Kornimate/medical-research-clean huggingface dataset:
an open label placebo study to assess the inhalation profile in asthmatic patients using the nexthaler® dry powder inhaler (dpi) device

Conditions: Asthma

Summary: phase iia, single-centre, open-label, single-arm study, to evaluate the inspiration profile through the nexthaler® device in adult asthmatic patients with varying degrees of disease control.

the primary objective of this study is to assess the inspiratory flow profile through the nexthaler® device in adult asthmatics with varying degrees of disease control. the study plan foresees one visit at clinic. at visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. if the subjects meet the inclusion/exclusion criteria, they will be instructed to use the nexthaler®. the patients will subsequently inhale through the device and the inspiration profile will be measured. a total of 40 asthmatic adults (≥18 years), 20 with controlled stable disease and 20 with partly controlled or uncontrolled disease according to gina guidelines (2011), will be enrolled.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of controlled, partly controlled or uncontrolled asthma according to gina guidelines (2011) * a cooperative attitude and ability to use dpis and to be trained in the proper use of the nexthaler® as confirmed by the activation of the training device bam exclusion criteria: * significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer * history of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in intensive care unit) * diagnosis of restrictive lung disease * significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.

Keywords: asthma pif
efficacy of nnc0142-0002 in subjects with rheumatoid arthritis (ra)

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the clinical efficacy of a single dose of nnc0142-0002 administered to subjects with active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * a diagnosis of ra meeting the american college of rheumatology 1987 (acr1987) criteria, obtained at least three months prior to dosing with the trial product * subjects with active ra having a disease activity score (das28-crp) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (mcp) joints (second to fifth) * concomitant treatment with methotrexate (mtx) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing * ability to be examined by magnetic resonance imaging (mri) * having failed no biologic therapies for ra and no more than two non-biologic disease modifying antirheumatic drugs exclusion criteria: * chronic inflammatory autoimmune disease other than ra (rheumatoid arthritis) * any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start * body mass index (bmi) below or equal to 18 or above or equal to 40 kg/m\^2
implementation of adjuvants in intercostal nerve blockades for thoracoscopic surgery in pulmonary cancer patients

Conditions: Postoperative Pain; Lung Cancer; Video Assisted Thoracoscopic Surgery; Thoracoscopic Surgery; Nerve Block; Local Anesthesia

Summary: to investigate the effect of intercostal blockade with and without adjuvants.

video-assisted thoracoscopic surgery (vats) is a minimally invasive routine procedure. it's less invasive than thoracotomy but postoperative pain is still a problem. at aalborg university hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing vats. adding adjuvants to the blockades may prolong the effect. the aim of this study is to investigate if intercostal nerve blockade with adjuvants (intravenous (iv) dexamethasone) will result in better pain management. the primary plan was to evaluate the effect of adding iv dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol n-20200040 approved by the ethics committee of northern jutland on february 2nd 2021).

Eligibility criteria:
inclusion criteria: ° consecutive adult patients over 18 years of age scheduled to undergo vats because of verified/suspected lung cancer. exclusion criteria: * inability to understand verbal and written information. * preexisting chronic pain condition. * preoperative daily treatment with pain medication (non-opioids, opioids, gabapentin/pregabalin). * previous thoracic surgery. * previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax. * pregnant women. * autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). general muscle weakness or atrophy. * hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline. * preoperative epidural anaesthesia.
a prospective study of pattern of chronic use of nsaids in patients admitted to emergency department in alexandria main university hospital.

Conditions: NSAIDs Administration

Summary: the goal of this observational study is to assess the pattern of chronic use of nonsteroidal anti inflammatory drugs in patients admitted to emergency department in alexandria main university hospital. the main question it aims to answer is: what is the prevalence of chronic use of nonsteroidal anti inflammatory drugs among patients admitted to emergency department in alexandria main university hospital?

this is a prospective cross sectional study of pattern of chronic use of nsaids in patients admitted to emergency department in alexandria main university hospital. three well trained emergency clinical pharmacists will start medication reconciliation process on admission by interviews with the patients or their care givers. the study aims to assess the pattern of chronic use of nsaids and evaluate the patients' knowledge about doses, duration and adverse events and other use precautions .finally to provide counseling service regarding nsaids medical information to patients admitted to emergency department in alexandria main university hospital.

Eligibility criteria:
inclusion criteria: all adults equal or more than 18 years - exclusion criteria:patients who cannot communicate or have no family members. -

Keywords: nsaids chronic use
bioequivalency study of zidovudine under fasting conditions

Conditions: HIV Infections

Summary: the objective of this study was to assess the bioequivalence of roxane's zidovudine 300 mg tablet compared to glaxosmithkline's retrovir® 300 mg tablet under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on physical exam, medical history, or clinical laboratory findings during screening. exclusion criteria: * allergic or adverse responses to zidovudine or any other comparable or similar products. * participation in clinical trial within 30 days of study initiation. * positive blood screen for hiv, hepatitis b and c.

Keywords: hiv
photodynamic therapy and topical antifungal for onychomycosis in patients with diabetes.

Conditions: Dermatologic Disease; Onychomycosis of Toenail; Diabetic Foot; Diabetes Mellitus

Summary: there are different therapeutic alternatives for onychomycosis. systemic therapy is widely used due to its easy accessibility, low cost and high efficacy, but may be associated with systemic adverse events and drug-drug interactions, so its use in patients with diabetes, immunocompromised and frequently take more than five drugs is not recommended even though these individuals are at serious risk of fungal infection. on the other hand, laser therapy would be contraindicated in patients with neuropathy or peripheral vascular disease (diabetic foot patients) because of possible burns. topical antifungals or lacquers are associated with a low risk of systemic adverse events and drug-drug interactions and would therefore be the most appropriate treatment for patients with diabetic foot. however, they require very long treatment periods, are generally applied daily for 12 months to allow the normal nail to grow and replace the regions damaged by the infection and have a lower cure rate. because of all the above difficulties, there is a need to augment topical treatments in routine clinical practice with adjunctive therapies such as photodynamic therapy for the treatment of onychomycosis in patients with diabetes. the main aim of this study is to observe the effectiveness and safety of the combination of photodynamic therapy with the usual antifungal treatment in consultation in patients with diabetes. secondary aims have been defined as follows: to determine whether 3 sessions of photodynamic therapy combined with topical therapy, over a period of 6 months, is sufficient to achieve clinical, mycological and complete cure of onychomycosis; and to analyse the influence of the type of onychomycosis (odl, total dystrophic, superficial), the causal fungal agent (dermatophyte, mould or yeast) and the degree of severity of onychomycosis (through the osi) on the response to treatment. patients included in the study will be visited every 2 weeks during the first two months, applying photodynamic therapy during visits 2, 3 and 4. subsequently, a check-up will be performed two weeks after the last application of photodynamic therapy and monthly visits for the remainder of the study. at each visit and at subsequent check-ups, the nail plate and peri- and subungual hyperkeratotic tissue will be debrided and reamed in order to improve the effects of the treatment.


Eligibility criteria:
inclusion criteria: * patients with diabetes diagnosed with toenail onychomycosis with positive microbiological culture/pcr. patients over 18 years of age. exclusion criteria: * patients who have received topical or systemic antifungal treatment in the previous month.
a randomised clinical investigation to assess efficacy of low volume transanal irrigation by qufora® irrisedo minigo versus conservative treatment for low anterior resection syndrome patients

Conditions: Gastroenterology; LARS - Low Anterior Resection Syndrome; Rectal Cancer

Summary: the purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of lars of low volume transanal irrigation by minigo in conjunction with conservative treatment versus conservative treatment at 3 months.


Eligibility criteria:
inclusion criteria: 1. adult aged from 18 years 2. patients electively treated for rectal cancer with a low anterior resection 3. between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable 4. lars score \>= 25 (minor or major lars) (emmertsen and laurberg 2012) and lars definition as consensus with at least one symptom that results in at least one consequence (keane et al. 2020) 5. adult for whom previous conservative treatments were started for at least a month 6. mental and physical capability of the patient to handle the minigo by himself. 7. check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by rectal digital examination of the anastomosis, any other exam used in the current practice 8. patient affiliated to the health social security system exclusion criteria: 1. contra-indication to use tai 2. former use of tai (post colo-rectal surgery) 3. clinically relevant stenosis 4. current metastatic disease or local recurrence 5. ongoing chemotherapy 6. postoperative radiotherapy for rectal cancer 7. history of diarrhoeal disease 8. inflammatory bowel disease 9. dementia 10. spinal cord injury, multiple sclerosis, parkinson's disease or other significant disease assessed to be a contributory cause to lars symptoms. 11. patient with cancer recurrence 12. patient with a life expectancy \< 1 year 13. participating to another clinical trial for the treatment of lars symptom 14. ongoing pelvic floor rehabilitation/biofeedback 15. pregnancy or intention to become pregnant during the trial period 16. inability and unwillingness to give informed consent

Keywords: lars transanal irrigation minigo rectal cancer
investigation of novel immunological biomarkers by mass cytometry in patients with early multiple sclerosis (cisco)

Conditions: Multiple Sclerosis

Summary: the objective of cisco is therefore to identify prognostic biomarkers of ms activity in early-stage patients.


Eligibility criteria:
patients : inclusion criteria: * patients with clinically isolated syndrome (cis) participating in the ofsep cohort (french ms observatory) * at least 18 years of age * diagnosed with ms according to criteria 2017 at the time of their last visit. * non-opposition to participation in the study * having had at least one visit in the year following collection * follow-up for at least 1 year after collection. * having signed the ofsep consent exclusion criteria: * cis patients with progressive ms healthy volunteers : inclusion criteria: * age 18 years or older * having participated in the abcd-sep clinical trial promoted by the rennes university hospital (nct03744351). * matched on age and sex to patients of interest in the ofsep cohort * not having objected to participation in the study exclusion criteria: * persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
treatments for depression: drug versus psychotherapy

Conditions: Depression

Summary: this 4-8 month study, with a 2-year follow up period, will compare sertraline (zoloft®), venlafaxine (effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.

mdd is one of the most prevalent psychiatric disorders. different forms of psychotherapy for depression have been found effective. this study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo. participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (zoloft) (followed by venlafaxine \[effexor\] if patients do not respond to sertraline), or placebo. the active phase of treatment lasts 4 months. the frequency of patients' visits depends on the assigned treatment. patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. at the end of the first 16 weeks of treatment, patients are thoroughly evaluated. those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. at the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.

Eligibility criteria:
inclusion criteria: * major depressive disorder diagnosis exclusion criteria: * psychotic or bipolar disorder diagnosis * substance dependence in the last 6 months

Keywords: major depressive disorder
nasal reconstruction using a customized 3d-printed nasal stent for congenital arhinia

Conditions: Arhinia

Summary: a 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3d-printed nasal stent to prevent nasal cavity constriction.

after reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. however there was no conventional stent available. a 3d-printed silicone nasal stent was custom made for the cavity and inserted.

Eligibility criteria:
inclusion criteria: * single patient * 7-year-old male * congenital arhinia * no history of previous treatment exclusion criteria: -
sb-681323 in subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this research is to find out how effective and safe sb-681323 will be in the treatment of ra when it is added to standard anti-rheumatic treatments.


Eligibility criteria:
inclusion criteria: * females cannot be pregnant or lactating. * must use defined contraceptive methods if of child-bearing potential. * bmi range: 18.5-35.0 kg/m2. * diagnosis of ra (rheumatoid arthritis) according to revised 1987 american college of rheumatology (acr) criteria. * if other ra-medication is used: disease-modifying anti-rheumatic drug (dmards) must be stable for at least 8 weeks before first trial visit. * if other oral anti-ra therapies are used, these must have been stable at least 4 weeks before first trial visit. * if methotrexate medication is used as ra-therapy, folate supplement must be taken with stable red cell folate levels. * must give informed consent. * must abstain from alcohol during the trial participation. exclusion criteria: * non-responder on biological ra treatment. * has a positive alcohol screen. * any history of liver disease. * positive hepatitis b surface antigen or hepatitis c antibody result within 3 months of screening. * have any significant disease that places the subject at unacceptable risk as a participant in this trial. * acute infection. * history of active tuberculosis. * history of repeated or chronic infection. * history of malignancy. * history of hiv or other immunosuppressive diseases. * participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies. * uncontrolled diabetes or psoriasis.

Keywords: sb-681323 crp rheumatoid arthritis sb-681323 crp ra rheumatoid arthritis ra
comparison of the effectiveness of cam therapies in pediatric patients undergoing sedation

Conditions: Neurological Disorders

Summary: the investigators conducted a prospective open unblinded clinical four-arm evaluation of complementary and alternate medicine (cam) interventions on children 1-12 years of age who were undergoing imaging by medical resonance imaging(mri) and receiving parenteral sedation. children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. the time frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). no further follow up was conducted.


Eligibility criteria:
inclusion criteria: * children ages 1-12 years undergoing mri studies exclusion criteria: * patients with significant congenital anomalies, genetic syndromes and central nervous system malformations

Keywords: cam sedation mri music therapy
long term barrett's endoscopic mucosal resection study

Conditions: Barretts Esophagus

Summary: analysis of long term outcomes of patients undergoing endoscopic mucosal resection for barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (imc).


Eligibility criteria:
inclusion criteria: * 18 years or over * have or have had barrett's oesophagus exclusion criteria: * do not have barrett's oesophagus * have not had barrett's oesophagus resected at westmead hospital
evaluating strategies to control hypercholesterolemia

Conditions: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia

Summary: to determine the cost-effectiveness of alternative strategies for cholesterol reduction.

background: the availability of effective treatment for hypercholesterolemia raised the hope that millions of americans could avoid or postpone the development of heart disease. because the interventions were potentially effective but were also costly, the cost-effectiveness of alternative approaches to detecting and treating hypercholesterolemia had become a critical issue for health policy. the study was part of a three-grant initiative, cost-effective strategies of cholesterol-lowering, which was recommended by the arteriosclerosis, hypertension, and lipid metabolism advisory committee in january, 1988 and given concept clearance at the september, 1988 national heart, lung, and blood advisory council. the request for applications was released in march, 1990 and awards made in april, 1991. design narrative: assessments were made of: effects of treatment on health outcomes (symptomatic coronary heart disease, death from coronary heart disease, and mortality from all causes); costs and effectiveness of specific dietary and pharmacological interventions; effects of delays in instituting treatment; effects of changing the interval between blood cholesterol tests on the probability and duration of treatment delay; cost and health consequences of modifying screening and treatment recommendations for other risk factors, age, and gender; population implications of screening and treatment strategies. data from the framingham heart study were used to estimate the time pattern of cholesterol levels, which was fundamental to the evaluation of changing the interval between cholesterol tests. framingham data were also used to estimate the relation of event rates to blood cholesterol levels. several components of the analysis were validated by testing model predictions against data from the multiple risk factor intervention trial. the cost estimates were based on several additional sources. individual-level cost-effectiveness estimates for several different interventions were presented along with population-level projections of the consequences of alternative strategies. the significance of altering assumptions about uncertain values, such as the long-term risks and benefits of specific medications, was tested in sensitivity analyses.

Eligibility criteria:
no eligibility criteria