Kornimate/medical-research-clean huggingface dataset:
duloxetine compared with placebo in the prevention of relapse in generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: this is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.


Eligibility criteria:
inclusion criteria: * patients presenting with generalized anxiety disorder (gad) in the absence of major depressive disorder (mdd). patients must suffer from gad and not from an adjustment disorder or anxiety disorder not otherwise specified (nos). symptoms of gad should not be situational in nature. exclusion criteria: * any current and primary diagnosis other than gad. patients diagnosed with or who have a history of mdd within the past 6 months or patients diagnosed with or who have a history of panic disorder, post-traumatic stress disorder (ptsd), or an eating disorder within the past year or patients who have been diagnosed with obsessive- compulsive disorder (ocd), bipolar affective disorder, psychosis, factitious disorder or somatoform disorders during their lifetime. * history of alcohol or any psychoactive substance abuse of dependence (as defined in the dsm-iv-tr) within the past 6 months * serious medical illness, including cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. clinically significant laboratory abnormalities are those, that, in the judgement of the investigator, indicate a serious medical problem. * acute liver injury (such as hepatitis) or severe cirrhosis (child- pugh class c)
effect of berberine on metabolic syndrome, efficacy and safety in combination with antiretroviral therapy in plwh.

Conditions: Metabolic Syndrome; HIV-1-infection; Glucose Intolerance; Dyslipidemias; Lipodystrophy; Lipoatrophy

Summary: with current antiretroviral therapy, people living with hiv reach virological suppression faster, which in turn leads to a higher life expectancy. nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance. berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with hiv under virological suppression. we hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * documented hiv-1 infection * stable antiretroviral therapy at least 6 months before enrollment * viral suppression * metabolic syndrome , defined by adult treatment panel-iii criteria * no previously known kidney or liver disease * signed informed consent exclusion criteria: * people younger than 18 years and older than 60 years * prior atherosclerotic cardiovascular disease * diabetes mellitus type 1 or 2 * previous use of glucose and/or lipid modifying medications * pregnancy * withdrawal of informed consent
effects of family work shop for children with developmental delays

Conditions: Developmental Delays

Summary: the purpose of this study is to identify the effects of family work shop for children with developmental delays.

methods： 1. the family work shop has 5 courses, with 6 families in one course. 2. intervention: 2-3 hours per session, one time per week, for a total of 6 weeks. effect： 1. investigate the effects of family work shop for children with developmental delays, including health related quality of life, functional performance. 2. investigate the effects of family care giver strain on family work shop for parents of children with developmental delays. 3. investigate the differences of family impact between children with development delays and children with normal development.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of developmental delays and must be able to attend 6 weeks of work shop exclusion criteria: * failed to obtain written informed consent

Keywords: family work shop
photobiomodulation for pediatric hypertrophic tonsils

Conditions: Pediatric Sleep Apnea; Obstructive Sleep Apnea; Tonsils Hypertrophy

Summary: pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. this is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. however, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea. the use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as pbm) has been a relatively new development within medicine. recently, dentists have begun to use pbm as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. to date, there are no known side effects to the use of pbm for the treatment of any sleep breathing disorders. however, no research has been published on the use of pbm for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children the purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting. the investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved ahi scores (be able to breath significantly better when sleeping) in these children.


Eligibility criteria:
inclusion criteria: * brodsky visually graded tonsils 3/4 * patient must assent, parent must consent, to all pre and post follow up including sleep testing * patient and parent must agree to normal referral protocols regardless of participation within this study or not exclusion criteria: * visual indication of cancerous growth * currently under treatment (pharmacologic, other) for hypertrophic tonsils * already scheduled for surgical intervention of hypertrophic tonsils
efficacy of an investigational thermal rehab machine on body cooling in hyperthermic individuals

Conditions: Cryotherapy Effect

Summary: exertional heat stroke (ehs) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. it is diagnosed when the rectal temperature is above 40°c with the presence of central nervous dysfunction (altered mental status). the gold standard method of care for ehs is immediate onsite whole body cooling using cold-water immersion (cooling rates \>0.15°c•min-1), which is reported to have the highest cooling rate. in the treatment of ehs, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°c to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. however, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. in this proposed study, the investigators aim to examine the cooling rates of the polar breeze® device (developed by statim technologies, llc, clearwater, fl) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.


Eligibility criteria:
inclusion criteria: * male between the ages of 18-35. * recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session) exclusion criteria: * chronic health problems, * fever or current illness at the time of testing * history of cardiovascular, metabolic, or respiratory disease * current musculoskeletal injury that limits physical activity * history of exertional heat illness in the past three years.
effectiveness of a developmental reciprocity treatment program in autism

Conditions: Autism Spectrum Disorder; Autism

Summary: this is a research study examining the effectiveness of a developmental reciprocity treatment program (drt-p) in treating social deficits in children with autism spectrum disorders (asd). developmental reciprocity treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits. researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement drp with in-home, therapist-implemented treatment. to determine the effectiveness of the drt-p, it will be compared to a delayed treatment group (dtg) by conducting a randomized controlled 24-week trial. this research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. we hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder based on autism diagnostic interview revised (adi-r), autism diagnostic observation schedule (ados-2), dsm-5, and expert clinical opinion; * males and females in good medical health between 2.0 and 5 years 11 months; * ability to participate in the testing procedures to the extent that valid standard scores can be obtained; * stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation; * availability of at least one english-speaking parent who can consistently participate in parent training and research measures; * clinical global impression(cgi) severity social interaction and communication integrated subscale ≥4; * meet the cutoff for autism on the ados-2. exclusion criteria: * current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.); * a well-established genetic syndrome, such as fragile x; * presence of active medical problem (e.g., unstable seizure disorder or heart disease); * child's primary language other than english; * previous adequate trial or training of a developmentally based intervention; * participants living more than 45 miles from stanford university; * children with more than 20 hours of in-home aba; * at least one room of the house must be available to be dedicated to treatment during session times; * there must be no serious health and safety risks present in the home environment; * the research team has the right to refuse to perform sessions in-home even if the criteria above are met.

Keywords: developmental
our experience in the management of therapeutic failures of fractures of the proximal end of the femur (about 35 cases)

Conditions: Proximal Femur Fractures

Summary: osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function. osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern. in light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. in cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (tha). however, it is essential to note that tha subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications.

the aim was to identify the causes of mechanical failures of osteosynthesis in order to prevent them. methods: we present the experience of the department of surgical orthopedic surgery, concerning 35 cases summarized after failure of surgical treatment of a fracture of the proximal end of the femur for a period spreading between january 2015 and december 2021. . the literature already found evidence of the greater complexity of this type of procedure compared to a first-line total hip prosthesis. accordingly, all this, prevention is better than cure these stiffnesses through good preoperative planning. other factors related to the terrain or to untimely loading of the implant are more difficult to control. whatever the cause, the surgeon remains by the rigor in these indications, the choice of the synthetic material the essential element in the prevention of osteosynthesis failures.

Eligibility criteria:
inclusion criteria: * • diagnosis of a fracture of the proximal end of the femur. * subsequent surgical intervention(s) due to failure of initial surgical treatment exclusion criteria: * • those initially treated with total hip arthroplasty. * patients lost to follow-up, not consistently monitored, or untreated after diagnosis of the complication. * cases with incomplete medical records

Keywords: femoral neck fracture pertrochanteric fracture internal osteosynthesis mechanical complications
greater occipital nerve block versus metoclopramide

Conditions: Migraine

Summary: we are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. this is a randomized, double-blind, double dummy study. the greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. standard therapy is metoclopramide 10mg iv.


Eligibility criteria:
inclusion criteria: eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the international classification of headache disorders-3β (1.1, migraine without aura). patients who meet criteria for probable migraine without aura (1.5.1) will also be included, provided they have had at least one similar attack previously. exclusion criteria: patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including p2y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, parkinson's disease, use of mao inhibitors, and use of anti-rejection transplant medications.
association between pilatis exercise, balance and stability measurements, and quality of life among elderly population

Conditions: Quality of Life; Accidental Falls

Summary: background: the elderly population in western countries and in israel is constantly growing. falls are one of the common problems among this population. thus there is a need for falls prevention exercise program to be offered in the different settings elderly reside. most methods for physical exercise are dedicated to muscle strengthening and improving balance by strengthening external muscles. pilatis exercise program focuses mainly on strengthening the in-depth muscles. the advantage of this method is in its simplicity and availability. this method is suitable also for special populations as patients in acute hospitalization. in this study, the investigators will evaluate if the pilatis exercise can improve balance of elderly population. physical exercise usually improves the mood. like any physical exercise, pilatis exercise has a mental advantage, therefore, this study will also examine if pilatis exercise can improve quality of life of elderly population. working hypothesis and aims: pilatis exercise will improve balance and stability measurements, and quality of life among elderly population. methods: randomized, prospective study among elderly patients aged 65 and above belonging to clalit health services primary care clinic . participants of the intervention and control group will receive a brochure that will include nutrition and healthy life style recommendations. intervention group: will receive 12 weeks of pilatis exercise 3 times a week. the control group will be offered the same intervention at the end of the study period. balance evaluation will be performed using the: tinetti balance gait scale, berg balance scale, multidirectional reach test, timed up and go, step execution test. the sf-36 questionnaire will be use to evaluate quality of life. importance: this study will examine the influence of pilatis exercise on balance among the elderly. if findings will determine that pilatis does improve balance in the elderly, the investigators can further examine pilatis's influence on falls prevention, and minimizing falls damages. probable implications to the welfare and health of the aged population: improving balance, falls preventing and minimizing falls damages among elderly; improvement in elderly quality of life.


Eligibility criteria:
inclusion criteria: * man and women aged 65 years old and above * able to walk independently without devices (cane is exceptable) exclusion criteria: 1. unstable diseases (unstable angina; heart failure- niha 3 or 4; lung disease with shortness of breath on light effort; end stage liver and kidney diseases; terminal malignant diseases) 2. mmse less then 24 3. after hip or knee surgery 4. after lower limb amputation 5. neurological diseases with significant gait and balance instability.

Keywords: independent 65 years old and above
a safety and efficacy pilot study comparing natrova creme rinse 1% and nix creme rinse

Conditions: Pediculosis Capitis; Head Lice

Summary: a pilot study to compare the safety and efficacy of natrova creme rinse 1% to nix creme rinse in subjects with pediculosis capitis

a phase 2b, randomized, single-site, investigator/evaluator blind, two-arm, parallel-group pilot study that tested the operational elements of an "actual use" study designed to evaluate the safety and efficacy of a 10-minute treatment and no-nit combing regimen of natrova creme rinse 1% versus nix creme rinse in subjects with at least a mild case of head lice.

Eligibility criteria:
inclusion criteria: * male or female, 6 months of age or older * subject must have a head lice infestation present at baseline * subject/caregiver must read english or spanish at a 7th grade level * subject must have an appropriately signed informed consent agreement * other members of the household with a lice infestation must be willing to be enrolled in the study or treat their infestations with a standard treatment * subject agreement to not use any other form of lice treatment during the course of the study * subject agreement to not cut or chemically treat their hair in the period between baseline and final, post-treatment visits exclusion criteria: * individuals with a history of irritation or sensitivity to pediculicides or hair care products * individuals with any visible skin/scalp condition at the treatment site that could interfere with the evaluation * individuals previously treated with a pediculicide or any other head lice treatment product within 48 hours prior to enrollment * individuals receiving systemic or topical drugs that may interfere with the study results * individuals who have participated in a clinical trial within 30 days of enrollment * individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to use the standard course of lice treatment * females who are pregnant or nursing * sexually-active females not using effective contraception

Keywords: pediculosis capitis head lice
rivastigmine study in adolescents with down syndrome

Conditions: Down Syndrome

Summary: the purpose of this study is to determine if short term use of rivastigmine can improve functional abilities (for example, language, memory, and executive function) in adolescents with down syndrome.

this 24 week, double-blind, placebo controlled trial will be completed at the clinical research unit of duke university medical center and at the kennedy krieger institute (kki). sixteen evaluable subjects will be enrolled at duke and 24 evaluable subjects will be enrolled at kki. the study consists of four visits, a screening visit (-4 weeks), a baseline visit (week 0); a safety visit at week 10, and a final/termination visit at week 20. the specific aims of this study are to: a) investigate efficacy of rivastigmine tartrate treatment; b) build upon our open-label treatment results of overall function and language improvement in adolescents with down syndrome (ds) in a double-blind, placebo-controlled clinical trial; and c) investigate other specific cognitive domains that may selectively respond to rivastigmine tartrate treatment. the original irb-approved protocol included the parent/caregiver rating form of the vineland adaptive behavior scales- second edition (vabs-ii) . the protocol was amended to replace the parent/caregiver rating form of the vineland adaptive behavior scales- second edition (vabs-ii) with the vineland adaptive behavior scales, second edition, survey interview form. the protocol was also amended to extend the trial from 12 weeks to 20 weeks. due to the changes in the amended protocol the subject enrolled prior to the irb amendment will not be included in the data analysis section.

Eligibility criteria:
inclusion criteria: 1. correct verbal responses for 7/9 of the expressive one word picture vocabulary test items. 2. subject able to put at least 2-3 words together in conversational speech. 3. subject's speech is understandable to the examiner for the majority of the time. 4. subjects are in good health and medically stable exclusion criteria: 1. subject uses sign language as a primary means of communication 2. subject has a medical history that contraindicate the use of rivastigmine (for example, patients with active seizure disorders, asthma, celiac disease, heart disease or heart rhythm disorders).

Keywords: clinical trial down syndrome adolescents cognitive rivastigmine