Kornimate/medical-research-clean huggingface dataset:
selegiline patch for treatment of nicotine dependence

Conditions: Tobacco Use Disorder

Summary: relapse to smoking is a common problem affecting smokers who seek treatment. the purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.

most smokers relapse following smoking cessation treatment. more effective smoking cessation therapies are needed to prevent the high rates of relapse. selegiline is a selective inhibitor of monoamine oxidase b (mao b) and has been used clinically in combination with levodopa to treat parkinson's disease. selegiline permits the stabilization of dopamine (da) levels in the brain by preventing the rapid degradation of da by means of mao b and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. selegiline's effect on mao b and the resulting effect on brain da has interesting implications for the treatment of nicotine dependence because brain da systems may play a key role in the mediation of reward learning behavior. previous research suggests that the brains of living smokers show a 40% decrease in the level of mao b relative to nonsmokers or former smokers. the purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation. participants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (sts) or 2) placebo. treatment with sts or placebo will be given for a period of 8 weeks. participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. follow-up visits will occur at weeks 24 and 52 to determine response to treatment.

Eligibility criteria:
inclusion criteria: * smokes greater than 20 cigarettes per day exclusion criteria: * history of parkinson's disease, high blood pressure, or severe liver or kidney disease * current substance abuse * mental illness * skin conditions that could interfere with patch use * using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any mao inhibitor) * pregnant or breastfeeding
open-label study to investigate systemic exposure in adult and pediatric atopic dermatitis patients treated 8.5 days with pimecrolimus cream 1% under occlusion

Conditions: Atopic Dermatitis

Summary: this study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.


Eligibility criteria:
inclusion criteria: * patients 2 - 18 years of age * patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the investigator's global assessment. ad to involve at least 30% of their body surface area as determined by the rule of nine or the lund and browder chart. exclusion criteria: * erythrodermic patients with netherton's syndrome * patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication * patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive hiv (elisa and western blot), hepatitis b surface antigen (hbsag) or hepatitis c test result other protocol-defined inclusion/exclusion criteria may apply

Keywords: atopic dermatitis ad pimecrolimus blood absorption systemic
aesculap® plasmafit® cementless acetabular system with vitelene® vitamin e stabilized highly crosslinked polyethylene

Conditions: Osteoarthritis, Hip; Rheumatic Arthritis; Degenerative Osteoarthritis

Summary: objectives of this study is evaluate effectivness of aesculap® plasmafit® plasmafit cementless acetabular system with vitelene® vitamin e stabilized highly crosslinked polyethylene compare to the sane sistem without vitamin e, and ceramic or metal femoral heads

osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. surgical treatment usually include installation of implants. every year new types of implants were fabricated from the new material. the effectiveness of this new devices need carefully independent assess in clinic.

Eligibility criteria:
inclusion criteria: * all patients who needs total knee replacement surgery * informed consent from the patients. exclusion criteria: -

Keywords: osteoarthritis hip orthopaedic surgery vitamin e crosslinked polyethylene hip arthroplasty ceramic femoral heads metal femoral heads
experiential avoidance in combat veterans with and without posttraumatic stress disorder

Conditions: PTSD; Suicidal Ideation

Summary: this study plans to examine if symptoms of ptsd affect how veterans who have served in combat think and react to certain information, and whether or not this has an influence on suicidal thoughts.


Eligibility criteria:
inclusion criteria: 1. history of combat service 2. diagnosis of ptsd confirmed by the caps or 3. no current diagnosis of ptsd 4. age 18-65 exclusion criteria: 1. inability to adequately respond to questions regarding the informed consent procedure. 2. history of significant neurological disease 3. diagnosis of schizophrenia or other psychosis 4. alcohol abuse/dependence or illicit drug use in the two weeks prior to testing 5. no history of combat service

Keywords: ptsd suicidal ideation cognitive processes
mr-guided litt therapy in patients with primary irresectable glioblastoma

Conditions: Glioblastoma

Summary: objective: in preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (litt) at radboud university medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with standard of care. study design: prospective randomized pilot study. randomization stopped (amendment september 2nd, 2021), study population: 20 patients aged \>= 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection. intervention: patients will be randomized to receive either (i) biopsy and litt (n=10) or (ii) biopsy alone (n=10).


Eligibility criteria:
inclusion criteria in order to be eligible to participate in the study, a patient must meet all of the following criteria: * informed consent, age \>18-year-old * supratentorial localization * maximal volume \<=70cc on post-contrast t1 mri * safe trajectory/trajectories possible for ablation of 70% of the tumour, avoiding eloquent structures or transgression of a ventricle or vessel . * karnofsky performance status (kps) \>= 70 exclusion criteria a potential subject who meets any of the following criteria will be excluded from participation in this study: * contra-indication for general anaesthesia or mri * lesion \>70cc on post-contrast mri on the day before intervention. * non-glioblastoma diagnosis as per frozen section analysis * pregnancy
natural history study in inherited retinal disease subjects caused by mutations in rpe65 or lrat

Conditions: Leber Congenital Amaurosis (LCA); Retinitis Pigmentosa (RP)

Summary: to evaluate the natural history of visual function in subjects with ird phenotypically diagnosed as leber congenital amaurosis (lca) or retinitis pigmentosa (rp) caused by rpe65 or lrat gene mutations.

this is a retrospective, uncontrolled, multicenter, case history study to determine the natural history of visual function in patients with ird phenotypically diagnosed as lca or rp caused by autosomal recessive mutation in rpe65 or lrat. up to 60 subjects will be enrolled in this study at approximately 12 study centers in canada, the us and europe.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 8 or older with ird (lca or rp) caused by inherited autosomal recessive mutation in either rpe65 or lrat. * subjects who have at least 2 documented kinetic visual field assessments of the same isopter(s) in at least one eye performed at least 2 years apart on the same type of equipment when the subject was between the ages of 6 and 65 years. * if applicable, subjects who provide informed consent for the study (the requirement for informed consent may be applicable to all sites or may be waived by the irb and/or local regulations). the parent or guardian must sign an approved informed consent form for the study for subjects younger than the age of majority. exclusion criteria: * subjects, who in the investigator's opinion, have any severe acute or chronic medical condition, psychiatric condition, physical examination finding or laboratory abnormality that may interfere with the interpretation of their visual function data. * subjects with concomitant bilateral ocular disorders that may affect visual acuity or visual fields (e.g., advanced glaucoma, optic neuritis, anterior ischemic optic neuropathy, advanced cataract, intraocular surgery).
vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix

Conditions: Premature Labour

Summary: to evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. all women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Eligibility criteria:
inclusion criteria: * women pregnant in dichorionic twins. * transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age. * no symptoms, signs or other risk factors for preterm labor. exclusion criteria: * age \ 35 years. * known allergy or contraindication (relative or absolute) to progesterone therapy. * pregnancy by in vitro fertilization (ivf) / intracytoplasmic sperm injection (icsi). * monochorionic twins. * known major fetal structural or chromosomal abnormality. * intrauterine death of one fetus or death of both fetuses. * fetal reduction in current pregnancy. * cervical cerclage in current pregnancy. * medical conditions that may lead to preterm delivery. * rupture of membranes. * vaginal bleeding.

Keywords: twins preterm labor progesterone short cervix
minimal clinically important difference of clinical test of sensory interaction on balance in individuals

Conditions: Stroke

Summary: "stroke is a major cause of disability worldwide, often leading to balance impairments due to deficits in sensory integration and motor control. these impairments hinder postural stability and functional independence, making balance rehabilitation a critical focus in sub-acute stroke care.

the objective of this study is to determine the minimal clinically important difference (mcid) for the clinical test of sensory interaction on balance (ctsib) in individuals with sub-acute stroke rehabilitation. ctsib evaluates the sensory contributions (visual, vestibular, and somatosensory) to balance by testing an individual's ability to maintain stability under various conditions. additionally, the berg balance scale (bbs) will be used to assess functional balance, and the global rating of change (grc) will be included as a subjective measure to gauge participants' perceived improvement in balance and functional performance.

Eligibility criteria:
inclusion criteria: * type of stroke participants must have experienced a first unilateral hemispheric supratentorial stroke, which may be either ischemic or hemorrhagic in nature. * only individuals who have been clinically diagnosed with a stroke within the past 3 to 6 months will be included. * participants must have a functional ambulation classification (fac) score of 3, indicating independent ambulation with supervision or the use of a walking aid. * the individual must have sufficient cognitive and communication abilities to understand and follow instructions during assessments. * the study will include patients in the early subacute phase of stroke recovery, defined as 7 days to 3 months post-onset. * participants must have a montreal cognitive assessment (moca) score of at least 24, indicating normal cognitive function or only mild cognitive impairment exclusion criteria: * individuals with severe cognitive impairments that prevent them from understanding, consenting to, or following simple instructions will be excluded. * participants with uncontrolled medical conditions such as cardiovascular disease or uncontrolled diabetes will not be eligible for the study. * individuals diagnosed with nerve compression conditions affecting motor or sensory function will be excluded. * patients exhibiting significant hemispatial neglect following a stroke will not be included in the study. * participants showing signs of unilateral spatial neglect, impacting their ability to process stimuli on one side, will be excluded. * patients who test positive for unilateral spatial neglect using the catherine line bisection test will be excluded. * individuals with severe visual impairments that compromise independent ambulation will not be eligible. * patients with gait disturbances due to conditions other than stroke (e.g., parkinson's disease, severe arthritis) will be excluded. * individuals who are unable to comply with study protocols or behavioral requirements will not be included.
clinical and paraclinical characteristics of severe bronchiolitis in children from 2 months to 12 months at the children's hospital 1 in ho chi minh city - vietnam

Conditions: Epidemiological, Clinical, Paraclinical Characterictics of Severe Bronchiolitis

Summary: goal: the aim of this study is to determine the epidemiological, clinical, paraclinical characteristics and treatment of severe bronchiolitis at the children hospital n01 in 2001-2002. materials and method: in this cross-sectional study, specimens of 51 patients with severe bronchiolitis at the children hospital n01 from march, 1 st 2001 to february, 28th 2002 are described and analyzed.


Eligibility criteria:
inclusion criteria: * children younger from 2-12 months present fever (usually ≤38.3ºc \[101ºf\]) ,cough, and respiratory distress (eg, increased respiratory rate, retractions, wheezing, crackles) * preceded by a one- to three-day history of upper respiratory tract symptoms (eg, nasal congestion and/or discharge) \] * respiratory distress. exclusion criteria: * refusal to give informed consent * mucus sample barlett \<=0
xiangtong tm full degradation sinus drug stent system prospective, open, single-center, randomized controlled clinical trial

Conditions: Chronic Rhinosinusitis (CRS)

Summary: xiangtong® fully degradable sinus drug stent system is a high-tech medical device independently developed by puyi bio, specially designed for patients with chronic rhinosinusitis (crs) undergoing endoscopic sinus surgery (ess).the product is implanted into the target site during and after surgery, which not only supports the separation of the wound and fixes the repaired mucosal flap, but also controls edema, prevents adhesions, maintains smooth drainage, and sustains the target site to fight against inflammation and promotes healing by means of slow-release hormones.


Eligibility criteria:
inclusion criteria: * subjects are 18-65 years of age, male or non-pregnant female. the subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs an informed consent form. subjects must meet the diagnostic guidelines for chronic rhinosinusitis, have a confirmed diagnosis of bilateral chronic rhinosinusitis, and have a ct scan confirming bilateral lund-mackay scores \>6 (ct scan within 3 months prior to surgery is valid). * female subjects who are not breastfeeding at the time of the screening visit and who do not plan to breastfeed or become pregnant for up to one year after the starting point. * subject has not participated in another clinical trial in the previous 3 months and agrees not to participate in another clinical trial until the endpoints of this trial have been met. exclusion criteria: * subject has a known allergic reaction or contraindication to the device material and its degradation products (mometasone acid, levulinic acid, racemic polylactic acid, propyl lactate, lactic acid). * the subject is on long-term oral hormonal medications. * the subject is receiving immunosuppressive therapy or has a known immunosuppressive or autoimmune disease: the subject has diabetes mellitus. * the subject has or has had glaucoma or high intraocular pressure. * the subject has cataracts. * the subject has an artificial eye. * acute bacterial sinusitis and acute fungal sinusitis. * subject has a life expectancy of less than 12 months. * subject has participated in a clinical trial of another drug or device that did not meet the primary study endpoint: subject is unable or unwilling to participate in this trial.
erwinia asparaginase after allergy to peg-asparaginase in treating young patients with acute lymphoblastic leukemia

Conditions: Adult Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia

Summary: this clinical trial is studying the side effects of erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to peg-asparaginase. drugs used in chemotherapy, such as erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

primary objectives: i. to determine if the 48-hour trough serum asparaginase activity is ? 0.1 iu/ml in young patients with acute lymphoblastic leukemia treated with erwinia asparaginase after allergy to peg-asparaginase. ii. to determine the frequency of asparaginase-related toxicity in these patients. iii. to characterize the pharmacokinetics of erwinia asparaginase in these patients. secondary objectives: i. to compare serum asparaginase activity and serum asparagine concentration between patients treated with erwinia asparaginase on this trial and historical controls treated with peg-asparaginase on ccg-1961 and ccg-1962. ii. to determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of erwinia asparaginase therapy. iii. to determine the presence of anti-erwinia asparaginase antibodies in patients treated with a course(s) of erwinia asparaginase following clinical allergy to peg-asparaginase (peg, pegaspargase). iv. to determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients. outline: this is a multicenter study. patients receive 6 doses of erwinia asparaginase intramuscularly (im) on a monday/wednesday/friday schedule as a replacement for each scheduled dose of peg-asparaginase remaining on the original treatment protocol. all other chemotherapy continues according to the original treatment protocol. blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies. after completion of study treatment, patients are followed periodically.

Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia * concurrently enrolled on a frontline children's oncology group treatment trial (i.e., cog-aall0232 or cog-aall0531, cog-aall0331, or cog-aall0434) at a participating institution * must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol * must have had a grade ? 2 hypersensitivity reaction to peg-asparaginase * no history of pancreatitis ? grade 2 * no prior erwinia asparaginase
comparison between olympus ez shot 3plus 19g and ez shot 2 19g in eus-guided fnb of solid pancreatic masses

Conditions: Pancreatic Neoplasms

Summary: endoscopic ultrasound-guided fine needle biopsy (eus-fnb) is a valid and recommended technique for tissue diagnosis of pancreatic masses. however, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. the eus-fnb of pancreatic masses is usually performed with a 22-gauge biopsy needle. the small diameter of the needle is usually responsible for the low yield of tissue samples for histopathological examination. the 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a larger amount of cellular material. thus, performing eus-fnb with a 19-gauge needle can maximize tissue acquisition and sample adequacy, which is important for appropriate diagnosis. contrariwise, the technical success rate for sample retrieval in patients with pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge needle. this is attributable to the technical difficulty to push the needle out of the endoscope in the duodenum. since about 60% of pancreatic cancers are located in the head region, it is therefore particularly important to improve technical success in these cases. the new 19-gauge biopsy needle "olympus ez shot3 plus" is more flexible than common biopsy needles such as "ez shot2" and should therefore provide improved access to regions like pancreatic head. the aim of this multicenter prospective randomized crossover study is to compare those two needles during eus-fnb of solid pancreatic masses. therefore this study will enroll 40 patients in five german centers with solid pancreatic masses and consecutive indication for eus-fnb. both needles will be used in each patient following a predetermined random order. primary endpoint is the correct histological diagnosis of the mass assessed by each needle. technical failure is regarded as a negative histological diagnosis. secondary endpoints include a comparison of technical failure using each needle, histological quality, duration of procedure and rate of adverse events.


Eligibility criteria:
inclusion criteria: * solid pancreatic mass and consecutive indication for eus-fnb exclusion criteria: * incapacity to give informed consent * haemorrhagic disease, disorder of hemostasis and coagulation (pt \ 42 sec. and platelets \<60000/µl) * oral anticoagulants * dual antiplatelet therapy with thienopyridines (e.g. clopidogrel) * pregnant or lactating

Keywords: endoscopic ultrasound-guided fine needle biopsy olympus ez shot 3plus olympus ez shot 2