Kornimate/medical-research-clean huggingface dataset:
shifting of intrauterine device and use of the menstrual cup: case-control study

Conditions: Menstrual Cup; Intrauterine Device Migration

Summary: in france, 26% of women of childbearing age use an intrauterine device (iud) containing copper or levonorgestrel as a method of contraception. failures of iud contraception are mainly due to shifting or expulsion of the iud. the risk factors for expulsion of iuds most often found in the literature are young age (\<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper iud rather than a levonorgestrel iud , a history of iud expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis). more and more women are turning to menstrual cups (mcs) as a means of periodic protection. but the use of mc has also been mentioned as a risk factor for iud expulsion (via a suction effect). in may 2013, reports of displacement, rupture, or even expulsion of copper iuds in cm users were reported to ansm. however, few studies have examined the risks associated with the concomitant use of an mc and an iud. the data are contradictory and insufficient to provide a clear answer to women. hence the interest in carrying out a larger prospective study to explore the relationship between iud expulsion and the use of mc.


Eligibility criteria:
inclusion criteria: * patient aged 18 or over * consultant for one of the following reasons: * iud control * iud expulsion * pregnancy on iud * other reason that required an ultrasound for the iud * consent to participate in the study exclusion criteria: * patient benefiting from a legal protection measure
evaluating pressures during non-invasive ventilation utilizing niv plus software

Conditions: Respiratory Distress Syndrome, Newborn; Apnea of Newborn

Summary: in the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (niv) have vastly improved. despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal niv. current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. recently, medtronic pb980 ventilators feature niv plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. in the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving niv admitted to nicu


Eligibility criteria:
inclusion criteria: * gestation age of 23-41 weeks * born at lac+usc medical center and admitted to nicu * received nippv or nasal cpap exclusion criteria: * infants with any congenital anomalies * infants receiving only comfort care measures. * infants receiving invasive mode of mechanical ventilation (intubated) * non-inborn neonates * re-admissions to the nicu
a comparison of dapsone and trimethoprim-sulfamethoxazole in the treatment of pneumocystis carinii pneumonia (pcp) in patients with aids

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first episode of pneumocystis carinii pneumonia (pcp) in aids patients. compare the rates and severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (tmp / purposex). establish relative toxicities with regard to suitability for outpatient treatment.


Eligibility criteria:
exclusion criteria concurrent medication: excluded: * requirement for other medications found to be effective in the treatment of pneumocystis carinii pneumonia (pcp) (i.e., dfmo, pyrimethamine, and sulfadiazine). patients with the following are excluded: * history of allergic reaction to dapsone. * requirement for other medications found to be effective in the treatment of pneumocystis carinii pneumonia (pcp) (i.e., dfmo, pyrimethamine, and sulfadiazine). * patients subsequently found to be glucose-6-phosphate dehydrogenase (g6pd) positive will be withdrawn from the study and treated with another regimen. prior medication: excluded: * requirement for other medications found to be effective in the treatment of pneumocystis carinii pneumonia (pcp) (i.e., dfmo, pyrimethamine, and sulfadiazine). patients who are glucose-6-phosphate dehydrogenase (g6pd) positive will be withdrawn from the study and treated with another regimen. hospitalized patients with first episode of pneumocystis carinii pneumonia (pcp) documented by giemsa or methenamine stain. * patients must: * be willing and able to give informed consent. * be expected to survive 1 week without therapy. * have less than 48 hours of treatment for pneumocystis carinii pneumonia (pcp) for this episode.

Keywords: trimethoprim-sulfamethoxazole combination aids-related opportunistic infections pneumonia, pneumocystis carinii dapsone acquired immunodeficiency syndrome
application of daptomycin in mrsa infected diabetic foot in comparison to vancomycin treatment

Conditions: Diabetic Foot

Summary: objective of the study is to test whether daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (mrsa) in comparison to antibiotic treatment with vancomycin (effective blood-plasma concentration of 15 mg/l). in case of microbiologically confirmed gram-negative co-infection effective antibiotic treatment according to microbiologic analysis will be administered upon medical decision in both therapy groups. the study will be carried out as a randomized, open label study.


Eligibility criteria:
inclusion criteria: * type 1 and type 2 diabetes mellitus * mrsa infected foot ulcus wagner 1-2 without primary surgical intervention * therapy duration will last at least more than 5 days * men and women age 18 - 80 years * declaration of patient's consent * ability and willingness to give written informed consent and to comply with the requirements of the study * sexually active females, unless surgically sterile, must be willing to use 2 forms of contraception through the end of the study. sexually active woman must, except if they were surgically sterilized, have to use for already 30 days before first dose of study medication an effective method of pregnancy prevention. acceptable forms of contraception for female subjects include: oral, transdermal, injectable or implanted contraceptives, intrauterine device (iud), female condom, diaphragm with spermicide, cervical cap, absolute waiver of sexual intercourse, use of a condom by the sexual partner, or sterile sexual partner. male subjects with partners of child-bearing potential should use barrier contraception in addition to having their partners use another method of contraception. exclusion criteria: * osteomyelitis according to international consensus guideline (3 of 5 criteria apply for diagnosis) * presence of a severe nephropathy (creatinine clearance \< 30 ml/min) * advanced diabetic retinopathy * simultaneous participation in another study or participation in a study in the past 30 days * non permissible concomitant medication e.g. therapy regimen using several antibiotics * contraindication for antibiotics * dialysis essential * pregnancy (to be determined by pregnancy test) or unsafe contraception * neutropenia * immunosuppression (oral immunosuppressives, corticoids exaggerating 7.5 mg prednisolon-equivalents) * chronic liver disease (ast or alt increased to 10fold, bilirubin increased to threefold compared to normal values)

Keywords: diabetic foot,mrsa, complicated skin and skin structure infections antimicrobial therapy daptomycin
challenge!, a health promotion/ obesity prevention program for teens

Conditions: Overweight

Summary: the purpose of challenge! is to determine if adolescents enrolled in a health promotion/ obesity prevention program will have a healthier bmi-for-age z-score and body composition (body fat %), will consume a healthier diet, and engage in higher levels of physical activity compared to those that did not receive the intervention over time.

pediatric overweight is a major public health problem in the us, with the prevalence of overweight among children of all ages increasing dramatically over the past several decades. interventions aimed at reducing the increased weight gain during adolescence have produced mixed results. challenge! is a randomized controlled trial for health promotion/ obesity prevention targeting low-income, urban, african american adolescents. healthy adolescents were recruited from an urban medical center and from local middle schools. weight status was not part of the inclusion criteria. the intervention was home- and community-based and delivered one-on-one to each adolescent by a college-age "personal trainer". the intervention focused on goal-setting, consuming a healthy diet (increase fruits, vegetables, and water, and decrease high-fat snack and convenience foods), and increasing physical activity. we hypothesized that the teens enrolled in the intervention would have a healthier bmi-for-age z-score and a healthier body composition (body fat %) compared to those that did not receive the intervention over time. additionally, we hypothesized that those enrolled in the intervention would consume healthier diets and have higher levels of physical activity compared to those that did not receive the intervention over time.

Eligibility criteria:
inclusion criteria: * ages 11-16, willing to participate in a randomized controlled trial for health promotion exclusion criteria: * outside of age range

Keywords: pediatric obesity african american adolescents intervention home-based community-based
powered surgical stapler in vats lung resection procedures in china

Conditions: Non-small Cell Lung Cancer

Summary: this prospective, single-arm multi-center study will provide clinical data in an observational setting using the echelon flex™ 45 and 60 powered endopath® stapler articulating endoscopic linear cutters (study endocutter). individuals undergoing vats lobectomy for suspected or confirmed non small cell lung cancer (nsclc), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc), and who meet study entry criteria, may be enrolled. study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.


Eligibility criteria:
inclusion criteria: 1. suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc); 2. scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; 3. performance status 0-1 (eastern cooperative oncology group classification); 4. asa score \< 3; 5. no prior history of vats or open lung surgery; 6. willing to give consent and comply with study-related evaluation and treatment schedule; and 7. at least 18 years of age. exclusion criteria: subjects satisfying the following criteria will be eligible for participation in this study: 1. suspected or confirmed of nsclc (up to and including stage ii), or individuals undergoing vats diagnostic wedge resection in accordance with their institution's standard of care (soc); 2. scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung; 3. performance status 0-1 (eastern cooperative oncology group classification); 4. asa score \< 3; 5. no prior history of vats or open lung surgery; 6. willing to give consent and comply with study-related evaluation and treatment schedule; and 7. at least 18 years of age.
kap asynchrony survey

Conditions: Respiratory Insufficiency; Ventilation Therapy; Complications; Ventilators, Mechanical; Respiration, Artificial

Summary: the investigators developed a web-based survey to assess knowledge, attitudes and practice of health care professionals about patient-ventilator asynchrony.

the investigators developed a survey, consisting of 25 multiple choice questions, and including snapshots of mechanical ventilator waveforms to assess the knowledge, attitudes and practice of physicians, nurses and respiratory therapists working in the icu and caring for patients under mechanical ventilator about patient-ventilator asynchrony. the survey is web-based and will be sent for health professionals working in the icu of the participating centers. all data will be treated anonymously with the intent of identifying knowledge gaps and inadequate practice that could be remediated by continuous medical education initiatives

Eligibility criteria:
inclusion criteria: * current working in the icu as a physician, nurse or respiratory therapist exclusion criteria: * refusal to sign informed consent * incomplete survey (less than 80% of the questions answered)
protein kinase c (pkc) inhibitor-diabetic retinopathy phase 3 study

Conditions: Diabetic Retinopathy

Summary: this study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * 18 years or older * meet specific requirements for diabetic retinopathy * free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema * hemoglobin a1c (hba1c) ≤13.0% exclusion criteria: * history of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina * investigators, site personnel directly affiliated with the study and their families * presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss * presence of medical disorder, cancer, or elevated laboratory measurements that could represent a safety risk during the study * women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control
sargramostim in treating patients with kidney cancer that has spread to the lung

Conditions: Kidney Cancer; Metastatic Cancer

Summary: rationale: colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may be an effective treatment for patients with kidney cancer that has spread to the lung. purpose: phase ii trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung.

objectives: * determine the 4-month progression-free survival rate and overall survival rate in patients with metastatic renal cell carcinoma to the lung treated with aerosolized sargramostim (gm-csf). * determine the toxicity of this regimen in these patients. * determine the immunomodulatory effects of this regimen in terms of natural killer cells cytotoxicity, and t-cell, b-cell, and dendritic cell activation markers. outline: this is a multicenter study. patients receive aerosolized sargramostim (gm-csf) by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21. treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity. patients are followed for disease progression and then every 3 months thereafter. projected accrual: a total of 21-48 patients will be accrued for this study within 7-20 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic renal cell carcinoma for which no known standard therapy that is potentially curative or capable of extending life expectancy exists (e.g., surgery) * measurable metastatic disease in the lung * at least one unidimensionally measurable lesion at least 20 mm by conventional techniques * no cns metastases that require treatment patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 12 weeks hematopoietic * absolute neutrophil count at least 1,000/mm\^3 * platelet count at least 75,000/mm\^3 * hemoglobin greater than 8.0 g/dl hepatic * bilirubin no greater than 2 times upper limit of normal (uln) * ast no greater than 3 times uln renal * creatinine no greater than 2.5 times uln pulmonary * no hemoptysis of grade 3 or greater * no reactive airway disease on active therapy other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no uncontrolled infection * no other metastatic malignancy within the past 3 years except basal cell skin cancer prior concurrent therapy: biologic therapy * more than 2 weeks since prior immunotherapy * more than 2 weeks since other prior biologic therapy chemotherapy * more than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) endocrine therapy * more than 2 weeks since prior corticosteroids * no concurrent systemic glucocorticoids radiotherapy * more than 2 weeks since prior radiotherapy * no prior radiotherapy to more than 10% of total lung volume in the radiation field other * at least 4 weeks since prior bronchodialators * no concurrent immunosuppressive agents

Keywords: stage iv renal cell cancer recurrent renal cell cancer lung metastases
comparison of two dual therapies in the first-line treatment of helicobacter pylori infection （share2301）

Conditions: Helicobacter Pylori Infection

Summary: helicobacter pylori (h. pylori) infection is a common global infectious disease of the gastrointestinal tract. helicobacter pylori eradication can effectively prevent the development of stomach cancer. progressive application of dual therapy for the eradication of helicobacter pylori. tegoprazan, a potassium-competitive acid blockers. the efficacy of p-cab agents represented by vonoprazan in h. pylori eradication therapy has been widely verified.

in 1989, it was suggested that amoxicillin combined with ppi could eradicate hp infection, and in 2015, a prospective, multicenter, randomized controlled study in taiwan with a large sample showed that the eradication rate of hp could reach 96.6% with dual therapy for primary treatment of hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. in 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. in terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating h. pylori. tegoprazan, a potassium-competitive acid blockers (p-cab), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing ppi and the low mucosal healing rate due to insufficient acid suppression. the efficacy of p-cab agents represented by vonoprazan in h. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the state drug administration for the new indication of eradication of h. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.

Eligibility criteria:
inclusion criteria: * helicobacter pylori infection (either positive for histopathological test, rapid urease test, or c13/c14 urea breath test). * patients who have not previously received helicobacter pylori eradication therapy. exclusion criteria: * serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%). * those who are not willing to take contraceptive measures during pregnancy, lactation or the trial. * active gastrointestinal bleeding. * history of drug allergy. * history of upper gastrointestinal surgery. * medication history of bismuth, antibiotics and ppi within 4 weeks. * other behaviors that may increase the risk, such as alcohol and drug abuse. * unable or unwilling to provide informed consent.
proof of concept study of oc000459 in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: this will be a randomised, double blind, placebo controlled, parallel group evaluation of the effect of oc000459 given orally for eight weeks on active eosinophilic esophagitis.


Eligibility criteria:
inclusion criteria: * previously diagnosed and symptomatic isolated eosinophilic esophagitis. * relevant eosinophil tissue inflammation as demonstrated by a mean eosinophil load \>= 20 eos/hpf in 8 biopsies at the baseline visit. * able to swallow placebo medication successfully under supervision in the clinic * free of all medications for eoe (including topical steroids) for at least 2 weeks prior to baseline and free of systemic steroids for at least 90 days before screening. a proton-pump inhibitor is allowed if required for treatment of secondary acid reflux. exclusion criteria: * other causes of esophagitis (gerd, peptic ulceration, infection etc.) * other causes of eosphagaeal or generalized eosinophilia (i.e. hypereosinophilic syndromes, parasitic infection, gerd) * the patient's eoe is dependant on the level of seasonal allergens and the patient's participation in the study will occur during the allergy season. * history of abnormal gastric or duodenal eosinophilia (e.g. hes, churg strauss vasculitis, eg or a parasitic infection) * receipt of forbidden prescribed or over the counter medication within the 4 weeks prior to the baseline visit and for the duration of the trial, including vitamins and herbal remedies.

Keywords: eoe
a study of zasocitinib in adults with psoriatic arthritis who have not taken biologic medicines

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (pso). the main aim of the study is to know how well zasocitinib (tak-279) works in participants with active psa who have not previously been treated with biologic disease-modifying antirheumatic drugs. the participants will be treated with either zasocitinib, active comparator, or placebo. participants will be in the study for up to 60 weeks.


Eligibility criteria:
inclusion criteria: age: 1. the participant is aged 18 years or older at the time of signing the informed consent form (icf). in south korea, the age requirement for adult participants is \>=19 years of age. disease characteristics: 2. the participant has had signs and symptoms consistent with psa for at least 3 months. 3. the participant meets the classification criteria for psoriatic arthritis (caspar criteria). 4. the participant has active arthritis as shown by a minimum of \>=3 tender joints in tjc68 and \>=3 swollen joints in sjc66 at the screening and baseline (day 1) visits. 5. the participant has at least 1 active lesion of plaque pso \>=2 cm in diameter, or any nail or nail bed changes characteristic of pso. medications for psa: 6. the participant has had at least one of the following: 1. inadequate response to a nonsteroidal anti-inflammatory drug (nsaid), or 2. inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csdmard). exclusion criteria: psa and pso: 1. the participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, lyme disease, gout, or fibromyalgia. 2. the participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque pso (erythrodermic, pustular, predominately guttate pso, inverse, or drug-induced pso).

Keywords: drug therapy latitude research program latitude psa latitude psa-3001