Kornimate/medical-research-clean huggingface dataset:
trial of propranolol in adults and adolescents with asd and predictors of response

Conditions: Autism

Summary: the purpose of this study is to explore the effects of propranolol on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled pilot trial.

the investigators' specific aim is to examine the effects of serial doses of propranolol on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in high functioning adults and adolescents with autism in a double-blinded, placebo-controlled trial. the investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as skin conductance and heart rate variability, and whether anxiety predicts treatment response. the investigators' hypothesis is that social functioning and language abilities will benefit from serial doses of propranolol, as the investigators have demonstrated in previous single-dose studies. the investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.

Eligibility criteria:
inclusion criteria: * for participants with autism: high-functioning, native-english speaking subjects with asd aged 15-30. high-functioning asd is defined in this study by the dsm-v criteria plus autism diagnostic interview-revised (adi-r) criteria for autism, and wechsler abbreviated scales of intelligence (wasi) full scale iq of at least 85. exclusion criteria: * for participants with autism: non-autism learning disability (e.g. dyslexia), * major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder), * other neurological diagnosis, * major head trauma, * any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, pregnancy, known hypersensitivity/adverse reaction to beta-blockers), * any of the following exclusionary criteria related to placebo (severe allergy to lactose), * any of the following exclusionary criteria related to the psychophysiological measurements (history of rash from adhesives).

Keywords: propranolol
efficacy and safety study of adjunctive troriluzule in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with obsessive compulsive disorder (ocd)


Eligibility criteria:
key inclusion criteria: 1. primary diagnosis of obsessive-compulsive disorder (ocd) as per diagnostic and statistical manual of mental disorders, fifth edition as confirmed by the mini at screening; the duration of the subjects illness must be ≥ 1year 2. an inadequate response to current standard of care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by uspi labeling); an inadequate response too current standard of car base on the ybocs score. 3. determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. subjects must be physically able and expected to complete the trail as designed. key exclusion criteria: 1. subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the mgh-trq-ocd. 2. current or prior history of: bipolar i or ii disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, tourette's disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, deep brain stimulation (dbs) or electroconvulsive therapy (ect); or general medical condition that may confound safety and/or efficacy results. 3. previous treatment in a study with troriluzole

Keywords: obsessive-compulsive disorder (ocd)
efficacy of percussion massage therapy applied to the lower extremity on pain, edema in pregnant women

Conditions: Pregnancy Complications; Edema Leg; Physiotherapy

Summary: this study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women.

aim: this study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women. methods: sixty pregnant women between 24 and 36 weeks of pregnancy were included in the study. pregnant women were randomly divided into two groups: the percussion massage treatment (pmt) group and the control group. pregnant women included in the pmt group received a total of 10 sessions of percussion massage therapy, applied to their bilateral medial gastrocnemius, lateral gastrocnemius, peronus longus and tibialis anterior muscles three times a week. no massage therapy was applied to the lower extremities of the pregnant women in the control group. pain assessment with visual analog scale (vas), ankle, knee, and thigh circumference measurements with tape measure, fatigue level with fatigue severity scale (fss), and quality of life assessment with short form- 36 (sf-36) were conducted.

Eligibility criteria:
inclusion criteria: * being pregnant between the ages of 18-40, * being in the 24-36 weeks of pregnancy, * not being at risk of pregnancy, * being pregnant with a single baby, * having complaints of pain or edema in the lower extremities, * volunteering to participate in the study 3 days a week exclusion criteria: * multiple pregnancies, * pregnant women with anemia, * presence of circulatory problems, * cardiovascular disease, * chronic orthopedic disease, * foot-related orthopedic and vascular disease.

Keywords: edema pain percussion massage therapy pregnancy quality of life
fracture of distal radius and ulna healed with shortening of one bone. clinical significance at skeletal maturity

Conditions: Forearm Injuries

Summary: the fractures of distal forearm are the most common trauma in children. sometimes one of the bones becomes shortened as a result of fracture fragments overlap. when some amount of shortening exists, concern regarding relationship of distal radio-ulnar joint (druj) arises. the common opinion is expressed in one of the textbooks and is represented by one sentence, which usually one bone shortening is well tolerated, probably does not cause a problem, and does not have clinical significance. however, pathology of ulna plus or minus variants is well described and may cause ulno-carpal abutting syndrome or radiocarpal pain. this concern may lead to more aggressive approach in treatment of a fracture, with attempts to make an equal bone length. we did not find in the literature study that investigates this problem. we postulate that obvious shortening of one bone may cause an inequality of druj and can be clinically significant.

we will evaluate the x-ray films of children that at the time of the injury were between the ages 1 day and 12 years. the selection of the x-ray films will be done based on the specific codes of the wrist x-rays (ulna or radius). the evaluation will be merely to children that were treated in our hospital from 1996 to 2000.we are aiming to find cases when the fractures were healed with 1cm or more of shortening of one of the forearm's bones (radius or ulna). we are going to compare these cases with another 20 patients with the same characteristics as the latter groups on the exception that their fractures were healed without shortening. the two groups will be matched by age, gender and the same diagnosis. these patients will be summoned to the clinic when they are adult in respect to the skeletal maturity. the patients will be evaluated, including clinical examination of the hand wrists (left and right), motion rang, motor muscle function, description of abnormalities if there are and x-ray of both wrists.

Eligibility criteria:
inclusion criteria: * children that had had ulna or radius x-rays * signing informed consent. exclusion criteria: - unwillingness to sign informed consent.

Keywords: fracture of distal radius
validation of the performance of the electrocardiogram (ecg) function in the masimo invsensor00057

Conditions: Healthy; Atrial Fibrillation

Summary: the objective of this study is to validate the performance of the electrocardiogram (ecg) function of the masimo invsensor00057 against contemporaneous measurements


Eligibility criteria:
inclusion criteria: * subject is 22 years of age or older * subject is comfortable to read and communicate in english\* * subject belongs to one of two groups: * subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (group1) * subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (group 2) \*this is to ensure the subject can provide informed consent (as masimo invsensor00057 ecg study materials are currently available in english only) and can comply with study procedures. exclusion criteria: * subjects who are physically unable to wear a wristwatch * subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site. * subjects with an implantable defibrillator or cardiac pacing device. * subjects with a skin condition which would preclude proper ecg electrode placement.. * subjects with known allergic reactions to adhesive tapes or ecg gel. * subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia. * subjects not suitable for the investigation at the discretion of the investigator or the clinical team
tramadol hydrochnoride as adjuvant to local anesthetic in ultrasound guided erector spinea plane block in management of chronic chest wall cancer pain

Conditions: Chronic Pain; Erector Spinea Plane Block

Summary: chest wall pain is a severe and distressing symptom. the erector spinae plane block (espb) is an interfascial plane block where local anesthetic is injected between the erector spine muscle and the transverse process. it is a simple procedure, with easy sonographic landmarks, for postoperative analgesia in patients undergoing thoracic, abdominal, lumbar, and urologic surgery. the espb was initially described to relieve chronic pain from metastatic disease and rib fractures.

chest wall pain is a severe and distressing symptom.interventional pain management aims to use invasive techniques such as joint injections, nerve blocks and/or neurolysis, neuromodulation, and cement augmentation techniques to diagnose and treat pain syndromes unresponsive to conventional medical management. the erector spinae plane block (espb) is an interfascial plane block where local anesthetic (la) is injected between the erector spine muscle and the transverse process. it is a simple procedure, with easy sonographic landmarks, for postoperative analgesia in patients undergoing thoracic, abdominal, lumbar, and urologic surgery. the espb was initially described to relieve chronic pain from metastatic disease and rib fractures. the espb provides blockade of ventral and dorsal ramus from t1-2 to t8-12 with easy insertion of a catheter into the distension induced by the injectate. it is performed away from the pleura and neuraxis, with low risk of complications in these structures.to our knowledge it is the first time study to evaluate the effectiveness of tramadol hydrochloride as adjuvant to local anaesthetic in ultrasound guided espb in the management of chronic chest wall cancer pain. our hypothesis is that tramadol, when added to the local anaesthetic solution injected for espb, may improve analgesia and decrease the opioid consumption in patients with chronic chest wall cancer pain

Eligibility criteria:
inclusion criteria: * patients with persistent chronic chest wall cancer pain (\>6 months) with vas pain score ≥ 5 on 0 to 10 scale despite of medical treatment with tramodine up to 200 mg daily exclusion criteria: * they have hypersensitivity to any of the studied drugs, * obesity (bmi \>35), * presence of local pathology such as recurrent cancer or infection at the site of injection, * abnormal coagulation profile, * an abnormal liver or renal function * unable to express their pain or * patient refusal

Keywords: chronic chest pain, tramadol hydrochroide, erector spinea plane block
control trial of intermittent hemodialysis with regional citrate vs priming heparin with predilution in patients at risk of bleeding

Conditions: Hemodialysis

Summary: the study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (prometheus system/frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit


Eligibility criteria:
inclusion criteria: * the patient has been correctly informed. * the patient must have given his/her informed and signed consent. * the legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent. * the patient has health insurance coverage via the french social security system. * the patient is at least 18 years old. * the patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage). * the patient requires an intermittent hemodialysis in a nephrology icu setting. exclusion criteria: * the patient is participating in, or has participated in over the past three months, another interventional trial. * the patient is in an exclusion period determined by a previous study. * the patient is under judicial protection. * the parents (or legal guardian) of the patient refuse to sign the consent. * it is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier). * contraindication to heparin treatment. * indication of continuous dialysis in icu. * pregnancy.
phase 2 study of nimotuzumab in pediatric recurrent diffuse intrinsic pontine glioma

Conditions: Recurrent Diffuse Pontine Gliomas

Summary: this is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (dipg) following one previous regimen for their disease. patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. patients are eligible without histologic confirmation. treatment regimen will consist of two phases-induction and consolidation.


Eligibility criteria:
inclusion criteria: * signed written informed consent * patients with recurrent, diffuse intrinsic pontine gliomas * patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis \< 6 months. * evidence of disease progression * have a lansky or karnofsky performance status of \> 40 * be between the age \>3 years to \< 18 years of age * have a tumor that is measurable radiologically * for female patients of childbearing age: presence of a negative pregnancy test within 7 days prior to day 0. * use of effective contraception * adequate hematological, renal, and hepatic function exclusion criteria: * a history of prior use of egfr-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors) * more than one line of treatment * patients with disseminated disease are not eligible * had radiation therapy completed within 12 weeks of enrollment * previous chemotherapy completed \< 2 weeks prior to enrollment * if female, is pregnant or lactating * has other existing serious medical conditions * has any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives * is currently taking or planning to take other investigational drugs during the study * known contraindications against antibodies

Keywords: diffuse intrinsic pontine glioma common terminology criteria epidermal growth factor receptor human antihuman antibody pharmacokinetics monoclonal antibody informed consent form
diclofenac add-on to treatment as usual for suicidal patients

Conditions: Depression Suicidal

Summary: the purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.

the study will start with a feasibility study including treatment of 10 patients with diclofenac.

Eligibility criteria:
inclusion criteria: * depressive disorder * montgomery asberg rating scale score more than 20 p. * recent suicide attempt (treated as inpatient due to a recent suicide attempt) * informed consent * competence to give informed consent exclusion criteria: * pregnancy * breastfeeding * serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases * ongoing substance abuse * schizophrenia or other psychotic disorders * ongoing psychosis * risk factors for cardiovascular events * ulcer or gastrointestinal bleeding * ongoing electroconvulsive therapy * previous allergic reaction to nsaid, acetylsalicylic acid, sulfonamides or the diclofenac or sugar pill content * galactose intolerance, lactase deficiency or glucose-galactose malabsorption * ongoing treatment with warfarin or other anticoagulants * ongoing treatment with ace inhibitors or angiotensin ii antagonists ongoing treatment with drugs known to effect the immune system ongoing treatment with rifampicin, carbamazepine or barbiturates
effect of broccoli sprout extract on keratinocyte differentiation in normal skin

Conditions: Epidermolysis Bullosa Simplex; Pachyonychia Congenita

Summary: adult participants will apply a broccoli sprout extract-jojoba oil compound to one arm every night under occlusion for 1 week. jojoba oil alone will be applied to the other arm. at the end of 1 week, a 6mm punch biopsy will be taken from both arms and analyzed via polymerase chain reaction (pcr) and immunohistochemistry for differences in various skin proteins.

10 adult volunteers, including african american, caucasian, male and female participants, will be recruited from parents of patients seen in the pediatric dermatology clinic. each participant will receive 7ml of broccoli sprout extract (bse) in jojoba oil, containing 3500nmol of sulforaphane (please see the preparation of broccoli sprout extract below). 500nmol of sulforaphane will be applied each night. the participants will apply the bse-jojoba oil mixture over a circle, 3cm in diameter, on the upper arm every night for 7 consecutive nights. the control arm will have only jojoba oil applied. both arms will be occluded with saran wrap every night. after the seventh night, the volunteers will have a 6mm biopsy taken from each arm (2 total), performed by a dermatology resident. the biopsies will be cleaned with alcohol, numbed with 0.5-1cc of 1% lidocaine with epinephrine, and closed with one 4-0 nylon nonabsorbable suture. the biopsy site will be covered with vaseline and a bandaid. the area will be kept covered for 24 hours, after which it may be washed with soap and water and then recovered with vaseline and a bandaid. the suture will be removed 10-14 days after the procedure. from the initial visit through the final visit for suture removal, we expect the duration of the trial to last approximately 1 month. the participants will be told to avoid applying any topical medications or over the counter lotions or creams for the duration of the study and will also be told to wash with dove soap in the shower. they will also be advised to avoid a diet high in cruciferous plants such as broccoli, mustard, and horseradish. the biopsy results will each be divided in half. one half to be frozen for cryosectioning and immunofluorescence staining and the other half to be used for protein or rna extraction for molecular assays (real time polymerase chain reaction and/or quantitative polymerase chain reaction for select messenger rnas and western blotting for select protein antigens). the levels of keratin 1, keratin 5, keratin 10, keratin 14, keratin 16, keratin 17, and nrf2 will be studied with both immunofluorescence and rna pcr.

Eligibility criteria:
inclusion criteria: * able to attend 3 visits at the designated times. exclusion criteria: * pregnant * known allergy to broccoli, lidocaine, or epinephrine
identification of egfr-tkis sensitivity or resistance markers in nsclc may help in optimal patient selection

Conditions: NON-SMALL-CELL LUNG CANCER

Summary: the aim of this study was to retrospectively evaluate associations between egfr and akt dna-polymorphisms involved in transcriptional regulation and overall survival in nsclc patients treated with egfr-tkis.

dna will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and snps genotyping will be done.

Eligibility criteria:
inclusion criteria: * availability of tumor tissue or blood samples. * diagnosis of nsclc * at least one treatment with egfr-tkis inhibitors exclusion criteria: * other than nsclc primary diagnosis * no treatment with egfr-tkis inhibitors * no archival tissue available