Kornimate/medical-research-clean huggingface dataset:
study comparing veliparib plus carboplatin and paclitaxel versus placebo plus carboplatin and paclitaxel in previously untreated advanced or metastatic squamous non-small cell lung cancer

Conditions: Squamous Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: 1. life expectancy \> 12 weeks 2. subject must have cytologically or histologically confirmed squamous nsclc. 3. subject must have advanced or metastatic squamous nsclc that is not amenable to surgical resection or radiation with curative intent at time of study screening. 4. subjects with recurrent squamous nsclc after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible. 5. subject must have at least 1 unidimensional measurable nsclc lesion on a computerized tomography (ct) scan as defined by response evaluation criteria in solid tumors (recist - version 1.1). exclusion criteria: 1. subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (cremophor). 2. subject has a known hypersensitivity to platinum compounds. 3. subject has peripheral neuropathy \>= grade 2. 4. subject has non-squamous nsclc, or a known epidermal growth factor receptor (egfr) mutation of exon 19 deletion or l858r mutation in exon 21, or a known anaplastic lymphoma kinase (alk) gene rearrangement. 5. subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for nsclc, except for adjuvant or neoadjuvant therapy.

Keywords: veliparib carboplatin paclitaxel poly adenosine diphosphate (adp)-ribose polymerase (parp) overall survival advanced metastatic abt-888 squamous randomized non-small cell lung cancer placebo controlled
investigation of the effects of different exercise on wound healing in patients wıth diabetic foot wounds

Conditions: Diabetic Foot Ulcer; Wound

Summary: exercise studies with patients with diabetic foot ulcers are very few. in this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. with the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.


Eligibility criteria:
inclusion criteria: * having been diagnosed with type ii diabetes and having a foot ulcer * being in the 1st or 2nd category according to the wagner classification * not to have a serious musculoskeletal, cardiac, neurological, etc. systemic disease that may interfere with the research. * not having any communication problems * having the same wound care procedure * not taking any other treatment that may have an effect on the wound. exclusion criteria: * individuals with a diagnosed psychiatric illness, * individuals who have received any physiotherapy treatment in the last 3 months, * individuals with acute infection, * individuals with toe pressure \< 40 mmhg * individuals with charcot foot and/or osteomyelitis * individuals with venous ulcer disease * individuals who are morbidly obese (bmi \>40) according to body mass index * individuals with incurable proliperative retinopathy

Keywords: diabetes mellitus, exercise, ulcer
tick-borne encephalitis virus research in limousin

Conditions: Tick-borne Encephalitis

Summary: cases of encephalitis of varying severity have been described in recent years in eastern france involving tick-borne encephalitis virus (tbev). the main objective is to demonstrate the presence of tbev in limousin, in patients with a positive lyme serology, or a neurological picture compatible with tbev.

cases of encephalitis of varying severity have been described in recent years in eastern france involving tick-borne encephalitis virus (tbev). the epidemiological situation in france is poorly known with about 20 cases diagnosed per year, mainly in alsace and haute-savoie. the infection can result in fever and an influenza-like picture, which can be complicated by encephalitis-like neurological disorders, or even death. tbev is transmitted by the tick ixodes ricinus, which also carries borrelia burgdorferi, the agent of lyme disease. limousin is one of the french regions with the highest prevalence of lyme disease. these ticks can harbor various pathogens, including tbev. a case was described in 2007 in bordeaux. more recently, a case was described in haute-loire. the investigators are therefore interested today in the emergence of this virus in limousin following a possible progression through the massif central, potentially favored by numerous anti-covid-19 control containments. the study begins with a computer extraction of patients with lyme serology from our glims laboratory software (with positive or negative results), a check for non-oppositions. then the investigators will measure by elisa in microplates the anti-tbev igg as well as the anti-tbev igm on the sera + in tbev igg. the investigators will then send a patient questionnaire with an information note to document the context of this tbev seropositivity and to eliminate false-positivities (vaccination). finally, the investigators will perform pcr on csf if serum positive and csf available, followed by an analysis of results.

Eligibility criteria:
inclusion criteria: * patient with lyme serology. neurological picture compatible with neuroborreliosis or encephalitis. * no objection from the patient to the use of biobank samples exclusion criteria: * patient's opposition.

Keywords: tick-borne encephalitis tbev serology pcr
bioavailability investigations of thyronajod mite tablets of dosage strengths 50 μg levothyrox-ine/75 μg iodine, and 100 μg levothyroxine/75 μg iodine vs. a levothyroxine drinking-solution: a randomised cross over study in healthy male individuals. currently: 100 μg/ 75 μg tablets

Conditions: Pharmacokinetics

Summary: the purpose of this study is to measure the area under the curve (auc0-48h; extent of systemic availability) and the maxi-mum concentrations (cmax) of total serum levothyroxine (tt4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.


Eligibility criteria:
inclusion criteria: * euthyroid men * age: 18 - 50 * normal values for ft4 und tsh * good state of health exclusion criteria: * thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism * history of thyroid function disorders * focal or diffuse autonomies of the thyroid gland * thyroid nodules \>1 ml according to sonographic examination * any acute or chronic illness * dermatitis herpetiformis

Keywords: levothyroxine bioavailability
randomized controlled trial of vaginal progesterone in women with threatened preterm labor

Conditions: Obstetric Labor, Premature

Summary: prematurity remains the most important single factor in perinatal morbidity and mortality. unfortunately, the rate of premature delivery is increasing in canada and is especially high in alberta with 7.5% of pregnancies ending before 37 weeks gestation. despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. progesterone is one candidate treatment. the purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor. pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. if they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. neither the women nor their clinician will know which group they are in. women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment. when the study is complete, the results for the progesterone group will be compared to the placebo group. if progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.


Eligibility criteria:
inclusion criteria: * women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics. * women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive. * gestational age 23(+0)-32(+6) weeks. * consent to taking part in the study. exclusion criteria: * placenta previa * preterm premature rupture of membranes at presentation * pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women * known major fetal anomaly detected on ultrasound * multiple pregnancy * maternal seizure disorder * active or history of thromboembolic disease * maternal liver disease * known or suspected breast malignancy or pathology * known or suspected progesterone-dependent neoplasia * plans to move to another city during pregnancy * previous participation in a progesterone trial during this pregnancy * known sensitivity to progesterone

Keywords: progesterone randomized controlled trial
angioplasty of the tibial arteries augmented radio frequency denervation of the popliteal artery

Conditions: Сhronic Ischemia of the Lower Extremities; Atherosclerosis of the Tibial Arteries; Lesion no More Than Two Tibial Arteries; Steno-occlusive Lesion of the Tibial Arteries

Summary: angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.


Eligibility criteria:
inclusion criteria: * chronic lower limb ischemia 3-6 degree by rutherford; * stenosis or occlusion of no more than 2 tibial arteries; * stenosis of the tibial arteries more than 70 %; * duration stenosis or occlusion no more than 70 mm; exclusion criteria: * diabetes mellitus type 2 * occlusion or stenosis of all tibial arteries * expressed calcification of tibial arteries angioplasty tolerant * hemodynamically significant stenosis of the popliteal artery; * chronic heart failure of iii-iv functional class by nyha classification; * decompensated chronic "pulmonary" heart; * severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 ml / min); * polyvalent drug allergy; * cancer in the terminal stage with a life expectancy less than 6 months; * patient refusal to participate or continue to participate in the study;

Keywords: radio frequency denervation tibial arteries atherosclerosis of the peripheral arteries
in the real world study, the efficacy and adverse reactions of ticagrelor on ischemic cerebrovascular disease

Conditions: Cerebral Infarction; Stroke; Nervous System Diseases; Ischemic Cerebrovascular Disease

Summary: this is a forward-looking, open, one-arm, and real clinical trial world. the researchers plan to recruit at least 50 qualified patients. the main purpose of this study is to establish a population pharmacokinetic model of ticagrelor , explore the correlation between its blood concentration and the events of ischemia and the adverse effects of hemorrhage, and evaluate the effectiveness and safety of ticagrelor in the treatment of ischemic cerebrovascular disease.

ischemic stroke and transient ischemic attack are the most common types of ischemic cerebrovascular disease. patients will suffer from physiological function damage, even mental symptoms, social function and other obstacles, seriously affecting the quality of life, and bringing heavy burden to families and society. ticagelor is a new p2y12 receptor antagonist. compared with clopidogrel, ticagelor has stronger and more lasting platelet inhibition, and can reduce the recurrence of ischemic events in patients with acute coronary syndrome . therefore, at least 50 patients with ischemic cerebrovascular disease using ticagelor will be included. before and after treatment, the laboratory examination data, nihss, mrs, combined medication and adverse events, and ischemic events of the patients will be collected. the population pharmacokinetics model of ticagelor was established to evaluate its effectiveness and safety.

Eligibility criteria:
inclusion criteria: 1. female or male aged ≥ 18 years. 2. clinically diagnosed as ischemic cerebrovascular disease. 3. take ticagelor for antiplatelet therapy. 4. provision of informed consent. exclusion criteria: 1. head ct or mri suggests the presence of intracranial hemorrhagic disease. 2. people with tumors and other serious systemic diseases. 3. allergy to ticagelor.

Keywords: vascular diseases ticagrelor
bovine colostrum to prevent absorption of gluten

Conditions: Celiac Disease; Gluten Sensitivity; Non-celiac Gluten Sensitivity

Summary: to investigate the use of hyperimmune bovine colostrum to reduce gluten absorption. a double-blind, cross-over study will be performed in which persons who are following a strict gluten-free diet will be challenged with oral gluten with or without the bovine colostrum.

physiologic double-blind, cross-over, study in which volunteers on a gluten-free diet will ingest gluten with or without colostrum. subject participation and study duration the study will imply 5 visits for each participant. at the second and fourth visit, they will either take gluten with colostrum powder or with a placebo. follow-up duration will be until three days after the last study visit. each participant will be given daily proton pump inhibitor (ppi) therapy (omeprazole 20 mg) at least one week before the first intervention, and for the entire duration of the study. each participant will be invited to fill a celiac disease patient reported outcomes questionnaire (celiac disease symptoms diary) for the 24 hours prior the study intervention and three days after. blood and urine samples will be collected during the 24 hours following each study intervention (gluten + colostrum or gluten + placebo) adverse events will be recorded during the entire study from enrollment to termination (termination will occur 3 days after the second challenge at the end of the patient reported outcome (pro) recording period).

Eligibility criteria:
inclusion criteria: * self-reported strict adherence to a gluten-free diet for at least 3 months. this may be a lifestyle choice, in solidarity with a child or other family/household member with celiac disease, because of non-celiac gluten sensitivity or because of celiac disease. * willing to provide informed consent for all study procedures * healthy volunteer according to the investigator assessment (history and physical exam) exclusion criteria: * definite or probable gluten exposure during the 72 hours preceding each study intervention visit * known active gastrointestinal disease. * use of an oral digestive enzyme supplement during the 72 hours preceding each study intervention (challenge) visit. * history of severe symptomatic reactions to gluten or milk proteins * history of allergy to beef or meat * history of allergy to apple * severe lactose intolerance * any medication or medical condition which, in the opinion of the investigators, could adversely affect the patient's participation in the trial. * allergy to ppi or other contraindication for ppi use (i.e history of interstitial nephritis attributed to ppi, history of ppi-induced diarrhea) * pregnant women (according to pregnancy test)

Keywords: celiac disease gluten colostrum
efficacy and safety of pasireotide lar (long-acting release) in japanese patients with acromegaly or pituitary gigantism

Conditions: Acromegaly; Pituitary Gigantism

Summary: to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide lar in japanese patients with active acromegaly or pituitary gigantism. primary objective was to assess the total-group efficacy of pasireotide lar on the reduction of mean gh levels to \< 2.5 µg/l and the normalization of insulin-like growth factor-1 (igf-1) at 3 months of study treatment.


Eligibility criteria:
inclusion criteria: * patients with medication naïve acromegaly or pituitary gigantism * patients with inadequately controlled acromegaly or pituitary gigantism exclusion criteria: * diabetic patients whose blood glucose is poorly controlled as evidenced by hba1c \>8% * patients who have congestive heart failure (nyha class iii or iv), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment * patients with risk factors for torsade de pointes, i.e. patients with a baseline qtcf \> 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long qt syndrome, or patients receiving a concomitant medication known to prolong qt interval

Keywords: som230 pasireotide acromegaly phase ii growth disorder gigantism pituitary adenoma pituitary gigantism
enamel remineralization potential of dentifrices in situ

Conditions: Dental Caries

Summary: this study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.


Eligibility criteria:
inclusion criteria: * good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health. * no current active caries or periodontal disease that may compromise the study or health of the subject. * all restorations in a good state of repair * currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm. * willing to have their denture modified to accomodate enamel test specimens * willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods. * salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 ml/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 ml/minute. exclusion criteria: * individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit. * current active caries or periodontal disease that may compromise the study or health of the subject.

Keywords: enamel remineralization fluoride caries
a study to evaluate the effects of celecoxib (celebrex®) or naproxen on blood pressure in pediatric subjects

Conditions: Arthritis, Juvenile Rheumatoid

Summary: this is a multicenter, active-controlled trial to evaluate the effects of celecoxib (celebrex®) or naproxen on blood pressure in pediatric subjects with juvenile idiopathic arthritis


Eligibility criteria:
inclusion criteria: * polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular jia for ≥3 months meeting the international league of associations for rheumatology (ilar) criteria for juvenile idiopathic arthritis (jia) * subjects with systemic jia with active arthritis in at least 1 joint but without active systemic features are eligible * ≥2 years of age and \<18 years of age prior to the baseline visit * body weight ≥10 kg at the baseline visit * candidate for chronic nsaid therapy in the investigator's judgment exclusion criteria: * psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of jia * active systemic features over the prior 12 weeks in children with systemic juvenile idiopathic arthritis (jia) * subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded * subjects with active systemic jia should not be enrolled

Keywords: juvenile arthritis; juvenile rheumatoid arthritis;blood pressure;juvenile idiopathic arthritis
exercise for anxiety

Conditions: Anxiety

Summary: 90 sedentary adults with a primary anxiety disorder and high anxiety sensitivity will be randomized to either 8 weeks of 1) low intensity exercise, or 2) flexible titration to high intensity exercise (hie). blinded, validated clinician-rated and patient-rated outcomes will be assessed over treatment and at 1- and 3-month follow-up. to better understand what mechanisms influence decisions to exercise in the real-world, we will use of heart rate (hr) as an objective mechanistic target for exercise intensity, examine changes in valuation of exercise through a neuroeconomics task, examine changes in interoceptive sensitivity with a heartbeat detection task, and integrate of ecological momentary assessment (ema) to measure effects of immediate changes in mood with exercise on anxiety outcomes and adherence.


Eligibility criteria:
inclusion criteria * males and females ages 18-65 * primary psychiatric diagnosis of generalized anxiety disorder (gad), social anxiety disorder, or panic disorder * anxiety sensitivity index-3 score of ≥23 (i.e., high anxiety sensitivity) * currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months) * body mass index \<40 * able and willing to provide informed consent exclusion criteria * lifetime history of bipolar i or ii or any psychotic disorder * bulimia or anorexia in the past 6 months * substance use disorder in the past 3 months * current ptsd (past ptsd is allowed) * high current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the columbia suicide severity rating scale (c-ssrs) consistent with a need for referral to higher level of care
safety and tolerability of pg110 in patients with knee osteoarthritis pain

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of pg110, a monoclonal antibody that inhibits the effects of the naturally occurring substance, nerve growth factor (ngf).


Eligibility criteria:
inclusion criteria: * moderate to severe pain attributed to knee osteoarthritis exclusion criteria: * significant comorbidity * significant pain states other than osteoarthritis * concomitant medications that might affect assessments