Kornimate/medical-research-clean huggingface dataset:
inositol for comorbid anxiety in children and adolescents with bipolar disorder

Conditions: Bipolar Disorder; Anxiety Disorders; Anxiety

Summary: this is an open trial that seeks to determine the safety and tolerability of using inositol for children and adolescents with bipolar disorder and comorbid anxiety disorders with an exploration of efficacy and dose-response.

anxiety disorders are common comorbidities among children and adolescents with bipolar disorder. treatment with standard pharmacologic agents may worsen mood problems or lead to drug dependency. inositol has shown benefits for bipolar depression in adults. this is an open multi-case control study. the investigators will enroll 20 children and adolescents ages 8-17 treated at the child and adolescent bipolar services (cabs) at western psychiatric institute and clinic. participants' involvement will be 14 weeks, including the initial titration of the supplement, maintenance, and taper. primary outcomes will include standard measures of mood and anxiety. also, physiologic measures including body mass index and bedside glucose will be followed.

Eligibility criteria:
inclusion criteria: 1. evidence in the medical record confirming the dsm-v diagnosis of bipolar disorder. if this documentation is not in the record, then the appropriate sections of k-sads will be administered to confirm the diagnosis. 2. evidence in the medical record confirming the dsm-v diagnosis of anxiety disorder including; separation anxiety disorder, generalized anxiety disorder, and/or social phobia. if this documentation is not present or is more than 2 years old, then the appropriate section of the k-sads will be administered to confirm diagnosis. 3. at least moderate severity of anxiety symptoms as determined by score of ≥ 13 on the pediatric anxiety rating scale (pars). 4. on a stable dose of psychotropic medications for at least one month, with no major changes projected. exclusion criteria: 1. presence of prominent diarrhea. 2. diagnosis of diabetes mellitus. 3. presence of active suicidal ideation and behavior or psychosis. b-ssrs ideation score greater than 1. b-ssrs behavior score greater than 0. 4. weight less than 20 kg. 5. known pregnancy.

Keywords: inositol
early application of cpap in hematologic

Conditions: Hematologic Disease

Summary: the purpose of this study is to evaluate the use of cpap in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .cpap applied preventively in hematological patients with high risk of arf may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of icu and hospital stay

immunocompromised patients with a hematological malignancy that requiring admission in intensive care unit (icu) and subsequently mechanical ventilation for respiratory failure was estimated between 20- 50 per cent of all admitted in hospital. the survival rate of this patients that requiring mechanical ventilation is very poor. in many cases the immunodepression with a great improvement in severe complication as infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone marrow transplantation and stem cell transplantation ) . pneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the all patient with acute respiratory failure (arf) . the trial was designed to enroll 40 patients in two groups to demonstrate reduction from 50% to 10 % of the need of mechanical ventilation , with a type i risk of error of 5% and a power of 80 %. patients were randomized to be treated for four days venturi mask at a fio2 of 0.4 (control) or with oxygen at a fio2 of 0.4 plus a cpap of 10 cm h2o (cpap). at the end of the 4-days period, patients passed a screening test breathing ambient air. patients returned to the assigned treatment if sao2 less than 95% a.a or respiratory rate more than 25 bpm.cpap was generated using a flow generator with an adjustable inspiratory oxygen fraction set to deliver a flow of up to 140 liters per minute (whisperflow, caradyne, ireland) and a spring-loaded expiratory pressure valve (vital signs inc, totoma nj) and applied using a latex-free polyvinyl chloride transparent helmet (castar, starmed, italy) (15); all centers measured the inspiratory oxygen fraction using an oxygen analyzer (oxicheck, caradyne, ireland) through the venturi mask or the helmet.

Eligibility criteria:
inclusion criteria: * neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) . * sao2 less than 95% ( a.a.) , * respiratory rate (rr ) more than 25 breaths/minute . exclusion criteria: * nyha class ii- iii- iv or unstable angina or mi * valvular heart disease or cardiac surgery ( previous 3 months) * implanted cardiac pacemaker * bmi less than 40 * history of dilated cardiomyopathy or cpe * severe copd ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting , fev1 \< 50 %) * diagnosis of sleep or neuromuscular disorders. * claustrophobia . * mechanical ventilation criteria: * severe hypoxemia (arterial oxygen saturation \< 80 % with maximal fio2 ) * ph \ 50 mmhg * signs of patient distress with accessory muscle recruitment and paradoxal abdomen movement * rr \> 35 breaths/minute .

Keywords: cpap hematologic neutropenic arf
searching of apraxia of speech in children with specific language impairment

Conditions: Apraxia of Speech

Summary: searching of apraxia of speech in children with specific language impairment


Eligibility criteria:
inclusion criteria: * children from 4 to 8 years old diagnosed as specific language impairment exclusion criteria: * 1. children with mental retardation or hearing impaired . 2. children with any neurological or psychiatric disorders.
usc and bodyport remote heart failure management study

Conditions: Heart Failure

Summary: a feasibility study investigating the bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at keck medical center of usc

heart failure is a debilitating disease associated with high hospitalization rates which could potentially be curbed by remote patient monitoring. remote monitoring may allow for the early detection of signs and symptoms of cardiac decompensation, enabling prompt interventions to reduce hospital admission rates or the duration of inpatient stay, and the quality of life of those suffering from heart failure. recent studies have demonstrated that structured remote patient management interventions can reduce the percentage of days lost to unplanned cardiovascular admissions. the investigators propose assessing the feasibility of a structured virtual cardiac care service leveraging the bodyport platform to optimize outpatient management of heart failure. this study will leverage the bodyport virtual cardiac clinic platform to deliver care for the heart failure patient population at keck medical center of usc. patients randomized to the intervention arm will receive the bodyport cardiac scale for home monitoring as well as heart failure education and non-clinical support from bodyport coaches. daily measurement uploads from the patients will be analyzed and changes in measurement data will be used to guide follow-up and care management, such as diuretic dose adjustments. for this initial feasibility study, the investigators will be focusing on patient and provider satisfaction of the virtual cardiac clinic along with the operational ease of executing this form of care compared to standard care.

Eligibility criteria:
inclusion criteria: * diagnosis of hfref or hfpef and hospital discharge for a heart failure exacerbation within 14 days of enrollment. * 18 years of age or older * english speaking * able to safely stand on the bodyport scale * patients must have a reliable and working phone for communication with the care team * all patients should have access to the internet via a computer or mobile device to access the bodyport care platform * patients must have a safe and secure place to store the bodyport device exclusion criteria: * weight \>375 lbs. * history of repeatedly missing follow-up appointments or being unreachable by phone * inability to stand on the bodyport scale for the duration needed to capture data * patient in jail or currently homeless * known or documented noncompliance with medical therapy * unable to speak english * unable or unwilling to answer survey questions * history of heart transplantation * chronic kidney disease stage iv or v and/or on hemodialysis * presence of a ventricular assist device * presence of a cardiomems pulmonary artery sensor
botulinumtoxin a treatment in epidermolysis bullosa simplex and pachyonychia congenita

Conditions: Epidermolysis Bullosa Simplex

Summary: this study evaluates the clinical effect of foot injection of the bacteria protein botulinum toxin a on plantar pain in patients with ebs (epidermolysis bullosa simplex) or pc (pachyonychia congenita).

epidermolysis bullosa simplex (ebs) is the most common subtype of epidermolysis bullosa and mutations in keratin genes (krt 5/14) are responsible for this condition. painful blisters and keratoderma of the feet are common and the blisters in ebs typically get worse in the summer due to sweating and increased environmental heat. since 2010, also the related condition pachyonychia congenita (pc) is included in the study. the primary objective of the study is to evaluate the clinical effect of botulinum toxin a (dysport®), injected in the foot, on plantar pain in patients with ebs or pc. quality of life, pain in feet, effect duration, plantar sweating and safety of the treatment will also be studied.

Eligibility criteria:
inclusion criteria: * informed consent received from patient * informed consent received from patient´s parents (when patient \< 18 years) * a solid ebs-diagnosis based on genetic analysis and/or phenotype. the ebs-diagnosis will be performed by professor anders vahlquist, swedish centre of genetic skin disorders, uppsala. * age \> 16 years * patients must be previously untreated with btx a * if female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control exclusion criteria: * contraindication to btx a * contraindication to general anaesthesia * use of aminoglycosides, tetracyclines , spectinomycin, lincomycin, polymyxin or muscle relaxants * pregnancy or lactation * patients unwilling to meet the requirements of the protocol * other medical or social reasons for exclusion at the discretion of the investigator
effects of sglt2 inhibitor on hemodynamic parameters in resistant hypertensive subjects

Conditions: Hypertension; Diabetes Mellitus, Type 2; Blood Pressure; Obesity; Cardiac Hypertrophy; Microalbuminuria; Vascular Stiffness

Summary: new strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. in this context, the sglt2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure levels, as well as target organ damage and adiposity in this high-risk population.

objective: the investigators aim to assess whether the intervention with the sglt2 inhibitor -dapaglifozin - reduces pa levels, target organ damage, fat profile and change the adipokines levels in patients with resistant hypertension with dm2. methods and design: this crossover randomized, double-blind, interventional study controlled by standard therapy will include 20 patients with resistant hypertension and type 2 diabetes, followed in outpatient clinic specialized in resistant hypertension at clinical hospital-unicamp. they will be randomly assigned into two groups (1) initially treated with dapagliflozin in combination with their usual antihypertensive therapy and metformin, at 12 weeks (n = 10) or group (2) control initially treated with glibenclamide at a dose of 5mg daily in combination with antihypertensive therapy usual and metformin, at 12 weeks (n = 10). office ambulatory and home bp measurements; anthropometric measurements, determination of vascular stiffness by pulse wave velocity, echocardiogram, body bioimpedance, enzyme immunoassays for the determination of adipokines, and lab tests to evaluate biochemical parameters will be performed pre- and after the use of both treatments. glycemic parameters, and weight will be assessed every 4 weeks. results and conclusion: the use of sglt2 inhibitor in these patients may provide new strategies for treatment of patients with resistant hypertension.

Eligibility criteria:
inclusion criteria: * resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up * use of metformin therapy * therapy adherence * agree to participate in the research protocol and sign the informed consent form exclusion criteria: * secondary hypertension * pseudoresistance hypertension (poor medication adherence and white coat hypertension) * patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases * pregnancy * smoking * autoimmune diseases
cycloergometer and rotator cuff tear

Conditions: Rotator Cuff Tear

Summary: the cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. the cycloergometer has been already employed in many fields of medicine. however, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in rotator cuff tear patients.

to evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness rct. since cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of rct patients.

Eligibility criteria:
inclusion criteria: * positive imaging diagnosis of full-thickness rct * surgery not considered as the first treatment of choice * willingness to sign the informed consent form. exclusion criteria: * inflammatory rheumatic diseases * history of fracture or operations around the shoulder region * neurological diseases * infections or tumours * diabetes * coagulation diseases * intra-articular injections of the involved shoulder within the last 12 months.

Keywords: disability pain rotator cuff tear rehabilitation range of motion (rom)
safety study of motifmesh (cptfe) in abdominal surgery

Conditions: Hernia

Summary: this study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cptfe).

cptfei s a mesh-like product designed to reduce associated post surgical complications.

Eligibility criteria:
inclusion criteria: has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired exclusion criteria: non-pregnant, breast feeding or plans to become pregnant during the study; using adequate birth control methods and agrees to continue using those methods for the duration of the study confirmation of incisional hernia or fascial defect by ct scan within 6 months incisional hernia or facial defect has no necrotic tissue. such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dl (0.15 g/l), serum albumin ≥ 2.0 g/dl (20 g/l). no abnormal pre-surgery laboratory values that, in the opinion of the principal investigator, place the subject at risk for the study. for subjects with diabetes mellitus, hba1c \<12% bmi ≤ 40 kg/m²
internet-based videoconferencing to address alcohol use and pain

Conditions: Chronic Pain; Alcohol Use, Unspecified

Summary: this research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in hiv-care delivered via internet-based videoconferencing. this first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.

this study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with hiv and determine its feasibility and acceptability. through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with hiv/aids (plwha) through videoconferencing. intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.

Eligibility criteria:
inclusion criteria: * engaged in hiv care, heavy drinking by more than 7/14 drinks per week (women/men) or by single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the brief pain inventory (bpi) non-cancer related pain. exclusion criteria: * psychoactive medication for pain or alcohol use for few than 2 months * history of bipolar disorder, schizophrenia, other psychotic disorder * current suicidal intent * prior history of alcohol withdrawal related seizures or delirium tremens * current behavioral treatment for pain or alcohol use * any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment

Keywords: hiv
sparing in neuromuscular blockade in covid 19 icu

Conditions: Neuromuscular Blockade; Human Characteristics; Complication of Medical Care; Intensive Care Unit Acquired Weakness

Summary: this is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (nmb) monitor on the consumption of nmb agents in patients under mechanical ventilation in the context of covid-19. the use of nmb agents during mechanical ventilation in patients with acute respiratory distress syndrome (ards) improves respiratory support conditions and reduces mortality. in the context of covid-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (icu) benefit from prolonged mechanical ventilation with frequent use of nmb agents. large amount of such patient admitted in a short time has led to a shortage of nmb agents, particularly cisatracurium. the use of nmb monitors (for example - train of four (tof)) is a well-established practice in general anesthesia. there is no recommendation for the use of nmb monitor in icu patients available up to date. however, in the attempt to reduce the consumption of nmb agents a nmb monitoring was used in icu patients during the covid-19 pandemic at university hospitals of hospices civil de lyon, with the endorsement of the local college of anesthetists. the aim of our study is to evaluate if the use of a nmb monitor decreases the consumption of nmb agents in patients under mechanical ventilation in the context of covid-19.


Eligibility criteria:
inclusion criteria: * pcr-proven sars-cov-2 infection * use of vm (mechanical ventilation) * use of nmb agents for at least 48 hours exclusion criteria: * pregnancy * extracorporeal membrane oxygenation (ecmo)

Keywords: neuromuscular blockade agent neuromuscular blockade monitor train of four (tof) critical illness covid 19
phase i/ii trial of doxil and hyperthermia for breast cancer patients with chest wall recurrence or stage iv disease with locally advanced breast cancer

Conditions: Breast Cancer

Summary: purpose: the purpose of this protocol is to evaluate the combination of doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. this protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). this chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. we are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response. methods: the patients will be treated with chemotherapy followed by heat treatment. this will be given for 6 cycles approximately every 4 weeks. for the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.


Eligibility criteria:
inclusion criteria: * patients with recurrent or metastatic breast cancer
phase i dose escalation study to investigate the safety of isth0036 in subjects with glaucoma undergoing trabeculectomy

Conditions: Primary Open Angle Glaucoma

Summary: this study evaluates the addition of isth0036, an antisense oligonucleotide against tgf-β2, to glaucoma filtration surgery (trabeculectomy). the treatment aims at improving the surgery outcome by prevention of excessive scarring and trabecular meshwork transformation.

the transforming growth factor beta (tgf-β) is known to play a key role in glaucoma. increased levels of tgf-β2 in the eye have been linked to trabecular meshwork transformation, increased intraocular pressure and direct optic nerve damage. trabeculectomy is the standard surgical intervention to reduce intraocular pressure in subjects no longer sufficiently responding to pressure-lowering medications. scarring of the surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the intraoperative use of mitomycin c to prevent this). tgf-β2 has been described to play a distinct role in the fibrotic process of bleb closure.

Eligibility criteria:
inclusion criteria: * subject scheduled for trabeculectomy with mitomycin c * subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma exclusion criteria: * history of relevant ocular trauma \< 6 months or ocular infection/inflammation \< 3 months * severe central visual field loss within 6 months unrelated to glaucoma * pregnant or nursing women or subjects not using adequate contraception * history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluations, procedures or interpretation

Keywords: glaucoma trabeculectomy