Kornimate/medical-research-clean huggingface dataset:
this study will examine the effects of gsk256066 to protect mild steroid-naive asthmatics against an antigen challenge

Conditions: Asthma

Summary: this will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of gsk256066 on bronchial hyper-reactivity to adenosine monophosphate.


Eligibility criteria:
inclusion: (all must apply) * males and females aged 18 to 55 years inclusive. * documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation. * pre-bronchodilator fev1 \>75% of predicted at screening. * documented sensitivity to amp with a provocative concentration of amp resulting in a 20% fall in fev1 (pc20 amp) of \<80 mg/ml at the screening visit. * demonstrate stable bronchoconstriction in response to inhaled amp at the run-in visit. 'stable bronchoconstriction' is a term to define a population of asthmatics who have a repeatable and reproducible response to a challenge agent that induces bronchoconstriction. the run-in pc20 needs to be within 1.25dd of the screening pc20. * non-smoking status as verified by urinary cotinine levels below 300 ng/ml cotinine at the screening visit. this can include ex-smokers who have given up smoking for \>6 months and have less than a 5 pack-year smoking history. * able and willing to give written informed consent to take part in the study. * available to complete all study measurements. exclusion: * pregnant or nursing females. * past or present disease, which as judged by the investigator, may affect the outcome of this study. * subject has known history of hypertension or is hypertensive at screening. * respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. * history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. * unable to abstain from prescription medication, other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments eg headache from 48h before the first dose until the follow-up visit. * the subject has participated in a clinical trial during the previous 3 months. * history of blood donation (450 ml) within 2 months of starting the clinical study. * the subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. * the subject has tested positive for hepatitis c antibody or hepatitis b surface antigen or hiv antibodies. * the subject has positive drugs of abuse test. * subjects weighing less than 50kg are to be excluded from participating in the study.

Keywords: gsk256066, allergen, challenge, repeat dose, amp, mild asthmatics
tolerability, pharmacokinetics and pharmacodynamics of bia 9-1067

Conditions: Parkinson's Disease (PD)

Summary: the purpose of this study is to assess the tolerability of bia 9-1067 after multiple rising dose regimens of bia 9-1067.

single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of bia 9-1067 in four groups of healthy male volunteers. in each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. an appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Eligibility criteria:
inclusion criteria: 1. a signed and dated informed consent form before any study-specific screening procedure is performed. 2. aged between 18 and 45 years, inclusive. 3. healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ecg). 4. nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay. exclusion criteria: 1. any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease. 2. acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1. 3. history of drug abuse within 1 year before study day 1. 4. history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day (12.5 cl glass of 10° \[10%\] wine = 12 g; 4 cl of aperitif, 42° \[42%\] whiskey = 17 g; 25 cl glass of 3° \[3%\] beer = 7.5 g; 25 cl glass of 6° \[6%\] beer = 15 g 5. have previously received bia 9-1067. 6. positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies. 7. positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma \[3,4-methylenedioxy-methamphetamine; ecstasy\]). 8. history of any clinically important drug allergy. 9. prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (imp) administration. 10. consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1. 11. use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before imp administration. 12. donation of blood (ie 450 ml) within 90 days before study day 1.

Keywords: parkinson's disease (pd) opicapone bial bia 9-1067
comparison of free gingival graft and modified apical repositioning flap techniques

Conditions: Periodontal Diseases

Summary: attached gingiva, a crucial component of the keratinized tissue, plays a vital role in preserving periodontal health. the free gingival graft (fgg) and modified apically repositioned flap (marf) techniques are frequently used for addressing issues related to insufficient attached gingiva. the aim of this study was to compare the efficiency of the fgg and the marf increasing the zone of attached gingiva in 2-year posttreatment.

the study included 15 participants who were both systemically and periodontally healthy, and these participants had a total of 21 teeth (10 for sdg and 11 for marf). all included teeth had an attached gingiva width ranging from 0.5 mm to 1.5 mm and showed no signs of bone dehiscence. sdg and marf methods were selected randomly (coin-to-coin). clinical parameters recorded at baseline, third month, at first and second years were plaque index (pi), pocket probing depth (ppd), keratinized tissue width (ktw), attached gingiva width (agw), bleeding on probing (bop), gingival recession (gr) and clinical attachment level (cal).

Eligibility criteria:
inclusion criteria: * having ≥15 permanent teeth excluding third molars, * not using any orthodontic appliance, * not being pregnant or breastfeeding, * not having any uncontrolled chronic and/or auto-immune disease, * not smoking. exclusion criteria: * having chronic and/or auto-immune disease * smoking.

Keywords: attached gingiva free gingival graft
efficacy of monosialotetrahexosylganglioside in the prophylactic treatment of bortezomib-induced peripheral neuropathy

Conditions: Multiple Myeloma

Summary: bortezomib was an important drug in the treatment of multiple myeloma (mm),and peripheral neuropathy (pn) is a significant dose-limiting toxicity of bortezomib that typically occurs within the first courses of bortezomib, reaches a plateau at cycle 5. up to now, no effective prophylaxis have been developed for pn. monosialotetrahexosylganglioside, a nerve-protecting drug,was often used to promote growth of nerve, and function restoration of damaged nerve.thus,the investigators hypothesized that combination of monosialotetrahexosylganglioside and bortezomib can reduce the incidence rate of peripheral neuropathy (pn) and promote the relief of peripheral neuropathy (pn) in multiple myeloma (mm) patients.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of multiple myeloma; * age:18-80 years; * eastern cooperative oncology group (ecog) status 0-3, * estimated survival time \> 3 months; * acceptable liver function (bilirubin\<2.5×uln, alanine transaminase (alt) or aspartate aminotransferase (ast)\<2.5×uln), * no history of other malignancies; * no previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation; * no other serious diseases which conflict with the treatment in the present trial; * no concurrent treatments that conflict with the treatments in the present trial; * voluntary participation and signed the informed consent. exclusion criteria: * the patients had the conditions below: clinically significant ventricular tachycardia (vt), atrial fibrillation (af), heart block, myocardial infarction (mi), congestive heart failure (chf), symptomatic coronary artery heart disease requiring medication; * the patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies; * the patients with neuropathy; * the patients with mentally ill / unable to obtain informed consent; * the patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results; * the patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects; * the patients with a history of allergy to test drug; * the patients not suitable to participate in the investigator judged by researchers.

Keywords: multiple myeloma peripheral neuropathy prophylaxis
randomized controlled trial in south africa comparing the efficacy of complementary food products on child growth

Conditions: Malnutrition

Summary: complementary food supplements (cfs), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. in africa, maize is a major staple food used for complementary feeding. compared to rice or wheat, maize has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit their absorption. the impact of cfs products in the context of a maize-based diet has not been well investigated. this study will test two newly developed fat-based cfs products made from soy. the first product is a fortified fat-based spread that contains essential fatty acids with added docosahexaenoic acid (dha) and arachidonic acid (ara), and phytase to improve iron and zinc bioavailability. the second product is a fortified fat-based product containing essential fatty acids. both products contain soy. the enrichment of the products with essential fatty acids is of particular interest in the south african context, as consumers are exposed to higher linoleic acid (la) diets due to the inclusion of mostly high la-containing sunflower oil during food preparation. the cfs products could contribute towards restoring the balance between la and alpha-linolenic acid (ala) intake. the results of this study will provide evidence on whether or not two types of fortified cfs have the potential to address malnutrition (linear growth) and improve psychomotor development in infants. if proven effective, this approach of providing multiple nutrients can be made available to infants in the developing world and may lead to sustainable actions.


Eligibility criteria:
inclusion criteria: * infants resident in the study area * aged 6 months exclusion criteria: * severe obvious congenital abnormalities * severe anaemia (haemoglobin \< 70 g/l) * severe malnutrition (weight-for-length z-score \<-3.00) * other diseases referred for hospitalization by clinic staff * plans to move out of the study area in the next 7 months * known food allergies/intolerances e.g. to peanuts, milk and fish * infants given special nutritional supplements * infants known to be hiv+ * not been borne as a singleton
a study of guselkumab therapy in participants with moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (sc) induction compared to placebo in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * signed informed consent form * 18 years of age or older * documented diagnosis of ulcerative colitis (uc) at least 12 weeks prior to screening * moderately to severely active uc as per the modified mayo score * demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol exclusion criteria: * diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease * surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention * receiving prohibited medications and treatments * uc limited to the rectum only * active severe acute respiratory syndrome coronavirus 2 (sars-cov-2) corona virus disease (covid-19) infection

Keywords: guselkumab colitis, ulcerative
evaluation of the atlas genetics io® ctng system

Conditions: Chlamydia Trachomatis; Gonorrhea

Summary: atlas genetics io® system results are compared with those obtained from comparator devices.

results from the atlas genetics io® system are compared with a composite infection status obtained from testing on three commonly used comparator devices. this is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult participants over 14 years of age who are undergoing testing for the presence of ct/ng.

Eligibility criteria:
inclusion criteria: 1. symptomatic and asymptomatic individuals ≥14 years of age exclusion criteria: 1. treatment with antibiotics known to be effective against chlamydia trachomatis and/or neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study. 2. unable to self-obtain a vaginal swab or urine sample of at least 30 ml
direct topical lung t3 treatment to improve outcome & sequelae of covid-19 acute respiratory distress syndrome

Conditions: Covid19; SARS-CoV Infection; ARDS; ARDS, Human

Summary: acute treatment of covid-ards with direct topical lung instilled t3 therapy for patients on mechanical ventilation.

post-hospitalization follow-up for 6 and 12-months of survival and end-organ dysfunction (lung, heart, kidney, neuropsychological), plus quality of life and return to work of those previously working

Eligibility criteria:
exclusion criteria: * pregnancy inclusion criteria: * diagnosis of sars-cov-2 with first positive test within 14 days, and, * diagnosis of ards by the berlin criteria (2012): 1. onset: \< 7 days 2. chest x-ray: bilateral patchy opacities, infiltrates 3. mechanical vent support: peep or cpap support \>= 5 cm h2o 4. pulmonary edema: not fully explained by cardiogenic etiology 5. hypoxia: pao2/fio2 ratio \< 300, or o2sat/fio2 ratio \< 315
feasibility of mobile game system for potential treatment of developmental delays

Conditions: Autism Spectrum Disorder; Autism

Summary: the investigators will test the feasibility and preliminary efficacy of a mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).


Eligibility criteria:
inclusion criteria: 1. parent or primary caregiver over 18 of a child with autism, we will enrich for children between the ages of 2 and 8 years old. 2. autism diagnosis confirmed by a screener such as the mobile autism risk assessment (mara) and or similar published tools. exclusion criteria: (1) physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.

Keywords: digital mobile autism
pressure-limited ventilation versus volume-targeted ventilation in preterm newborns

Conditions: Neonatal Respiratory Failure

Summary: aims: there is increasing evidence that volume-targeted ventilation (vtv) holds benefits for preterm infants in comparison to pressure-limited ventilation. this study aims to compare pressure-limited to vtv in preterm infants. hypothesis: volume-targeted will be associated with more rapid achievement of weaning criteria compared to pressure-limited ventilation primary outcome: time taken to achieve pre-specified weaning criteria. methods: ventilated infants less than 34 weeks gestational age at birth were recruited within the first 24 hours of life and randomly allocated to receive either pressure-limited or vtv. adjustments to ventilator settings were made according to the trial protocol. infants were deemed to have met failure criteria if they required hfov, required peak pressures of more than 26 cm of water or developed pulmonary haemorrhage. analysis will be by intention-to-treat.


Eligibility criteria:
inclusion criteria: * mechanically ventilated * \<34 weeks gestation * within first 24 hours of life exclusion criteria: * congenital diaphragmatic hernia * congenital heart disease * oesophageal atresia

Keywords: neonate premature pressure limited ventilation volume ventilation
a study to assess the safety, tolerability, pk and pd of am1030-cream in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of am1030-cream in patients with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * males and/or females of any ethnic origin between 18 and 65 years of age * body mass index between 18.0 and 35.0 kg/m2 * subjects with ad as defined by the hanifen and rajka criteria and with mild to severe disease activity (iga 2-4) * ad lesions amenable to cutaneous treatment located on the trunk and/or limbs exclusion criteria: * subjects with scars, moles, tattoos, sunburn or other blemishes in test areas * systemic treatment with immunosuppressants, immunomodulators or corticosteroids within 2 weeks prior to dosing * topical treatment with corticosteroids, antibiotics and/or immunomodulators within 4 days prior to dosing * treatment with systemic antihistamines within 24 hours of the first dose administration * treatment with ssris within 2 weeks of the first dose administration * subjects who have received phototherapy within 4 weeks prior to dosing
virtual reality for pain management and patient satisfaction during outpatient hysteroscopy

Conditions: Pain, Acute; Satisfaction, Patient

Summary: the investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (oh). 60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group. the intervention in the study group was to use a virtual reality (vr) device (meta quest2) as a distraction technique during the oh. the investigators wanted to study if the distraction generated by the vr could improve patients' perceived pain or satisfaction with the oh

the investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (oh). 60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group. in the standard hysteroscopy protocol, all patients are advised to take an ibuprofen 400-600mg or paracetamol 650-1000 mg two hours before the procedure. they are also suggested to take bromazepam 1.5 mg two hours before the procedure if they feel anxious. the standard care group had a trained nurse providing distraction and emotional support. the study group had a vr device (meta quest 2) with a video consisting of a gondola ride through the canals of venice with relaxing music played on the headset the investigators wanted to study if the distraction generated by the vr could improve patients' perceived pain or satisfaction with the oh, comparing it with the standard care group.

Eligibility criteria:
inclusion criteria: * consecutive women candidates to undergo an oh * women aged 18 to 70 years old exclusion criteria: * visual impairment * hearing impairment * language barrier impeding the correct explanation of the study * contraindication for using the vr device * confirmed malignant endometrial disease * anatomical characteristics impeding the office hysteroscopy

Keywords: hysteroscopy
a randomized controlled trial of mandatory naps for physicians in training

Conditions: Fatigue

Summary: this study will consist of a randomized controlled trial in which the investigators test the feasibility and effectiveness of mandatory nap programs for physicians in training. one site will be the general medical service of the philadelphia veterans affairs medical center. the other will be the oncology service of the hospital of the university of pennsylvania. the primary outcome will be the amount slept while on call. the first year will test the efficacy of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour mandatory nap schedule.

background: the release of the institute of medicine report on resident work hours and patient safety highlighted the risks to patient and resident safety of extended duty on-call shifts. objectives: the purpose of this study is to test the feasibility and effectiveness of mandatory naps during extended duty overnight shifts for residents. methods: for each site (pvamc and hup), every other month residents will be randomized to either work the standard schedule (which involves interns being on duty for 30 continuous hours) vs. the mandatory nap schedule, which involves interns signing out their beepers for 5 hours in the middle of the night to covering night floats and for 3 hours in year 2. the primary outcome will be the amount slept as measured by actigraphs, with secondary outcomes of cognitive alertness measured by 3-minute psychomotor vigilance testing (pvt), stanford sleepiness scale, and other measures of resident and patient well-being. status: recruitment complete, analyses phase only

Eligibility criteria:
inclusion criteria: * residents in the university of pennsylvania internal medicine training program who are rotating through either philadelphia va medical center medical service or hospital of university of pennsylvania oncology service exclusion criteria: * refusal to consent to participate

Keywords: sleep deprivation fatigue