Kornimate/medical-research-clean huggingface dataset:
this trial is a clinical performance validation study that will evaluate the clinical agreement of the sky medical™ rapid antigen test comparing the antigen rapid test to rt-pcr

Conditions: COVID-19; Sars-CoV-2 Infection

Summary: prospective study that will evaluate the clinical agreement of the sky medical™ rapid antigen test compared to sars-cov-2 rt-pcr.

clinical performance characteristics of the sky medical™sars-cov-2 antigen rapid test was compared to a reference extracted eua sars-cov-2 rt-pcr. the test kit was evaluated in the u.s in which patients were sequentially enrolled and tested. symptomatic subjects were enrolled within six days of the onset of symptoms from a multi-site prospective clinical study. a total of 69 nasopharyngeal samples, were tested in one (1) clia waived investigational site by five (5) minimally trained operators in the u.s during the 2022 covid-19 season. np swab specimens collected from the patients with covid-19 like symptoms in the u.s during the 2022 covid-19 season and stored in bd universal transport media tube were provided by our site in the u.s. all the np swab specimens were confirmed as positive or negative and validated with ct value by the fda eua rt-pcr as a comparator method prior to the study. a total of 69 samples consisting of 39 confirmed positive nasopharyngeal (np) swabs, 30 confirmed negative np swab specimens were collected. the specimens were aliquoted, randomized, and blinded into sample panels that were tested by each operator, using the instructions provided by the quick reference instructions (qri). all the study samples were randomized and assigned with a unique study subject id by the sponsor prior to testing at the study site. the expected results of the samples were completely blinded to the operators. all the samples were tested by five (5) operators according to the quick reference instructions only.

Eligibility criteria:
inclusion criteria: * provision of informed consent. * subject is suspected case of covid-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) and with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable covid-19 case in the last 14 days prior to onset of symptoms. * subject is an appropriate candidate for nasopharyngeal sample collection. * subject is willing to provide nasopharyngeal samples. exclusion criteria: * individuals who present with 10 or greater days of covid-19 related symptoms, (fever, cough, fatigue, decreased appetite, shortness of breath, myalgia) or post- defervescence and/or convalescence.
efficacy and safety study of mongersen (ged-0301) for the treatment of subjects with active crohn's disease

Conditions: Crohn Disease

Summary: the purpose of study is to test the effects of an experimental medication ged-0301 (mongersen) in patients who have active crohn's disease. the study will test ged-0301 compared to placebo for 52 weeks. the study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of crohn's disease. after 12 weeks in the study until the end of the study, patients who do not have an improvement in their crohns disease symptoms will have the option to enter a long term active treatment study. participants who discontinued the study anytime or completed the study at week 52 were then observed for an additional 4 weeks.


Eligibility criteria:
inclusion criteria: subjects must satisfy the following criteria to be enrolled in the study: * male or female ≥ 18 years * active crohn's disease (cd) disease as determined by the crohn's disease activity index (cdai) score and the simple endoscopic score for crohn's disease (ses-cd) * must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period * subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of cd. exclusion criteria: the presence of any of the following will exclude a subject from enrollment: * diagnosis of ulcerative colitis (uc), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis * local manifestations of crohn's disease (cd) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy * intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the screening visit * ileostomy or a colostomy * subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study.

Keywords: crohn's disease ged-0301 mongersen ibd safety efficacy
the analysis of physical, physiological and behavioral data collected from sensors that track the mental condition of psychiatric patients

Conditions: Psychiatric Disorders Mood

Summary: an observational study that uses a digital system to collect physiological, physical and behavioral data using worn sensors on psychiatric patients suffering from schizophrenia, bipolar and schizoaffective disorders. the system will enable to analyze the data using a personal digital algorithm in order to detect changes in mental condition and or changes in adherence to medication treatment, and assist in identification of illegal drug usage.

an observational study that uses a digital system to collect physiological, physical and behavioral data using worn sensors on psychiatric patients suffering from schizophrenia, bipolar and schizoaffective disorders. it is a known fact that patients suffering from these disorders are more prone to changes in their mental health condition. sometimes this change is due to change in medical treatment(whether it was the doctor's decision or low adherence to medication treatment).the mental health condition influences physiological, physical and behavioral aspects which could be detected through the personal digital algorithm and could prevent psychiatric deterioration. for example, in a case of a person in a manic episode investigators would expect to find changes in the personal digital algorithm in physiological aspects(increased heart rate, elevated heart rate variability), physical aspects such as increased number of steps per day, and behavioral aspects(increased hours spent outside of home, excessive activity). an early detection can help in the prevention of psychiatric deterioration in this case and help minimize the suffering caused to the patient and caregivers and perhaps assist in minimizing the need for hospitalization. the data will be collected using wrist watches. the sensors will collect the physiological data(heart rate variability), physical data(number of steps per day) and the behavioral data(quality of sleep). this data will then be collected and analyzed through big data analysis.

Eligibility criteria:
inclusion criteria: * psychiatric patients diagnosed with schizophrenia, bipolar, or schizoaffective disorder according to the dsm 5 * panss and cgi scores are 4 and above * participants must have the ability to informed consent * own a smartphone android 2.3 or ios 2010 and above exclusion criteria: * violent or suicidal participant * terminal illness * dialysis treatment * participants who have a legal guardian * participants who do not own a personal smartphone
survey on lymphedema after sentinel lymph node biopsy in people with cervical or vulvar cancer

Conditions: Cervical Cancer; Vulvar Cancer

Summary: the purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (lel) after sentinel lymph node biopsy (sln) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure. please note that, during this study, the researchers will collect information from a questionnaire completed by people who had sln and lnd+/- sln during surgery for early-stage cervical or vulvar cancer. no form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.


Eligibility criteria:
inclusion criteria: * presented to msk with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile. °early stage: stage 1-2 * underwent primary surgery at our institution between january 2006 and january 2022. * alive at the time of study activation * english comprehension * capable of providing informed consent exclusion criteria: * had documented macroscopic evidence of metastatic disease at the time of initial diagnosis

Keywords: questionnaire sentinel lymph node biopsy lymphedema 22-002
individualized analgesia for pediatric adenotonsillectomy

Conditions: Adenotonsillectomy; Analgesia

Summary: the objective of this randomized clinical trial is to assess the safety and effectiveness of post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.

patients will be randomly assigned to individualized opioid analgesia regimen group or conventional opioid analgesia regimen group. intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath after sevoflurane induction. a positive result is defined as a decrease of more than 50% in spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test). otherwise it is defined as a negative result. all the patients are given regular paracetamol and ibuprofen after surgery. the addition of rescue oral morphine is given as needed. the dose of oral morphine is determined according to the results of fentanyl test in the individualized group, while the patients in the conventional group are given the routine dose. the faces scale is used to assess analgesic effectiveness by parents from postoperative day 1 to day 10. if the faces scale score \> 6, the child receive rescue oral morphine analgesia. at the preoperative appointment, parents are provided with a pulse oximeter including oxygen saturation sensors to take home. the oxygen saturation per night during sleep will be monitored using the pulse oximeter by parents from postoperative day 1 to day 10. the research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. the primary outcome measure is desaturation events during sleep per night.

Eligibility criteria:
inclusion criteria: * children, asa physical status i or ii, who is scheduled to undergo adenotonsillectomy will be recruited. exclusion criteria: * children with craniofacial deformities, neuromuscular diseases, mental retardation, body mass index \> 30kg/m2 , or a recent history of opioid use are excluded.

Keywords: adenotonsillectomy individualized opioid analgesia respiratory parameters children
study evaluating safety, tolerability, and action of oap-189 in subjects with type 2 diabetes on metformin

Conditions: Diabetes Mellitus

Summary: this is a study to evaluate the safety, tolerability, and activity of oap-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.


Eligibility criteria:
inclusion criteria: * subjects must have been diagnosed with type 2 diabetes, with hba1c level \>=7.0% and \<=11.0% and a fasting glucose level \<=280 mg/dl. * men or women of nonchildbearing potential (woncbp), aged 18 to 65 years inclusive on study day 1. * body mass index in the range of 27 to 40kg/m² (inclusive) and body weight \>=50 kg. * subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study. * subjects must currently be treated for diabetes with metformin alone at a total daily dose of \>=1gm (administered qd or bid) and that dose must have been stable for at least 4 weeks before study day 1. * nonsmoker. exclusion criteria: * any significant disease with the exception of diabetes mellitus. * any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product. * acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1. * any clinically important problems in physical examination results, vitals sign measurements, ecgs, or clinical laboratory test results. * positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies. * positive findings of urine drug screen * use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.
treatment for major depressive disorder with intermittent theta-burst stimulation

Conditions: Depressive Disorder, Treatment-Resistant

Summary: the main purpose of this study is to investigate the two different intermittent theta burst (itbs) repetitive transcranial magnetic stimulation (rtms), its effectiveness in alleviating depressive symptoms. all patients are randomized to two different itbs groups.


Eligibility criteria:
inclusion criteria: 1. the diagnosis of major depressive disorder according to dsm-5 2. total ham-d17 score of greater than or equal to 18 and item 3 score less than 4 at screening visit. cgi-s score less than 4. 3. before treatment, patient have to stop antidepressant for at least 1 weeks. 4. capable and willing to provide informed consent. exclusion criteria: 1. have a concomitant major, unstable medical or neurologic illness : * psychiatric disorder: schizoprenia, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, substance use disorder. * severe brian disease: brain tumor, encephalitis, brian injury. 2. intracranial implant and other ferromagnetic materials close to the head. 3. history of seizures. 4. cardiac pacemaker. 5. pregnancy.

Keywords: repetitive transcranial magnetic stimulation mood disorders
the neuralert stroke monitor pilot trial

Conditions: Stroke; Surgery

Summary: this trial aims to demonstrate that the neuralert monitoring system will detect strokes before they would be identified by current standard of care. each patient will be monitored for up to five days, depending on device connectivity or battery duration. each monitoring session will consist of wearing a neuralert device on each arm. for this pilot trial, we are interested in learning about wi-fi connectivity, successful data transmission, integration into clinical workflow, usability and tolerability.


Eligibility criteria:
inclusion criteria: * age ≥ 22 years * admitted to or planned admission to the hospital of the university of pennsylvania and followed by the cardiothoracic (ct) surgery or vascular surgery services * considered at high risk for stroke while in the hospital based on: 1. interventions or procedures performed during the hospitalization including: intracardiac surgical or endovascular procedures including valve replacement, ascending aorta or aortic arch surgical or endovascular repair, and open surgical or endovascular carotid revascularization 2. other ct surgery or vascular surgery procedures in patients with high risk characteristics including: atrial fibrillation, prior stroke/tia, hypercoagulable state (i.e., prior clotting events attributed to active malignancy or a diagnosed thrombophilia) requiring lifelong anticoagulation, severely reduced left ventricular cardiac ejection fraction (i.e., \<30%) or anterior left ventricular wall akinesis, or age ≥ 80. exclusion criteria: * any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. * baseline asymmetric upper extremity weakness as assessed by the study team at time of enrollment, defined as an nihss upper extremity motor score \>0 in either arm. * a limb amputation above the wrist in the upper extremities * unwilling to provide informed consent and no legally authorized representative willing to provide informed consent if the patient is unable
efficacy and safety of fentanyl ethypharm for breakthrough pain in opioid-treated patients with cancer

Conditions: Breakthrough Pain; Cancer

Summary: the purpose of the study is to assess the clinical effectiveness of fentanyl ethypharm when used to relieve breakthrough pain (btp) in opioid-treated cancer patients.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. malignant solid tumor or a hematological malignancy causing cancer-related pain 3. background opioid treatment at a stable dose for at least a week 4. one to four episodes of breakthrough pain per day main exclusion criteria: 1. hypersensitivity to fentanyl or to any of the excipients 2. intrathecal opioids 3. recent history of substance abuse 4. recent or planned therapy that would alter pain 5. moderate or severe hepatic or renal disease

Keywords: fentanyl breakthrough pain opioid treated cancer patients
chemotherapy via an implantable pump compared with a subcutaneous port for unresectable liver metastases in patients with resected colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug or giving the drugs in different ways may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.

objectives: i. compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. ii. compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients. outline: randomized study. the following acronyms are used: cf leucovorin calcium, nsc-3590 5-fu fluorouracil, nsc-19893 arm i: single-agent chemotherapy with drug modulation. 5-fu; with cf. weekly infusion via an implantable pump. arm ii: single-agent chemotherapy with drug modulation. 5-fu; with cf. weekly infusion via a subcutaneous infusion port. arm iii: single-agent chemotherapy with drug modulation. 5-fu; with cf. monthly infusion via an implantable pump. arm iv: single-agent chemotherapy with drug modulation. 5-fu; with cf. monthly infusion via a subcutaneous infusion port. projected accrual: a total of 336 patients will be entered in this multicenter study.

Eligibility criteria:
disease characteristics: primary colorectal cancer with unresectable liver metastases less than 75% involvement of the liver radical resection of primary colon or rectal tumor required no local recurrence or extrahepatic metastases no portal vein thrombosis, ascites, or cirrhosis patient characteristics: age: 18 to 76 performance status: karnofsky 70%-100% hematopoietic: wbc greater than 3,000 platelets greater than 100,000 hepatic: bilirubin no greater than 4 mg/dl alkaline phosphatase no greater than 1,200 u/l coagulation tests normal renal: creatinine no greater than 2.5 mg/dl other: no prior malignancy prior concurrent therapy: see disease characteristics no prior intra-arterial chemotherapy for liver metastases no prior hepatic chemoembolization at least 3 months since fluorouracil

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases
phase 1 study to assess safety and efficacy of ang003

Conditions: Exocrine Pancreatic Insufficiency

Summary: randomized, parallel, active-treatment phase 1 study of a single dose of orally administered ang003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. the study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ang003.

the phase 1 study was designed to compare a 24h baseline substrate absorption challenge test (sact) period with no enzymes to a 24h ang003 sact period with enzymes. eligible subjects will be randomly assigned with equal allocation to one of four active dose levels of lipase, protease and amylase. approximately 48 to 60 eligible subjects are planned to be enrolled in the study with 12 to 15 subjects assigned to each dose level from up to 21 investigational sites.

Eligibility criteria:
inclusion criteria: 1. male and female subjects 18 years of age or older. 2. confirmed diagnosis of cf defined as: a) cf signs and symptoms and b) two cf-causing mutations on genetic testing or sweat chloride \>60 meq/l. 3. documented history of fecal elastase \<100 µg/g stool. 4. epi clinically controlled with minimal clinical symptoms and on a stable dose of pert for 90 days before screening as determined by the investigator. 5. adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects. exclusion criteria: 1. subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on days 1 and 5 for a daily total of 6 hours. 2. involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \>5% of body weight within 1 month. 3. requires use of naso-gastric, j-tube, g-tube, and/or enteral feeding for the study duration. 4. cf pulmonary exacerbation within 30 days prior to the baseline sact period (visit 2). 5. subjects who cannot discontinue omega-3 supplements \>500 mg of dha and epa daily. 6. subjects unable to tolerate missing a dose of pert.

Keywords: cystic fibrosis
tadalafil plus tamsulosin for male luts and ed

Conditions: Prostatic Hyperplasia, Benign; Lower Urinary Tract Symptoms; Erectile Dysfunction; Metabolic Syndrome

Summary: metabolic syndrome (mets) is a complex epidemic disorder with an impact on both lower urinary tract symptoms (luts) and erectile dysfunction (ed). combination therapy of daily tadalafil and tamsulosin may provide relief to both diseases. aim of the present study is to assess the impact of combination therapy of tadalafil 5mg plus tamsulosin 0.4mg on luts and ed, according to presence vs. absence of mets.

75 consecutive men presenting with ed and luts suggestive of bladder prostatic obstruction were enrolled. patients were divided into two groups according to mets presence or absence. all subjects were then treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12 weeks. patients were re-evaluated after 12 weeks of treatment with uroflowmetry and pvr, ipss, ipss qol, oab-q and iief-5 and comparison were made in and between groups.

Eligibility criteria:
inclusion criteria: * mild to severe ed (international index of erectile function-erectile function-5 \<22) * moderate to severe luts (international prostate symptom score \>7) exclusion criteria: * hypersensitivity to tadalaﬁl or tamsulosin * prostatic cancer or suspected with prostate-speciﬁc antigen (psa) \>4 ng/ml * bladder lithiasis * previous prostatic surgery * urinary tract infection * neurogenic bladder * ﬁnasteride or dutasteride use within 3 or 6 months respectively * clinical history of urethral and/or proven bladder neck obstruction

Keywords: tadalafil tamsulosin bph luts ed pde5-i alpha-blockers mets