Kornimate/medical-research-clean huggingface dataset:
feasibility study of the new norma-sense

Conditions: Vaginal Infection

Summary: * in-vitro study * collect data regarding the color appearance on the new developed indicator strips (new norma-sense), in contact with vaginal secretion with elevated ph * measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic subjects * detect these indicator strips' performance, in contact with urine

this in-vitro study was designed to collect data regarding the color appearance on the new developed indicator strips (new norma-sense) when coming in contact, in-vitro, with vaginal secretion with elevated ph, and to measure the buffering capacity of vaginal secretion from non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips' performance when come in contact with urine.

Eligibility criteria:
inclusion criteria: 1. women, aged between 18 and 45, with or without symptoms of vaginal infection. 2. subjects are ready to sign the informed consent form. exclusion criteria: 1. subjects are unable or unwilling to cooperate with the study procedures. 2. subjects are currently participating in another clinical study that may directly or indirectly affect the results of this study. 3. subjects that suffer from vaginal bleeding or menstruate. 4. subjects that have had sexual relations within the last 12 hours. 5. subjects that applied local antiseptic, antibiotic or vaginal treatment within the last 3 days. 6. subjects that applied vaginal douching within 12 hours prior to the visit at the clinic.

Keywords: vaginal infection color appearance new developed indicator strips (new norma-sense) in-vitro vaginal secretion elevated ph
effect of a component of fish oil on exercise-induced bronchoconstriction and airway inflammation in asthma

Conditions: Asthma; Exercise-Induced Bronchoconstriction

Summary: the primary aim of this study will be to evaluate the effects of lyprinol® supplementation on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals with asthma. the investigators hypothesize that lyprinol® supplementation, compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced bronchoconstriction in asthmatic individuals.

our research group has shown, on numerous occasions that fish oil has a markedly protective effect in suppressing airway inflammation and exercise-induced bronchoconstriction in elite athletes and asthmatic individuals. purified fish oil and the marine lipid fraction pcso-524™ (lyprinol™) have both been used in supplementation studies in asthma \[2, 10, 11\]. while fish oil is a rich source of the omega-3 fatty acids eicosapentaenoic acid (epa) and docosahexaenoic acid (dha), lyprinol® is a patented extract of stabilized lipids from the new zealand green-lipped mussel, perna canaliculus, combined with olive oil and vitamin e. epa and dha are the main ingredients of fish oil, and thus there will be similarities between lyprinol and fish oil in terms of mechanism of action. thus, we are aiming to show that lyprinol® can modulate these inflammatory eicosanoids to exert anti-inflammatory effects.

Eligibility criteria:
inclusion criteria: * have been diagnosed with asthma and eib. evidence of a diagnosis of asthma will include medication use as well as history and symptoms as outlined in the nhlbi guidelines for the diagnosis and management of asthma. for the diagnosis of eib, subjects must demonstrate a fall in fev1 of ≥ 10% after dry air eucapnic voluntary hyperventilation (evh), a simulated exercise challenge; fev1 is a measure of lung function * not currently be taking any fish oil supplements * limit their fish consumption to 1 fish meal per week during the course of the study exclusion criteria: * severe asthma is indicated. these subjects will be identified by a post-evh drop in fev1 that is greater than 50% during their first lab testing session or will have a history of severe asthma-related events such as hospitalizations or emergency room visits. only mild to moderate asthmatics (i.e. subjects whose fev1 drops by 10-50%) will be included in this study. * they taking currently taking asthma maintenance medications * they are pregnant * they have a history of hyperlipidemia (high cholesterol), hypertension, diabetes, bleeding disorder, delayed clotting time, or seizure disorder * they are allergic to shellfish, fish, corn, or soy products

Keywords: asthma exercise-induced bronchoconstriction lipids n-3 pufa airway inflammation bronchoconstriction
impact of a non-drug choice on cocaine reinforcement

Conditions: Cocaine Dependence

Summary: cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. the goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. this study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.


Eligibility criteria:
inclusion criteria: * cocaine dependence, otherwise healthy exclusion criteria: * laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
effects of intra-articular versus subacromial steroid injections on clinical outcomes in adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: the primary objective is to compare the clinical outcomes of patients with a clinical diagnosis of adhesive capsulitis who receive intra-articular versus subacromial steroid injections. the secondary objective is to verify that steroid injections in combination with physical therapy lead to more favorable outcomes than local anesthetic injections in combination with physical therapy.

current treatment for adhesive capsulitis involves physical therapy. steroid injections have not been shown to be as effective alone without the physical therapy. however, there are multiple studies that document the benefit of adding a steroid injection to the physical therapy. after a review of the literature, there are studies that compare different dosages of intra-articular steroid injections,value and site of the injections, and accuracy of clinical injections. there are currently no studies that compare the results after intra-articular versus subacromial injections in combination with physical therapy. this study would help us determine if location of the injection is a major factor in regaining motion. if it is significantly important to be intra-articular with the steroid, than it may be important to send patients for fluoroscopic guided injections routinely rather than risk the chance of not being within the joint.

Eligibility criteria:
inclusion criteria: * meet clinical diagnosis of primary adhesive capsulitis * restriction in abduction to less than 130 degrees * 50% reduction in external rotation as compared with the contralateral side * an intact rotator cuff * between 18-75 years of age exclusion criteria: * previous shoulder capsular surgery * history of steroid injection(s) into affected shoulder * inability to provide informed consent * iodinated contrast dye allergy * allergy to lidocaine * other suspected shoulder pathology (i.e., tumor, rotator cuff rupture. infection, arthritis) * known bleeding diathesis * cervical spine pathology * history of trauma to the shoulder * pregnancy

Keywords: adhesive capsulitis subacromial injection intraarticular injection
bortezomib and pegylated liposomal doxorubicin in brca wild-type platinum-resistant recurrent ovarian cancer patients

Conditions: Ovarian Neoplasm Epithelial; High Grade Serous Carcinoma

Summary: this study is a phase ii clinical trial to evaluate the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin combination therapy in a histologic type of high-grade serous carcinoma without brca mutation among patients with platinum-resistant recurrent ovarian cancer.

subjects are dosed with bortezomib and pld for a maximum of 6 cycles of 4 weeks. the response rate is evaluated with ct according to recist criteria ver 1.1. the efficacy and safety of the drug are assessed at the time of recurrence, at the time of death, or after 24 months after the end of the study drug administration.

Eligibility criteria:
inclusion criteria: * patients diagnosed with epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer based on histologic findings obtained from biopsy/surgery and having a histologic type of high-grade serous cancer. * in the absence of a mutation of the brca gene (no germline mutation should be identified, not in the case of a somatic mutation) * recurrence within 6 months after platinum-based chemotherapy. * ecog performance 2 points or less. * blood tests performed within 2 weeks of enrollment meet the following results: neutrophil \> 1,500/mm3; platelet \> 100,000/mm3; hemoglobin \> 9.0 g/dl; total bilirubin \< 1.5 x upper limit of normal (uln); ast/alt \< 3.0 x uln (or \< 5 x ulm in case of liver metastases); creatinine \< 1.5 x uln; electrolytes should be within normal limits. * patients who understand the content of the study description and voluntarily agree in writing. * patients who are willing and able to adhere to the visit schedule, treatment plan, laboratory tests, and other testing procedures. exclusion criteria: * patients previously treated with three or more anticancer regimens. maintenance therapy is not considered a separate regimen (eg\> paclitaxel-carboplatin-bevacizumab therapy). in the combined chemotherapy, when one drug is subtracted due to toxicity, the regimen is not counted as a change (eg\> paclitaxel-carboplatin chemotherapy, paclitaxel was discontinued due to neurotoxicity and carboplatin alone was not considered as a change of regimen). * previous refractory to ovarian cancer chemotherapy. * patients diagnosed with other tumors other than ovarian cancer for the last 5 years (not cis). * pregnant woman. * patients with uncontrolled infection. * in the case of congenital immune disease or acquired immune deficiency syndrome. * women in lactation. * history with grade 3 or higher peripheral neuropathy. * history of hypersensitivity reactions to pld or bortezomib. * if the physician is judged to have any serious illness or medical condition for which the patient is not suitable for the study. * patients with confirmed brca somatic mutations. * patients with acute diffuse infiltrative lung disease and cardiovascular disease.
nebulized hypertonic saline for better prevention of mucus plug in critical adult tracheostomized patients

Conditions: Critical Illness; Tracheostomy Complication; Mechanical Ventilation Complication; Plug; Mucus

Summary: tracheostomy is an important tool in the management of respiratory failure in the critically ill patient under mechanical ventilation. although mechanical ventilation can be a lifesaving intervention, it is also known to carry several side-effects and risks. among the most frequent complications of mechanical ventilation, obstruction of the airway secondary to a mucus plug is both life threatening and a prevalent phenomenon related to mucociliary system dysfunction, artificial airway itself and the loss of strength that prevents adequate airway clearance. the main indication of tracheostomy is the need for prolonged mechanical ventilation that usually occurs in more severe patients, this circumstance having also been related to the development of intensive care unit (icu) acquired weakness. currently, the approach to secretion clearance in critical patients is focused on rehabilitation therapy and humidification. hypertonic saline (hs) is largely used in cystic fibrosis to increase airways clearance while little evidence is available in other settings although promising results have been reported. in this sense, the use of hs could be beneficial in the prevention of airway obstruction in tracheostomized critical patients.


Eligibility criteria:
inclusion criteria: * age \>= 18 years. * respiratory support through tracheostomy performed during icu stay. * informed consent signed by the relatives or legal representative of the patient. exclusion criteria: * pregnancy. * any terminal disease. * known hypersensitivity to any component of hyaneb (hypertonic saline of nacl (7%) in combination with hyaluronic acid). * participation in another research study. * any other condition that, according to the investigator, may prevent a participant to complete all the procedures required.

Keywords: critical illness tracheostomy mechanical ventilation complication plug mucus
evaluation of first-void urine as an alternative to cervical sampling for human papillomavirus (hpv) testing in cervical cancer screening (single-center study).

Conditions: Uterine Cervical Cancer

Summary: papillomaviruses are responsible for almost all cervical cancers. in france, there are more than 3000 new cases of cervical cancer each year and nearly 1000 deaths. one of the ways to prevent this cancer is screening by pcr on cervical sample for which national coverage rate remains very insufficient (\<60%). the invasive and uncomfortable nature of cervical sampling has been identified as a major obstacle to screening. in this context, an alternative sample, such as the first-void urine, seems to be judicious. nevertheless, some studies have shown a lack of sensitivity of the hpv pcr test on urine. as underlined by the french national authority for health (has), this is mainly due to a lack of standardization of urine collection. in this study, the investigators therefore propose to evaluate the performance of the hpv pcr test on first-void urine using a standardized protocol. through a questionnaire, they will also evaluate the acceptability of the first void urine collection device.


Eligibility criteria:
inclusion criteria: * female * age between 30 and 65 * consulting in the gynecology-obstetrics department for primary cervical cancer screening * patient affiliated or entitled to a social security regimen * patient who has received information about the study and expressed non-opposition exclusion criteria: -

Keywords: hpv cervical cancer cancer screening
bariatric surgery for the treatment of type 2 diabetes - clinical effects and underlying mechanisms

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: the main purpose of this project is to further explore the metabolic effects and the mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. the project will involve both prevention and treatment of type 2 diabetes (t2d), and both pre-diabetic as well as diabetic subjects with obesity will be included. this part of the project focuses on patients with manifest t2d and they will be assigned to surgical and non-surgical intervention, respectively, in a strictly controlled and randomized manner.


Eligibility criteria:
inclusion criteria: * males and females aged 18-60 years * type 2 diabetes mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or glucagon-like peptide-1 (glp-1) analog. exclusion criteria: * pregnant or planning to be pregnant during the study. * known or suspected history of significant drug abuse. * history of alcohol abuse or excessive intake of alcohol as judged by investigator. * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator * sleep apnea * any previous serious cardiovascular event, stroke , acute myocardial infarction. * diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an estimated glomerular filtration rate (egfr) \<60, foot ulcers, symptomatic neuropathy * medications within 3 months : insulin, thiazolidinediones * any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety * judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
leptin and visfatin in diabetic patients with periodontitis before and after periodontal therapy

Conditions: Chronic Periodontitis; Type 2 Diabetes Mellitus

Summary: 1. are adipokines involved in pathogenesis of periodontal disease in diabetic patients? 2. does their level change after periodontal therapy?

patients with chronic periodontitis only and patients with chronic periodontitis and diabetes were evaluated for levels of leptin and visfatin in the gingival tissues before and after non-surgical periodontal therapy.

Eligibility criteria:
inclusion criteria: * diabetic patients having diabetes mellitus ≥5 years prior to the study. * chronic periodontitis with clinical attachment loss \> 5 mm. * otherwise systemically healthy subjects. exclusion criteria: * any known systemic diseases other than diabetes. * pregnancy or lactation. * smokers. * receiving periodontal treatment in the last 6 months. * taking any drugs or medications other than anti-diabetic drugs.

Keywords: leptin visfatin chronic periodontitis diabetes mellitus non-surgical periodontal therapy
validation of point of care liver function tests

Conditions: Liver Diseases; Healthy; Cirrhosis, Liver; Fibrosis

Summary: this study is testing the accuracy of a point of care device that tests liver function within 20 minutes. the target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.

outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. sometimes patients do not make it to laboratory testing if a lab is not available on site. delays in testing can affect medical outcomes or patients can be lost to follow up. group k developed a paper microfluidic platform with an accompanying mobile application(app). the paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. these areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. an app is then used to interpret the color change and output results to a doctor. the target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital

Eligibility criteria:
inclusion criteria: * have a liver function testing for the required 6 tests completed (alanine aminotransferase (alt), aspartate aminotransferase (ast), alkaline phosphatase (alp), albumin, bilirubin, and total protein) * 18 years or older exclusion criteria: * inadequate blood sample obtained from finger stick * inconclusive liver function testing * not all 6 liver tests completed on the same sample * liver tests not drawn for normal method at same time as finger stick.
this is a randomized study of early involvement of palliative care along side standard treatment versus standard treatment alone in newly diagnosed patients with advanced or metastatic soft tissue sarcoma (sarquality)

Conditions: Sarcoma

Summary: the goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma. participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.


Eligibility criteria:
inclusion criteria: * signed written and voluntary informed consent. * have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic. * age ≥ 18 years. * have not received any previous systemic treatment with palliative intent for advanced sarcoma. * performance status of 0-2 on the eastern cooperative oncology group (ecog) performance scale. * life expectancy \> 6 months. * willing/able to complete questionnaires. exclusion criteria: * clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion. * patient in need of urgent home support services or symptom management through a palliative care team. * patient is being actively followed by a palliative care physician. * active psychiatric disorder or drug abuse. * insufficient english literacy to complete questionnaires.

Keywords: sarcoma palliative care
drug-drug interaction study of vx-770 and vx-809 in healthy subjects

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to assess the pharmacokinetics and safety of vx-809 and vx-770 alone and in combination in healthy subjects.

this is a phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered vx-809 and vx-770 in healthy subjects. this study will evaluate safety and tolerability of vx-809 and vx-770 alone and in combination. subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. in treatment period 1, subjects randomized to study drug will receive vx-809 every 24 hours. in treatment period 2, subjects randomized to study drug will receive vx-770 every 12 hours. in treatment period 3, subjects will receive vx-809 every 24 hours and vx-770 every 12 hours. subjects randomized to placebo will receive placebo during all treatment periods. enrollment is planned at 1 clinical site (lenexa, kansas). up to 72 subjects will be enrolled. the study will be separated into 3 dose escalation cohorts. cohort 1 and cohort 2 will enroll 24 subjects. cohort 3 is optional and may be conducted after a review of safety and pharmacokinetic data by vertex.

Eligibility criteria:
inclusion criteria: * male or female subject between 18 and 55 years of age, inclusive * body mass index (bmi) between 18.5 and 30.0 kg/m2, inclusive * subjects of child bearing potential and who are sexually active must meet the contraception requirements * female subject must have a negative serum pregnancy test at screening and day -1 exclusion criteria: * history of any illness that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject * participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer) before the screening visit * subject who has received vx-770 or vx-809 in a previous clinical study