Kornimate/medical-research-clean huggingface dataset:
soiled airway tracheal intubation and the effectiveness of decontamination by paramedics

Conditions: Airway Management; Intubation, Intratracheal; Laryngoscopy; Vomiting

Summary: in more than one-in-five cases of out-of-hospital cardiac arrest, airways are blocked by vomit and blood. sometimes, paramedics cannot clear the airway using methods they have been taught. if the airway cannot be cleared, the patient will die. usually, these patients will have a breathing tube placed into their windpipe (intubation), as this provides protection from vomit and blood. to do this, the paramedic needs to be able to see the entrance to the windpipe. a new method of clearing the airway called salad has been used in patients to help insert a breathing tube, but it is not known whether the method can help paramedics. this study will use a manikin to see if paramedics can insert a breathing tube more often on their first attempt, using salad.


Eligibility criteria:
inclusion criteria: * aged 18 and over * hcpc registered paramedic employed by yorkshire ambulance service * authorised to intubate within yorkshire ambulance service * no salad training in the last 3 months exclusion criteria: * not an hcpc registered paramedic employed by yorkshire ambulance service * not authorised to intubate within yorkshire ambulance service * allergy to artificial 'vomit' ingredients * unwilling to provide consent * salad training in the last 3 months
evolution of pulmonary capillary blood volume

Conditions: Pulmonary Embolism

Summary: the purpose of this monocentric, preliminary study is to assess the evolution of pulmonary capillary blood volume (vc), measured by the double diffusion nitric oxide/carbon monoxide (no/co) method (guenard et al.; respir physiol 1987), from the starting of the anticoagulant therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (bnp; troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data.


Eligibility criteria:
inclusion criteria: * patient with a first episode of symptomatic pulmonary embolism, treated with anticoagulant * age from 18 to 75 years-old exclusion criteria: * confirmed pulmonary embolism in the past * massive pulmonary embolism, thrombolytic treatment * confirmed left heart systolic dysfunction * confirmed asthma, chronic obstructive pulmonary disease or pulmonary fibrosis * expected life below 6 months * pleural effusion with indication of evacuation * bronchopulmonary cancer * pulmonary surgery with resection of two lobes minimum * predictable incapacity to complete the 6 minutes walking test

Keywords: pulmonary embolism pulmonary capillary blood volume double diffusion no/co method
combined rituximab and lenalidomide treatment for untreated patients with follicular lymphoma

Conditions: Follicular Lymphoma

Summary: the purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the follicular lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for follicular lymphoma.

follicular lymphoma (fl) is a cancer of a b lymphocyte, a type of white blood cell. fl is typically a slowly progressing but incurable disease. follicular lymphoma cells produce a specific defect in the patient's immune system impairing their ability to control their cancer. lenalidomide has been shown to reverse the specific immune defect caused by fl in the patient. by including lenalidomide, the relevance study aims to eliminate the cancer while restoring the patient's immune competence. the 'relevance' cooperative group trial is being conducted as two companion studies: rv-fol-gelarc-0683 (n=750) and rv-fol-gelarc-0683c (n=250); the combined total of 1000 follicular lymphoma patients enrolled in both studies will be analyzed.

Eligibility criteria:
inclusion criteria: * histologically confirmed follicular lymphoma grade 1, 2 or 3a, stage ii-iv * have no prior systemic treatment for lymphoma * symptomatic follicular lymphoma requiring treatment. * age ≥18 years * eastern cooperative oncology group performance status 0-2 * willing to follow pregnancy precautions exclusion criteria: * clinical evidence of transformed lymphoma or grade 3b follicular lymphoma. * major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent. * known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv) * known sensitivity or allergy to murine products. * presence or history of central nervous system involvement by lymphoma * at high risk for a venous thromboembolic event (vte) and not willing to take vte prophylaxis * any of the following laboratory abnormalities: * serum aspartate transaminase or alanine transaminase \> 3x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma * total bilirubin \> 2.0 mg/dl (34 µmol/l) except in cases of gilberts syndrome and documented liver or pancreatic involvement by lymphoma * creatinine clearance of \< 30 ml/min

Keywords: follicular lymphoma non-hodgkins follicular lymphoma treatment for follicular lymphoma rituximab treatment rituximab and lenalidomide treatment
the safety and effectiveness of indinavir sulfate plus efavirenz

Conditions: HIV Infections

Summary: to estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with dmp 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose dmp 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, hiv-1 seropositive patients. it is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that: 1. the observed proportion of patients with serum viral rna \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks. 2. the safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and cns-related symptoms) and will continue to be so after 48 weeks. 3. the two groups will be similar with respect to changes from baseline in serum viral rna and cd4 counts and will continue to be so after 48 weeks.

it is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that: 1. the observed proportion of patients with serum viral rna \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks. 2. the safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and cns-related symptoms) and will continue to be so after 48 weeks. 3. the two groups will be similar with respect to changes from baseline in serum viral rna and cd4 counts and will continue to be so after 48 weeks. patients are randomized to one of two regimens: a control regimen of indinavir plus dmp 266 or an experimental regimen of indinavir plus dmp 266, each at different doses than in the control regimen.

Eligibility criteria:
inclusion criteria patients must have: * hiv-1 seropositive status. * cd4 count \>= 100 cells/mm3. * serum viral rna levels \>= 10,000 copies/ml. exclusion criteria prior medication: excluded: * prior protease inhibitor therapy. * prior non-nucleoside reverse transcriptase inhibitor therapy.

Keywords: acquired immunodeficiency syndrome drug administration schedule hiv protease inhibitors indinavir reverse transcriptase inhibitors anti-hiv agents efavirenz
safety, tolerability, pharmacokinetics and pharmacodynamics of single dose cfz533 in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and subcutaneous doses of cfz533 in healthy subjects and intravenous doses in rheumatoid arthritis patients.

this was a healthy volunteer only study originally, but after an amendment to protocol, rheumatoid arthritis patients will be starting 7-mar-2014 and thus, the protocol is now registered.

Eligibility criteria:
inclusion criteria (for healthy volunteers): 1. healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age (for cohort 9 only, subjects must be of chinese descent) 2. vital signs (systolic and diastolic blood pressure and pulse rate) should be within normal limits 3. weight 50-150 kg and a body mass index (bmi) 18-32 kg/m2 inclusion criteria (for rheumatoid arthritis patients): 1. healthy male and surgically sterilized or post-menopausal female subjects 18 to 55 years of age 2. fulfilled 2010 acr/eular classification criteria for ra per investigator 3. treatment with a stable oral ra treatment regimen for ≥ 4 weeks before randomization 4. systemic corticosteroids allowed if on a stable dose (≤ 10 mg/day of prednisone or equivalent) ≥ 4 weeks prior to randomization 5. subjects taking nsaids (cox-1 or cox-2 inhibitors) as part of their ra therapy must be on a stable dose for at least 4 weeks before randomization exclusion criteria (for healthy volunteers): 1. history of hypersensitivity to vaccines, the study drug, or to drugs of similar chemical classes (i.e., biologic agents) 2. abnormal hematology, coagulation or inflammatory lab results 3. history or evidence of tuberculosis. exclusion criteria (for rheumatoid arthritis patients): 1. use of anti-tnf or other biologics in previous 3 months 2. any intra-articular injection therapy (e.g., corticosteroid, hyaluronan) required for treatment of acute ra flare within 4 weeks before randomization 3. previous treatment with a b cell-depleting biologic agent or any other immunomodulatory biologic agent within 5 half-lives (experimental or approved) 4. current treatment with cyclophosphamide 5. autoimmune disease other than ra 6. adult juvenile rheumatoid arthritis 7. ra functional status class iv according to the acr 1991 revised criteria other protocol-defined inclusion/exclusion criteria may apply

Keywords: rheumatoid arthritis, ra, first-in-human, single ascending dose, safety, tolerability
growth hormone resistance of beta-cells

Conditions: Gestational Diabetes; Obesity; Healthy

Summary: the purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) at the university of missouri. the aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.


Eligibility criteria:
inclusion criteria: * singleton, full term pregnancy within the past 5 years * hemoglobin hba1c ≤5.6% and fasting blood glucose \<100 mg/dl * body mass index ≥30.0 kg/m2 and \<45.0 kg/m2, because the majority of women with gdm have overweight/obesity group specific inclusion criteria: * gestational diabetes group: history of gestational diabetes in the most recent pregnancy * control group: no history of gestational diabetes exclusion criteria: * pregnant, planning to become pregnant during the study, or breastfeeding * current diagnosis or history of type 1 or type 2 diabetes * use of medications that can impact the study outcomes (e.g., glp-1 receptor agonists) * history of bariatric surgery * known hypothyroidism or use of thyroid medications * history of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as turner syndrome, prader-willi syndrome, or renal impairment * current cancer or cancer that has been in remission less than 5 years * first degree relative with diabetes diagnosis * evidence of significant anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease) * alcohol use disorder, use of controlled substances, or smoking \>2 cigarettes per day * greater than 3% weight loss within three months of screening or engaged in regular (≥3 days per week), continuous moderate- or high-intensity exercise of ≥30 min duration * mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent
omepral® tablets special clinical experience investigation in patients with erosive esophagitis

Conditions: Reflux Esophagitis

Summary: this open label, non-interventional study is to compare the efficacy of omepral® tablet and any other treatments excepting proton pump inhibitors (ppis) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.


Eligibility criteria:
inclusion criteria: * patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy. * patients who answered questionnaires of quality of life (qolrad-j), symptom severity and frequency and treatment satisfaction. * during the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity exclusion criteria: * patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment. * patients who cannot answer questionnaires of quality of life (qolrad-j), symptom severity and frequency and treatment satisfaction. * patients included previously in this study.

Keywords: reflux esophagitis omepral® qolrad
peroperative assessment of malignancies of the head and neck using high-resolution 18f-fdg-pet/ct

Conditions: Head and Neck Neoplasms; Thyroid Neoplasm; Skin Neoplasm

Summary: in this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18f-fdg ((18)f-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. following the resection, the 18f-fdg-infused malignancy will be investigated utilizing a novel high-resolution positron emission tomography (pet) and computed tomography (ct) scan. slicing of the malignancy will be followed by additional pet/ct-scanning and autoradiography of the sliced specimen. the results found during image analysis will be compared to the results of the gold standard of histopathology. as this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.


Eligibility criteria:
inclusion criteria: * patients with one or multiple pathologically proven malignancies in the head and neck region (targeted lesions), independent of origin and stage. * patient is planned for the surgical resection of the targeted lesion. * age ≥ 18 years. * karnofsky performance scale ≥30 * patient has given informed consent according to the international conference on harmonization (ich) good clinical practice (gcp) guidelines in accordance with the declaration of helsinki. exclusion criteria: * patient is planned for a treatment regimen which does not include standard surgical resection of the targeted lesion. * pregnant or actively lactating women. * blood glucose level ≥ 200mg/dl or more on the day of surgery.
point of care susceptibility testing in primary care

Conditions: Urinary Tract Infections

Summary: the purpose of this study is to determine whether point-of-care susceptibility testing improve correct choice of antibiotics, clinical and microbiological outcome in patients with uncomplicated urinary tract infection in general practice compared to point-of-care urine culture.

700-900 patients with symptoms of uncomplicated urinary tract infection, consecutively contacting their gp, randomized to either point of care test (poct) urine culture and empirical treatment or poct urine culture and susceptibility testing and targeted treatment. patients are included until 440 with verified positive cultures are included. the two groups are compared with regard to correct choice of antibiotics, clinical remission and microbiological cure rates.

Eligibility criteria:
inclusion criteria: * female adult patients * 18 years or older * presenting at their gp with dysuria * frequency or urgency, which have been present for 7 days or less and where the gp suspects uncomplicated uti. * patients should be able to deliver a mid-stream urine sample, to provide informed consent and be willing and able to fill out a symptom diary. exclusion criteria: * negative dipstick analysis * complicated urinary tract infection * known pregnancy * severe systemic symptoms, high fever, flank pain * recent bladder surgery (within past 4 weeks) * urinary tract abnormalities * serious systemic disease * life-threatening cancer * insulin dependent diabetes * long-term corticosteroid treatment * other conditions with compromised immunity * former participation in the study * patients presenting on a friday (since the poct must be read after 24 hours)

Keywords: antibiotic resistance point of care tests primary health care
functional brain imaging of pain phenotype and genotype

Conditions: Pain

Summary: this study has two purposes: first, to locate and identify the "brain activation" (the areas of the brain) which respond to pain; and second, to look at how brain activation is influenced by a person's genetics (the traits they inherited from their parents). a magnetic resonance imaging (mri) scanner will be used to gather pictures of the brain (similar to an x-ray, but based on different scientific principles) that will be used to determine which areas are active. the hypothesis is that the variation in brain activity between people can be partially explained by genetic differences. this study consists of an two pain tasks applied during a one time visit to the mri suite. there are no followup visits.


Eligibility criteria:
inclusion criteria: * age 18 to 50 * right-handed * male or female * healthy individuals not taking any medication. exclusion criteria: * pregnancy * diagnosed with any treated or untreated medical or neurological conditions * using any prescription drugs, including antidepressants, pain medications, sedative medications, blood pressure medications, seizure medications, or antipsychotics. oral contraceptives are permitted * using any over-the-counter medications including aspirin, tylenol, or herbal supplements * using any illicit substances * contraindications to magnetic resonance imaging.

Keywords: pain functional magnetic resonance imaging
preventing alcohol misuse and consequences in vulnerable women

Conditions: Alcohol Drinking

Summary: heavy alcohol use is a pressing public health issue that results in more negative consequences for young adult women, despite them drinking at lower rates than their male peers. however, particular groups of women, such as women who identify as lesbian and bisexual (i.e., sexual minority women), evidence markedly higher rates of alcohol misuse as well as negative consequences from this use. sexual minority women are more likely to use alcohol, do so at problematic levels, and to meet criteria for alcohol use disorders than heterosexual women and sexual minority men. despite these disparities, as well as evidence that sexual minority women have unique mechanisms of risk (e.g., minority stress, social context), there are currently no interventions designed to reduce alcohol misuse among sexual minority women. this study represents the first attempt to design an in-person intervention specifically tailored to sexual minority women, which will be accomplished through an intervention mapping framework to identify behavioral determinants of their use (e.g., minority stress and distress; social context) and then map effective behavior change strategies onto these determinants.

this particular study aim is devoted to the piloting of a brief motivational intervention to reduce alcohol misuse and consequences among sexual minority women. the objective of this study aim is to examine the preliminary feasibility and acceptability of the intervention following treatment development and refinement. participants will be randomized to a brief intervention or an attention-matched control arm. participants in both conditions will complete: a baseline survey as well as a follow-up assessment at 1- and 4-months post-intervention. the investigators hypothesize that the developed intervention will be feasible (as indicated by the number of women eligible who consent, attend their intervention session, and return for follow up). the investigators also hypothesize that the intervention will be acceptable to sexual minority women. the investigators will also obtain preliminary evidence of intervention efficacy in terms of alcohol use outcomes. specifically, the investigators hypothesize that participants in the intervention will report less frequent heavy episodic drinking and fewer alcohol consequences post-intervention compared with those in the control group.

Eligibility criteria:
inclusion criteria: * female; * english speaking; * currently reporting heavy drinking; * identifies as a sexual minority woman. exclusion criteria: * unwilling or unable to provide informed consent; * low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them) * women who report intention to move away during study period. * active suicidality.
efficacy of acupuncture combined with moving cupping and ear point tapping for moderate and severe acne vulgaris

Conditions: Acne Vulgaris

Summary: this trial is designed to evaluate the efficacy of different frequencies in treating the moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear point tapping.

background: acne vulgaris is a common skin disease, especially in adolescents and young adults. acne affects approximately 85% of teenagers, but can occur in most age groups and can persist into adulthood. there is no mortality associated with acne, but there is often significant physical and psychological morbidity. acupuncture combined with moving cupping and ear point tapping may effectively relieve the skin lesions, but the evidence is limited. also, young patients usually have no time to see the doctor frequently, thus it's necessary to figure out a better frequency of treating.

Eligibility criteria:
inclusion criteria: * diagnosed as acne vulgaris. * gags score between 19 and 38 points. * age of 15 to 35 years. exclusion criteria: * other types of acne: acne conglobate, acne fulminans，acne medicamentosa, premenstrual acne，cosmetic acne and trade acne. * presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or thyroid diseases, or atypical congenital adrenal hyperplasia；or by any medication prescribed for the treatment of the systemic diseases. -- use of any topical acne treatment or systemic antibiotics or traditional chinese medicine within 2 weeks before study initiation. use of a systemic retinoid within 9 months before study initiation. use of a systemic steroid within 9 months before study initiation. presence of any change in the use of oral contraceptive pills or anti-inflammatory drugs within 3 months before study initiation. * presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea. * presence of severe heart, liver, kidney or hematopoietic system diseases, as well as severe malnutrition. * pregnancy or lactation. * recent use of this research scheme within 4 weeks before study initiation.

Keywords: acne vulgaris acupuncture cupping ear point tapping randomized controlled trial