Kornimate/medical-research-clean huggingface dataset:
patient reported outcome instruments in sarcoidosis

Conditions: Sarcoidosis

Summary: evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.


Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis by established criteria. * patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit. * ability to understand and read english at least at a 7th grade level. * have access to a computer, ipad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform. * the subject is willing to wear a daily activity and sleep tracker wristband (fitbit ™ wristband) for 6 months. exclusion criteria: • life expectancy of \< 1 year.
hyperbaric oxygen therapy and spect brain imaging in traumatic brain injury

Conditions: Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury

Summary: hypothesis: that spect brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (hbot) for chronic traumatic brain injury.

the study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent spect brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. the purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.

Eligibility criteria:
inclusion criteria: * adults or children with traumatic brain injury at least one year old exclusion criteria: * none

Keywords: traumatic brain injury
comparison between respiratory therapy with cough assist technique and usual respiratory therapy in intensive care patients suffering of neurologic disorder

Conditions: Neurologic Disorder

Summary: the present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. the investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.


Eligibility criteria:
inclusion criteria: * peak flow \< 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia exclusion criteria: * death expected in the following 24h * bulbar dysfunction if extubated * pneumothorax * intracerebral mass effect * elevated intracranial pressure

Keywords: respiratory therapy in neurologic disorder
a study of adjunctive treatment of cognitive deficits in schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of pf-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * in stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months * stable symptoms of schizophrenia for at least 3 months. exclusion criteria: * subjects with a psychiatric disorder other than schizophrenia * substance dependence or abuse * women who have child bearing potential.
safety and efficacy study of cefdinir oral suspension, in pediatric subjects to treat acute otitis media

Conditions: Acute Otitis Media

Summary: to evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.


Eligibility criteria:
inclusion criteria: * male and female children between 6 months and 4 years of age * weight does not exceed 40 kg * clinical diagnosis is acute otitis media * have evidence of middle ear fluid * at risk for persistent or recurrent otitis media * generally in good health exclusion criteria: * sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications * presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear * treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin g benzathine) within 4 weeks prior to the study * concomitant infection, that requires additional antimicrobial therapy * presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
comparison of cardiac output measurement between transpulmonary thermodilution and photoplethysmography

Conditions: Hypovolemia

Summary: monitoring could secure management for patient but stay invasive. the purpose of this study was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary thermodilution(reference method) and digital photoplethysmography (non invasive) for absolute value and dynamics changes before and after fluid expansion for patients with indication of fluid challenge.

* the time frame of the study period was included between the arrival at the icu after cardiac surgery and before spontaneous breathing on mechanical ventilation * time-to-event outcome measures was period of time between the arrival at the icu after cardiac surgery and before spontaneous breathing on mechanical ventilation. the event (hypotension) was defined as systolic arterial pressure under 90mmhg,less than 40mmhg, mean arterial pressure under 70mmhg, tachycardia upper 100 beats/min, presence of skin mottling, low cardiac output or previous blood loss.

Eligibility criteria:
inclusion criteria: * postcardiac surgery patients with arterial pressure monitoring and transpulmonary thermodilution monitoring with indication of fluid challenge * patients more than 18 years old exclusion criteria: * patients under 18 years old * pregnant women * patient without invasive monitoring * urgency surgery
changes in doppler signals from the lung due to cardiac resynchronization in heart failure patients

Conditions: Change in LDS Signals Due to Cardiac Synchronization Therapy

Summary: study purpose and rationale the purpose of this study is to evaluate the lung doppler signals changes during cardiac resynchronization procedure. as the lds represent the various mechanical events of cardiac origin it is assumed that they may reflect the relative timing between contraction of the ventricles and atria and thus serve for effective synchronization of these activities. aim of the study: the aim of the study is to assess whether the changes in lung doppler signal (lds) waves' characteristics will mimic the changes in echocardiographic parameters designed to assess diastolic inflow and systolic flow in patients undergoing echo-based crt optimization.


Eligibility criteria:
inclusion criteria: * male and female patients 18 years or older, who met the indications for cardiac synchronization therapy (crt) per the accf/aha guidelines, underwent successful system implant for more than 3 months, and were referred to the crt non-responder clinic at the ohio state university for crt- echo optimization due to absence of clinical improvement in functional class or ejection fraction after the implant per the judgment of the referring physician. exclusion criteria: 1. chronic atrial fibrillation or new cardiac arrhythmias detected at the time of the visit that are known to affect the response to crt (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or frequent premature ventricular contractions). 2. crt device malfunction 3. inadequate crt programming that has contributed to lack of response to crt 4. coronary sinus lead anatomical or electrical malfunctions at the time of the visit 5. acute systemic illness that can explain their lack of functional improvement (i.e., anemia, severe electrolyte imbalance, pneumothorax, pericardial effusion, pneumonia) 6. inability to sign informed consent
dna variations in the gene in young patients with wilms' tumor

Conditions: Kidney Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at dna variations in the rassf1a gene in young patients with wilms' tumor.

objectives: primary * determine the presence of the a133s polymorphism in the rassf1a tumor suppressor gene by screening germline dnas of children with wilms' tumor. * determine the inheritance pattern of the a133s polymorphism by evaluating the parents of children who carry this polymorphism. secondary * determine the differences in age at diagnosis, stage, histology, site of primary tumor, and outcome, between patients with vs without the a133s polymorphism. * determine whether the s131f rassf1a variant is a true polymorphism in these patients. * determine the polymorphic differences in this gene between these patients based on ethnicity and sex. outline: this is a multicenter study. patients are stratified according to age at diagnosis, stage, histology, site of primary tumor, and outcome. genomic dna samples are purified from peripheral blood of patients and controls and analyzed by polymerase chain reaction for the rassf1a gene. dna is also analyzed from parents of patients with the a133s polymorphism. projected accrual: a total of 471 participants (229 wilms' tumor patients and 200 control participants plus 42 parents) will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of wilms' tumor or * control participants matched for race, sex, and age * no prior or concurrent history of cancer or * parents of children involved in the study patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: recurrent wilms tumor and other childhood kidney tumors stage i wilms tumor stage ii wilms tumor stage iii wilms tumor stage iv wilms tumor stage v wilms tumor
evaluate the safety and efficacy of stsg-0002 injection in patients with chronic hepatitis b

Conditions: Chronic Hepatitis b

Summary: this trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of stsg-0002 injection in patients with chronic hepatitis b treated with oral antiviral therapy(long-term follow-up).


Eligibility criteria:
inclusion criteria: * patients with chronic hbv； * receiving anti-hb viral therapy； * 10 iu/ml≤hbsag≤3000 iu/ml. exclusion criteria: * patients co-infected with hepatitis c virus, hiv, hav, hdv, hev; * liver cirrhosis; * hepatocellular carcinoma; * autoimmune liver disease; * clinical hepatic decompensation; * fibroscan\>12 kpa; * a. hemoglobin\ 1.5 ×uln，alt\>2 × uln，serum albumin\ 1.5；d. serum creatinine \>1.5×uln.
dilution of verapamil during intraarterial administration

Conditions: Vasospasm;Peripheral; Burning; Pain

Summary: this study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (ia) verapamil diluted with normal saline compared to undiluted ia nicardipine during transradial access (tra) for percutaneous coronary angiography. patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via tra will be included. patients who are non-english speaking, pregnant, or intubated will be excluded. patients will be randomized to one of the two following groups: 1. group 1 will receive ia verapamil 5 mg (2ml) diluted with 8 ml of normal saline 2. group 2 will receive ia nicardipine 400 mcg (undiluted, 8 ml) the investigators will document the patient's level of discomfort on the visual analogue scale 30 seconds before and after administration of ia verapamil/nicardipine. the investigators will also document the presence of radial artery spasms.


Eligibility criteria:
inclusion criteria * english speaking patients who are age 18 or older * patient must be able to provide own consent and communicate with staff * patient's undergoing transradial access (tra) for the left heart catheterization (lhc) exclusion criteria * intubated or sedated patients * agitated patients requiring moderate sedation prior to tra * patient's undergoing femoral access for the lhc * non-english speaking patients * contraindications to verapamil or nicardipine: including allergies to these medications, hypotension (mean arterial pressure \<65), bradycardia (heart rate\<40) * emergent cardiac catheterization * inability to obtain radial artery access * conversion to radial artery access from another access site

Keywords: cardiac catheterization intra-arterial calcium channel blockers radial artery spasm
preventing postpartum depression in african american home visiting clients

Conditions: Depression

Summary: the goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income african american pregnant and recently delivered women who are enrolled in home visiting programs.

this study will conduct a randomized controlled trial (rct) with women from four baltimore city home visiting programs. we will screen 200 women who are pregnant or have a child \< 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (ppd) will be randomized to an intervention (mb course) or usual home visiting control group. women in the intervention group will receive the 6-week mb course delivered in a group setting by the study clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. primary outcomes include depressive symptoms and depressive episodes.

Eligibility criteria:
inclusion criteria: * pregnant or has child \< 6 months of age * enrolled in home visiting program * exhibiting elevated depressive symptoms and/or personal history of clinical depression exclusion criteria: * no current clinical depression at time of enrollment

Keywords: depression, african american, home visiting, prevention
study of aro-alk7 in adult volunteers with obesity with and without type 2 diabetes mellitus

Conditions: Obesity; Diabetes Mellitus, Type 2

Summary: this study will evaluate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of single and multiple doses of aro-alk7 in adult volunteers with obesity without type 2 diabetes mellitus (t2dm) (part 1) and the safety, tolerability, and pd of multiple doses of aro-alk7 in adult volunteers with obesity with and without (t2dm) receiving tirzepatide (part 2). in part 1a eligible participants with obesity will be randomized to receive a single dose of aro-alk7 or placebo (pbo) administered on day 1. in part 1b, eligible participants with obesity will be randomized to receive two doses of aro-alk7 or pbo administered on day 1 and day 85. in part 2, eligible subjects with obesity with and without (t2dm) will randomized to combined therapy with tirzepatide and aro-alk7 (intervention arm) or tirzepatide and pbo (control arm). tirzepatide will be initiated on day 15 and administered by subcutaneous (sc) injection weekly. aro-alk7 or pbo will be administered by sc injection on day 1 and day 85. subjects in both part 1 and part 2 will undergo adipose aspiration pre and post dose.


Eligibility criteria:
inclusion criteria: * obesity, defined as bmi between 30-50 kg/m2, inclusive, with weight at screening not to exceed 159 kg (350 lbs) * at least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * no abnormal finding of clinical relevance at screening that could adversely impact participant safety during the study or adversely impact study results * participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later exclusion criteria: * self-reported (or documented) weight gain or loss \>5% within 3 months prior to screening * use of glp-1ras (liraglutide, semaglutide, etc.) for any indication within 6 months prior to screening * use of non-glp-1r medications for weight loss within 3 months prior to screening including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate and other prescription or over-the-counter medication or supplement taken for weight loss purposes * obesity attributable primarily to medication use, endocrinologic or monogenic disorders * history of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures) * use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to screening * type 1 diabetes mellitus note: additional inclusion/exclusion criteria may apply per protocol
nitric oxide, endothelin-1, and the patency of ductus arteriosus in preterm infants

Conditions: Patent Ductus Arteriosus

Summary: background patent ductus arteriosus (pda) is a frequent clinical event in preterm infant. the cardiopulmonary functions of these preterm babies may be adversely affected by the patency of ductus arteriosus. ductal tissues are sensitive to the constricting effect of endothelin-1 and the dilating effect of prostaglandins, inflammatory mediators, and concentration of oxygen. objective to examine the role of endogenous nitric oxide (no) and endothelin-1 (et-1) in the pathogenesis of patent ductus arteriosus of the preterm infants. we hypothesize that the patency of ductus arterious in preterm infants is probably due to inappropriate production of endogenous nitric oxide and the interaction with various inflammatory mediators and prostaglandins, which is different from those of term infants. in addition, the secretion of endothelin is probably decreased. the purpose of this study is to monitor the changes of these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus in preterm infants. methods and materials 1. inclusion criteria: 1. preterm infants with gestational age less than 32 weeks or birth weight less than 2000 gm. 2. informed consent 2. numbers of study population: with 80-100 evaluable infants (40-50 patients in pda and non-pda groups, respectively) 3. blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is assessed for inflammatory mediator (il-8, il-10), nitric oxide metabolites (nitrite and nitrate), endothelin-1, and cgmp 4. statistical analysis: student t-test testing the differences of clinical data, wilcoxon signed rank test for comparing data obtained between the pda and non-pda patients, the pda patients before and after intravenous indomethacin, and those who are responsive or refractory to the therapy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of the patency of ductus arteriosus exclusion criteria: * congenital anomalies

Keywords: preterm infant, patent ductus arteriosus, nitric oxide,endothelin-1
a real-world study of immune checkpoint inhibitors and chemotherapy for advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: the role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. immunotherapeutic agents such as immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. however, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. this study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed as esophageal squamous cell carcinoma * kps≥80 * adequate organ function * no distant metastasis * the diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist exclusion criteria: * incomplete medical record which affects statistical analysis * have participated in previous interventional clinical trials * other situations evaluated by investigators not meet the enrollment

Keywords: esophageal cancer real-world study immunotherapy chemotherapy
effects of covid-19 forced isolation context on adolescents with and without somatic symptom disorder

Conditions: Somatic Symptom Disorder

Summary: the purpose of this study is to evaluate whether a forced isolation context (such provided by the ongoing covid-19 pandemic restrictive measures) could reduce the burden of somatic symptoms among a group of patients with somatic symptom disorder (ssd). secondary objective is to assess if a reduction in terms of depression tendency and anxiety occurs in this specific population and which are the effect of such a context among a group of adolescents without ssd. we want to compare these results with data obtained at the end of the pandemic.

this study aims to evaluate whether the forced isolation context provided by the ongoing covid-19 pandemic is providing an advantage in terms of reduction of somatic symptoms burden among an italian group of adolescents with ssd, assessed by the patient health questionnaire (phq15) administered during and at the end of the pandemic. secondary objectives of the study are: * to investigate the difference in anxiety and depression scores assessed by the multidimensional anxiety scale for children (masc2) and child development inventory (cdi-2) questionnaires among a group of ssd adolescents, during and after the pandemic isolation context. * to investigate the difference in anxiety and depression scores assessed by the multidimensional anxiety scale for children (masc2) and child development inventory (cdi-2) questionnaires among a group of adolescents without ssd, during and after the pandemic isolation context. * to compare the difference in anxiety and depression scores time modification between the two groups of adolescents. * to explore through tailored questions which adolescents' coping strategies are during a pandemic isolation context among ssd patients and a group of controls without ssd.

Eligibility criteria:
inclusion criteria: * adolescents aged between 12 and 17 years old who received a diagnosis of ssd within the last six months or before unless assessed and confirmed by a specialist within the last six months * adolescents without a diagnosis of ssd, who previously accessed the institute for maternal and child health "burlo garofolo" emergency department for traumatic injuries or the pediatric clinic/day hospital service for oral immunotherapy because of food allergies. * adolescents experiencing a quarantine period during the covid19 pandemic. exclusion criteria: * adolescents with cognitive impairment. * adolescents with chronic diseases. * adolescents with other neuropsychiatric disorders according to the fifth edition of the diagnostic and statistical manual of mental disorder (dsm v). * for the group without ssd diagnosis, any access to emergency department for unexplained chronic pain or any history of other psychiatric comorbidities.

Keywords: ssd adolescents coping strategies social media