Kornimate/medical-research-clean huggingface dataset:
comparing cognitive-behavioral therapy versus mindfulness-based therapy for autistic adults

Conditions: Autism Spectrum Disorder; Depression; Anxiety

Summary: autistic adults are at a greater risk for mental health problems compared to the general population, with 50% meeting criteria for a co-occurring psychiatric condition. depression and anxiety are the most common of these conditions among autistic adults, contributing to long-term detrimental effects on health, day-to-day functioning, and quality of life. this study will conduct the first large-scale head-to-head comparison of the two most widely studied mental health interventions for autistic adults: cognitive-behavioral therapy (cbt) and mindfulness-based therapy (mbt). both interventions are well-established, empirically supported treatments for depression and anxiety in the general population, and both interventions have demonstrated efficacy among autistic adults. however, their comparative effectiveness and heterogeneity of treatment effects have not been established in autistic adults. both interventions will be delivered by telehealth.

this study includes three aims: aim 1. evaluate the effectiveness of two different mental health interventions, cbt versus mbt, to improve patient-centered mental health outcomes, quality of life, well-being, and functional impairment among autistic adults with co-occurring anxiety and/or depressive disorders. aim 2. explore patient characteristics (e.g., expressive language ability, intellectual ability, alexithymia, sensory sensitivity) that may moderate the relationship between cbt or mbt and patient outcomes. aim 3. compare implementation outcomes of acceptability and feasibility of cbt relative to mbt as reported by patients and clinicians using mixed methods.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * co-occurring depression and/or anxiety as determined by a total score ≥10 on the phq-ads * living in north carolina or virginia * ability to participate in therapy sessions over telehealth * english-speaking * provide proof of a professional diagnosis of autism or meet or exceed clinical cut-off on the social responsiveness scale (srs-2) autism screening instrument exclusion criteria: * altered mental status that precludes the ability to provide informed assent or consent (acute psychosis, intoxication, or mania) * imminent risk of suicide

Keywords: autism spectrum disorder depression anxiety
evaluation of human milk fortifiers in preterm infants

Conditions: Infant Growth

Summary: the purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.


Eligibility criteria:
inclusion criteria: * birth weight of 700 g-1500 g. * ≤ 32 weeks and 0 days ga at birth. * appropriate for ga (aga). * enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0). * mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified. * parent(s) agrees to allow infant to receive both human milk and hmf. * singleton or twin births only. exclusion criteria: * enteral feeding of preterm infant formula or hmf for \> 7 days. * expected to be transferred to another facility and will not be able to be followed for at least 15 days. * serious congenital abnormalities or underlying disease that may affect growth and development. * 5 minute apgar ≤ 4. * steroids used at the time of randomization. * grade iii or iv periventricular/intraventricular hemorrhage (pvh/ivh). * mechanical ventilator dependence. * maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with hiv therapy. * infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia). * asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by apgar score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24). * confirmed necrotizing enterocolitis (bell's stage ii or iii, appendix j) or confirmed sepsis (positive culture requiring antibiotic treatment). * infant has any other condition that, in the opinion of the investigator, precludes participation in the study. * participation in another study that has not been approved as a concomitant study by an.
pilot study on caffeine efficiency in adcy5-related dyskinesia

Conditions: Dyskinesias

Summary: heterozygous mutations in the adcy5 gene cause involuntary early-onset hyperkinetic movements. in addition, patients may have associated psychiatric disorders.there is currently no treatment. as the pathophysiology is linked to adcy5 hyperactivity, the investigative team has treated patients with caffeine, an antagonist. the investigator wishes to interview patients on the effect of caffeine on their motor symptoms and their overall clinical condition, and on the possible existence of psychiatric comorbidities using phone questionnaires.

heterozygous mutations in the adcy5 gene cause involuntary early-onset hyperkinetic movements. the phenotype combines chorea, dystonia and / or myoclonus with frequent facial involvement, axial hypotonia, fluctuations and / or episodes of paroxysmal dyskinesia which can be nocturnal and / or painful. many treatments have been tried, with no obvious efficacy. two patients from the same family (a father and daughter) told investigators that caffeine had a dramatic effect on their paroxysmal episodes. they said that taking coffee would prevent episodes and reduce their duration (efficacy estimated at 80%), an effect specific to caffeine since it was reproduced by the ingestion of caffeine citrate capsules. very interestingly, there is a rationale underlying this phenomenon. indeed, caffeine is an antagonist of the adenosine a2a receptors (a2ar), receptors which activate adcy5 and which are localized preferentially in striatal neurons expressing dopamine d2 receptors. as caffeine is an a2ar antagonist, it likely inhibits adcy5, and therefore induces clinical improvement in patients with hyperactivity of this protein. in addition, the investigative team noted anxiety in some of its patients, and the question of the presence of psychiatric disorders in adcy5 patients was recently raised in the literature. the investigative team wishes to collect standardized preliminary data by questioning patients on the effect of caffeine on their motor symptoms and their overall clinical state, and on the possible existence of psychiatric comorbidities using structured questionnaires which will be carried out by phone.

Eligibility criteria:
inclusion criteria: * proven genetic diagnosis of adcy5-related dyskinesia * caffeine intake * non opposition by the patient or the legal representatives if the patient is a minor. no exclusion criteria.

Keywords: adcy5 mutation
pediatric ocular trauma in minia governate

Conditions: Pediatric Ocular Trauma

Summary: the most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. the epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and creative activities and type of registration and recording of data. about half a million people in the world are blind as a result of eye injuries. about 30-40% of monocular blindness is due to ocular trauma


Eligibility criteria:
inclusion criteria: * age below 16 years exclusion criteria: * age above 16 years previous ocular surgery
diabetic retinopathy study (drs)

Conditions: Diabetic Retinopathy; Blindness

Summary: to determine whether photocoagulation helps prevent severe visual loss from proliferative diabetic retinopathy. to determine whether a difference exists in the efficacy and safety of argon versus xenon photocoagulation for proliferative diabetic retinopathy.

by the 1950s, diabetic retinopathy had become a leading cause of blindness and visual disability in the united states. the use of photocoagulation to treat proliferative retinopathy gained widespread use in ophthalmic practice following its introduction in 1959. however, only a few studies of photocoagulation incorporated any of the basic principles of controlled clinical trials, and these involved inadequate numbers of patients. consequently, there has been inadequate evidence of the actual value of the procedure. because of the clinical importance of diabetic retinopathy and the increasing use of photocoagulation in its management, the diabetic retinopathy study (drs) was begun in 1971. this randomized, controlled clinical trial involved more than 1,700 patients enrolled at 15 medical centers. one eye of each patient was randomly assigned to immediate photocoagulation and the other to followup without treatment, regardless of the course followed by either eye. the eye chosen for photocoagulation was randomly assigned to either of two treatment techniques, one using an argon laser and the other a xenon arc photocoagulator. patients were followed at 4-month intervals according to a protocol that provided for measurement of best corrected visual acuity. treatment was usually completed in one or two sittings and included scatter (panretinal) photocoagulation extending to or beyond the vortex vein ampulae. the argon treatment technique specified 800 to 1,600, 500-micron scatter burns of 0.1 second duration and direct treatment of new vessels whether on or within one disc diameter of the optic disc (nvd) or outside this area (nve). focal treatment was also applied to microaneurysms or other lesions thought to be causing macular edema. followup treatment was applied as needed at 4-month intervals. the xenon technique was similar, but scatter burns were fewer in number, generally of longer duration, and stronger, and direct treatment was applied only to nve on the surface of the retina.

Eligibility criteria:
patients were eligible if they had best corrected visual acuity of 20/100 or better in each eye and the presence of proliferative diabetic retinopathy in at least one eye or severe nonproliferative retinopathy in both eyes. they could not have had prior treatment with photocoagulation or pituitary ablation, and both eyes had to be suitable for photocoagulation. all eligible patients were younger than 70 years, and the examining physician assessed the outlook for survival and availability for 5 years of followup to be good.

Keywords: vision loss
efficacy and safety of hemostyp as an adjunct for management of secondary hemostasis in the operative setting

Conditions: Hemostasis; Bleeding

Summary: the purpose of the study is to assess efficacy and safety of hemostyp as an adjunct for management of secondary hemostasis in the operative setting.

this study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare hemostyp with surgicel® in the management of bleeding during surgery.

Eligibility criteria:
inclusion criteria: 1. elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery); 2. at time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical; 3. ages: pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and 4. subjects or parent or legal guardian of the subject who are willing and able to sign consent. exclusion criteria: 1. physical or psychological condition which would impair study participation; 2. indications for emergency surgery; 3. pre-operative laboratory findings of a hematologic disorder; 4. subjects with history of moderate to severe allergies; 5. subjects undergoing minimally invasive laparoscopic surgery; 6. subjects who will require platelet or fresh frozen plasma transfusion during surgery; 7. subjects who are pregnant or breast-feeding at the time of surgery; or 8. subjects on p2y12 platelet inhibitor (plavix) less than 5 days prior to surgery, warfarin or xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.
study of the long term safety of serlopitant for the treatment of pruritus (itch)

Conditions: Pruritus; Prurigo Nodularis; Atopic Dermatitis; Psoriasis

Summary: study of the long term safety of serlopitant for the treatment of pruritus in adults.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older at consent. * pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis. * female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug. * willing and able to comply with study visits and study related requirements including providing written informed consent. exclusion criteria: * malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies). * any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment. * untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject. * investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study. * treatment with other neurokinin-1 receptor (nk1-r) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks. * treatment with strong cytochrome p450 3a4 inhibitors within 4 weeks. * currently pregnant or breastfeeding or planning to become pregnant during the study.
effects of surgical timing on perioperative clinical outcomes in pancreaticoduodenectomy

Conditions: Pancreaticoduodenal; Fistula; Surgery Timing; Perioperative Complication

Summary: with the advancement of surgical techniques and the increase in pancreatic oncologic diseases, the volume of pancreaticoduodenal surgeries has been increasing year by year in our center, and multiple pancreaticoduodenal surgeries are often performed on the day of surgery. this study will compare the effect of pancreaticoduodenal surgery performed at different times on patient prognosis. this study plans to divide the patients into morning group, afternoon group, and night group through the start time of surgery, and this study plans to analyze subgroups such as laparoscopic pancreaticoduodenal surgery. the outcome indicators include perioperative complications such as pancreatic fistula, bleeding, abdominal infection, hospitalization cost, and length of hospital stay. the conclusions drawn from this study will suggest to surgeons whether pancreaticoduodenal surgery performed at different times of the day will have different outcomes for patients and will guide surgeons on the timing of pancreaticoduodenal surgery.


Eligibility criteria:
inclusion criteria: 1. patients must be required to sign an informed consent form; 2. age 18-80 years, male and female; 3. ecog physical status score (ps score) 0 or 1. 4. pancreaticoduodenectomy at our center without contraindications related to the surgery. exclusion criteria: 1. pre-existing or concurrent other malignant tumors 2. severe cardiopulmonary and renal dysfunction. 3. autoimmune disease or history of immunodeficiency 4. active infections and infectious diseases requiring systemic therapy. 5. history of psychotropic substance abuse, alcoholism or drug addiction. 6. failure to meet the inclusion criteria as determined by the investigator.
evaluation of a third and fourth dose of staphvax® in adults with end-stage renal disease

Conditions: Staphylococcal Infections; Chronic Kidney Failure

Summary: this study is a continued evaluation of the immune response to staphvax , a staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. the immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.


Eligibility criteria:
inclusion criteria: * participation in prior study nabi-1371 * written informed consent * negative serum pregnancy test, where appropriate * expect to comply with protocol procedures and schedule exclusion criteria: * known hiv * immunomodulatory drugs * malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer) * active infection in the 2 weeks prior to study injection * serious s. aureus infection within the last 2 months prior to injection * hypersensitivity to components of staphvax

Keywords: staphylococcus aureus vaccine randomized controlled trial
vaccine responsiveness in patients with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Summary: assessment of sars-cov2 (mrna and adenovirus-based vaccines) and conjugated pneumococcal (pcv13) in patients with chronic lymphocytic leukemia


Eligibility criteria:
inclusion/exclusion criteria: * age \>18 years. * diagnosis of cll or sll according to who criteria. * for patients receiving btk inhibitor (cohorts 1 and 2): * patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of cd20 monoclonal antibody within 6 months. * patient must have no known clinical or radiographic evidence of cll progression. * for patients not on active therapy (cohort 3): * patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of cd20 monoclonal antibody within 6 months. * the treating investigator must have no intention to initiate cll therapy within 2 months. * patients must have not received pcv13 within 2 years. for patients with pcv13 within 5 years, s. pneumonia igg antibody concentrations must be less than the reference value for at least 50% of s. pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a,19f and 23f. patients can have received prior ppv23 within any time frame. * patient must have no known history of hiv or primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication (e.g. steroids, methotrexate, etc.).
study of telitacicept in generalized myasthenia gravis

Conditions: Myasthenia Gravis, Generalized

Summary: the purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of patients with generalized myasthenia gravis.

this study consists of a screening period, a double-blind treatment period (part a) and an open-label treatment period (part b). after screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous telitacicept 240 mg or placebo once a week for 24 doses (part a). completing part a, subjects will automatically enter part b. in part b, all subjects will receive weekly subcutaneous telitacicept 240 mg for 24 weeks.

Eligibility criteria:
inclusion criteria: 1. written informed consent provided; 2. male or female patients aged 18-80 years; 3. diagnosis with generalized myasthenia gravis; 4. mgfa class ii, iii, or iva; 5. achr-ab or musk-ab positive; 6. a total mg-adl score of ≥ 6 with less than 50% of the total score due to ocular symptoms; 7. qmg ≥ 8, with ≥ 4 items score at least 2; 8. have been on a stable mg soc regimen. exclusion criteria: 1. patients with autoimmune diseases other than mg; 2. abnormal laboratory results； 3. use of immunosuppressants other than standard therapy within 1 month before randomization; 4. use of biologic agents targeting therapy, such as rituximab or complement c5 inhibitors, within 6 months before randomization; 5. use of neonatal fc receptor (fcrn) antagonists, intravenous immunoglobulin (ivig), or plasmapheresis within 2 months before randomization; 6. significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the study; 7. acute or chronic infection requiring treatment; 8. current active hepatitis; 9. hiv antibody positive; 10. patients currently suffering from thymoma-associated immunodeficiency syndrome (good's syndrome) or who underwent thymectomy within 6 months before screening; 11. received or plan to receive any live vaccine within 3 months prior to randomization; 12. patients with malignant tumors; 13. allergy to biological products of human origin; 14. participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer); 15. pregnant or lactating women, and those intending to become pregnant during the trial; 16. patients considered unsuitable by the investigator to participate in the trial (e.g., patients with severe mental disorders); note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: myasthenia gravis autoimmune diseases muscle weakness
garlic with lime juice and chlorhexidine mouthwash

Conditions: Gingival Bleeding

Summary: the study about herbal mouthwash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and their effect on gingival bleeding and plaque and salivary bacteria.

the study about herbal mouth wash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and show their effect on gingival bleeding and strepococcus bacteria present in saliva and plaque. 1. preparation of garlic with lime juice will occur under aseptic condition.and give it to the first group. provide chlorhexidine to the second group. 2. collection of plaque and saliva samples will be obtained from children who fulfilled the inclusion criteria. 3. asses gingival condition by asking patient. 4. subjects will be instructed to rinse for 14 days, twice daily. 5. morning after breakfast and night before going to bed. 6. with 10 ml (undiluted) of the assigned mouthwash for 30 s and then expectorate the rinse. 7. again after 14 days, the saliva and plaque samples will be taken and inoculated on blood agar plates to determine the colony count and the gingival index by loe and illness will be assessed.

Eligibility criteria:
inclusion criteria: 1. children aged between 9 and 12 years. 2. children are having normal occlusion (no crowding), non-compromised oral health (brushed their teeth once-daily) using toothbrush and non-fluoridated toothpaste. and practicing no other oral hygiene measures. 3. medically free history. 4. absence of orthodontic appliances. exclusion criteria: 1. history of current or recent (at least for the past 1 month) antibiotic usage or other medications. 2. presence of abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment. 3. not willing to comply with the study.