Kornimate/medical-research-clean huggingface dataset:
collection and study of cerebrospinal fluid in patients with hunter syndrome

Conditions: Hunter Syndrome

Summary: the purpose of the study is to collect data on csf biomarkers in patients with hunter syndrome that would serve as reference data for comparison with cognitively impaired patients with hunter syndrome, patients with other lysosomal storage diseases, or other diseases with cns involvement.

to determine levels of glycosaminoglycans (gags), including dermatan sulfate (ds) and heparan sulfate (hs), gag-degradation products, and other biomarkers of central nervous system (cns) and lysosomal function in cerebrospinal fluid (csf) in pediatric and adult patients with hunter syndrome.

Eligibility criteria:
inclusion criteria: * the patient is male and has a documented diagnosis of hunter syndrome (mpsii). * the adult patient has completed a cognitive assessment at screening/baseline or within the previous 3 months and has been determined to have an intelligence quotient (iq) ≥78. note: cognitive evaluation of pediatric patients is not required. * the adult patient or the adult patient's legally authorized representative(s) has voluntarily signed an institutional review board/independent ethics committee-approved informed consent form after all relevant aspects of the study have been explained and discussed. * the pediatric patient must be scheduled to undergo a non-study related lumbar puncture or other medical or diagnostic procedure that requires the administration of general anesthesia. the pediatric patient's parent(s) or legally authorized representative(s) must have provided written informed consent (with patient assent as relevant), after all relevant aspects of the study have been explained and discussed, to allow csf sample collection for this study in conjunction with performance of the non-study related procedure requiring general anesthesia. exclusion criteria: * the patient has a history of complications from a previous lumbar puncture(s) or technical challenges in conducting lumbar puncture. * the patient has received a hematopoietic stem cell transplant. * the patient has taken aspirin, non-steroidal anti-inflammatory drugs (nsaids), or other over-the-counter or prescription medications that could affect blood clot formation within the 7 days prior to lumbar puncture, or has ingested such medications within 7 days prior to any study-related procedure in which a change in potential blood clot formation would be deleterious. * the patient is currently receiving treatment with intrathecal idursulfase-it. * the patient is currently enrolled in an interventional clinical trial. * the patient has participated in a clinical trial of any investigational drug, including idursulfase-it, or device within the 30 days prior to study entry.

Keywords: hunter syndrome mucopolysaccharidosis ii iduronate 2-sulfatase deficiency lumbar puncture cerebrospinal fluid (csf) pediatric adult biomarkers
a test of behavioral intervention for women at high risk for hiv infection

Conditions: HIV Infections

Summary: the purpose of this study is to find out if it is possible to conduct a group counseling program for women at risk for hiv infection. women have been the fastest-growing group with new aids diagnoses. the need for ways to reduce hiv infection in women is urgent. it is important to reduce the risk of hiv infection through sexual contact, but it is also important to address drug use. group counseling may be an effective method.

women have constituted the fastest-growing group of persons with new aids diagnoses for several years. the need to develop and evaluate interventions to reduce the incidence of hiv infection among women is urgent. the behavioral intervention method tested in this study integrates elements from diverse theories and empirical evidence for women to feel empowered to use methods of protection against disease. although the overall objective of the study intervention is to reduce the risk of hiv infection through sexual contact, the intervention must also address drug usage among women. women are randomized in a 1 to 1 ratio to either the intervention or control condition. the intervention group participates in 4 group sessions over the course of 1 month and then in an additional reunion session approximately 1 month after the 4th group session. sessions are 2.5 hours long and include 6 to 10 participants. the sessions involve talking about hiv, ways to avoid hiv, and ways women can support each other. all participants complete a short-term assessment visit 1 week after the 4th group intervention session. the control group does not participate in group sessions. all participants are paid for their time and effort.

Eligibility criteria:
inclusion criteria women may be eligible for this study if they: * are at least 18 years old. * took part in the vps2 study and completed 12 months of follow-up, or each participant must meet at least 1 of the following conditions: 1) has sex with an hiv-infected male; 2) has sex with a male who has injected drugs in the last 5 years; 3) has had sex with 5 or more male partners in the last year; 4) exchanged sex for money or drugs in the last year; 5) was diagnosed with syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomonas in the last year; or 6) used crack cocaine in the last year. * can speak english. * can give information for the purpose of locating. * have had at least 30 percent of vaginal or anal intercourse unprotected by condoms in the 6 months before the study. * are hiv-negative. exclusion criteria women will not be eligible for this study if they: * have had sex with only 1 man for 2 years or more who is hiv-negative and does not inject drugs. the man should not have had sex with anyone else during this time. * have a mental condition that would interfere with the study. * have any other condition that would interfere with the study.

Keywords: risk factors behavior therapy substance-related disorders feasibility studies
three induction treatments on cryptococcal meningitis

Conditions: Cryptococcal Meningitis; HIV/AIDS

Summary: three induction treatment strategies \[ voriconazole +5fc vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5fc vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5fc \] for hiv-infected patients with cryptococcal meningitis were compared.

hiv-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5fc, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5fc ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5fc). after induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of hiv infection; 2. newly diagnosed cryptococcal meningitis by positive india ink staining or culture result, or both in cerebrospinal fluid (csf); 3. anti-viral treatment naïve patients 4. anti-fungal treatment naïve patients exclusion criteria: 1. hepatitis virus co-infection; 2. liver cirrhosis; 3. congestive heart failure; 4. chronic renal disorders; 5. chronic obstructive pulmonary disease (copd); 6. tuberculosis co-infection; 7. malignances 8. severe mental and neurological diseases 9. women during pregnancy and lactation 10. intraveneous drug user (idu) 11. patients with follow abnormal test results:hemoglobin \ 3 times normal level upper limit, serum creatinine \> 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase \> 3 times normal upper limit, total bilirubin \> 2 times normal upper limit 12. patients who are unwilling to anticipate.

Keywords: voriconazole;amphotericin ;cryptococcal meningitis
compassion-focused therapy for distressing mood swings: a case series

Conditions: Bipolar Affective Disorder

Summary: the goal of this case series is to investigate whether a brief compassion-focused intervention is a safe, acceptable and feasible therapy for clients with bipolar affective disorder. the secondary questions are whether a brief compassion focused intervention for bpd clients is associated with changes in bipolar mood symptoms and/ or with changes in psychological processes linked to mood symptoms in bipolar, including: self-compassion, perfectionism, social comparison and social safeness. four visual analogue scales will also be completed daily by each participant throughout the project. these scales will measure domains relevant to bpad symptomology and self-compassion. participants will complete a 4 session compassion-focused therapy intervention. the first session will involve completion of the psychoeducation and formulation work which was started during the initial assessment session. each intervention session will also involve the introduction and practice of cft techniques or exercises. the trial therapist will introduce the exercise and practice it together with the participant during the session. participants will then be asked to continue practicing the exercises for homework. their experience of the practice and any difficulties can then be discussed at the start of the next session.


Eligibility criteria:
inclusion criteria: * adults (18 years and older) * diagnosis of bipolar affective disorder exclusion criteria: * client considered to be actively at acute risk - judgement made by responsible clinical team and also by risk assessment at our first assessment session. high risk clients are excluded as due to time constraints it will be difficult to address risk issues and complete the intervention in the short time frame we have outlined. * client already receiving some form of cft intervention, as this be a potential confounder. * level of english not strong enough to complete assessment and intervention sessions without use of interpreter. again, due to time constraints it would be difficult to complete the intervention with clients in the timeframe outline whilst using an interpreter or navigating the language barrier.
antiplaque effect of essential oils with and without alcochol on an in situ model of oral biofilm growth

Conditions: Biofilms; Oils, Essential; Periodontitis

Summary: the accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. however, for patients, it is not easy to achieve a proper level of plaque control. the efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. it was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures. the essential oils have been presented as a realiable alternative to the "gold standard" (chlorhexidine). however, it use has been limited clinically due to their alcohol contain. some years ago, a new alternative without alcohol has been launched to the market. this formulation has not been already deeply tested specific antiplaque studies in which the structure of the biofilm remained intact. the aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (based on an essential oils formulation with and without alcohol) in the short term with a posterior analysis on "non-destructured" biofilm with confocal laser scanning microscope combined with fluorescence staining.


Eligibility criteria:
inclusion criteria: * systemically healthy adults. * minimum of 24 permanent teeth. * no gingivitis (community periodontal index score = 0). * no periodontitis (community periodontal index score = 0). * absence of untreated caries. exclusion criteria: * smoker or former smoker. * presence of dental prostheses. * presence of orthodontic devices * antibiotic treatment or routine use of oral antiseptics in the previous 3 months. * presence of any systemic disease that could alter the production or composition of saliva.

Keywords: biofilms essential oils alcohol microscopy, confocal mouthwashes
expanded access study of tj004309 in patients with advanced or metastatic cancer

Conditions: Cancer

Summary: this expanded access protocol was designed to provide tj004309 in combination with atezolizumab to the remaining three patients with advanced or metastatic cancer who plan to continue with treatment.


Eligibility criteria:
inclusion criteria: 1. participation in the tracon sponsored 4309st101 or i-mab sponsored tj004309stm103 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from dosing of tj004309 in combination with atezolizumab. 2. willing or able to comply with study treatment and standard of care testing and procedures. exclusion criteria: 1. any unresolved ongoing toxicity or clinical event that would make continued treatment with tj004309 inappropriate. 2. current treatment in another clinical study or treatment with other standard of care therapy. 3. currently pregnant. 4. current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
esoxc-er efficacy and safety of an extended release (er) formulation of oxcarbazepine (apydan extent) in epileptic patients

Conditions: Epilepsy

Summary: the aim of the observational study is to investigate the safety of oxcarbazepine extended release (er) during long-term therapy in epileptic patients. in addition, quality of life parameters should be documented if assessed.


Eligibility criteria:
inclusion criteria: * patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures * mono- or combination therapy * male and female from the age of 6 exclusion criteria: * hypersensitivity to oxcarbazepine mr or one of its excipients

Keywords: open, non-interventional
comparison between melatonin and diazepam for prevention of recurrent simple febrile seizures

Conditions: Febrile Seizures

Summary: to evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

to evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.

Eligibility criteria:
inclusion criteria: * children aged 6 months to 5 yrs . * simple febrile seizures exclusion criteria: * complex febrile seizures * child with history of neonatal seizure. * afebrile seizures. * history of anticonvulsive therapy. * children suffering from epilepsy. * children with abnormal eeg. * children with abnormal neurological examination. * positive family history of epilepsy.

Keywords: melatonin diazepam recurrence prophylaxis febrile convulsions
lung screen uptake trial

Conditions: Lung Cancer

Summary: this study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. those who attend will undergo a "lung health check" and be invited to a baseline screening scan if eligibility criteria are fulfilled.

lung cancer screening using low dose computed tomography (ldct) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large united states (us) trial, and screening is now being carried out in the us. studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented. in this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. the investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. eligible individuals will be invited by their general practitioner to a "lung health check appointment" via one of two randomly allocated invitation strategies. the control materials will be similar to those used by uk screening programmes for other cancer types. the intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds. those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline ldct scan. data will be collected with respect to demographics, risk and various clinical and radiological outcomes.

Eligibility criteria:
inclusion criteria: * recorded as a current smoker during the year 2010 or in subsequent years since then. exclusion criteria: * active diagnosis of lung cancer or metastases * ct thorax within the past year * inability to consent to study * palliative care register * gps alert to co-morbidity that contraindicates screening or treatment for lung cancer

Keywords: screening early detection health inequality uptake
effects of losartan versus atenolol on aortic and cardiac muscle stiffness in adults with marfan syndrome

Conditions: Marfan Syndrome

Summary: marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from aortic dilation and dissection. the degree of aortic dilation and response to beta-blockade (standard of care) vary in adults with marfan syndrome. however, aortic stiffness is often present, and can be a predictor of aortic dilation and cardiovascular complications. in addition, adults with marfan syndrome develop left ventricular diastolic dysfunction, which can progress to heart failure. aortic stiffness and diastolic dysfunction are important and logical therapeutic targets in adults with marfan syndrome. tgf-beta mediates disease pathogenesis in marfan syndrome and contributes to aortic stiffness. the angiotensin receptor blocker, losartan, inhibits tgf-beta activity and reverses aortic wall pathology in a marfan mouse model. losartan also decreases aortic stiffness and improves diastolic function in hypertension, renal disease and hypertrophic cardiomyopathy. this trial is a randomized, double-blind trial of 50 adults with marfan syndrome, treated with 6 months of atenolol vs. losartan. arterial tonometry for aortic stiffness and echocardiography for diastolic function will be performed at the beginning and end of treatment. a blood draw for serum markers of extracellular matrix turnover and inflammation will also be performed at 0 and 6 months. we plan to determine whether losartan decreases aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.

please see summary.

Eligibility criteria:
inclusion criteria: * age greater than 25 years * clinical marfan syndrome exclusion criteria: * previous aortic or cardiac surgery * pregnancy * renal insufficiency * medication intolerance

Keywords: marfan syndrome losartan atenolol diastolic function aortic stiffness
the preventive effect of helicobacter pylori eradication on the development of gastric cancer

Conditions: Helicobacter Pylori; Eradication; Gastric Cancer; Medical Care Cost

Summary: recently, the preventive effect of helicobacter pylori (hp) eradication treatment on the incidence of gastric cancer has been reported. by hp eradication treatment being performed for hp-infected people in iijima town, we will evaluate whether the incidence of gastric cancer and/or the medical care cost can be reduced as compared with those in the previous years.


Eligibility criteria:
inclusion criteria: * people who live in iijima town at their age of 19 to 69 years
postural control, grip strength and body posture in children with intellectual disability and dyslexia

Conditions: Developmental Disability; Developmental Dyslexia; Intellectual Disability

Summary: this study investigates physical changes in children with dyslexia and intellectual disability. participants divided into three groups and body posture, postural control and hand grip strengths was evaluated.

children with intellectual disability and dyslexia have academic and behavioral problems but also they might have physical changes related to poor motor development. three evaluation method was used in study. postural deformities were evaluated by posturescreen mobile app which is a mobile app allows to assess photographic body posture in four aspects (anterior, posterior, lateral) postural control was tested by wii balance board. wii balance board is a force plate that can measure person's center of gravity displacements hand grip strength tested by jamar hand dynamometer. it was completed according to american hand therapist's association guidelines. all data collected from participants have analysed within the control group (typical developed children)

Eligibility criteria:
inclusion criteria: 1. no comorbid diagnosis alongside id and dyslexia (dysgraphia, dyscalculia, attention deficit hyperactivity disorder, etc.) 2. no orthopedic/physical disability exclusion criteria 1. presence of previous training for physical or motor development 2. previous surgery.

Keywords: postural control, body posture hand grip
tissue eosinophils in non-small cell lung cancer (the ten study)

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective is to describe eosinophil infiltration in resected (early stage) nsclc. secondary objectives are: * to investigate the correlation of t-eos and b-eos in the aforementioned patient population; * to investigate the correlation between t-eos and overall \& disease-free survival; * to investigate the localization of t-eos (periphery vs. center of the tumor lesions).


Eligibility criteria:
inclusion criteria: * resected, early stage nsclc between 01-01-2015 and 30-04-2022 with available tumour tissue exclusion criteria: * inclusion in a clinical study contraindicating enrollment in the present study