Kornimate/medical-research-clean huggingface dataset:
a phase i pharmacokinetics and safety study of two dapivirine intravaginal gels

Conditions: HIV Infections

Summary: ipm 012 is a double-blind, randomized, placebo-controlled phase i study conducted at one research center in belgium among 36 healthy, hiv-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either dapivirine gel 4750, 0.05%, 2.5g or dapivirine gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal hec-based universal placebo gel.


Eligibility criteria:
inclusion criteria: * women between 18 and 40 years of age, inclusive * willing and able to give written informed consent * available for all visits and consent to follow all procedures * healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function * hiv-negative as determined by a hiv-1 elisa test at enrollment * willing to abstain from sexual activity for the duration of the study * on stable oral contraceptive regimen for 2 months prior to enrollment and willing to continue * upon pelvic/speculum examination, the cervix and vagina appear normal * willing to refrain from the use of vaginal products from 14 days prior to enrollment and for the duration of the study exclusion criteria: * history of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact adherence with protocol requirements * history of sensitivity/allergy to any component of the study product or to latex * currently pregnant or breast-feeing, or within 3 months of last pregnancy outcome * currently or within one month of participating in any other clinical research study * history or current diagnosis and/or treatment for a std within the last three months prior to enrollment * current vulvar, vaginal or cervical symptoms/abnormalities as determined by pelvic/speculum exam or colposcopy that could influence the study results * history of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months * current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption * smoking more than 10 cigarettes a day

Keywords: hiv-1 infection hiv seronegativity
treatment of soft tissue expansion in inactive thyroid eye disease patients using drops of prostaglandin analogues

Conditions: Thyroid Associated Ophthalmopathies

Summary: prostaglandin analogues eye drops are common and effective treatment for decreasing intra-ocular pressure (iop) in glaucoma patients. a number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. in this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive thyroid eye disease (ted) patients, as a conservative substitute for surgical intervention.


Eligibility criteria:
inclusion criteria: * inactive ted (clinical activity score below 3) * significant exophthalmos or orbital fat expansion. exclusion criteria: * previous prostaglandin analogues treatment due to glaucoma * known prostaglandin analogues sensitivity.

Keywords: ted prostaglandin analogues
expiratory flow limitation assessment

Conditions: Acute Respiratory Distress Syndrome

Summary: this study intended to assess the expiratory flow limitation (efl) during tidal breath in patients intubated in intensive care unit (icu) for moderate or severe acute respiratory distress syndrome (ards). efl is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. it reflects airway closure. early studies have been done using the negative expiratory pressure (nep) technique, which is no longer available. we proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. we aimed at assessing efl at positive expiratory pressure (pep) 5 cmh2o in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. higher pep levels will be tested, namely 10, 15 and a trans-pulmonary pep of 3 cmh2o, in semi-recumbent position.


Eligibility criteria:
inclusion criteria: * 18 years or more in age * moderate to severe ards according to the berlin definition : intubated (or tracheotomized) and mechanically ventilated in the icu * no pregnancy * informed consent from the next of kin exclusion criteria: * contra-indication to pep \> 5 cmh2o * extracorporeal membrane oxygenation (ecmo) * chest tube * mean arterial pressure \< 65 mmhg * contra-indication to oesophageal device * underlying disease fatal in less than one year * active therapy limitation * under guardian * refusal to participate * not affiliated to insurance regimen * speaking barrier of the next of kin * investigator not available

Keywords: ards expiratory flow limitation trans-pulmonary pressure airway closure
ayurveda self-management for flu like symptoms during the covid-19 outbreak

Conditions: Flu Like Symptom; Flu Like Illness

Summary: from the end of january 2020, coronavirus disease 2019 began to spread in united kingdom (uk). during the same time, seasonal flu continued to circulate across the uk. with similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. present study aimed to evaluate the effect of self-managed ayurveda on flu like symptoms in people who self-isolated at home for 7-days in march 2020 during the covid-19 outbreak in uk.


Eligibility criteria:
inclusion criteria: * flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration * willing to consent and follow up exclusion criteria: * pregnant/lactating * participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress * clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - known hypersensitivity to any ayurveda herbal substances
therapeutic intervention of eriocitrin in the reduction of hyperglycemia in pre-diabetic individuals

Conditions: Pre Diabetes

Summary: supplementation with citrus bioflavonoids (hesperidin, naringin, diosmin and eriocitrin, among others) has been associated with an improvement in the glycidic and lipid profile, reduction of insulin resistance and systemic inflammation, and reduction of endothelial damage. this study aims to evaluate the effects of eriocitrin supplementation on the metabolic parameters of pre-diabetic individuals. participants will be adults with pre-diabetes who will receive 200 mg / d of eriocitrin. before, during and after treatment, anthropometric measures (weight, body composition and circumferences), biochemical (lipid and glucose profile, inflammatory parameters, endothelial markers, liver function, renal function) will be evaluated. metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin.

individuals aged 35-60 years and who present at least one of the following criteria: (1) increased fasting blood glucose from 6.1 to 7.0 mmol / l, (2) decreased glucose tolerance of 7 , 8 to 11.1 mmol / l, and (3) glycated hemoglobin with values between 5.7 and 6.4% 10 will be eligible to participate in this study. the exclusion criteria will be to use hypoglycemic, hypolipidemic drugs, dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds), exercise intensely (more than 10 hours per week), history of cardiovascular diseases , diabetes mellitus, liver and kidney disease. the selected individuals will be distributed randomly in 2 groups through random number generator program. group a (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, with washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks; group b (n = 20) will receive 200 mg / d placebo for 12 weeks with washout for 2 weeks and then receive 200 mg / d placebo for 12 weeks. the primary endpoint will be fasting blood glucose, blood glucose 2 hours after oral glucose tolerance test (gtto), and hba1c. the secondary endpoint will be insulin, homa-ir, total cholesterol, triglycerides, hdl-cholesterol, ldl-cholesterol, alp, ygt, ast, alt, tnf-α, il-6, crp, body weight, body mass index bmi), muscle mass, fat mass, body fat and waist-hip ratio, and macronutrient intake.

Eligibility criteria:
inclusion criteria: * 35-60 years * increased fasting blood glucose from 6.1 to 7.0 mmol / l or, * decreased glucose tolerance of 7 , 8 to 11.1 mmol / l or, * glycated hemoglobin with values between 5.7 and 6.4% exclusion criteria: * use hypoglycemic, hypolipidemic drugs, * use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds), * exercise intensely (more than 10 hours per week) * history of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

Keywords: eriocitrin citrus bioflavonoids flavanone pre-diabetes blood glucose
trial comparing different stimulation paradigms in patients treated with vagus nerve stimulation for refractory epilepsy

Conditions: Epilepsy

Summary: patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Eligibility criteria:
inclusion criteria: * 16 years or older * at least 1 seizure/month with alteration of consciousness * documented seizure diary, at least 3 months prior to implantation (baseline) * no change in anti-epileptic drugs 1 month before implantation * at least one or more aeds exclusion criteria: * active cardiac, pulmonary or gastrointestinal disease * vagotomy * concomitant use of an investigational drug * unstable medical condition * unstable psychiatric condition
a theory based hiv prevention video for rapid hiv testing: a randomized trial

Conditions: HIV

Summary: oraquick is a safe, rapid test that accurately identifies hiv in as little as 20 minutes. by providing an accurate, quick method for detecting a person's serostatus and access to immediate post-test counseling, rapid testing has a crucial role in identifying hiv status and improving post-test counseling rates in populations who are at high risk of hiv infection and high failure to return rates. this prospective randomized control trial compared the educational effectiveness of a fifteen-minute post-test counseling video with the normal practice of a session with an hiv counselor.

a convenience sample of stable patients presenting to the walk-in section of the jacobi medical center adult ed were recruited for rapid hiv testing. after consenting for the rapid hiv test and completing measures on condom intention and condom use self-efficacy, participants were randomized to either a fifteen-minute hiv post-test educational video available in english or to an hiv counselor for post-test counseling. afterwards, both groups completed a measure of hiv knowledge assessing relevant testing information and level of satisfaction. an equivalence analysis was carried out to assess whether the video was at least as good as counseling, measured by total score on the knowledge questionnaire, with a lower equivalence bound of -5%.

Eligibility criteria:
inclusion criteria: * all adult patients presenting to the urgent care area at jacobi medical center exclusion criteria: * patients that were in to much pain, unable to understand the consent process or spoke another language other than the languages offered via the video or were hiv tested with in 6 months.

Keywords: hiv prevention rapid hiv testing
kidney cancer observational protocol

Conditions: Renal Cancer

Summary: the aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

a databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form. each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. at each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. the data collected will be handled following the most strict gcps and privacy norms. the main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

Eligibility criteria:
inclusion criteria: * 18 years or older * kidney cancer diagnosis * indication to cancer removal through surgery * ability to read and sign the informed consent exclusion criteria: * age \< 18 years * absence of kidney cancer * inability to read and sign the informed consent

Keywords: renal cancer radical nephrectomy partial nephrectomy relapse renal cancer diagnosis renal cancer treatment
incidence of colorectal cancer in southwest china: based on scc database

Conditions: Colorectal Cancer

Summary: to evaluate recent trends in crc incidence, treatment, and survival in the southwest china.

the epidemiological feature of colorectal cancer (crc) showed different trends among countries. studying the epidemiological and management characteristics between china and the us has important implications for understanding the current status of cancer occurrence, treatment and survival. we established the southwest china colorectal (scc) database, aiming to provide reference information on the diagnosis and management of crc in china.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of colorectal cancer; 2. received treatment in medical institutions; 3. regular follow-up after the diagnosis. exclusion criteria: patients who lost to follow-up
a phase 1/2 trial of tc-510 in patients with advanced mesothelin-expressing cancer

Conditions: Mesothelioma; Mesotheliomas Pleural; Mesothelioma, Malignant; Mesothelioma Peritoneum; Ovarian Cancer; Ovarian Serous Adenocarcinoma; Pancreatic Cancer; Pancreatic Adenocarcinoma; Colorectal Cancer; Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer; Ovarian Adenocarcinoma; Pancreatic Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Cholangiocarcinoma; Non Small Cell Lung Cancer

Summary: tc-510 is a novel cell therapy that consists of autologous genetically engineered t cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human mesothelin, fused to the cd3-epsilon subunit which, upon expression, is incorporated into the endogenous t cell receptor (tcr) complex and second, a pd-1:cd28 switch receptor, which is expressed on the surface of the t cell, independently from the tcr. the pd-1:cd28 switch receptor comprises the pd-1 extracellular domain fused to the cd28 intracellular domain via a transmembrane domain. thus, the switch is designed to produce a costimulatory signal upon engagement with pd-l1 on cancer cells.


Eligibility criteria:
inclusion criteria: * patient is \> 18 years of age at the time the informed consent is signed. * patient has a pathologically confirmed diagnosis of either mpm, serous ovarian adenocarcinoma, pancreatic adenocarcinoma, tnbc, and colorectal cancer * patient's tumor has been reviewed with confirmed positive msln expression on \>/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. patients with epithelioid mpm, confirmation of msln expression is not required prior to enrollment. * prior to tc-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol * patients has an ecog performance status 0 or 1 * patient is fit for leukapheresis and has adequate venous access for the cell collection. * patient must have adequate organ function as indicated by the laboratory values in the clinical protocol exclusion criteria: * inability to follow the procedures of the study * known or suspected non-compliance, drug, or alcohol use
adalimumab in combination with topical treatment (calcipotriol/betamethasone) in subjects with moderate to severe psoriasis and insufficient response to classic systemic treatment

Conditions: Chronic Plaque Psoriasis

Summary: the objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

additional information regarding sponsors: abbott gmbh \& co. kg is sponsor for eu member states. abbott us is sponsor for non-eu member states.

Eligibility criteria:
inclusion criteria: * subject is \>= 18 years of age * subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis * subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral puva * subject is judged to be in generally good health as determined by the principal investigator exclusion criteria: * subject has previous exposure to adalimumab * subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid uvb or puva phototherapy * subject is taking or requires oral or injectible corticosteroids * subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis * subject considered by the investigator, for any reason, to be an unsuitable candidate * female subject who is pregnant or breast-feeding or considering becoming pregnant * subject has a calcium metabolism disorder

Keywords: psoriasis moderate psoriasis severe psoriasis chronic plaque psoriasis severe chronic plaque psoriasis
evaluation of an mri-compatible vital signs sensor system

Conditions: Anxiety; Claustrophobia; Hyperventilation; Stress

Summary: this study is to determine the possibility of assessing the level of anxiety in mri patients by means of the respiration rate (rr) and heart rate (hr) indicators acquired by a fiber-optic sensor system. the mean rr and/or hr values recorded at the beginning and the end of an mri scanning will be referred to the state trait anxiety inventory (stai) scores completed before and after the mri scanning, respectively.

the main purpose of the study is to determine the possibility of assessing the level of anxiety by means of the respiration curve and/or ballistocardiographic (bcg) signal acquired from mri patients using a fiber-optic sensor system. in many patients, the mri examination causes enormous stress due to limited space in the scanner, isolation during the examination and high noise levels. usually, anxiety or stress triggers an increase in respiration rate (rr), leading to hyperventilation in extreme cases. there are also frequent cases of disturbances in heart rate (hr). thus, the symptoms of claustrophobia can be detected by monitoring respiration activity and heart work. the fiber-optic sensor system consists of a sensor mat, an interrogator and a personal computer (pc), and records respiratory and bcg signals in patients during mri. the metal-free sensor mat is placed under the patient's back, does not pose a threat to the patient and has no influence over the quality of imaging. the interrogation module detects the optical signal including vital signs, and the pc with software developed for signal processing and visualization enable the mri operator to monitor patient's rr and hr. up to 200 mri patients in different age, weight, and gender will be participated in the study. they will be asked to complete the state trait anxiety inventory (stai) questionnaire in order to estimate anxiety level before and after the mri scanning. relations between the stai x-1 scores and the mean rr and/or hr values recorded at the beginning and the end of the mri scanning will be analyzed using descriptive statistic methods. the research scheme includes also the collection of the stai x-2 scores before the mri scanning. finally, the values of the physiological parameters, which may indicate a dangerous level of anxiety will be determined. positive results of the clinical evaluation will predestine the fiber-optic sensor system to be implemented in routine mri procedures.

Eligibility criteria:
inclusion criteria: * mri patients exclusion criteria: * same as in mri procedures

Keywords: fiber-optic sensor system magnetic resonance imaging medical monitoring physiological parameters
pdei following mitral valve surgery in patients with pulmonary hypertension

Conditions: Pulmonary Hypertension; Mitral Valve Surgery

Summary: a randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of sildenafil administration in the cardiac icu following mitral valve (mv) surgery in patients with pre-operative significant pulmonary hypertension.


Eligibility criteria:
inclusion criteria: 1. age ≥ 22 2. undergoing mitral valve surgery (either repair or replacement) with or without coronary revascularization, aortic valve replacement (avr) or repair; or tricuspid valve surgery. 3. pre-operative pulmonary arterial systolic pressure \>50 mm hg as determined by resting echocardiography and post-operative spap \> 45 mmhg as obtained from invasive hemodynamics measurements. 4. willing and able to give written informed consent prior to the procedure exclusion criteria: 1. hypersensitivity to study drug 2. women of child-bearing potential 3. expected need to administer nitrates that are clinically indicated peri-operatively 4. post-operative hypotension (systolic blood pressure (bp) \<80) or evidence of shock (postoperative evidence of any kinds of shock) 5. cardiac or systemic amyloidosis 6. active malignancy other than bcc (basal cell carcinoma) 7. stable kidney dysfunction with creatine clearence (crcl) \<30 ml/min during the screening period or hepatic failure other than mild 8. significant anemia (hemoglobin \<8 mg/dl) preoperative. 9. known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate; 10. any illness other than cardiac which might reduce life expectancy to less than 1 year from screening

Keywords: pulmonary hypertension