Kornimate/medical-research-clean huggingface dataset:
a study on antiretroviral therapy (art) naïve patients on different regimens to treat hiv (northiv)

Conditions: HIV

Summary: the present study aims to compare efficacy, side-effects, and treatment adherence of three different treatment regimens given to antiretroviral naïve hiv-1 infected patients. treatment will be initiated in accordance with the swedish national guidelines. in the twice daily (bid) arm (1), which could be considered as a standard regimen at present, lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors (nrtis) administrated bid. the first once daily (qd) arm (2) combines the protease inhibitor (pi) atazanavir/ritonavir with 2 nrtis administrated qd, and in the second qd arm (3), the non nucleoside reverse transcriptase inhibitor (nnrti) efavirenz is combined with 2 nrtis administrated qd. all drugs used in the study are licensed in the participating countries and patients will be followed as in clinical practice. patients could optionally, after informed consent, be followed with additional measurements of hiv-1 rna after 1, 2, and 3 weeks of treatment to asses the kinetics of viral decline after initiation of treatment.


Eligibility criteria:
inclusion criteria: * male or female, aged 16 years of age * hiv-1 infected as documented by a licensed hiv-1 antibody elisa * ability to understand and provide informed consent * indication for antiretroviral treatment * antiretroviral naïve * all clinical laboratory values not clinically significant exclusion criteria: * subjects being pregnant * women of childbearing potential not practicing birth control * subjects with renal failure requiring dialysis * drug interactions with any of the study drugs that are not manageable * resistance to any of the study drugs

Keywords: hiv antiretroviral therapy efavirenz lopinavir atazanavir randomised controlled clinical trial
comparison of water sorption capacity and the composition of bronchial fluids of healthy persons and patients with chronic obstructive bronchitis (copd)

Conditions: COPD; Healthy

Summary: pilot basic research study on the properties of bronchial mucus. examination of the sorption and desorption properties, mucin concentration, and structure of the mucus from healthy airways compared to patients with chronic obstructive pulmonary disease (copd).

mucus, of the correct composition, maintains airway hydration and protects the airway from inhaled particles through mucociliary transport. in chronic inflammatory airway diseases such as copd or cystic fibrosis, infectious agents, inflammatory cells and products of inflammation such as dna, increase mucus viscosity which results in decreased mucociliary clearance of inhaled particles, increasing the likelihood of respiratory infections. this pilot study is planned as basic research on the properties of bronchial mucus. water isotherms and efficient water activity (sorption and desorption) of the collected samples are examined in defined temperature and humidity settings using dvs intrinsic (dynamic vapour sorption system, surface measurement systems, london, uk). findings will provide insights into possible treatment programs targeted at altering specific mucus components.

Eligibility criteria:
inclusion criteria: * age\>18 * copd or other disease requiring bronchoscopy or elective surgery * signed informed consent form exclusion criteria: * not able to consent * linguistic, cognitive, or other obstacles

Keywords: mucociliary clearance mucus sorption of water
effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

Conditions: Polycystic Ovarian Syndrome; Insulin Resistance

Summary: the purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

polycystic ovarian syndrome is a complex endocrine condition characterized by metabolic abnormalities such as insulin resistance, excess weight or obesity, diabetes, and an increased risk of cardiovascular disease.despite previous studies reported that physical exercise improves insulin resistance in females with polycystic ovarian syndrome, there is no study yet investigate the effect of whole body vibration on insulin resistance

Eligibility criteria:
inclusion criteria: 1. females with polycystic ovarian syndrome. 2. their ages will range from 20 to 35 years. exclusion criteria: * 1-smoking. 2-history of chronic disease.
endodontic regenerative procedure for immature non-vital teeth

Conditions: Tooth, Nonvital

Summary: in this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called regenerative endodontic procedure (rep). this treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. these cells could help to increase the thickness and length of the root canal walls resulting in root end maturation. results from the 50 participants who will receive the rep treatment will be compared with findings with historical data.

all participants will be prospectively assigned to the rep treatment group. results from the treatment group will be compared to historical controls of all subjects treated by ca(oh)2 or mta apexification in the last 10 years (2007-2017) at the boston university henry m goldman school of dental medicine. all materials used in this protocol are fda approved and commercially available for similar applications. this study does not seek a new use or application of any materials, instead recommendations of the american association of endodontists (aae) will be followed to evaluate outcomes associated with the rep compare to the standard of care ca(oh)2 or mta apexification. the overall objective for this research is the elimination of any clinical symptoms and the evidence of bony healing as examined by radiographs. other objectives include increased root wall thickness and/or increased root length and positive response to vitality testing, which if achieved, could indicate a more organized vital pulp tissue.

Eligibility criteria:
inclusion criteria: subjects followed prospectively * 7-18 years old * salvageable permanent non-vital tooth with immature apex whether anterior or posterior * receiving dental care at the henry m. goldman school of dentistry historical controls * 7-18 year old * salvageable permanent non-vital tooth with immature apex whether anterior or posterior * received care and has accessible records at the henry m. goldman school of dentistry * had either the calcium hydroxide apexification or mta apexification between 2007 and 2017 exclusion criteria: * allergic to medications necessary to complete procedure * health status not in: a) asa-1 no organic pathology or patients in whom the pathological process is localized and does not cause any systemic disturbance or abnormality; nor b) asa 2 a moderate but definite systemic disturbance, caused either by the condition that is to be treated or surgical intervention or which is caused by other existing pathological processes * history of dental trauma within 6 months due to possibility of internal and external root resorption. * if tooth pulp space is needed for post/core final restoration * pregnancy in female subjects

Keywords: regenerative endodontic procedure (rep) mineral trioxide aggregate (mta) apexification calcium hydroxide -ca(oh)2 permanent non-vital tooth children 7-18 years of age
the impact of obesity on short stem total hip arthroplasty

Conditions: THA; Obesity

Summary: the purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty.

short stem total hip arthroplasty (tha) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain. while studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem tha, data on its use in obese patients is still rare and not sufficiently conclusive. some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends. in this context, the aim of this study was to investigate the relationship between bmi, postoperative subsidence and clinical outcomes in the setting of short stem tha.

Eligibility criteria:
inclusion criteria: 1. patients who underwent primary short stem hip arthroplasty with mathys optimys short stem between 01.01.2018 and 31.12.2020 2. availability of preoperative and postoperative radiographs for assessment of subsidence 3. a minimum bmi of 30kg/m2 for the obese group 4. a minimum follow-up of 24 months. exclusion criteria: 1. former surgeries of the hip in question 2. incomplete clinical data 3. incomplete radiological data

Keywords: subsidence obesity short stem total hip arthroplasty tha
ventilation of the extremely premature infants optimized by dead space washout

Conditions: Extremely Low Birthweight Infant; Continuous Tracheal Gas Insufflation; Medical Device; Lung Protection; Ventilator-Induced Lung Injury

Summary: the continuous tracheal gas insufflation (ctgi) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. this objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. the principle of this option is to continuously blow an additional flow of 0.2 l/minute at the tip of the endotracheal tube to purge expired co2 trapped in the prostheses, to have a co2-free volume of gas available for subsequent insufflation. the goal of this clinical trial is to learn if continuous tracheal gas insufflation (ctgi) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. it will also learn about the safety of ctgi. the main questions it aims to answer are: * does continuous tracheal gas insufflation (ctgi) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation? * does continuous tracheal gas insufflation (ctgi) reduce the age at the weaning of any ventilatory support and/or oxygen supplementation. researchers will compare the clinical outcome of patients mechanically ventilated with the ctgi-device to the outcome of patients ventilated without the ctgi device, to see if the ctgi ventilation works to reduce ventilation dependence. participants will: • be mechanically ventilated using ctgi (if randomly assigned in the ctgi-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.


Eligibility criteria:
inclusion criteria: * gestational age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days * age between 0 and 7 days of life * need for intubation and mechanical ventilation before day 8 of life * availability of the research-associated medical devices * beneficiary of a social security system (in france: cmu or securité sociale) * parental consent for their infant to participate in this trial exclusion criteria: * known severe congenital malformation (potential life-threatening malformation) * known preexisting severe intraventricular haemorrhage (grade 3 or 4) and/or other brain abnormality that can alter life prognosis * known genetic disorder (potential life-threatening malformation) * preexistent mechanical ventilation for a duration of more than 12 hours * participation in another interventional research trial before inclusion

Keywords: lung protection extremely low birthweight infant ventilator-induced lung injury mechanical ventilation
individualized preoperative rehabilitation pilot

Conditions: Quality of Life; Complex Gastrointestinal Surgery

Summary: a pilot to test feasibility of improving patient/caretaker quality of life and resilience.

our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. this initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.

Eligibility criteria:
1. patients who are being seen for pancreatic, esophageal, rectal or hepatic neoplastic disease, will undergo neo-adjuvant therapy and may require complex gi surgery and their care givers. 2. are able and willing to participate in all aspects of the study; and 3. have been provided with, understand the consent.

Keywords: quality of life deficits complex gastrointestinal surgery
comparative effects of paraffin bath therapy and eswt on quality of life and sleep in de quervain tenosynovitis

Conditions: De Quervain Disease

Summary: there is no study in the literature comparing effects of both paraffin bath therapy and extracorporeal shock wave therapy (eswt) on life and sleep quality of patients with de quervain tenosynovitis . the aim of this study is performing this comparison.


Eligibility criteria:
inclusion criteria: * being 18 years or older * meeting de quervain diagnostic criteria * not having applied any physical therapy modality to the hand-wrist in the last 1 month * not using pain medication in the last 1 month, * not using local anesthetics or steroid injections on the hand-wrist in the last 3 months * have received written consent to participate in the study, and have come to the last control at the 6th week. exclusion criteria: * neurological diseases (especially neuropathies), * malignancy * rheumatological diseases * pregnancy * history of hand/wrist fracture or surgery * hand/wrist trauma in the last 1 month * coagulation disorder diseases
high flow nasal oxygen therapy an implementation study in pediatric wards

Conditions: Moderate Respiratory Distress; Severe Respiratory Distress

Summary: the purpose of this study is to prospectively evaluate the process of implementing hfno in several msf projects, varying according to geographical and programmatic contexts, population, health structures, human resources, and management. it will generate evidence on the operational feasibility (in terms of human resources, equipment, logistics and costs) of integrating hfno into picu standard of care, as well as on the users' and caregivers' perspectives on hfno and on the children clinical outcomes observed where hfno is implemented. this relevant information will guide msf in the decision making of scaling up hfno therapy in its projects.

mixed method study: quantitative component for the data of the children and qualitative data for the perception for health staffs and parents

Eligibility criteria:
inclusion criteria: * prescription of hfno by clinician * parent consenting to the use of the data

Keywords: oxygen high flow pneumonia pediatrics
combination chemotherapy with or without anlotinib in the maintenance treatment of non-squamous non-small cell lung cancer.

Conditions: Non-squamous Non-small-cell Lung Cancer

Summary: this study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with non-squamous non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. the primary endpoint of the study is progression-free survival (pfs); the secondary endpoints are disease control rate (dcr), objective response rate (orr) and overall survival (os).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤ 75, ecog ps: 0\~1, estimated survival duration more than 3 months; 2. subjects with histologically or cytologically confirmed locally advanced and/or advanced non-squamous nsclc; 3. signed and dated informed consent; 4. adequate hematological, liver and renal function exclusion criteria: 1. prior chemotherapy or treatment with another systemic anti-cancer agent 2. malignancies other than nsclc within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or dcis 3. evidence of tumor invading major blood vessels 4. current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes 5. history of haemoptysis \>/=grade 2 6. clinically significant cardiovascular disease
iyengar yoga for young people with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare a standardized 6 week iyengar yoga program (iyp) for adolescents and young adults with rheumatoid arthritis to a standard care wait-list condition. in addition to effects on function and pain, this study will explore intervention effects on disease activity, immune response, hrqol, functionality, and mood. results will shed light on the feasibility and potential efficacy of a novel intervention (iyengar yoga) for rheumatoid arthritis symptoms. the hypotheses are: 1. the iyp will be safe, acceptable and feasible: at least 80% of subjects will complete the iyp. 2. following the iyp, participants will show significantly improved disease status, general functioning, arthritis-functioning and hrqol relative to controls. the benefits will be apparent post-treatment and at two-month follow-up. 3. following the iyp, participants will report significantly improved pain, immune response and mood compared to controls. these improvements will be evident at both post-treatment and at two-month follow-up.


Eligibility criteria:
inclusion criteria: * people with rheumatoid arthritis between the ages of 16-35 * diagnosis of ra, according to the revised 1987 acr criteria, or juvenile idiopathic arthritis (jia) for at least 6 months * concomitant use of disease modifying antirheumatic medications (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etc) biologic agents (infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra) is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial * concomitant use of non-steroidal anti-inflammatory drugs (nsaids) and low dose corticosteroids (e.g prednisone at doses of 10 /day prednisone or equivalent is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial * disease activity, as defined using a 28 joint count by \> 5 tender joints, \> 5 swollen joints, and one of the following: esr \> 28 mm/hour, crp \> 1.5 mg/dl, duration of a.m. stiffness \> 45 minutes * ability to provide written informed consent * ability to speak and understand english exclusion criteria: * intra-articular steroid injections within 4 weeks of screening * treatment with any investigational agent within 8 weeks of screening or 5 half-lives of the investigational drug (whichever is longer) * history of drug, alcohol, or chemical abuse within 6 months prior to screening * any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that might affect the interpretation of the results or render the patient at high risk from treatment complications * inability to comply with study and follow-up procedures * currently pregnant * inability to speak or understand english * any recent injury.

Keywords: rheumatoid arthritis yoga adolescents young adults
treatment of ige associated eczema with omega-3 long chain polyunsaturated fatty acids in infancy and the development of bronchial asthma in childhood

Conditions: Food Allergy; Eczema; Sensitisation

Summary: although some causal factors in allergy development such as allergen exposure and environmental pollution have decreased during recent years, the incidence of the allergic diseases has increased in the western world. since the genetic predisposition to develop allergies cannot change in such a short time it is conceivable that, instead of the emerging of some new and unknown risk factors, some protective factors seem to have disappeared in the western world. allergic disease is a tendency to develop allergies to allergens in the surrounding environment. the most common symptoms are eczema and food allergy in the early life, bronchial asthma (ab) later in childhood and allergic rhino conjunctivitis (arc) during school age and adolescence, the so-called allergic march. some person may develop only one, but others some or all of the symptoms. inheritance, environment and allergen exposure are important factors affecting this march but there are important factors that predict later development of diseases. sensitization to egg (positive skin prick test or specific ige to egg in the serum) combined with skin problems in infancy predispose strongly to the development of allergic asthma in later life. the purpose of this work is to supply children with early development of ige associated eczema and food allergy with omega-3 lcpufa before the age of 12 months and assess the effect of the supplementation on the future development of skin symptoms, food allergy, sensitisation against inhalant allergens and asthma in these children. we will also assess immunological markers of th2-skewed immunity in relation to clinical effect of the supplementation. families with children younger than 12 months referred to the paediatric department at linköping university hospital, motala, norrköping and jönköping hospitals in the south east of sweden, with the diagnosis ige associated eczema and sensitised against food allergens (egg, milk, wheat and/or soya) will be invited to participate in this study. clinical examination by a paediatrician and assessment of disease severity with scorad will be performed by a research nurse at inclusion. the children will be assessed every six months by a nurse until 2.5 years of age and by a paediatrician at 3 years of age. later clinical assessment will be performed yearly until age 7.


Eligibility criteria:
inclusion criteria: * eczema and sensitisation to food allergens exclusion criteria: * fish allergy within family

Keywords: food allergy eczema sensitisation omega-3 long chain polyunsaturated fatty acids prevention asthma
validation of a novel simplified head up tilt test (hutt) protocol versus the conventional protocol

Conditions: Syncope; Syncope;Heat Induced

Summary: the purpose of the study is to compare the positivity rate associated with a novel simplified tilt-table (tt) test protocol versus the conventional tt protocol

all patients with unexplained syncope at initial evaluation with indication to perform a head up tilt test (hutt) will be randomized to "conventional" hutt protocol or "fast" hutt protocol characterized by a stabilization phase of 5 min in the supine position; a passive phase of 10 min at a tilt angle of 60 degrees; a provocation phase of further 10 min after 300 micrograms ntg sublingual spray. the novel simplified "fast" hutt protocol has been designed to provide non inferior positivity rates as compared with the conventional protocol in the selected population.

Eligibility criteria:
inclusion criteria: * all patients with unexplained syncope at initial evaluation and indication to perform hutt exclusion criteria: * no informed consent * pm/icd device recipients