Kornimate/medical-research-clean huggingface dataset:
a study of l-735,524 in hiv-positive children and adolescents

Conditions: HIV Infections

Summary: to evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( mk-639; crixivan ) in hiv-seropositive older children and adolescents. to compare the plasma concentration profile after the initial dose with data from a historical group of adults. to obtain preliminary data on antiviral activity of mk-639.

patients receive mk-639 for 14 and one-third days. repeat plasma samples are collected up to 8 hours following the first and last dose. urine samples are collected on days 1 and 5.

Eligibility criteria:
inclusion criteria patients must have: * hiv positivity. * no active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina. * body surface area at least 1.0 sqm. * consent of parent or guardian. prior medication: allowed: * aerosolized pentamidine. * topical antifungals. * tmp / smx. * azt. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * significant hepatic disease including hbsag or hepatitis c positivity. * significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder. * significant cardiac disease including dysrhythmia or cardiomyopathy. * significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results. * has a social situation that may interfere with study participation. concurrent medication: excluded: * oral contraceptives. patients with the following prior conditions are excluded: * history of serious allergic drug reactions. * history of significant cardiac disease. * participation on another clinical trial within the past 4 weeks. * donated blood within the past 4 weeks. prior medication: excluded within the past 4 weeks: * hematopoietic growth factors. excluded within the past 2 weeks: * antiretroviral agent other than zidovudine. * oral contraceptives. * prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and tmp/smx. * any other medication unless approved by merck clinical monitor. current illicit drug use.

Keywords: acquired immunodeficiency syndrome aids-related complex hiv protease inhibitors indinavir
parasternal nerve block in cardiac patients

Conditions: Coronary Artery Disease; Pain, Postoperative

Summary: exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. the purpose of this study is to determine whether use of exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.

this is a phase 2, single-institution, randomized, double-blind, parallel-group, placebo-controlled trial of patients undergoing a median sternotomy for primary cardiopulmonary bypass grafting (cabg) surgery. 78 subjects (39 per treatment arm) will be randomized in a 1:1 ratio to receive a single-dose, parasternal nerve block with either 266 mg exparel or placebo (0.9% normal saline solution). the nerve blocks will be performed under direct visualization at the end of surgery, just prior to sternal closure.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * non-emergent coronary artery bypass grafting surgery (on and off pump) * median sternotomy exclusion criteria: * concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements). * redo sternotomy. * \ 50 kg). * pregnant or nursing * history of alcohol, narcotic or illicit drug abuse * participation in another study evaluating investigational medications within the past 30 days * taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids. * chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics. * pre-operative mild liver insufficiency as defined by liver function tests \[(i.e. alanine aminotransferase (alt), aspartate aminotransferase (ast)\] ≥ 1.5 times the upper limit of normal (uln: alt: 0-35 u/l, ast: 0-35 u/l, alk phos 35-105 u/l, total bilirubin: 0-1.2 mg/dl) * pre-operative mild renal insufficiency (cr ≥ 1.5 mg/dl) * allergy to amide-type anesthetics * recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction \< 30% at time of pre-operative screening/evaluation. * unable to provide informed consent or unable to understand how to use pain rating scales. * inability to understand or operate the patient-controlled analgesia (pca) machine.

Keywords: pain management anesthetic, local nerve blockade coronary artery bypass surgery analgesics, opioid postoperative complications bupivacaine
sotagliflozin multiple-dose study in healthy chinese subjects

Conditions: Diabetes Mellitus

Summary: primary objective: to assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in chinese healthy subjects. secondary objectives: * to assess the pharmacokinetic (pk) parameters of sotagliflozin after a multiple oral dose administration in chinese healthy subjects. * to assess the pharmacodynamics (pd) parameters of absolute urinary glucose excretion after a multiple oral dose administration in chinese healthy subjects.

the study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.

Eligibility criteria:
inclusion criteria : * male or female subjects, between 18 and 45 years of age, inclusive. * body weight between 50.0 and 95.0 kg, inclusive, for male or female subjects; body mass index between 18.5 and 27.9 kg/m2, inclusive. * certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination), vital signs, electrocardiogram, and clinical laboratory parameters. exclusion criteria: * any history or presence of clinically relevant illness at screening, which could interfere with the objectives of the study or the safety of the subject's participation. * frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). * blood donation any volume, within 2 months before inclusion. * symptomatic postural hypotension. * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * history or presence of drug or alcohol abuse. * smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. * if female, pregnancy, breast-feeding. * any medication (including st john's wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
screening of bone mineral density in women who have received chemotherapy

Conditions: Bone Density; Cancer

Summary: the hypothesis is that postmenopausal women who have received chemotherapy have a greater bone loss than the same age controls. the aim of this study is to obtain baseline bone mineral density (bmd) data on women with breast and gynecological cancers who have received chemotherapy. by comparing the z scores of postmenopausal women who have received chemotherapy with age matched controls this hypothesis can be evaluated. another goal of the study is to compare the t-score of a heel bone density scan to the t-score of the dxa scan to see if there is a good correlation between peripheral and dxa scores.

it is generally accepted that women who develop breast cancer have an increased bone mineral density (bmd) probably due to endogenous estrogen production. after menopause, bmd decreases rather rapidly particularly during the first years after natural menopause. bone loss typically is more rapid and severe in a premature induced menopause (surgical, chemotherapeutically, or hormonal). the bone loss appears to be more rapid and at an earlier age which advances bone age to a greater degree than actual age. chemotherapeutically-induced menopause accelerates this process by an average of 10 years. gnrh agonist in premenopausal women causes amenorrhea in \>95% with associated loss of both cortical and trabecular bone. in women undergoing ovarian ablation therapy, losses in bone mass as high as 13% have been reported in the first year of treatment. premenopausal women who by treatment become amenorrheic remain amenorrheic posttreatment in the vast majority of cases. adjuvant therapy for cancer can exaggerate bone mineral density loss. chemotherapy may have an effect on estrogen levels but may also have an effect on bone loss via direct cytotoxic effect on bone cells. although there is data concerning bmd in patients who have received chemotherapy as children and in men with prostate cancer, there is very little data concerning bmd in gynecologic oncology patients who have received chemotherapy. several different chemotherapeutic agents have been incriminated in their effects on the bone mineral density. the alkylating drugs, particularly cytoxan, have been shown to decrease bone mineral density. methotrexate and more recently the taxanes appear to have the same effect. since most chemotherapy today is given as a combination, one or more of the cytoxic agents on the bone are included and therefore this study will evaluate any postmenopausal women who has received chemotherapy. data collection: women participating in this study will undergo two scans: a heel scan which measures the bone mineral density in the heel area and a dxa scan which measures bone mineral density in the lumbar region of the spine and the hip. both scans provide a t-score and a z-score for the subject.

Eligibility criteria:
inclusion criteria: * postmenopausal woman * diagnosed with breast or gynecological cancer * treated with chemotherapy

Keywords: osteoporosis cancer chemotherapy bone density dxa scan heel scan
feasibility of a web-based patient reported outcome symptom monitoring application in danish lung cancer patients

Conditions: Lung Cancer Stage IV

Summary: the trial is a pilot study prior to a following phase iii trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application.

this pilot study will test if the use of ambuflex (a generic on-line system for self-recorded patient reported outcomes) is feasible for a following randomized trial (pro-wide trial - patient reported outcomes used for weekly internet-based detection of progressive disease in lung cancer; a randomized controlled trial). the rct (randomized controlled trial) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in danish lung cancer patients during follow-up or maintenance treatment. a threshold mechanism will automatically send an alert to the hospital in case of alarming symptoms and the patient will be contacted by the clinicians. in the pilot study, initial interviews with 7-10 patients will explore possible missing items and conceptual issues in the questionnaire. based on the results an adjustment of the questionnaire will be considered. then the system including the alert trigger mechanism will be tested on 20 patients in medical antineoplastic treatment for three consecutive weeks. acceptability, usability and relevance will be evaluated by a questionnaire at the end of the study period. inclusion-rate, number of alerts per completed questionnaire and time usage of alert-management will be registered. for final evaluation, interviews with two nurses and two doctors will be made at the end of the study.

Eligibility criteria:
inclusion criteria: 1. stage iv lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks. 2. access to internet connection 3. performance status ≤ 2 4. patient has given his/her written informed consent exclusion criteria: 1. persons deprived of liberty or under guardianship or curators 2. dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial.

Keywords: patient reported outcomes symptom monitoring follow-up
visual field defect estimation using sequentially optimized reconstruction strategy on healthy and glaucoma subjects

Conditions: Glaucoma, Open-Angle

Summary: perimetry is a well-established method that is used to measure the visual field functions of humans. commercially available products, such as the octopus 900 (haag-streit ag, koeniz, switzerland), are commonly used for assessing the visual field. such devices are of critical value for patients suffering of glaucoma and neuro-ophthalmic conditions. the operating principle is to sequentially present light stimuli of different intensity at different locations within the visual field in an automatic way. algorithms that select what locations and intensities to present over time are called strategies. these have the goal to provide both a fast and accurate estimation of the visual field function. recently, new strategies were developed that are faster and equally accurate as the strategies used today. the technological advancement of these new methods lies primarily in the ability to estimate location sensitivities without observing them directly but by leveraging previously queried locations. for this the investigators plan to implement the next generation of perimetry strategies into an octopus 900 and to test it in healthy subjects and glaucoma patients.


Eligibility criteria:
inclusion criteria: * cataract yes or no * age range 40 - 80 years * normal visual field (md: \< +2 db) * refractive error within ±5 dpt. spherical equivalent * astigmatism of \< -3 dpt. * visual acuity of ≥0.3 logmar (decimal ≥0.5) * experience in perimetry (history of at least one perimetry examination) * false positive or negative errors each less than 20% in each examination * primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma * early to moderate visual field loss (md: +2 to +12 db) * written informed consent exclusion criteria: exclusion criteria are children (\<18 years old), inability to follow the procedure, insufficient knowledge of project language, the history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
postural modification and hearing aids in presbycusis

Conditions: Age-Related Hearing Loss; Postural; Defect; Hearing Aid

Summary: presbycusis could be associated to increased risk to fall. there is little about the impact on postural balance of hearing aids. in this study, the investigators describe the postural balance evolution before and after hearing aid fitting in presbycusis-affected adults (55-80years old) consulting angers university hospital ent department and ent medical doctor of le mans .

after being informed about te study and consentment, patients meeting inclusion criteria consulting for presbycusis and in indication for hearing aids will be included to have posturometry (v0). posturometry is performed 3 months later, before the first hearing aid installation (v1a) and after (v1b), as well as three months after hearing aid wearing (v2). evolution of posturometry parameters without hearing aids between v0 and v1a serve as control and is compared to the evolution of posturometry parameters after hearing aid wearing between v1b and v2.

Eligibility criteria:
inclusion criteria: * 55 to 80 years old * arhl within pta superior to 30dbhl, and intelligibility threshold 30db or worse defining hearing aid fitting indication in france non inclusion criteria: * hearing aid fitting refusal or contrindication * vestibulare rehabilitation in past 3 months * unusual physical activity the day of the posturography test * incapacity to understand the instruction, or to stand up the time of posturography without help * predictable incapacity to perform posturography in the time of the study exclusion criteria: * acute affliction that could affect the posturography test * daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography

Keywords: age-related hearing loss presbycusis posture hearing aid
joint application of human insulin and rapid insulin analogue in control of postprandial glycemia

Conditions: Diabetes Mellitus, Type 1

Summary: postprandial glycemic control is essential for diabetes compensation. insulin pump therapy control blood glucose released in response to both high and low glycemic index carbohydrates in a mixed diet using normal, square and dual-wave boluses. the investigators hypothesize a mixture of rapid insulin analogue and human insulin has the same effect. this pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by combined prandial application of insulin aspart and human insulin. mixed-meals with high, both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios of analogue to human insulin mixture. subjects are followed by continuous glucose monitor for six days (phase one), changing between the experimental or their standard protocol for insulin injection on consecutive days. the outcome was measured by comparing average glycemia and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable salad. the next three-to-four week period of therapy was evaluated by glycated hemoglobin before and after the intervention (phase two). expected outcomes are postprandial and complex improvement of diabetes control, similarly to the insulin pump therapy.


Eligibility criteria:
inclusion criteria * pubertal children, adolescents, young adults able to follow instructions, regardless of their long-time compliance * willing to undertake a prandial application of two kinds of insulin using two standard insulin applicators. * willing to complete detailed meal, insulin and/or combination insulin and hypoglycemia diary throughout the study. exclusion criteria: * acute illness and celiac disease, but not euthyroid autoimmune thyroiditis, defined as thyroid stimulating hormone (tsh)\<4 miu/l.

Keywords: diabetes mellitus, type 1 prandial glycemia rapid acting insulin analogue human insulin
number of weekly steps, fatigue, quality of life, well-being during cancer treatment: impact of recommendations strengthened by the provision of web interface and tele-coaching.

Conditions: Cancer, Treatment-Related

Summary: study to correlate this level of objective physical activity with the levels of fatigue and quality of life in cancer patient being treated.

study to objectify the level of physical activity of patients by a tool, often used in the global population: the pedometer. several measurements per questionnaire also will be carried out repeatedly (weekly) in order to correlate this level of objective physical activity with the levels of fatigue and quality of life. the hypothesis we formulate is as follows: the number of weekly steps is negatively correlated with the level of fatigue, positively with the quality of life and well-being.

Eligibility criteria:
inclusion criteria: * patients being treated, medical day hospital / had exclusion criteria: * inability to walk declared by an site medical doctor

Keywords: pedometer
utilized scan body technique for triple function

Conditions: Digital Technology; Dental Implant; Occlusion

Summary: a triple function scan body were done on healed dental implant, thus simplifying the workflow for full arch cases and reducing the number of visits to only 3 visits. in this technique, scan bodies were utilized for implant position scanning, facial scan alignment and as stoppers for jaw relation capturing as scan bodies were used as stoppers for jaw relation registration.

the present article describes a novel technique for merging a patient's facial scan with implant scan body and in the same time utilizing the same scan body for recording the jaw relation in only one visit. as a result, a facially driven full-arch implant-supported interim prosthesis can be fabricated first followed by the final restoration in a simplified approach. the aim of this study is to determine whether there is a difference between virtual design and reality using scan body technique (triple function scan body which reflects the accuracy of the scanning protocol. the null hypothesis established that there was consistency between the virtual design and prosthesis in patient's mouth. the scan body was placed in the edentulous arch in the jaw scan step so that bite registration would be easier for the intraoral scanner (ios) in order to be able to capture both the teeth of the antagonist and part of the scan body in the edentulous jaw simultaneously.

Eligibility criteria:
inclusion criteria: * patient had at least one edentulous arch with at least 5 osseointegrated implants with healing period of 3 months after surgical procedure. * implants are stable * systemically free exclusion criteria: * smokers * uncooperative patients

Keywords: jaw relation scan body full arch dental implants
amlodipine use in the prevention and treatment of iron overload in patients with thalassemia major

Conditions: Thalassemia Major

Summary: this study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. the study will follow 10 patients with thalassemia major: 5 will openly receive amlodipine and 5 will serve as controls, not receiving any additional drugs. patients will be monitored through one year with an additional year of follow up after the group using amlodipine stops its use. monitoring will occur through the measurement of blood ferritin as well as live and heart t2\* by mri.


Eligibility criteria:
inclusion criteria: * patients with thalassemia major over 6 years of age in use of iron chelating therapy. exclusion criteria: * pregnancy; * advanced heart failure with nyha iii/iv or lvef \< 35%; * formal contra-indications to an mri study; * patient with advanced heart block.

Keywords: thalassemia major calcium channel blockade magnetic resonance imaging