Kornimate/medical-research-clean huggingface dataset:
potential for drug-drug interactions between boceprevir and etravirine in hiv/hepatitis c virus negative volunteers

Conditions: Hepatitis C; HIV

Summary: the investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. the investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.

to investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. the pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be compared.

Eligibility criteria:
inclusion criteria: * men and women ages 18-60 years * absence of hiv-1 and hcv antibodies at screening * ability and willingness to give written informed consent before the first trial-related activity exclusion criteria: * pregnancy * breastfeeding * active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements. * participation in any investigation drug study within 30 days prior to study. * currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results. * use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions:aspirin, acetaminophen, once daily multivitamins, mineral supplements and hormonal oral contraceptives (other than those that contain drospirenone). concomitant medications other than those listed above must have been discontinued at least 14 days before study entry. * currently active dermatitis or urticaria or diagnosis of eczema or psoriasis. * history of significant drug allergy (i.e., anaphylaxis and/or angioedema) * subjects with the following laboratory abnormalities at screening as defined by the 2004 division of aids table for grading the severity of adult and pediatric adverse events and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (\>1.1 x upper limit of laboratory normal range (uln); hemoglobin grade 1 or greater (≤ 10.9 g/dl); platelet count grade 1 or greater (≤ 124.999 x 109/l); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/l); aspartate aminotransferase (ast) or alanine aminotransferase (alt) grade 1 or greater (≥ 1.25 x uln); total bilirubin grade 1 or greater (≥ 1.1 x uln), any other laboratory abnormality of grade 2 or above

Keywords: hcv hiv
preventing substance use and risky behavior among rural african american youth

Conditions: Risky Sexual Behavior

Summary: the rural african american families health (raafh) project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural african american families. one program, fuel, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. this program deals with diet and exercise, the influence of tv and magazines on eating habits, and handling stress. the second program, the strong african american families teen program (saaf-t), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. the sessions deal with goal setting, peer pressure, and staying in school.


Eligibility criteria:
inclusion criteria: * african american student in 10th grade * agree to randomization and assessment * resides in targeted county * target and parent speak english exclusion criteria: * active psychoses
safety of bilateral hto: one-stage vs.two-stage: a randomized controlled study

Conditions: Gonarthrosis; Primary; Varus Gonarthrosis

Summary: in this study, bilateral simultaneous high tibial osteotomy (hto) was compared with staged bilateral hto in terms of complications. we did not use any grafts to support the osteotomy line and the patients were mobilized immediately with a full load on a postoperative day 1. and our hypothesis is that bilateral simultaneous applications are safe in comparison to the staged ones in terms of complications.

knee osteoarthritis is the most common orthopedic chronic disease, and varus knee abnormalities can often be related. the load from the medial tibiofemoral joint increases significantly in varus alignment disorder and it plays an important role in the structural progression of knee osteoarthritis. varus malalignment and patients with medial tibiofemoral disease comprise a common patient subset. the probability of progressing to severe disease is 3 to 4 times higher in these patients compared to those with a neutral knee alignment. although the long-term results of high tibial osteotomy are well documented, but data on bilateral simultaneous hto are insufficient. in general, staged surgery is preferred in bilateral cases due to the difficult rehabilitation, healing of the osteotomy line, and complications related to surgery. advances in post-surgical rehabilitation have been made due to increased confidence in stability due to improvements in the technology of plates.the advantages of an bilateral simulatneous hto is single administration of anesthesia, total shortening of the hospitalization periof and reduced costs.

Eligibility criteria:
inclusion criteria: * bilateral primary genu varus gonarthrosis exclusion criteria: * secondary gonarthrosis
the development path

Conditions: Absenteeism

Summary: the aim of this project is a research-based evaluation of a multidisciplinary program focusing on moving citizens from unemployment and social security benefits to employment and education in sonderborg municipality. the citizens who are assigned cannot readily enter the labor market or can get education through employment initiatives in the job centre in sonderborg municipality because of complex health-related troubles. the project is designed to include a prospective observational study and a qualitative study using questionnaires, observations, interviews and informations about employment from the sonderborg municipality.


Eligibility criteria:
inclusion criteria: * assigned to a multidisciplinary program in sonderborg municipality (the law on active employment §68 https://www.retsinformation.dk/forms/r0710.aspx?id=164698#kap2 ) exclusion criteria: * not able to communicate in danish
effect of specific anti-toxoplasmatic add-on medication in toxoplasma gondii seropositive individuals with schizophrenia or major depression

Conditions: Schizophrenia; Major Depression

Summary: we investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for toxoplasma gondii (tg) infection. as tg modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. therefore, on the basis of an ex juvantibus approach, specific anti tg medication might further improve psychiatric symptomatology in affected patients. this is investigated in a double-blind, placebo-controlled, randomized treatment trial.


Eligibility criteria:
inclusion criteria: * schizophrenia or major depression * both genders * adult * patients are able to give informed consent exclusion criteria: * additional diagnosis of substance abuse/dependency * continuous treatment with medication not compatible with study medication * medical status not compatible with study medication * any condition that increases study risk considerably * pregnancy, nursing

Keywords: schizophrenia psychosis depression affective disorder
study of tramadol addiction impact on dental anesthesia success among algerian males

Conditions: Dental Procedure

Summary: dental anesthesia is considered by far one of the main procedures in dentistry; the performance of a good dental anesthesia with a correct technique is paramount in controlling pain, facilitating the work of the dentist and gaining the confidence and cooperation of the patient tramadol is an fda-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours half-life and different dosages as 50mg, 100mg, 200mg and 300mg. due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug

tramadol is an fda-approved medication for pain relief indicated mainly for moderate to severe pain, it is an opioid with 6 hours half-life and different dosages as 50mg, 100mg, 200mg and 300mg. due to possible abuse and addiction potential, limitations to its use should be for pain that is refractive to other pain medication, such as non-opioid pain medication, unfortunately, the almost non-existent of censorship in algeria and the disorderly framing made the obtain of tramadol as a medicine very easy which has led to a very alarming abuse of this drug meanwhile, apart from the systemic manifestations resulting from the abusive consumption of tramadol, it has become very clear that this opioid has a negative impact on the rapid and sufficient analgesic effect of dental anesthesia, it has been noticed that the anesthesia does not hold easily and the number of cartridges needed is increased, and therefore, a very particular attention must be attributed to the organization and control of its obtaining in order to limit its addiction in young people, an improvement of the care of patients must be offered according to the parameters necessary in the case of an addiction to tramadol

Eligibility criteria:
inclusion criteria: * males * ≥18 years * with no comorbid conditions (htn, diabetes \& epilepsy) * tramadol addict (regular tramadol user) exclusion criteria: * females * ˂ 18 years * with comorbid conditions (htn, diabetes \& epilepsy) * ≥ 65 years males

Keywords: dental anesthesia tramadol
evaluation of software enhancements to the respironics bipap autosv device compared to bipap s/t device

Conditions: Sleep Disordered Breathing

Summary: this study is being undertaken to collect data from respironics, inc's bipap autosv3 and compare with data from respironics, inc's bipap s/t device, to confirm that the algorithms in the bipap autosv3 device can safely and effectively treat participants experiencing comp sas no worse than the bipap s/t device. this will be determined using a comparative, randomized design with the participants blinded to the therapy. additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.

primary hypothesis and end-point: the use of the bipap autosv3 device in participants with comp sas will treat those participants no worse than when compared to the bipap s/t device with respect to: * apnea-hypopnea index (ahi) secondary hypothesis and end-points: the use of the bipap autosv3 device in participants with comp sas will treat those participants no worse than the bipap s/t device, with respect to: * sleep variables * rem, nrem and total sleep time (tst) indices * apnea hypopnea index (ahi) * center apnea index(cai) * obstructive apnea index (oai) * mixed apnea index (mai) * hypopnea index (hi) * sleep onset latency (sol) * rem onset latency (rol) * wake after sleep onset (waso) * total sleep time (tst) * sleep efficiency (se %) * wake (w), stages n1,n2,n3 (nrem), and rem (r) sleep (in minutes) * wake (w), stages n1,n2,n3 (nrem), and rem (r) sleep (% tst) * arousal index \[total, ah-related, plm-related, 'spontaneous'\] * nocturnal oxygenation (measured by continuous pulse oximetry during sleep study) * ahi (rem, nrem and tst) using modified hypopnea rule. * ahi (rem, nrem and tst) during epochs for which leak is determined to exist within acceptable limits

Eligibility criteria:
inclusion criteria: * age 21-80. * ability to provide consent. * documentation of medical stability by investigator. * currently using bipap s/t (at least 4 weeks on therapy). * participants who previously demonstrated complex sleep apnea (csa), with a central apnea index (cai) ≥5 during diagnosis study or on positive airway pressure (pap) titration. exclusion criteria: * participants, who are acutely ill, medically complicated or who are medically unstable. * participants in whom pap therapy is otherwise medically contraindicated. * participants who are unwilling to wear pap. * participants who are currently prescribed oxygen therapy. * participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (paco2 ≥ 45mmhg). * participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days. * participants with untreated, non-obstructive sleep apnea (osa)/csa sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome periodic limb movement (plm) arousal index \> 15). * participants who are unwilling to participate in the study.
video-interpreting in prehospital emergency medicine - feasibility study

Conditions: Communication Barriers

Summary: 50 responsive patients with language barriers will be included in this study. the prehospital emergency physician will start video-interpreting via a tablet. feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed.


Eligibility criteria:
inclusion criteria: * adult patients, at least 18 years old * awake, responsive patients * language barrier (albanian, dari, romanian, turkish, modern standard arabic, arabic, farsi, russian, hungarian, bosnian-croatian-serbian, kurdish (kurmanci), slovakian, bulgarian, polish, and czech) exclusion criteria: * unconscious patients * out-of-hospital cardiac arrest patients * delay of treatment or transportation due to e-interpreting * refusal of video-interpreting by the patient

Keywords: communication barriers prehospital emergency medicine emergency medicine emergency physician
feasibility test of virtual reality obstacle detection for low vision walking

Conditions: Hemianopsia; Homonymous Hemianopia; Tunnel Vision; Visual Field Defect, Peripheral; Visual Field Constriction Bilateral; Visual Field Defect Homonymous Bilateral

Summary: the investigators are developing a new test of pedestrian hazard detection in virtual reality (vr) head-mounted display (hmd) headset, which shows virtual oncoming pedestrians in 3d while subjects are walking in real-world environment, for evaluation of visual field expansion to improve mobility in people with visual field loss.

the investigators will develop a new pedestrian hazard detection test and conduct a single arm interventional clinical trial to evaluate simulated low vision assistive devices in a sample of field loss subjects. pedestrian detection performance with and without field expansion information will be tested and compared. the study will include 1 to 4 visits (each 2 to 4 hours) depending on the number of trials and experimental conditions (e.g., with and without simulated assistive devices) the subject is comfortable completing. the time between visits may vary depending on scheduling constraints and availability. during each visit, the subject will complete a series of simulated collision avoidance trials in vr requiring the detection and natural avoidance of a colliding pedestrian (alongside non-colliding pedestrians) while physically walking through an empty corridor. the study will be considered minimal-risk since there will be no physical obstacles that present actual collision risks.

Eligibility criteria:
inclusion criteria: * at least 14 years of age (no upper age limit) * in sufficiently good health to be able to complete sessions lasting 2-3 hours * able to understand english * able to give voluntary, informed consent * able to independently move short distances * binocular vision parameters within normal limits (stereopsis ≤ 100 arc sec on any stereo test) * visual field loss, either peripheral field loss (\<30 degrees diameter) or hemianopic field loss (blind in half of visual field) * better than 20/100 visual acuity in the worse eye exclusion criteria: * patients with any self-reported physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study * any person with a self-reported medical history (such as pacemaker use or photosensitive epilepsy) or physical condition listed on the device manual of the oculus / hmd system used for the experiment as a contraindication * any self-reported history of seizures (any type) in the last 6 months

Keywords: walking collision field expansion visual field loss
the significance of mri in the development of diagnostics and treatment of breast cancer

Conditions: Mammary Ductal Carcinoma

Summary: the purpose of this study is to determine how mri changes the treatment and diagnostics of ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the study.


Eligibility criteria:
inclusion criteria: * tumor size less than 2cm * ductal carcinoma unifocal exclusion criteria: * previous breast cancer

Keywords: carcinoma ductale mammae
long-term follow-up of interleukin-1b and h+,k+-atpase mrna expression after helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: we will evaluate the long-term changes of gastric h+, k+-adenosine triphosphatase (h+, k+-atpase) and interleukin-1b mrna expression according to helicobacter pylori (h.pylori) infection and intestinal metaplasia and investigate the long-term effect of h. pylori eradication

h. pylori suppresses gastric acid secretion by repressing gastric acid pump, h+, k+-atpase, and stimulating interleukin-1b. in this study, we will evaluate the expression of h+, k+-atpase and interleukin-1b mrna according to h. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. in addition, we observe the changes of h+, k+-atpase and interleukin-1b mrna expression over 5 years after h. pylori eradication.

Eligibility criteria:
inclusion criteria: * controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy * patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report exclusion criteria: * subjects with previous eradication treatment for h. pylori * subjects with previous gastrectomy

Keywords: helicobacter pylori interleukin-1 beta gastric h+, k+- aptase
the effect of gabapentin (neurentin) and pregabalin (lyrica) in pain reduction after photorefractive keratectomy

Conditions: Refractive Errors

Summary: the studied patients will be given randomly one of three following drugs1:gabapentin2: pregabalin or placebo for 3 days after photorefractive keratectomy surgery. the pain will be measured based on visual analog scale(vas) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.


Eligibility criteria:
inclusion criteria: * patients candidate for prk, 17\<age\<70 exclusion criteria: * use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of nsaids or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding
rct to determine the efficacy of combining hemospray with medical treatment in acute variceal bleeding

Conditions: Variceal Hemorrhage

Summary: introduction acute variceal bleeding (avb) is a severe complication of portal hypertension in patients with liver cirrhosis. the primary therapy includes the administration of vasoactive drugs, antibiotics and endoscopic therapy; preferably esophageal banding ligation (ebl) and/or cyanoacrylate injection when bleeding occurs from gastric varices. in this context, the idea is to assess "hemospray" (cook medical, winston-salem, nc) as an initial therapy in patients with massive bleeding as a temporary "bridge" until definitive treatment could be instituted. the data generated from the pilot study performed between erasme hospital, ulb and tbri , cairo showed that adding hemospray as early as possible in the management steps could increase the bleeding control rate up to 95 % at 24 hours. objective the primary efficacy objective of this study is to assess the efficacy of hemospray in combination with standard of care (soc) medical treatment compared to the efficacy of soc in the control arm in patient with acute variceal bleeding in cirrhotic patient. the primary safety objective of this study is to evaluate the safety of hemospray when used in combination with soc compared to soc in the control arm. 1.1. secondary: * to evaluate the effect of timing of hemospray treatment on the outcomes of bleeding patients * to evaluate the adverse effects on both therapeutic regimens (saes and clinically significant aes).

study endpoints : 1.1. primary endpoint: hemostasis is the primary end point: which is a combined endpoint of endoscopic hemostasis at (12-24) hours and clinical hemostasis during (12-24) hours. 1.2. secondary endpoints: * need for rescue endoscopy (before 12h) * safety * interaction with coagulation profile * rebleeding at 5 days. * survival at 5 days * survival at 30 days

Eligibility criteria:
inclusion criteria: * subject must be over 18 years of age. * suspected or proven acute variceal bleeding , gastric lavage will be done for all patients at admission (acute bleeding is confirmed on the presence of blood in stomach) * subjects must be willing to give written informed consent for the trial * known or suspected cirrhosis exclusion criteria: * patient is: \< 18 years of age * unable to consent * contraindicated to undergo endoscopy, * already hospitalized for another illness * pregnant or lactating * patients with altered post-surgical anatomy of the stomach * previously placed intrahepatic portosystemic shunt * patient treated by other endoscopic or surgical modalities within 30 days prior to the intended application of hemospray