Kornimate/medical-research-clean huggingface dataset:
optimising anterior pallidal deep brain stimulation for tourette's syndrome

Conditions: Tourette's Syndrome

Summary: the motor tics associated with tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. the best area within this brain region and the best stimulation device settings are currently unknown. this is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. the hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. at the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.


Eligibility criteria:
inclusion criteria: * age 14 to 60 years * patient group with tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication exclusion criteria: * surgical contraindications to deep brain stimulation surgery * major depressive episode within the previous 6 months * schizophrenia or other psychotic disorder * personality disorder impairing ability to reliably comply with study protocol * significant cognitive impairment

Keywords: tourette's syndrome deep brain stimulation stereotactic surgery globus pallidus interna tics
the natural history and outcome of sleep disordered breathing in children

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: sleep-disordered breathing in children is characterized by recurrent events of partial or complete upper airway obstruction during sleep, resulting in disruption of normal gas exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. the major symptom is snoring or noisy breathing. sleep disordered breathing (sdb) is a wide spectrum of disorders that includes primary snoring, uars and osa. the main etiology for sdb in children is enlarged tonsils and adenoids and therefore the first line of treatment in pediatric sdb is adenotonsillectomy. the objectives of this study are: 1. to investigate the natural history of primary snoring 2. to investigate the effect of seasonality on sdb severity 3. to compare the effect of adenoidectomy to adenotonsillectomy in the treatment of sdb in children 4. to characterize the children referred for repeated psg following adenoidectomy or adenotonsillectomy and the indications for second psg evaluation.


Eligibility criteria:
inclusion criteria: * healthy normally developing children that underwent psg evaluation at the tel aviv medical center between 2005-2010 exclusion criteria: * chronic medical and neurodevelopmental conditions. * congenital anomalies.
barriers to eye screening for people with diabetes in india

Conditions: Diabetic Macular Edema

Summary: brief summary: diabetic retinopathy (dr) is a leading cause of visual impairment and has major public health implications globally and especially in countries such as india where the prevalence of diabetes is high. with timely screening and intervention, the disease progression to blindness can be prevented but several barriers exist to the provision of care. the long term aim is to identify the barriers to dr screening and to plan potential interventional strategies. from the qualitative study, the reasons such as lack of awareness or knowledge, distance to travel, lack of reminder system were identified as a reason for poor follow-up. this lead to the development of interventional strategies. this was a randomized, investigator-masked clinical trial that was conducted in a tertiary eye care centre in south india. consecutive patients with diabetes who were residents in chennai and its vicinity of approximately 100 km radius and who were undergoing repeated intravitreal injections for dme were recruited into the trial. the aim of the study is to investigate the effect of sms informational reminders among patients with diabetic macular edema for the follow-up. they study consists of 2 groups, sms reminder group receives the reminders 1 week and 2 days prior to the scheduled appointments with the concerned doctor on a particular date and time, whereas other group does not receive any reminders for the appointment schedule. after the follow-up, the patients will be screened for the attendance at the review visit.


Eligibility criteria:
inclusion criteria: * adults with \> 40 years of age * diagnosed as centre involving diabetic macular edema (dme) * patients who received intravitreal injections for dme * ability to give informed consent exclusion criteria: * patients from outside the area of residence who stayed more than 100 km from the hospital * patients with ocular co-morbidities other than dme

Keywords: screening follow-up short message service
visual function and ocular pigmentation in albinism

Conditions: Albinism; Albinism, Ocular; Albinism, Oculocutaneous

Summary: to study the relationship between visual function and ocular (iris, retina/choroidal) pigmentation in patients with albinism and other hypomelanotic disorders. to identify the carrier state in relatives of patients with ocular albinism.

visual function and ocular pigmentation are being studied in patients with albinism and other disorders associated with hypopigmentation. the degree of ocular pigmentation is assessed clinically by estimating the melanin content of the iris, retinal pigment epithelium, and choroid. visual function is measured in the conventional manner to study central vision, and electrophysiological methods to detect a misrouting of the visual pathways. the purpose of this study is to document the visual deficit and the pigmentary changes of patients with albinism, to observe their natural course, and to determine whether misrouting of the visual pathways is present and is correlated with pigmentation.

Eligibility criteria:
patients have been recruited into the study by referral from an ophthalmologist or pediatrician. entrance into the study was dependent upon clinical evidence of decreased or absent pigmentation in skin, hair, and/or eyes. the definition was purposefully broad to include the broad range of phenotype variations and clinical heterogeneity. the purpose of the study id to be able to document iris and retina/choroidal pigmentation and correlated these finding with visual function.

Keywords: albinism ocular albinism oculocutaneous albinism tyrosinase negative tyrosinase positive
mobile study to measure and predict lupus disease activity using digital signals

Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus

Summary: oasis: a mobile study to measure and predict lupus (sle) disease activity using digital signals the oasis study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be used to predict changes in lupus disease activity. you may receive a withings steel hr smartwatch as part of this study. the purpose of this study is to look for factors that affect lupus disease activity and potentially predict lupus flares through non-clinical tests


Eligibility criteria:
inclusion criteria: * female or male age 18 or older * participant is currently not enrolled in another study * able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures exclusion criteria: * not able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures * known to be pregnant

Keywords: lupus sle
oritavancin for staphylococcus aureus infections in opioid users

Conditions: Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis

Summary: this will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with staphylococcus aureus (s. aureus) in opioid users. the purpose of this pilot proposal is to collect information for a subsequent large, randomized intervention. primary endpoints will be 1) safety and tolerability, and 2) duration of hospitalization and rate of recurrence.

this will be an early phase, single center, open label pilot study of 15 participants designed to evaluate the effects of oritavancin in patients with opioid use disorder and/or intravenous drug use and systemic s. aureus infections. in this study systemic infections refers to bacteremia or infectious endocarditis. participants who meet inclusion and exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for ie. participants will be evaluated weekly until completion of treatment and then at week 4 and week 6 after the infusion of oritavancin. participants will have blood drawn at each visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by culture for the presence of relapse of the infection. at the last visit, participants will have an echocardiogram.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * systemic infection with s. aureus * afebrile for \>48 hours * negative blood cultures for at least 48 hours * absolute neutrophil count (anc) equal or greater 750/mm3 * hemoglobin \> 9.0 g/dl * platelet count equal or \> 50,000/mm3 * creatinine \< 2.0 x uln * ast ; alt, and alkaline phosphatase \< 2.0 x uln * willing to use a medically accepted method of contraception exclusion criteria: * require valve replacement surgery * have prosthetic material in body (this includes prosthetic heart valves and/or prosthetic joints) * septic emboli to central nervous system or lungs * breast feeding during entire participation * pregnant * polymicrobial infection * require anticoagulation * allergy to vancomycin or oritavancin
oatmeal and insulin resistance: oma-ir

Conditions: Diabetes Mellitus Type 2; Insulin Resistance

Summary: insulin resistance is a central feature of diabetes mellitus type 2 (stumvoll et al. 2005). hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ada et al. 2006 diab care) and with the development of microvascular complications (ukpds 34 lancet 1998). a long known therapy for the acute treatment of patients with deteriorated glucose metabolism and insulin resistance are carbohydrate days. the principle of the therapy was firstly introduced in 1903 by carl von noorden (noorden et al. 1903). the diabetic patients were treated for several days with a carbohydrate rich diet with fat restriction. surprisingly, this resulted in an amelioration of glucosuria. today it's still a valuable tool for patients with uncontrollable diabetes mellitus and severe insulin resistance (willms b. 1989). but up to now there has been no systemic evaluation of carbohydrate days in patients with deteriorated diabetes mellitus and insulin resistance. the investigators conducted a pilot study with 14 patients to evaluate the efficacy of two days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and after a four week outpatient period. inclusion criteria were type 2 diabetes with deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than 1 u per day and kg bodyweight. within this pilot trial the investigators found a marked decrease of insulin requirements (\~40%) and mean daily blood glucose to a mean blood glucose of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period (lammert et al. 2006). the most important shortcomings of this study were the hypocaloric interventions in both groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to attribute the observed effects to oatmeal alone as well as the uncontrolled nature. these design flaws have been addressed within this new clinical trial. the investigators plan an open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted diet: \~ 1200kcal/d). the intervention comprises two days of oatmeal (third and fourth day) within a 5 day hospital stay. the control is only treated with 5 days of diabetes adapted diet. thereafter, the patients are followed every four weeks for an overall of 16 weeks.


Eligibility criteria:
inclusion criteria: * diabetes mellitus 2 * insulin therapy * stable therapy modality within the last 3 months * deteriorated glucose metabolism (hba1c \> 7%) * insulin resistance, defined as more than 1 unit of insulin per kg and day exclusion criteria: * acute vascular event within the last 3 months * planed weight reducing therapy * acute and chronic inflammatory disease * therapy with corticosteroids * pregnancy
outcomes 8 years after minimal invasive tha

Conditions: Osteoarthritis, Hip

Summary: there exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (mi) total hip arthroplasty (tha). the investigators examined in a randomized study design 157 patients 8 years after tha, which were performed via 3 different surgical approaches.

in contrast to reported short-term advantages of minimally invasive (mi) total hip arthroplasty (tha) there exists only limited scientific evidence concerning medium- to long-term benefits. the investigators therefore sought to answer the following questions: is the functional medium-term outcome in tha patients with mi-anterior(mi-a) and mi-anterolateral (mi-al) approach superior to those treated by direct lateral approach (dla)? is the level of life quality increased by mi-tha? is patient satisfaction higher by mi-tha? is the revision rate reduced by mi-tha?

Eligibility criteria:
inclusion criteria: * clinical and radiologic signs of advanced hip joint degeneration * patients from age 18 to 75 exclusion criteria: * osteoporosis and * osteomalacia, * preceding surgery or radiation therapy in the proximity of the affected hip joint, * progressive neoplasia, * preceding or manifest infection of the affected joint and its surrounding soft tissues, * rheumatoid arthritis, * hip dysplasia hartofilakidis type 2 or 3, * non-compliance, * chronic neurological or psychiatric diseases, * ongoing pregnancy

Keywords: total hip arthroplasty minimally invasive patient-relevant outcomes
study of oral debio 0123 in combination with carboplatin in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study has two parts: dose escalation and dose expansion. the primary objective of the study, in the dose escalation part is to determine the recommended phase 2 dose (rp2d) of debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available. the primary objective of the study, in the dose expansion part is to characterize the safety and tolerability of debio 0123 when administered in combination with carboplatin at the rp2d determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of debio 0123 when administered in combination with carboplatin.


Eligibility criteria:
inclusion criteria: dose escalation: * histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available * able and willing to undergo tumor biopsy * prior platinum-based therapy (carboplatin or cisplatin). * life expectancy of at least 3 months * ecog ps 0-1 dose expansion: * histologically or cytologically confirmed, recurrent solid tumors of selected types. * participants must have progressed after at least 1 prior platinum-based line of therapy for advanced/metastatic disease. * participants must be platinum resistant (defined as progression within 6 months of completion of their most recent platinum-based chemotherapy). prior poly (adp-ribose) polymerase (parp) inhibitor therapy is allowed. platinum-based therapy does not need to be the last treatment prior to study entry. * measurable disease per response evaluation criteria in solid tumors (recist) version 1.1 * documented progressive or recurrent disease according to recist 1.1 since the last anti-cancer therapy and prior to study entry * able and willing to undergo tumor biopsy * ecog ps 0-1 * life expectancy of at least 3 months exclusion criteria: dose escalation and dose expansion: * history of other malignancies requiring active treatment in the last 6 months * brain tumors and/or symptomatic brain metastases * receiving other investigating agents * presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites * prior exposure to any wee1 inhibitor

Keywords: wee1-inhibitor
neurobiology of posttraumatic stress disorder dysfunction and recovery following cognitive processing therapy

Conditions: Posttraumatic Stress Disorder

Summary: posttraumatic stress disorder (ptsd) is a significant personal and societal burden. the purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity changes related to ptsd dysfunction and recovery before and after treatment with cognitive processing therapy.

using functional magnetic resonance imaging approaches, the present research aims to examine the relationship between traumatic experience and the neural mechanisms of various ptsd symptoms, and determine how this relationship changes during ptsd extinction. also, this proposal aims to better understand how the genetic/epigenetic profile of several genes predicts, and perhaps changes, in response to recovery from ptsd along with its neural correlates. this understanding will help identify individuals who will respond most optimally to a specific empirically based ptsd treatment, cognitive processing therapy, while further connecting genetic biomarkers of risk with neural intermediate phenotypes underlying ptsd symptomatology.this study is observational as the investigator does not assign specific interventions to the participants of the study.

Eligibility criteria:
inclusion criteria: * ptsd diagnosis, as measured by the clinician administered ptsd scale for dsm-5 * history of chronic childhood trauma due to relational abuse * ability to understand and sign informed consent * enrollment in cpt program at mclean hospital * both genders, all ethnic backgrounds, age between 18 and 55 * fluent english speakers * normal or corrected vision exclusion criteria: * history or current schizophrenia spectrum disorder or other psychotic disorders * history or current bipolar or other related disorders * alcohol and/or substance use disorder within the past month * metal implants * medical or neurological illness (e.g., seizures, head injury in which they experienced a loss of consciousness) * positive pregnancy test

Keywords: ptsd biomarker cognitive processing therapy
the effect of erector spinae plane block on quality of recovery and postoperative analgesia after inguinal hernia repair

Conditions: Postoperative Pain; Inguinal Hernia; Acute Pain

Summary: inguinal hernia repair (ihr) is one of the most commonly performed operations in general surgery practice. different pharmacological approaches and interfascial plane blocks are used to control postoperative pain. erector spinae plane (esp) block is a relatively new interfascial plane block which was reported to be effective in different types of surgeries. in this study, the primary aim is to assess the effect of esp on recovery of patients following open ihr surgery.

inguinal hernia repair (ihr) is one of the most commonly performed operations in general surgery practice. unfortunately, 40% of the patients experience moderate-to-severe acute pain in the early period. erector spinae plane (esp) block is a relatively new interfascial plane block which was described in 2016. in this prospective, controlled trial, the primary hypothesis is that ultrasound-guided unilateral esp block will provide an increase in the quality of recovery-15 scores which will be assessed at the postoperative 24th hour following open ihr surgery. the secondary hypothesis is that esp block will reduce postoperative pain scores, need for rescue analgesia and time to first mobilization.the study will be conducted as a single-center, prospective, randomized, controlled, double-blinded trial in a university hospital. patients scheduled for an elective unilateral open ihr under spinal anesthesia, will be screened for enrollment to the study. at the end of the operation, patients will be randomized to receive a unilateral esp block with 30 ml of 0.25% bupivacaine or 30 ml of normal saline at the level of t12 vertebrae. a blinded anesthesiologist will collect outcome measures in the postoperative period.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i-ii * elective unilateral open inguinal hernia repair under spinal anesthesia exclusion criteria: * coagulation disorder * known allergy to study drugs * chronic opioid use * infection at the injection site * use of pain medications * psychologic disorder or inability to cooperate quality of recovery-15 (qor-15) test * preoperative pain related to inguinal hernia nrs \> 4/10

Keywords: erector spinae plane block inguinal hernia interfascial plane postoperative pain