Kornimate/medical-research-clean huggingface dataset:
safety extension trial of inhaled molgramostim in autoimmune pulmonary alveolar proteinosis

Conditions: Autoimmune Pulmonary Alveolar Proteinosis

Summary: sav006-03 is an open-label extension study for participants who had completed the impala study. at the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; gm-csf) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment. participants will be treated with inhaled molgramostim for up to 36 months. during the trial, whole lung lavage will be applied as rescue therapy.


Eligibility criteria:
inclusion criteria: * completer of the impala trial. * females who have been post menopausal for \>1 year, or females of child-bearing potential who are not pregnant or lactating and are using acceptable contraceptive methods. * males agreeing to use using acceptable contraceptive methods. * willing and able to provide signed informed consent. exclusion criteria: * treatment with gm-csf products other than molgramostim nebuliser solution within three months of baseline. * treatment with any investigational medicinal product other than inhaled molgramostim within four weeks of baseline. * history of allergic reactions to gm-csf. * connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone. * previous experience of severe and unexplained side effects during aerosol delivery of any kind of medicinal product. * history of, or present, myeloproliferative disease or leukaemia. * apparent pre-existing concurrent pulmonary fibrosis. * any other serious medical condition which in the opinion of the investigator would make the subject unsuitable for the trial.
the effect of olive oil and centaury oil on rash

Conditions: Diaper Dermatitis

Summary: diaper dermatitis is a preventable health problem. no study evaluating the efficacy of centaury oil in diaper dermatitis was found in the literature. this study will be conducted to investigate the effect of olive oil and centaury oil in the management of diaper dermatitis.

diaper dermatitis is estimated to have an incidence of between 7% and 35%, although the prevalence cannot be determined precisely because it is not usually seen as a disease by parents and most patients are treated at home. prevention of diaper dermatitis should be the main approach in treatment and care. once it occurs, the aim of treatment is to accelerate the healing of the damaged area and prevent its spread. in the prevention and treatment of diaper dermatitis, practices such as ventilating the baby's diaper, changing the diaper frequently, keeping the area dry, cleaning with appropriate methods, using barrier creams and not tying the diaper tightly have been reported to be beneficial. in the literature, studies using methods such as water, herbal cream (chamomile cream, calendula cream, aloe vera cream), barrier cream (zinc oxide) and herbal mixture (honey, beeswax, olive oil) were found in the treatment of infants with mild to moderate diaper dermatitis. it has been stated that the rates of diaper dermatitis will continue to increase if parents are not given adequate information about appropriate care and which products are beneficial or even harmful. in conclusion, diaper dermatitis is a preventable health problem. no study evaluating the efficacy of olive oil and centaury oil in diaper dermatitis was found in the literature. this study will be conducted to examine the effect of olive oil and centaury oil in the management of diaper dermatitis.

Eligibility criteria:
inclusion criteria: * the baby has mild diaper dermatitis according to the diaper dermatitis severity rating scale * the baby receives antibiotic treatment * the baby gets additional food * the baby is between 6-18 months exclusion criteria: * infants with moderate or severe diaper dermatitis according to the diaper dermatitis severity rating scale * babies with open wounds on the perineum, * babies with any skin disease * babies who use barrier creams or special oils in routine care

Keywords: olive oil centaury oil diaper dermatitis
change in fascial tension in open abdomens

Conditions: Abdominal Wall Defect; Incisional Hernia

Summary: the goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.

for subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. the eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. the natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. this information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. this study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. a tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.

Eligibility criteria:
inclusion criteria: * adult patients with an open abdomen and plan for abdominal re-exploration exclusion criteria: * patients under the age of 18 years * pregnant patients * patients who have no available legally authorized representative to provide consent. * patients with a current hernia * patients with a prior component separation
nurse-led pain education clinical trial in chronic pain patients

Conditions: Pain, Chronic

Summary: chronic pain is a multidimensional problem that consequently requires interventions on multiple levels. pain education by physicians is one of the interventions that shows promising results in patient reported outcomes. it is however unclear if nurse-led chronic pain education could be equally effective on pain attitude and behavior in chronic pain patients. the aim of this clinical trial is to investigate the effects of a nurse-led consultation with chronic pain patients on pain attitude and patient satisfaction compared with regular care without nurse specialist intervention.


Eligibility criteria:
inclusion criteria: * 18 years old * dutch speaking * first time consultation exclusion criteria: * palliative care patients * patients with dementia diagnosis * urgent referral to the pain clinic by other physicians
arthroscopic ankle arthrodesis: measuring post-operative pain to assess the potential for outpatient surgery.

Conditions: Osteoarthritis

Summary: post-operative pain will be measured using a pain diary for one week post-surgery. the purpose is to test the assumption that the arthroscopic technique leads to less post-operative pain and results in shorter hospital stays when compared to the open technique. it is believed that the arthroscopic technique will result in minimal pain when compared to the open technique, allowing this procedure to be performed as day surgery.


Eligibility criteria:
inclusion criteria: * ankle osteoarthritis with adequate bone stock exclusion criteria: * mental or physical inability to consent or answer pain questions, pre-operative or peri-operative morbidity impairing mobility, pre-operative opioid therapy, non-steroidal anti-inflammatory drugs or steroids within 24 hours before skin incision, kidney or liver dysfunction, morbid obesity, smoking, significant bony deformity, significant loss of bone stock or diabetes with sensory changes will be cause for exclusion.

Keywords: ankle arthrodesis pain arthroscopic technique ankle osteoarthritis
pharmacokinetic, safety, tolerability and immunogenicity study of sb4 in healthy male subjects

Conditions: Healthy

Summary: the purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of sb4 and enbrel (eu sourced enbrel and us sourced enbrel) in healthy male subjects.

* part a: comparison between sb4 and eu sourced enbrel * part b: comparison between sb4 and us sourced enbrel * part c: comparison between eu sourced enbrel and us sourced enbrel

Eligibility criteria:
inclusion criteria: * healthy male subjects * have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive. exclusion criteria: * history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference ip formulation or comparable drugs. * active or latent tuberculosis or who have a history of tb. * history of invasive systemic fungal infections or other opportunistic infections * systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process * serious infection associated with hospitalisation and/or which required intravenous antibiotics * history of and/or current cardiac disease * have received live vaccine(s) within 30 days prior to screening or who will require live vaccine(s) between screening and the final study visit. * intake medication with a half-life \> 24 h within 1 month or 10 half-lives of the medication prior to the first administration of ip.

Keywords: pharmacokinetics
fracture and bone mineral density in hiv+ patients recently started on antiretroviral therapy (art)

Conditions: HIV; Osteoporosis

Summary: in a group of hiv-positive patients under observation since their first exposure to art or monitored off of art, bmd changes over one year will be determined. for each subject, the investigators will also determine associations between changes in bmd and 1) art initiation, 2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated through the measurement of interleukin-6 {il-6}, tumor necrosis factor alpha {tnf-a}, high-sensitivity c-reactive protein {hscrp}). hypotheses: bmd will decrease less in persons initiated on art than those monitored off of art, after excluding those subjects treated with tenofovir. bmd will decrease most significantly in hiv-positive subjects with the highest levels of cumulative viremia. hiv-positive persons with highest cumulative viremia will have the highest levels of inflammation, as measured by pro-inflammatory cytokines. additionally, the investigators will evaluate fracture incidence in a 5% national medicare sample and fracture association with the use of varying art medications among dual-eligible persons in medicare and medicaid datasets. hypotheses: fracture incidence will be greater in hiv-positive subjects compared to hiv-negative subjects.fracture incidence will be greatest in subjects with the shortest duration of art exposure.


Eligibility criteria:
inclusion criteria: * treatment naïve patients seen in the 1917 clinic between january 1, 2000 and may 1, 2010 * currently under care at the time of the initiation of the study (\>1 clinic visit in the past 12 months) exclusion criteria: * history of chronic renal failure (estimated gfr \<30ml/min) * known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary hyperparathyroidism, paget disease, osteogenesis imperfecta) * multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease, or persons currently treated with or plans to begin an osteoporosis-specific medication (including estrogen) * treatment with oral glucocorticoids and anticonvulsants

Keywords: hiv bone mineral density bone turnover fracture inflammation
comparison of the efficacy of pharmacology and non-pharmacological treatment in women with primary dysmenorrhea.

Conditions: Pelvic Floor; Exercise; Telerehabilitation; Acupressure; Dysmenorrhea Primary; Drug Effect

Summary: primary dysmenorrhea is a common problem in women. women use many treatment methods to deal with primary dysmenorrhea. therefore, this study aims to find the most effective treatment by determining the effectiveness of conservative and non-conservative treatment in women with primary dysmenorrhea. another aim of the study is to generalize the use of conservative treatment methods in the treatment of primary dysmenorrhea.on the other hand, it aims to spread the telerehabilitation method, which allows the global covid 19 outbreak to be maintained remotely online, in the world and in our country.

this study aims to determine the effects of different treatment approaches in women diagnosed with primary dysmenorrhea. patients who are examined by a physician and diagnosed with primary dysmenorrhea using ultrasonography will be included in the study. the cases will be divided into 5 groups by randomization. in the first group, patients who are prescribed diosmin by the attending physician will be taken. the second group; patients who are prescribed naproxen sodium by the attending physician will be taken. the third group; pelvic floor exercises will be performed 2 days a week and 12 weeks a week using the motor imagination technique created by the women health physiotherapist. in the fourth group, acupressure technique applied by applying pressure to non-invasive acupuncture points will be applied daily for 12 weeks. the fifth group will be the control group. online access will be synchronized with the phone or computer, and training sessions will not be recorded to protect the patient's personal information. cases will be evaluated online at the beginning of the study and at the end of the 12-week program.

Eligibility criteria:
inclusion criteria: * over the age of 18 whose menstrual cycle continues, * primary dysmenorrhea was diagnosed by the obstetrician by ultrasonographic evaluation. * participants who agree to participate in the study will be included. * participants in the diosmin group who were prescribed diosmin by the physician * participants in the nsai group who were prescribed an nsai by the physician exclusion criteria: * receiving hormone therapy * those receiving psychiatric treatment for stress disorder or anxiety * intrauterine contraceptive device * using birth control pills * women diagnosed with secondary dysmenorrhea * with neurological deficits * patients who were not suitable for nsai and diosmin treatment by the physician were excluded by the physician and were not included in our study.

Keywords: pelvic floor dysmenorrhea primary drug therapy telerehabilitation acupressure
study of subcutaneous rehydration with recombinant human hyaluronidase for infants and children

Conditions: Dehydration

Summary: the aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (sc) rehydration using hylenex-augmented sc infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

pediatric patients (2 months to 10 years of age), presenting to the emergency department (ed) with mild to moderate dehydration and requiring parenteral rehydration, were treated with hylenex-augmented subcutaneous (sc) rehydration. an initial volume of 20 ml/kg of isotonic fluid was to be administered by continuous sc infusion over the first hour, and additional sc rehydration could be continued as clinically indicated. the preferred anatomic site for the sc infusion was the anterior thigh, unless there was an overriding preference for an alternate site. the duration of hylenex-augmented sc rehydration was to be a minimum of 1 hour and a maximum of 72 hours. the investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of sc infusion or at discharge from the ed. other assessments of effectiveness and safety were made directly during the rehydration period and ed stay, and by telephone on days 3 and 7 after discharge from the ed.

Eligibility criteria:
inclusion criteria: * child, 2 months to 10 years of age * body weight less than 42 kg * presenting at emergency department with mild to moderate dehydration (gorelick dehydration classification: presence of 1 to 6 \[of possible 10\] moderate or severe signs and symptoms) requiring parenteral rehydration exclusion criteria: * in shock or life-threatening situation (other than dehydration) * severe dehydration * requires intravenous (iv) therapy for another indication * indwelling iv catheter (excepting one intended strictly for clinical laboratory sample collection) * already received rehydration therapy iv within prior 48 hours or substantial oral fluid immediately before enrollment * condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site * reason for hospital admission or extended emergency department stay other than dehydration * known hypersensitivity to hyaluronidase or another ingredient in hylenex * hyponatremia or hypernatremia * hypokalemia * medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments * medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results * participated in study of any investigational drug or device within 30 days prior to this study

Keywords: dehydration fluid therapy pediatrics emergency medicine hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rhuph20
passive stretching in peripheral arterial disease patients

Conditions: Peripheral Arterial Disease; Walking, Difficulty; Inflammation

Summary: peripheral artery disease (pad) leads to higher mortality rates and strains healthcare systems due to increased costs. it causes leg pain during walking due to reduced blood flow. nitric oxide (no) deficiency contributes to vascular issues in pad, with few effective treatments available. passive calf muscle stretching boosts no levels, vascular health, and walking ability in pad patients. however, the inflammatory processes underlying these improvements are unclear. this study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. the study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in pad patients. this research is crucial for improving physical function and addressing exercise intolerance in pad.


Eligibility criteria:
inclusion criteria: ankle-brachial index of 0.90 or less stable condition for at least 3 months exclusion criteria: habitual exercise or cardiovascular rehabilitation program during the past 3 months critical limb ischemia, amputation, or leg pain at rest major surgery or lower extremity revascularization in the last 3 months heart failure kidney disease beet allergy crohn's current smoker

Keywords: cardiovascular
prostate mechanical imager (pmi) clinical bridging study

Conditions: Prostatic Neoplasms; Prostatic Hyperplasia

Summary: the purpose of this study is to evaluate an imaging capability prostate mechanical imager (pmi), a pc-based device utilizing a transrectal probe with pressure sensor arrays and motion tracking system, aimed at providing composite elasticity images of the prostate.

the clinical application of a prostate mechanical imaging (pmi) technique for prostate assessment is examined in this study. pmi technology is based on the visualization of internal structures and dimensions of the prostate by measuring mechanical stress patterns on the gland surface with pressure sensor arrays. temporal and spatial changes in the stress pattern provide information on the hardness of the prostate. projected patient sample size for the study is 40 men over the age of 21. patients will be selected for the study if both of the following criteria are met: (1) abnormal dre findings; and (2) patients who are scheduled for a trus-guided prostate biopsy and/ or radical prostatectomy due to an abnormal dre, and/or increased psa, and/or other clinical indications. the study is designed to assess the imaging capability of the pmi in three clinical sites, performed by four physicians. each clinical investigator will perform pmi examination on 10 respective patients with dre detected abnormality. pathology data will be collected from trus-guided biopsy or radical prostatectomy and will be used as reference data in case there is a discrepancy between the dre findings and pmi images. study hypothesis: proportion of patients with pmi reconstructed image is anticipated to be consistent with the 84% imaging capability demonstrated in the previous clinical study conducted with the prior version of the pmi device.

Eligibility criteria:
inclusion criteria: * all racial and ethnic groups, * males 21 years of age or older, * able to withstand body positioning for the entire length of examination, * presence of dre detected abnormality, * scheduled for trus-biopsy or surgical removal or prostate, * able to comprehend, sign, and date the written informed consent form (icf) exclusion criteria: * previous pelvic surgery, * significant hip and / vertebral arthritis, * rectal crohn's disease, * locally disseminated cancer of pelvic structure, * anal fissure, anal fistula, infected anal fistula, * anal cancer, * rectal cancer, * 1st, 2nd or 3rd degree hemorrhoids, * pelvic irradiation, * dehydrated impacted stool, * no vulnerable patients such as students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity will be included in the study
celecoxib in colposcopic directed biopsy

Conditions: Colposcopy

Summary: women often experience pain and discomfort during colposcopic examination especially at time of colposcopic directed excisional biopsy, pre-procedure anxiety, women pain threshold may also increase pain, woman's cooperation during the procedure is affected by all these factors, which also may hinder the colposcopist from obtaining adequate data and biopsies. several pharmacological and non-pharmacological methods have been studied to reduce pain associated colposcopic directed biopsy (cdb). we aim to study the effect of celecoxib to reduce pain associated with cdb.


Eligibility criteria:
inclusion criteria: • females 18-65 years old who undergoing colposcopic directed biopsy exclusion criteria: * a known allergy to celecoxib, aspirin or another nsaid. * active peptic ulceration or gastrointestinal bleeding. * inflammatory bowel disease. * congestive heart failure (nyha ii-iv). * established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. * history of neurologic deficit. * known hepatic or renal impairment. * pregnancy. * breast-feeding. * post-hysterectomy. * bleeding disorders. * drug abuse. * cervical and vaginal infection.

Keywords: colposcopy - colposcopic directed biopsy - celecoxib