Kornimate/medical-research-clean huggingface dataset:
a study of encapsulated cell technology (ect) implant for participants with early stage retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to look at the safety and effectiveness of cntf implants on vision in persons with retinitis pigmentosa, usher type ii \& iii, and choroideremia. this research is being done because there are no effective therapies for people with these retinal degenerations. they are genetic disorders that affect one's ability to see at night, and later cause tunnel vision and loss of central vision. retinal degenerations affect the retina, a light sensitive layer of cells in the back of the eye. slowly over time, these cells die and cause permanent loss of vision. the implant is a small capsule that contains human retinal pigment epithelium cells. these cells have been given the ability to make cntf and release it through the capsule membrane into the surrounding fluid. in this study, two different cntf dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.

this study will involve about 18 visits over 2½ years for specific tests of the participant's vision and health. these visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. the primary effectiveness outcome for this study will be a visual field score one year after the implant surgery. there will be about 12 centers participating in this study, and up to 60 people enrolled, across the us. each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on each eye, one of which will include a very small cell-filled implant. follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat retinitis pigmentosa (rp).

Eligibility criteria:
study inclusion / exclusion criteria: criteria for patients to qualify for the study include, but are not limited to: * over 18 years of age, and less than 65 years of age * diagnosis of retinitis pigmentosa, usher syndrome type 2 or 3 or choroideremia * visual acuity no worse than 20/63 * experience with at least two full threshold humphrey visual field 30-2 tests, one completed within the year prior to enrolling in this study the following criteria will exclude patients from the study: * pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception. * retinitis pigmentosa caused by a classic syndrome, including usher type i * other eye diseases including advanced cataract. * chronic systemic disease requiring continuous treatment with systemic steroids, immunosuppressive medications or insulin.

Keywords: retinitis pigmentosa eye disease retinal disorder cntf
screening for hip and knee osteoarthritis in the general population: predictive value of a questionnaire and prevalence estimates

Conditions: Hip and Knee Osteoarthritis

Summary: objective: to study the feasibility and validity of a two-step telephone screening procedure for symptomatic knee and hip osteoarthritis (oa) in the general population. method: the screening questionnaire was based on signs and symptoms, previous diagnosis of oa, and validated oa criteria. a random sample of telephone numbers was obtained and, at each number, one individual aged 40 to 75 years was included. a physical examination and knee or hip radiographs were offered when the screen was positive. a sample of individuals with negative screens was also examined. the diagnosis of hip/knee oa was based on either american college of rheumatology criteria for signs and symptoms and kellgren-lawrence radiographic stage 2 or greater. prevalence rates were estimated with correction for the performance of the screening procedure.


Eligibility criteria:
inclusion criteria: * individual aged 40 to 75 years
comparative controlled study of analgesic, antiasthenic and anti-anxiety effects of xenon in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this study evaluates the hypothesis that the gas mixture with xenon will have a positive effect on the symptoms in patients with parkinson's disease. the study will test the hypothesis that the gas mixture with xenon has a symptomatic treatment potential for patients with parkinson's disease, as measured by change from baseline in the unified parkinson disease rating scale (updrs).


Eligibility criteria:
inclusion criteria: * the patient must be male or female over the age of 18. * the subject must have idiopathic parkinson's disease. * the subject has stage iii by hoehn and yahr in the "on" state on a screening visit * subjects suffering from anxiety, depression, cognitive dysfunction * dopaminergic drugs should be taken in a stable dosage for 28 days prior to registration, and throughout the study * patients who have signed an approved consent form and are consistent with both the clinical trial plan and follow-up. exclusion criteria: * patients have atypical parkinsonism (eg, neuroleptics, metoclopramide, flunarizin), metabolic neurodegenerative disorders (eg, wilson's disease), encephalitis, cerebrovascular disease or degenerative disease (e.g. progressive supranuclear palsy) * patients who received deep brain stimulation * patients with cancer, hiv, kidney or liver disease. * patients taking new antipsychotic, antidepressant, anxiolytic or narcotic drugs for less than 3 months
assessing the impact of incorporating charlson comorbidity scores on patient anxiety and satisfaction

Conditions: Prostate Cancer

Summary: the purpose of this study was to determine whether providing patients with life expectancy (le) information in the form of their prostate cancer comorbidity index (pcci) scores impacted their decisional conflict or anxiety about prostate cancer or death.

patients with newly diagnosed prostate cancer were consented and randomized to receive standard of care counseling (soc) versus the same counseling plus provision of their specific le (pcci). patients were blinded to the specific content of their counseling session. after counseling, patients completed the decisional conflict scale (dcs), death anxiety scale (das), memorial anxiety scale for prostate cancer (max-pc), and patient satisfaction questionnaire (psq-18). treatment preferences were assessed.

Eligibility criteria:
inclusion criteria: * men 18 years and older * newly diagnosed prostate cancer exclusion criteria: * non-english speaking * prior history of prostate cancer
l-methylfolate supplementation to oros-methylphenidate pharmacotherapy in adhd adults

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this pilot study seeks to evaluate initial evidence for the effect of l-methylfolate supplementation to oros-methylphenidate pharmacotherapy on adhd symptoms and associated features in adults with adhd, as well as tolerability of this supplementation. the investigators will conduct a 12-week double-blind randomized placebo-controlled trial with l-methylfolate supplementing open-label oros-methylphenidate (oros-mph). the investigators propose to examine 40 adult (ages 18-55) subjects satisfying the dsm-iv diagnostic criteria for adhd.


Eligibility criteria:
inclusion criteria: 1. male or female adults ages 18-55 years of age. 2. a diagnosis of childhood onset adhd, meeting all but the age of onset criteria according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv), based on clinical assessment. childhood onset will be defined according to established research criteria, requiring onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. 3. a score of 24 or more on the adult adhd investigator symptom report scale (aisrs). exclusion criteria: 1. a history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician. 2. a history of intolerance to l-methylfolate supplementation. 3. pregnant or nursing females. 4. serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease. 5. glaucoma. 6. clinically unstable psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, history of or current marked anxiety, tension or agitation potentially exacerbated by a stimulant, or lifetime history of any other clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis. 7. significant impairment due to tics, based on clinician judgment. 8. a family history or diagnosis of tourette's syndrome 9. current (within 3 months) dsm-iv criteria for abuse or dependence with any psychoactive substance other than nicotine. 10. multiple adverse drug reactions. 11. any other concomitant medication considered to be effective for management of adhd; individuals on stable treatment with agents with central nervous system activity will be allowed to participate, as detailed in the concomitant medication portion of the protocol. 12. current use of mao inhibitor or use within the past two weeks. 13. investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. 14. use of supplemental folic acid greater than 400 mcg per day, l-methylfolate, or omega-3 fatty acids greater than 800 mg per day within two weeks prior to the baseline study visit.

Keywords: adhd attention deficit hyperactivity disorder deplin l-methylfolate natural treatments medical food
circadian rhythm disruption in the hospital intensive care environment

Conditions: Surgery; Cardiovascular Diseases

Summary: abrupt changes to one's lifestyle disrupt biorhythms. acute effects are well known from jet lag where transmeridian travel leads to insomnia, fatigue, irritability, gastrointestinal symptoms and other complaints. several studies in the hospital environment reported dampened and misaligned biorhythms, suggesting that the inpatient experience is replete with circadian disruptors. however, comprehensive assessments of how circadian clocks are affected in intensive care and how this predicts post-operative recovery and risk are largely missing.


Eligibility criteria:
inclusion criteria: * adults scheduled for cardiac surgery; * ≥18 years of age; * capable of giving informed consent; * own a smartphone (apple devices only). exclusion criteria: * taking sleep aids (antihistamines, melatonin, etc.) * history of alcohol abuse (more than 2 drinks a day with last drink within the past 3 days) * history of substance abuse at risk of postoperative withdrawal; * active diagnosis of alcohol or substance abuse; * recent travel across more than two (2) time zones (within the past month); * planned travel across more than two (2) time zones during the planned study activities; * subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; * subjects without access to wifi in their or close to home or at work; * patients with hearing aids; * heart transplant patients; * patients in isolation.
the potential biochemical diagnosis criteria and therapeutic effect indexes: sex hormone binding globulin levels and free androgen index in blood of patients with polycystic ovary syndrome

Conditions: The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;; At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;; 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;; The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.

Summary: to explore whether free androgen index（fai）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with polycentric ovary syndrome（pcos）. also to explore whether sex hormone-binding globulin（shbg） and fai can be seen as therapeutic effect indicatrixes of women with pcos.


Eligibility criteria:
inclusion criteria: * the clinical diagnosis criteria for pcos by european society of human reproduction and embryology, and rotterdam working group of american society for reproductive medicine (eshre /asrm ) exclusion criteria: * hyperprolactinemia and other endocrine diseases such as high androgen hormone in blood, namely cushing's syndrome, congenital adrenal hyperplasia ( cah ), ovarian or adrenal tumor and so on
sepsis in icu:causes and outcomes in diabetics and non diabetics

Conditions: Sepsis

Summary: identify prevalence of sepsis in icu of assiut university hospital 2.clarify different causes of sepsis in patients admitted to icu . 3.compare causes and outcomes of sepsis between diabetics versus non diabetics . 4.screening for the co1.mmonest organism causing sepsis in critically ill patients .

sepsis, is defined as an infection with organ dysfunction, there is wide variation in sepsis rates, causative microorganisms, and outcome in icu patients around the world. many conservative estimates considered sepsis as a leading cause of mortality and critical illness worldwide . sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock . factors such as advancing age, immunosuppression and multidrug-resistant infection play a role in increasing incidence of sepsis during recent decades . patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications. patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients. the prevalence of diabetes mellitus in icu patients is as high as 30%, and such patients are at increased risk of experiencing in-hospital complications, compared to patients without diabetes. infective complications may be reduced with lower blood glucose concentrations moreover, in critically ill patients without diabetes, hyperglycemia is associated with increased mortality, risk of infection, kidney injury and cardiovascular complications. moreover, diabetes is a major risk factor for both acute kidney injury and sepsis. sepsis also is a major cause of acute kidney injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteraemia or shock . sepsis-related aki is associated with high mortality rates of up to 70%.

Eligibility criteria:
inclusion criteria: * according to sofa criteria suspected /documented infection+sofa score \>_2 or +ve q sofa defined as 2or more 1_ hypotesion sbp\ 22 or septic shock criteria * previous history of pulmonary problem previous history of cardiac disease previous history of autoimmune disease
role of antibiotics to reduce infectious complications in tube thoracotomy management of traumatic hemopneumothorax

Conditions: Hemopneumothorax; Pneumothorax

Summary: the purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.

in this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. a placebo is something that looks like a "real" medication, but it doesn't contain any active medication. as a participant in this study, you may receive the active medication (cefazolin sodium injection or clindamycin) or you may receive a placebo.

Eligibility criteria:
inclusion criteria: 1. age ≥ 16 years of age. 2. admission to trauma, general surgery, and/or surgical critical care services. 3. traumatic pneumothorax, hemothorax or hemopneumothorax exclusion criteria: 1. pregnancy 2. open fracture 3. immunocompromised 4. require antibiotics for treatment of other injuries 5. chest tube placement greater than 72hrs after admission

Keywords: traumatic hemopneumothorax thoracotomy antibiotics
prophylactic oxytocin before versus after placental delivery to reduce blood loss in vaginal delivery

Conditions: Postpartum Hemorrhage

Summary: randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.

400 patients will be recruited for the study,informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients. the recruited patients will be subjected to the following: * history taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history. * checking vital signs, general and abdominal examination. * laboratory investigations: complete blood count (cbc) * findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram. * all deliveries will be attended by a senior resident in the hospital. * included patients will receive the medication according to randomization tables. * after allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss. * all patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord. * all patients will undergo cord clamping and cutting within 30 seconds of delivery. * all patients will undergo uterine massage for 30 seconds after placental delivery. * vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery. * cbc will be collected 6 hours after delivery.

Eligibility criteria:
inclusion criteria: 1. multiparous women (had previous one, up to four deliveries) 2. term pregnancy (37 completed weeks at least). 3. singleton viable cephalic pregnancy. 4. vaginal delivery. exclusion criteria: 1. primigravida.(first pregnancy) 2. grand multiparous. (had previous 5 or more deliveries) 3. maternal illness (involving pregnancy induced condition; pih,gdm or chronic medical condition; hypertension, cardiac , renal problems) 4. previous cesarean section, uterine surgery. 5. patients with bleeding tendency. 6. previous history of ante-partum hemorrhage. 7. previous history of postpartum hemorrhage. 8. abnormal site of the placenta (detected by ultrasound) 9. macrosomic baby (efw more than 4000 gm estimated clinically or by ultrasound) 10. polyhydramnios.(detected by ultrasound) 11. multiple gestation. 12. chorioamnionitis. 13. suspected fetal problem(anomaly, distress) 14. instrumental delivery. 15. multiple or deep vaginal tears that compromise the estimation of uterine blood loss. 16. cesarean delivery
invasive decoding and stimulation of altered reward computations in depression

Conditions: Major Depressive Disorder

Summary: novel invasive neurostimulation stimulation strategies through neurosurgical interventions are emerging as a promising therapeutical strategy for major depressive disorder. these have been applied mostly to the anterior cingulate cortex, but other limbic brain regions have shown promise as anatomical targets for new neurostimulation strategies. the researchers seek to study neural activity in limbic brain areas implicated in decision behavior and mood regulation to identify novel targets for treatment through electrical stimulation. to do this, the study team will record local field potentials (lfps) from the orbitofrontal cortex, hippocampus and amygdala of epilepsy participants undergoing invasive monitoring (intracranial encephalography, ieeg) during choice behavior. leveraging the high co-morbidity of depression and intractable epilepsy (33-50%), neural responses will be compared to reward across depression status to identify abnormal responses in depression. finally, the researchers will use these as biomarkers to guide development of neurostimulation strategies for the treatment of depression.

participants (n=24) will complete a decision-making task in which participants will make decisions under uncertainty and seek to maximize rewards. the researchers will assess behavioral (risk attitudes) and neural (lfp) responses using a combination of intracranial recordings and computational modeling. a subset of patients will complete the game a second time under electrical stimulation of pre-identified anatomical targets in orbitofrontal cortex, hippocampus or amygdala. in addition, patients' depression status will be assessed through questionnaires (bdi-ii and hdsa). finally, the researchers will examine whether electrical stimulation results in behavioral or mood modulation.

Eligibility criteria:
inclusion criteria: - the study will follow clinical criteria for epilepsy patient recruitment for invasive monitoring. as a results, individuals of adults of all ages are expected to be included in this study. exclusion criteria: * adults over 80 years of age will be excluded as per concerns of cognitive decline. * children under 18 will be excluded from the study since the maturation of frontal lobes continues through adolescence and significant differences in frontal lobe functioning between children younger than 18 and adults are often observed.

Keywords: electrophysiology stereotactic encephalography brain stimulation
safety and efficacy of different add powers with a new presbyopic lasik treatment algorithm

Conditions: Ametropia

Summary: this is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center pmcf clinical study whereby presbyopic patients undergoing refractive surgery will receive a supracor treatment for the correction in the non-dominant eye and a proscan refractive treatment in the dominant eye to correct for ametropia. the participants will be randomized to either a supracor regular (100%) or supracor strong (130%) treatment with a 1:1 ratio.


Eligibility criteria:
inclusion criteria: * presbyopia * willingness for a refractive presbyopia correction * signed informed consent form exclusion criteria: - ocular comorbidity