsive disorder (ocd), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. these disorders appear linked in terms of phenomenology and possibly biology. fifteen subjects with ocrds will be treated in an open-label fashion with epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. the hypothesis to be tested is that epidiolex will result in reduction in symptoms of ocrds (improvement in symptoms will be indicated by lower scores on established outcome measures of ocrds symptoms that have been used in prior studies).

Eligibility criteria:
inclusion criteria: * men and women age 18-65 * primary diagnosis of ocd, hoarding disorder, skin picking disorder, trichotillomania, or tourette syndrome * ybocs score of at least 18 at baseline * ability to understand and sign the consent form. exclusion criteria: * unstable medical illness based on history or clinically significant abnormalities on baseline physical examination or labs * current pregnancy or lactation, or inadequate contraception in women of childbearing potential * subjects considered an immediate suicide risk based on the columbia suicide severity rating scale (c-ssrs) * past 12-month dsm-5 psychiatric disorder other than ocd * illegal substance use based on urine toxicology screening * initiation of psychological interventions within 3 months of screening * use of any other psychotropic medication * previous treatment with epidiolex * cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Keywords: obsessive compulsive disorder cbd hoarding tourettes trichotillomania skin picking disorder body focused repetitive behaviors