Kornimate/medical-research-clean huggingface dataset:
favipiravir in high-risk covid-19 patients

Conditions: Covid19

Summary: the study aims to investigate the efficacy of favipiravir in high-risk covid-19 patients. the study population includes symptomatic mild-to-moderate covid-19 inpatients, within first 7 days of illness, who are 50 years old and above, and have 1 or more comorbidities. the study is designed as a randomised, open-label, multicenter clinical trial where the patients are randomised 1:1 to groups receiving favipiravir (5 days) versus no favipiravir.


Eligibility criteria:
inclusion criteria: * patients are eligible to be included in the study only if they fulfil all the following criteria: * rt-pcr confirmed covid-19 cases * aged 50 years and above, and have one or more co-morbidities * within the first 7 days of illness (from symptom onset) * mild to moderate clinical severity exclusion criteria: * asymptomatic stage 1 patients * patients with spo2 less than 95% without oxygen therapy * patients who needs oxygen supplements * patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study * patients with congestive heart failure * patients with severe hepatic impairment (\>grade 3: alt \>10 times of upper normal limit) * impaired kidney function (creatinine clearance according to cockcroft-gault formula less than 30 ml/min) at the time of screening. * malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others). * pregnant or nursing women or women planning pregnancy. * female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration * male patients whose partner cannot agree to use the contraception method described in (9) * patients with a history of gout or on treatment for gout or hyperuricemia * patients receiving immunosuppressants * patients who received interferon or drugs with reported antiviral activity against covid-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness. * patients in whom this episode of infection is a recurrence or reinfection of covid-19 infection * patients who have previously received favipiravir * patients who are not able to provide written consent by themselves * other patients judged ineligible by the principal investigator or sub-investigator
randomized trial for pain management in low-grade subarachnoid hemorrhage

Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)

Summary: headaches associated with subarachnoid hemorrhage (sah) cause severe pain. headache management is complex, requiring a balance between pain control and preservation of neurological assessment. sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. most critically, all narcotics can result in respiratory depression and sedation. for patients who present without neurological defects but debilitating pain, management is particularly challenging. the sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. in order to control the pain associated with sah headaches, the use of narcotics is often required despite the risks. this standard therapy involves an iv bolus dose delivered by the provider regularly as needed for pain control. a common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (pca). with the pca method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. we hypothesize that this approach to pain relief for sah headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.


Eligibility criteria:
inclusion criteria: * age\>18-75 * glasgow coma scale (gcs) 13 or greater * hunt and hess grade i, ii conditions * admitted within 2 days of initial sah event \>6/10 pain on presentation exclusion criteria: * aphasia * head trauma within the past 30 days * need for craniotomy * h/o obstructive sleep apnea or respiratory disease * h/o opioid tolerance * evidence of vasospasm * h/o liver disease
abx-egf as second line treatment of advanced non-small-cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer; Neoplasm Metastasis; Lung Cancer

Summary: rationale: overexpression of epidermal growth factor receptor (egfr) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. tgfa and egf, the ligands for egfr, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. blocking this stimulus by blocking activation of egfr with abx-egf, a fully human monoclonal antibody against egfr, may prevent tumor growth and perhaps shrink tumors. purpose: this is a phase 2 clinical trial to evaluate the safety and efficacy of abx-egf in the treatment of advanced nsclc following failure of paclitaxel and carboplatin therapy on treatment arm 1 of immunex protocol 054.0004 (amgen protocol 20025404), part 2.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * diagnosis of nsclc. * unidimensionally measurable disease. * documented disease progression within 6 months of the subject's last dose of carboplatin and paclitaxel in treatment arm 1, part 2 of immunex protocol 054.0004 (amgen protocol 20025404). * disease stage iiib with pericardial or pleural effusion, or stage iv. * life expectancy of at least 12 weeks. * anc greater than or equal to 1.5 x 10\^9/l, platelet count greater than or equal to 100 x 10\^9/l. * adequate hematology function * adequate renal function * adequate hepatic function * ecog score of less than 2. * brain metastases, if present, must be controlled and asymptomatic. exclusion criteria: * calcium \>uln (treatment for hypercalcemia allowed). * use of any investigational therapy within 30 days of abx-egf infusion. * any cancer therapy for nsclc other than paclitaxel and carboplatin per immunex protocol 054.0004 (amgen protocol 20025404), such as radiation therapy, surgery, or steroids. * paclitaxel or carboplatin within 30 days before the first abx-egf infusion. * radiation therapy within 2 weeks before abx-egf infusion. * lvef less than 45% as measured by muga. * symptomatic ventricular arrhythmia or symptomatic conduction abnormality. * myocardial infarction within 1 year before first dose of study drug. * history of cancer that has required treatment or been active within past 5 years, other than nsclc, basal cell carcinoma, or cervical carcinoma in situ. * women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an iud during the course of the study and for 6 months following treatment. * men not willing to use contraception upon enrollment into this study and for 1 month following treatment. * women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration. * known to be hiv positive. * any patient who's best medical interests would not be met by entry in the study in the opinion of the investigators.
a study of aripiprazole lauroxil (also known as aristada tm) in subjects with schizophrenia

Conditions: Schizophrenia

Summary: this study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as aristada, alks 9070).


Eligibility criteria:
inclusion criteria: * has demonstrated tolerability to test doses of oral aripiprazole during screening; or has a history of tolerated use of aripiprazole * has a diagnosis of schizophrenia * is clinically stable * has received at least 3 doses of risperidone long acting injection (risperdal consta) or paliperidone palmitate (invega sustenna) prior to screening. * has no antipsychotic medication regimen change for 4 weeks prior to day 1 * agreed to abide by the contraceptive requirements o the protocol * resides in a stable living situation * additional criteria may apply exclusion criteria: * is currently pregnant or breastfeeding, or is planning to become pregnant during the study * has received invega trinza, aripiprazole lauroxil, or im depot aripiprazole within 6 months of screening * has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product * has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening * additional criteria may apply

Keywords: alkermes aristada aripiprazole lauroxil schizophrenia
assessing testing strategies for safe return to k-12 schools in an underserved population

Conditions: Covid19

Summary: the primary goal of this study is to determine the most effective sars-cov-2 testing strategy for successful return of in-person school in the under-served communities of st. louis. regular screening testing has been recommended by the cdc as an additive mitigation strategy for in-person schools in areas of high community transmission. we will compare the effectiveness and acceptance of two different school-based testing strategies among students and school staff (symptomatic testing only versus weekly surveillance testing plus symptomatic testing), measuring school-based sars-cov-2 transmission through a cluster randomized trial.

we will complete a cluster randomized trial to compare the incidence of school-based sars-cov-2 transmission between weekly screening testing of students and school staff versus testing only symptomatic students and staff. in this proposal, 16 middle and high schools from five school districts in the st. louis metropolitan area will be cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. the symptomatic testing will be provided to the entire school community as well as household members of students and staff. the second aim will evaluate existing mitigation strategies utilized in schools and the rate of school-based sars-cov-2 transmission by defining the mitigation strategies utilized in participating schools through survey tools developed with cdc and their impact on school-based covid-19 transmission and quantifying the rate of covid-19 transmission in schools and the impact of this transmission on households through extensive interviews and testing of contacts and household members. our 3rd aim involves partnering with community-based organizations to specify and address the social, ethical, and behavioral implications of in-person schooling during the covid-19 pandemic and the impact of sars-cov-2 testing on the school and community. listening sessions will be utilized to understand barriers and facilitators to testing, ethical concerns of the community in research participation, and the behavioral health impact of lack of in-person schooling.

Eligibility criteria:
inclusion criteria: * a student or staff in one of the five school districts. * household members of a student or staff member in the five school districts. exclusion criteria: * people not affiliated with the school.

Keywords: sars-cov-2 screening testing school-based covid-19 transmission
efficacy and tolerability of propiverine hydrochloride in patients with neurogenic detrusor overactivity

Conditions: Neurogenic Urinary Bladder Disorder; Urinary Bladder, Neurogenic; Bladder Disorder, Neurogenic; Urinary Bladder Disorder, Neurogenic; Neurogenic Bladder Disorder; Urinary Bladder Neurogenic Dysfunction; Urologic Diseases; Overactive Detrusor Function; Urinary Incontinence

Summary: the purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.


Eligibility criteria:
inclusion criteria: * male or female caucasian patients aged ≥18 and ≤70 years * voluntarily signed informed consent * neurogenic detrusor overactivity with occurrence of reflex detrusor contractions * reflex volume of ≤250 ml * intact reflex arcs in the area of segments s2-s4 exclusion criteria: * patients suffering from multiple sclerosis under unstable conditions * augmented reflex bladder * patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible * acute urinary tract infection * electrostimulation therapy (within 4 weeks propir to visit 1) * anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis) * radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma * surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery) * pre-existing medical contraindications for anticholinergics * cardiac insufficiency (nyha stage iii/ iv) * therapy with botulinum toxin within the last 12 months * evidence of severe renal, hepatic or metabolic disorders * history of drug or alcohol abuse * concomitant medication known to have a potential to interfere with the trial medication * known hypersensitivity to propiverine hydrochloride or excipients contained in the trial medication, respectively * pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method * patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study

Keywords: antimuscarinics neurogenic bladder propiverine urodynamics
validation of the "apneascan" algorithm for the detection of sleep disordered breathing in chronic heart failure

Conditions: Sleep-disordered Breathing; Chronic Heart Failure

Summary: a prospective observational multi-centre study for the validation of the apneascan algorithm (integrated in icd devices (with or without cardiac resynchronization therapy function) of the "incepta" series for the screening of sleep disordered breathing in patients with stable symptomatic chronic heart failure, using portable polygraphy monitoring device ("embletta gold") as reference for the apnea-hypopnea-index (ahi). secondary objectives are the detection of severe sleep disordered breathing in patients with clinically indicated in-laboratory polysomnography, as well as correlations of the ahi detected by apneascan with other clinical endpoints like mortality, hospitalization, atrial fibrillation and ventricular arrhythmia.


Eligibility criteria:
inclusion criteria: * age over 18 years * patient´s written informed consent * patients with a cardiac rhythm management device (icd with or without cardiac resynchronization therapy function) of the "incepta" series (including the apneascan algorithm) already implanted for at least 8 weeks (corresponding to the duration of the leads´ healing process); in order to standardize the enrollment period, inclusion should be effected between the first (the earliest 8 weeks after implantation) and the second routine control of icd-function (the latest 9 months after implantation) * stable symptomatic chronic heart failure for either ischemic or non-ischemic reason (moderately to severely impaired systolic left ventricular function with nyha-class ii to iii) under optimal pharmacological treatment (according to guidelines 2012 of the european society of cardiology) exclusion criteria: * unstable heart failure (nyha-class iv) or asymptomatic chronic heart failure (including patients with very mild exercise induced dyspnea, i.e. nyha-class i) * patients already treated for sleep apnea syndrome (i.e. continuous positive airway pressure mask) or chronic obstructive pulmonary disease with gold-class iv (i.e. long-term oxygen therapy) * a limited ahi detection by the apneascan algorithm until the planned inclusion (randomly defined by \<50% of countable ahi detection-points within the last 2 weeks). * patients with limited mobility due to orthopedic, neurologic or oncologic diseases (because of restricted assessment of exercise induced dyspnea) * patients on dialysis (either acute or chronic) * alcoholism or regular intake of hypnotics * pregnancy and lactation

Keywords: sleep-disordered breathing chronic heart failure implantable cardioverter-defibrillator apnea-hypopnea-index portable polygraphy monitoring polysomnography
the patient's journey - the time to final diagnosis in patients with sinet

Conditions: Neuroendocrine Tumors

Summary: "the patient's journey" is an interview based study assessing the patients' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors.

the project focus on patients with small intestinal neuroendocrine tumors (sinet's) with an incidence of 1-2/100 000 yearly. the primary tumor(s) are often small and symptoms usually arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to local growth. as the tumors grow slowly and the symptoms in many cases are rather diffuse and develops gradually over a long time period there is often a long delay from onset to a final diagnosis both depending on "patient's delay" and "doctor's delay" the aim of the current project is to map and analyze the patient's journey from the first appearance of symptoms to the time point of a final diagnosis and to try to identify factors contributing to a delayed process. the method is interview based and the interviews will be analyzed through the design thinking methodology

Eligibility criteria:
inclusion criteria: * patients living in western sweden * \> 18 years of age * performance status 0-3 * expected remaining survival of \> 6 months * diagnosed with a small intestinal neuroendocrine tumor during 2016-2018 exclusion criteria: * not able to read and/or understand swedish language * dementia/memory loss * performance status \>3
luteal antagonist versus conventional treatment in women with severe early ovarian hyperstimulation syndrome (ohss)

Conditions: Ovarian Hyperstimulation Syndrome

Summary: the study aims to compare the novel method of gnrh antagonist administration in the luteal phase versus conventional treatment in ivf patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.

gnrh antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early ohss, causing rapid regression of the syndrome on an outpatient basis. the approach has been described as tertiary ohss prevention, thereby complementing the primary prevention (gnrh antagonist protocol) and secondary prevention (gnrh agonist trigger) that constitute the ohss-free clinic concept. no randomized controlled trials (rct) exist to date comparing luteal gnrh antagonist administration versus conventional treatment. the aim of the present study is to compare the novel method of gnrh antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe ohss regression, in ivf patients who develop severe early ohss and have all their embryos cryopreserved.

Eligibility criteria:
inclusion criteria: * women with established severe early ohss. * criteria for the diagnosis of severe ohss require: * the presence of moderate (or higher) ascites and at least two of the following: * enlarged ovaries (\>100 mm maximal diameter), * haematocrit (ht) \>45%, * white blood cell count (wbc) \>15,000/mm3. exclusion criteria: * women not fulfilling the above criteria

Keywords: severe ohss antagonist administration conventional treatment
lm-302 for the treatment of subjects with claudin18.2-positive gastric and gastroesophageal junction adenocarcinoma.

Conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

Summary: this study will assess the efficacy and safety of lm-302 versus treatment of physician's choice (tpc) in subjects with locally advanced or metastatic, claudin (cldn) 18.2-positive, gastric or gastroesophageal junction adenocarcinoma who have progressed on or after 2 lines of systemic therapy


Eligibility criteria:
inclusion criteria: * age 18-80 years old, male and female * has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (g/gej ac). * has received and progressed on at least 2 lines of systemic therapy. a prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. * centrally confirmed cldn18.2-positive * her2 negative * at least one measurable lesion according to the solid tumor response evaluation criteria (recist 1.1) * ecog: 0-1 * expected survival ≥12 weeks; * good blood reserve and liver, kidney and coagulation function * willing to provide informed consent for study participation. exclusion criteria: * within the first 5 years of randomization, there is a history of malignant tumors other than gc/gej adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment * individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation * urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\>1g * individuals with a history of severe cardiovascular and cerebrovascular diseases * individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening * current peripheral sensory or motor neuropathy ≥ grade 2 * uncontrollable third space effusion in clinical practice * received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization * the researcher determined that there are other situations that are not suitable for participation in this study