Kornimate/medical-research-clean huggingface dataset:
single dose truvada study

Conditions: Medication Adherence; HIV Prevention

Summary: this study examines tenofovir (tfv) drug concentrations in adults one day after taking a single dose of truvada® - a pill used to prevent and treat hiv infection. the results of this study will be used to improve the (efficacy/accuracy) of a white coat adherence (wca) detection test - a blood test that can be used to indicate medication adherence. participants will receive one dose of truvada®, and provide 2 total samples of blood.

to establish the plasma and peripheral blood mononuclear cells (pbmc) concentrations of tfv and tfv diphosphate (tfv-dp), respectively, following a single oral dose of truvada® \[300 mg tenofovir disoproxil fumarate (tdf) in fixed dose combination with emtricitabine (ftc)\], the same formulation used for hiv pre-exposure prophylaxis (prep), and in prior benchmarking adherence studies (hptn 066). this will be compared to steady-state tfv and tfv-dp concentrations to more robustly differentiate single dose concentrations from steady-state concentrations. this is part of a larger project to determine the frequency of white coat adherence in several clinical studies where doses are not observed. for purposes of diagnosing wca with tdf, the investigators define wca quantitatively as taking a single dose of tdf preceded by no doses in the prior week. the investigators will compare tfv and tfv-dp concentrations following an observed single oral dose of tdf/ftc to steady-state concentrations of tfv and tfv-dp after daily dosing under observation. the study plan involves a screening visit to assess eligibility, followed by two study visits. visit one involves pre-dose blood testing, followed by a single dose of truvada. visit two occurs 24-hours after visit one, and involves collection of a final post-dose blood sample. blood will be assessed for tenofovir and tenofovir analyte concentrations.

Eligibility criteria:
inclusion criteria: * healthy with no acute medical illness * willing to provide written informed consent * age 18 years of age or older * negative qualitative urine pregnancy test at screening and on day of dosing, prior to dosing, female participants only * hiv-1 negative at screening, as documented by combo ag/ab hiv-1/hiv-2 immunoassay * at screening, no evidence of hepatic or renal impairment \[creatinine clearance \> 60 ml/min, total bilirubin ≤ upper limit of normal (uln), alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 1.5 uln\] exclusion criteria: * concomitant antiretroviral or other medication use, for which there is a known risk of pharmacokinetic or pharmacodynamic drug interactions. * active medical or psychological condition that, in the opinion of the investigator, might put the volunteer at undue risk or interfere with the participation of the study.
gelatin sponge vs ptfe membrane for socket sealing after immediate implant placement

Conditions: Dental Implant Failed; Teeth Absent; Soft Tissue Injuries

Summary: digital panoramas will be made to assess the implant sites. the included patients are assigned to their respective groups randomly. after implant submerging in the study group 2 layers of hemostatic resorbable gelatin sponge is fixed in the implant site; while with the control group ptfe is fixed. after 3 weeks the ptfe was removed while the gelatin sponge should be resorbed. 3 months later the implants are to be assessed for stability and a reverse torque test was used to confirm osseointegration during uncovering. follow-up appointments at 1,3 weeks and 1,2 \& 3 months were planned.

dental implants are considered the gold standard for treatment of edentulous spaces. immediate implant placement has multiple advantages including the shorter treatment span, less surgical procedures and faster loading possibility \[1\]. one of the drawbacks of immediate implant placement is proper soft tissue coverage of the submerged implant to prevent socket infection and allow implant stability and osseointegration \[2\]. to overcome these issues the use of membranes has been the standard procedure \[3\]. polytetrafluoroethylene membranes (ptfe) have been reported vastly in literature and their results and clinical effect on soft tissue healing and guided tissue regeneration (gtr) around implants and in surgical sites. dense ptfe allows for gtr by only promoting non-bacterial migration and improving cellular adhesion which promotes tissue regeneration underneath it \[4\]. on the other hand, ptfe membranes are quite expensive and with the economic crisis the world is facing the use of other less expensive options is crucial. gelatin sponges are vastly used as hemostatic agents in minor surgical procedures and have shown excellent results in terms of hemostasis and rapid resorption \[5\]. the application of such material are multiple; such as with sinus lift procedures \[6\], microvascular decompression\[7\] and as a wound dressing \[8\]. the investigators hereby propose the use of hemostatic gelatin sponges as membranes for submerged immediate implants as a simpler and cheaper alternative to ptfe.

Eligibility criteria:
inclusion criteria: * patients with badly broken down tooth indicated for immediate implantation * generally healthy patients 22-50 years of age * non smokers * good oral hygiene exclusion criteria: * poor bone quality * poor oral hygiene * non compliant patient

Keywords: ptfe immediate implantation gelatin sponge dental socket
intravitreal aflibercept injection or early vitrectomy for diabetic vitreous hemorrhage

Conditions: Diabetic Vitreous Hemorrhage

Summary: prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

selected patients were divided into two groups, group i for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group ii for whom early vitrectomy was done.

Eligibility criteria:
inclusion criteria: * age above 18 years. * any sex. * type ι or ιι dm, * recent diabetic vh which is causing vision impairment, precluding complete prp and needing treatment. * bcva is less than 20/70 (log mar bcva 0.6) and better than 20/1000 (log mar bcva 1.7). exclusion criteria: * tractional retinal detachment. * previous prp. * history of anti vegf therapy within the past two months. * neovascular glaucoma * subhyaloid hemorrhage. * vitreomacular traction. * diabetic macular edema . * patients with systemic contraindications for anti vegf or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.

Keywords: aflibercept panretinal photocoagulation vitrectomy
retrieval study and histological examination of a hip femoral components with hydroxyapatite coatings

Conditions: Femoral Neck Fractures

Summary: retrieval study and histological examination of bimetric femoral components with hydroxyapatite coatings.

a single type of femoral component with 3 different ha coatings will be evaluated in this study. patients with fractured neck of femur requiring hemi-arthroplasty will be recruited. safety and performance of the device will be determined by adverse events (device related or non-related), survival and histological exam.

Eligibility criteria:
inclusion criteria: * fractured neck of femur requiring hemi-arthroplasty. selection of subjects for this evaluation should include the following considerations:-. * a likelihood of obtaining relief of pain and improved function. * full skeletal maturity. * ability to follow instructions. * good general health for age. * willing to return for follow-up evaluations . * no bias to sex. exclusion criteria: • none
the role of nitric oxide in cognition in schizophrenia

Conditions: Schizophrenia; Psychotic Disorders

Summary: this study evaluates the role of the nitric oxide system in cognition in patients with schizophrenia. participants will be randomised to 2 equal groups and receive either the nitric oxide donor molecule glyceryl trinitrate, or a placebo. performance on several cognitive tasks will be assessed.

nitric oxide \[no\] is a gaseous neurotransmitter substance found in the brain. nitric oxide is integrated with the glutamate system. glutamate has received considerable attention as an important factor in the cognitive distortions and cognitive impairments that underlie schizophrenia. deficits in glutamate in schizophrenia may impact upon cognition via the no system, as glutamate receptors signal by way of no. here the investigators aim to extend knowledge of glutamate-no systems by directly examining the role of no in cognition in patients with psychosis. we aim to assess the role of the no system in cognition, downstream of glutamate and before patients are started on any anti-psychotic medication which perturb brain neurochemistry. the primary outcome measure is change in a particular style of cognition referred to as 'jumping to conclusions' following the administration of a potent nitric oxide donor molecule \[glyceryl trinitrate (gtn)\], under placebo-controlled, double-blind conditions. this will shed light on the direct role of no in cognition in psychosis, beyond the glutamate system.

Eligibility criteria:
inclusion criteria: * 18-40 years of age * patients undergoing an acute psychotic episode (defined as score \> 4 on question p1 of the panss positive subscale) requiring full-time hospitalisation according to clinical referral by the relevant mental health service * demonstrates capacity and willing to give informed consent * female participants willing to have a pregnancy test before treatment * currently unmedicated with antipsychotic medication exclusion criteria: * major physical illness * prior history of intolerance to glyceryl trinitrate * homicidal or suicidal * pregnant or breast feeding

Keywords: nitric oxide cognition
shock wave and spastic cerebral palsy equines foot

Conditions: Cerebral Palsy

Summary: a double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. the two groups received traditional therapeutic exercises for 12 weeks. additionally, study group received resw (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4hz, energy of 0.030 mj/mm2). all children were evaluated at baseline, and after 12 weeks by modified ashworth scale, biodex system 4 isokinetic dynamometer, gross motor function measure (gmfm-88), dimensions "d" standing and "e" walking, trost selective motor control test, and single leg standing test.

both groups underwent conventional physical therapy program which included muscle stretching, strengthening exercises, neurodevelopmental techniques, proprioceptive training, and balance and gait training for three months (3 days/week ,1 hour/day). study group subjects in this group received the traditional physical therapy treatment plus true radial eswt.a resw pneumatic device (shock med, italy) was used to provide one session per week (for a total of 12-week) of shock wave intervention. the pressure pulses were focused on the muscle belly of the planter flexor hypertonic muscles. standard ultrasonic gel was used as a contact medium. a total of 1500 shots with a pressure of 1.5 bar and an energy flux density (efd) of 0.030 mj/mm2 were applied with the repetition frequency of shock wave irradiation of 4 pulses per second (hz). the resw session lasted about 6 minutes and was painless; thus, local anesthesia was not required.

Eligibility criteria:
inclusion criteria: * 1) children who could walk independently or with assistive devices ,2) children with motor dysfunction graded as a 1 or 2 on the gross motor function classification system (gmfcs), 3) children scoring 1or1+ on the modified ashworth scale (mas), 4) dynamic ankle contracture which was confirmed if ankle equinus was observed during ambulation and passive dorsiflexion of the ankle could be accomplished beyond the neutral position with knee extended exclusion criteria: * 1) children older than 9 years or younger than 7 years, 2) previous botulinum toxin type a injection in the gastrocnemius muscle or serial casting of the ankle within 6 months prior to enrollment, 3) fixed ankle contracture, and 4) surgery of the lower limbs in the past 12 months.

Keywords: cerebral palsy extracorporeal shock wave therapy hemiplegia selective motor control
evaluation of metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals

Conditions: Geriatrics; Fragility; Locomotor; Physical Fitness; Balance

Summary: metabolic syndrome (mets) or syndrome x, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. it causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. low levels of physical activity can be caused by a wide variety of factors including environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. factors such as genetic differences, diet, physical activity, age, gender and eating habits are reported to affect the prevalence of (mets) and its components. frailty is also emerging as a major issue for the elderly due to its debilitating effects on health outcomes. frailty is a geriatric syndrome characterized by a gradual decrease in homeostatic tolerance and physiological reserve following exposure to stressors. frailty predisposes older people to falls, delirium, hospitalizations and even death and is therefore considered a crucial transition between healthy ageing and disability. as a result of aging, degenerative changes in the central and peripheral vestibular system have been found. with age, the ability to regulate movement is impaired as a result of insufficient information in any of the sensory receptors or any disorder affecting the processing of these messages. this directly affects balance and postural control, leading to an increased risk of falls. in the light of the results of the studies in the literature, degenerative changes are observed in many systems in geriatric individuals and while the incidence of metabolic syndrome in these individuals is high, the number of studies evaluating their effects is not sufficient. based on these deficiencies, it is aimed to examine metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals.


Eligibility criteria:
inclusion criteria: * individuals aged 65 and over, * volunteering to participate in the research * no cooperation and communication problems exclusion criteria: * individuals with neurological and orthopedic problems * uncontrolled hypertension * those with cardiac disorders * those with cooperation and communication problems
a pilot study of dextromethorphan for the prevention and treatment of methotrexate neurotoxicity

Conditions: Neurotoxicity Syndromes

Summary: the purposes of this study are to find out whether dextromethorphan can prevent the short or long-term neurologic side effects of methotrexate, and whether dextromethorphan can improve symptoms of short-term neurologic side effects if they do occur.

we believe that we are beginning to understand the biological cause of the neurotoxicity that happens after treatment with methotrexate. dextromethorphan, an ingredient in common cough medicines, may be able to prevent and/or treat this neurotoxicity. we have given dextromethorphan to a small group of patients who developed severe neurologic side effects after methotrexate. all had a complete recovery within one day.

Eligibility criteria:
inclusion criteria: * newly diagnosed acute lymphocytic leukemia (all), non-hodgkin's lymphoma (nhl) or os. patients will be separately stratified and randomized by disease. * patients with history of seizures are eligible but will be stratified separately. exclusion criteria: * patients taking monoamine oxidase inhibitors (maois) will be excluded from the study, because of the risk of severe drug interactions. * pregnant or lactating women.

Keywords: methotrexate neurotoxicity
the clinical effect of adaptive posture-balance cardiac rehabilitation exercise on cardiovascular diseases

Conditions: Cardiac Rehabilitation; Exercise Therapy; Balance Exercises; Cardiovascular Diseases

Summary: the whole experiment included one-month apbcre therapy and two assessments. the one-month apbcre consisted of twelve exercise sessions, evenly three times per week. at baseline and after rehabilitation, participants underwent one assessment, including car-diopulmonary exercise testing (cpet), resting metabolic rate (rmr) detection, and quality of life questionnaire (qol). the primary outcomes were exercise capacity measured by function parameters at anaerobic threshold (at) and other cpet physiological indexes. the secondary endpoints were the rmr level and qol score.


Eligibility criteria:
inclusion criteria: * age between 18 and 90 years * with cardiovascular diseases exclusion criteria: * abnormal blood pressure response * unstable angina pectoris * acute heart failure * congenital heart disease * severe musculoskeletal diseases
remediation of working memory in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. to accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. in both conditions participants will receive computer training three times a week for 4 months. the investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. in addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. a second study goal is to examine the stability of the intervention-induced changes in cognition. cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. the val158met polymorphism of the comt gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. the study will test whether the comt polymorphism is predictive of response to cognitive remediation.


Eligibility criteria:
inclusion criteria: * veterans with a dsm-iv diagnosis of schizophrenia or schizoaffective disorder * no hospitalizations in the previous 4 weeks * no antipsychotic medication changes in the previous 4 weeks * age 18-60 * does not meet dsm-iv criteria for substance dependence in the previous 6 months or substance abuse in the previous month exclusion criteria: * history of clinically significant head injury or neurological disease * poor comprehension of the english language * history of diagnosis of mental retardation or pervasive developmental disorder * unable to give informed consent
tongue depressor-related ischemia-reperfusion injury in tongue

Conditions: Side Effect; Ischemia Reperfusion Injury; Edema; Tongue Enlarged

Summary: this study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using usg in patients undergoing suspension laryngoscopy (sl) procedures.

suspension laryngoscopy (sl) is a surgical procedure for both diagnostic and therapeutic purposes. in this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.the tongue is an ideal organ for evaluation with ultrasonography. this study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in sl procedures.

Eligibility criteria:
study group inclusion criteria: * patients aged 20 years or older * patients who undergo suspension laryngoscope procedure exclusion criteria: * refusal to participate * age of \<20 years * history of syndromal craniofacial abnormalities * occurrence of tongue masses * history of craniofacial surgery * history of burns, trauma or radiotherapy involving the head and neck region * neurologic disorders and patients with obstructive sleep apnea syndrome (osas) * active inflammation in the head and neck region * cervical rigidity limiting neck flexion and head extension control group inclusion criteria: patients aged 20 years or older patients who did not need suspension laryngoscopy and any head and neck procedures

Keywords: tongue ischemia-reperfusion injury side effect edema suspension laryngoscopy