Kornimate/medical-research-clean huggingface dataset:
tissue repair gel in venous leg ulcers (us)

Conditions: Venous Leg Ulcer; Venous Ulcer; Venous Stasis Ulcer; Venous Stasis; Wound Heal; Wounds; Venous Insufficiency of Leg; Non-healing Wound

Summary: the goal of this clinical trial is to learn if tr987 0.1% gel + standard of care works better than standard of care alone to treat venous leg ulcers (vlus). it will also provide additional information about the safety of drug tr987 0.1% gel.

this is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: tr987 0.1% gel + standard of care and standard of care alone in participants who have a non-healing venous leg ulcer (vlu). the primary objective is to assess the proportion of participants with complete closure of the target ulcer at or before the week-16 end of treatment (eot) visit. secondary endpoints include: • proportion of participants with complete closure of the target ulcer at or before the week 16 visit and for whom the ulcer remains closed at the 3-month follow-up visit after such closure (a composite endpoint). • change from baseline in participant's perception of pain level at 12 weeks. • percent change from baseline in the target ulcer area at 12 and 16 weeks. in the event of complete closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint. • proportion of participants with complete closure of the target ulcer at or before the week 12 treatment visit. • proportion of participants with any significant reduction in pain at or before 12 weeks. there are also some supplementary and safety endpoints.

Eligibility criteria:
inclusion criteria: * adults 18 years and older * venous insufficiency has been clinically diagnosed clinically and medically confirmed. * females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control. * the venous ulcer should be between 2 cm2 and 12 cm2 at randomization. * target ulcer age must be ≥ 4 weeks at screening. * participants must have adequate arterial flow as confirmed by abi/tbi, tb, spp, tcpo2, or duplex doppler. * body mass index (bmi) ≤ 50 kg/m2. * hba1c ≤12%. exclusion criteria: * target ulcer has been treated with prohibited medications or therapies. * history of radiation at the target ulcer site. * target ulcer decreases in area by 30% or more during screening period. * history of osteomyelitis at the target ulcer within 6 months of screening. * history of cancer in the preceding 5 years (except as noted in the protocol). * participants considered nutritionally deficient.

Keywords: tissue repair glucoprime tr therapeutics debridement vlu
cabergoline and hydroxyethyl starch in ovarian hyperstimulation syndrome prevention

Conditions: Complications Associated With Artificial Fertilization; Disorder of Endocrine Ovary

Summary: the purpose of this study is to assess whether, in gnrh agonist in vitro fertilization (ivf) cycles, where there is a risk of ovarian hyperstimulation syndrome (ohss), the addition of cabergoline to the hydroxyethyl starch infusion could decrease ohss incidence and severity.

women undergoing ivf cycles with gnrh agonist protocols, at risk of ohss (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/ml). slow infusion of 500 ml of 6% hes during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hcg administration.

Eligibility criteria:
inclusion criteria: * to be at risk of ohss were invited to participate in the study exclusion criteria: * age \> 40 years

Keywords: ivf ovarian hyperstimulation syndrome cabergoline hydroxyethyl starch prevention
study of safety, tolerability, and pharmacokinetics of topical selinexor (kpt-330) diabetic foot ulcer (dfu) patients

Conditions: Diabetic Foot Ulcers

Summary: patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. this is a randomized trial. all patients will receive standard-of-care treatment. additionally, some patients will receive treatment with topical selinexor gel and some will receive topical placebo gel.

approximately 30 patients who meet the eligibility criteria will be enrolled. eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure. after screening, qualified patients will be treated for up to 12 weeks. patients who achieve complete ulcer closure will be followed for an additional 12 weeks. all patients will receive standard-of-care treatment. after randomization some patients will be treated with topical selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. patients receiving selinexor will be assigned to a sequential treatment cohort, either a 10 μm (μmol/l), 30 μm, or 70 μm dose.

Eligibility criteria:
inclusion criteria: * patient has a clinical diagnosis of type i or type ii diabetes mellitus with an hba1c ≤ 10.0 and has a bmi ≤40. * the dfu(s) to be treated must be: * anatomically discrete, * non-healing, but has persisted for ≤12 months * measures 1 cm2 ≤ area ≤ 5 cm2 following debridement, * has a wagner grade 1 (i.e., not involving bone, muscle, tendons, or ligaments), * the target dfu is located distal to the ankle (i.e., below the malleolus), and * is able to be adequately off-loaded. * the patient has adequate arterial blood supply in the affected limb at screening. * patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using semmes-weinstein 5.07 monofilament at screening. exclusion criteria: * patient has a foot ulcer that is clearly of non-diabetic pathophysiology. * patient has more than two (2) dfus on the target lower extremity. * dfu is clinically infected. * patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease

Keywords: diabetes foot ulcers dfu kpt-330 selinexor karyopharm
comprehensive cognitive and affective intervention for mild cognitive impairment (mci) for foreign-born arab americans

Conditions: Mild Cognitive Impairment

Summary: the purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born arab american dyads consisting of the person with mild cognitive impairment (mci) and participants caregiver. this study will evaluate the feasibility of a cognitive and affective intervention combining cognitive behavioral therapy (cbt), cognitive rehabilitation therapy (crt), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with mild cognitive impairment (mci) or those with cognitive complaints. the study team hypothesizes that combining evidence-based cognitive and affective therapies (crt+cbt) with lifestyle modifications is feasible and will improve the cognitive performance and quality of life (qol) in patients with mci and participants caregivers compared to usual care.


Eligibility criteria:
inclusion criteria for persons with mci: * all patients diagnosed with mci or persons with montreal cognitive assessment (moca) less or equal to 25 * disease duration less or equal to 3 years * age older than 60 years * foreign-born arab origins, language: arabic or english * cognitive impairment ≥ 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory) * participants who can provide consent or legally authorized representative who can provide consent on their behalf inclusion criteria for caretakers: * identified by the patients as the person that provides the most care for them with regards to medical care; may be a spouse, an adult child, a sibling, a relative, or family friend * above the age of 18 years fluent in arabic and/or english * can complete a self-report questionnaire by interview or self-report. exclusion criteria persons with mci: * history of traumatic brain injury (tbi) * diagnosed with covid-19 * patients with other neurosensory or neurodegenerative diseases * younger than 60 years * psychiatric disorders other than mild to moderate anxiety and depression * diagnosed sleep disorders * visual or auditory impairment * current or history of alcohol or substance abuse/dependence * patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources, and referred to their primary care provider exclusion criteria for caretakers: - paid caregivers

Keywords: caregiver quality of life cognitive behavioral therapy modifiable lifestyle factors cognitive rehabilitation therapy arab american
open-angle glaucoma subjects with one prior trabeculectomy treated concurrently with one suprachoroidal stent and two trabecular micro-bypass stents

Conditions: Open-Angle Glaucoma

Summary: evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (iop) lowering effect of two istent stents in combination with one istent supra stent and a postoperative prostaglandin.

evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (iop) lowering effect of two istent stents in combination with one istent supra stent and a postoperative prostaglandin.

Eligibility criteria:
inclusion criteria: * phakic patients or pseudophakic patients with posterior chamber intraocular lenses (pc-iols) * open-angle glaucoma (including pseudoexfoliative) exclusion criteria: * aphakic patients or pseudophakic patients with anterior chamber iols (ac-iols) * prior alt * prior slt within 90 days of screening visit

Keywords: open angle glaucoma prior trabeculectomy
cardiorespiratory assessment and quality of life after surgical correction of congenital wall malformations

Conditions: Funnel Chest

Summary: the main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

the secondary objectives are: * to measure the quality of life of patients operated on for pectus excavatum * identify and describe post-operative complications * follow-up on the body mass index changes post-surgery * evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively

Eligibility criteria:
inclusion criteria: * patient with pectus excavatum * the patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --or-- the patient is scheduled for corrective surgery during the inclusion period * collection of informed written consent (patient and legal guardian, if applicable) * obligation of affiliation or beneficiary of a social security programme exclusion criteria: * impossibility for the patient to participate in his/her next annual follow-up visit * absence of exercise test data and respiratory function test data performed during the preoperative check-up * subject in exclusion period required by another protocol * pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to french health code articles l.1121-6, l.1121-7, l.1211-8, l.1211-9) * subject deprived of liberty by judicial or administrative decision * participation of the subject in another interventional protocol * failure to properly inform the patient (e.g. a language barrier)
effects of anti-il5 biological treatments on blood ige levels in severe asthmatic patients

Conditions: Asthma; Asthma; Eosinophilic

Summary: real-life, observational, retrospective, multicenter study to evaluate the effects of anti-il5 biological treatments on blood total ige levels in atopic patients with severe eosinophilic asthma.

severe asthma, i.e. asthma that is not controlled despite maximal optimized therapy and/or that worsens when high dose treatment is decreased (gina guidelines - available at https://ginasthma.or), is a major unmet medical need. major advances in the management of severe asthma occurred in the past few years due to the new targeted biological therapies. mepolizumab and benralizumab are humanized monoclonal antibodies able to block interleukin (il)-5 and the receptor for il-5, respectively. these biological treatments block the eosinophilic driven inflammation. the effects of these treatments on an other key effector molecule of the t2-immune response, i.e. ige, is virtually unknown. to explore this issue, we set up a real life, observational, retrospective, multicenter study. the study will enroll patients with severe eosinophilic asthma already treated with mepolizumab or benralizumab. the following variable will be collected before the the biological treatment and at 4±2 months after the initiation of the pharmacological regimen: * demographic data * age of onset of asthma * smoking habit * concomitant pharmacological regimens * number of asthma exacerbations since last visit * concomitant diseases (particularly gastroesophageal reflux, nasal polyposis, atopic dermatitis, obesity, anxiety-depressive syndrome). * white blood cell count and differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils) * lung function tests (spirometry)

Eligibility criteria:
inclusion criteria: * atopy * severe eosinophilic asthma (according to gina guideline - available at https://ginasthma.org) * patients treated with monoclonal antibody anti il-5 (mepolizumab) or with il-5 anti-receptor monoclonal antibody (benralizumab). * stable asthma (free from asthma exacerbation for at least 8 weeks) exclusion criteria: * asthma exacerbation in last 8 weeks * patients treated for copd

Keywords: ige eosinophils mepolizumab benralizumab severe asthma
a phase 1, non-randomized, open-label, single-dose study to evaluate the pharmacokinetics, safety, and tolerability of dimebon [pf 01913539] in subjects with severely-impaired and normal renal function

Conditions: Alzheimer's Disease; Huntington's Disease

Summary: this study is to compare the pharmacokinetics of dimebon in subjects with severe renal impairment to subjects with normal renal function after oral administration of a single oral 20-mg dose of dimebon. this study is also to assess the safety and tolerability of a single oral 20-mg dose of dimebon in subjects with severe renal impairment and subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * male and/or female subjects between the ages of 18 and 75 years, inclusive * for severe renal impairment group, subjects with creatinine clearance of less than 30 ml/min, but not yet on dialysis and in good general health commensurate with the population with chronic renal disease; however, subjects with type 1 and 2 diabetes that are reasonably controlled and who do not have a predisposition to severe hypoglycemia can both be included. * for normal renal function group, healthy subjects with creatinine clearance of greater than 80ml/min and demographically comparable to subjects with impaired renal function exclusion criteria: * pregnant or nursing women; women of childbearing potential (wocbp) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication. * for normal renal function group, use of prescription or non-prescription drugs, vitamins, or dietary supplements within 7 days of 5 half-lives (whichever is longer) prior to the first dose of study medication. herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. acetaminophen at doses of ≤ 2 grams/day is permitted. * for renal impairment group, a known history of clinically significant coronary heart disease, cerebrovascular disease or peripheral vascular disease and/or an event/intervention during the past 6 months. systemic therapy with cyp3a or cyp2d6 inhibitors within 7 days or 5 halflives (whichever is longer) prior to the first dose of trial medication.

Keywords: dimebon renal impairment pharmacokinetics
modified urinary conduit to lower strictures after radical cystectomy

Conditions: Bladder Cancer

Summary: cystectomy is the chosen treatment of bladder cancer in 400 cases every year in dk. in replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (ad modum bricker). ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. the left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion. a modified urinary diversion have been tested in two small studies. the modified diversion is prolonged with 5cm compared to the conventional urinary diversion. the prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.


Eligibility criteria:
inclusion criteria: * bladder cancer with the indication for robot assisted radical cystectomy * ileal conduit ad modum bricker as planned urinary diversion * ability to understand the participant information orally and in writing * signed consent form exclusion criteria: * previous abdominal or pelvic radiotherapy * previous major abdominal surgery involving resection of bowel or construction of an enteric stoma * urostomy planned on the left side of the abdomen * single kidney * complete ureteral duplication (either uni- or bilaterally), known at time of inclusion * pregnancy

Keywords: ureteral strictures urinary diversion
craniseal post approval study

Conditions: Leak, Cerebrospinal Fluid

Summary: to collect post-approval data comparing the safety and effectiveness of craniseal dural sealant to duraseal dural sealant. the study has been powered specifically to determine whether the craniseal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the duraseal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (csf) leaks. additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years of age * patient is scheduled for an elective infratentorial or supratentorial cranial procedure that entails a dural incision. * patient requires a procedure involving surgical wound classification class i/clean * patient signs a written informed consent form to participate in the study, prior to any study mandated determinations or procedures. * patients who are able to comply with study requirements. exclusion criteria: * patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded * patient has had a prior intracranial neurosurgical procedure in the same anatomical location. * patient with diagnosis of severely altered renal (creatinine levels \> 2.0 mg/dl) or hepatic (total bilirubin \> 2.5 mg/dl) function * patient diagnosed with a compromised immune system or autoimmune disease (wbc count less than 4000/ul or greater than 20,000/ul) * patients undergoing cranial procedures involving petrous bone drilling * patients with traumatic injuries to the head or dural disease in planned dural closure area. * patients who are pregnant or lactating * patient with an active infection * patient is undergoing cranial procedures involving synthetic or non-autologous duraplasty material that are not collagen based * patient with a known allergy to fd\&c blue #1 dye * patient is not able to tolerate multiple valsalva maneuvers, or an intraoperative csf shunt does not allow for transient elevation of csf pressure during valsalva maneuvers. * patient with a diagnosis of uncontrolled diabetes (e.g., persistent hba1c elevation of \>9% despite standard diabetes care), * patient has a documented, uncorrectable clinically significant coagulopathy (e.g., ptt\>37 seconds or inr \>1.5 units) * patient is not likely to comply with the follow-up evaluation schedule. * contraindications to both an mri and ct scan. * patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy.
treating the partners of drug using pregnant women: stage ii

Conditions: Drug Addiction

Summary: this is a two group randomized design that will compare a novel therapy package (i.e., research supported treatment intervention, contingency-based voucher incentives for the male partner's drug abstinence, specialized mi couples counseling) to standard care for helping drug using partners of drug dependent pregnant women obtain and maintain drug abstinence. participants will be followed for 22 weeks and have scheduled twice weekly urine sample collection and all participants will have follow-up interviews post-study entry.


Eligibility criteria:
inclusion criteria: * are 18 years of age or older on admission; * pregnant as determined by sonogram results * have a current sexual partner who they have seen recently at least 3 times a week * male partner has regular alcohol or illicit drug use (at least 4 of 7 days typical use) and is not incarcerated. exclusion criteria: * woman or partner report current suicidal ideation * woman or partner meet diagnostic criteria for a current dsm-iv axis i thought disorder (i.e. schizophrenia) * woman or partner demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery * woman has evidence of physical violence or abuse

Keywords: male female couple cocaine opiate methadone detoxification pregnancy