Kornimate/medical-research-clean huggingface dataset:
topical timolol for superficial infantile hemangioma

Conditions: Hemangioma

Summary: infantile hemangioma (ih) is the most common benign vascular tumor in pediatric population. the characteristic natural history of this tumor is rapid growth in the first year of life and follows by spontaneous involution. however, it may cause cosmetic unacceptable. early intervention in superficial ih may help to minimize the risk of residual aesthetic problems. topical timolol, a non selective beta-blocker, is an emerging treatment which has been reported in efficacy and safety for the treatment of ih. however, the reported studies were case-series or small study. this study is a prospective double-blind,randomized-controlled study to evaluate the efficacy and safety of 0.5% timolol maleate solution for treatment in superficial ih. the patient will be treated with topical timolol for at least 6 months and instructed to 4 times daily apply 1-2 drop of timolol solution on the lesion and rub over the entire lesion with a finger. photographs of the lesion will be taken at the baseline and every 1-month visit. clinical evaluation of the treatment efficacy is carried out by 2 investigators independently to determine the change in lesion size and visual analogue scale of the lesion color. the main outcome is to evaluate the efficacy of 0.5% timolol maleate solution in treatment of infantile hemangioma compared to placebo.


Eligibility criteria:
inclusion criteria: * patient who is less than 2 years * patient who has been diagnosed with superficial infantile hemangioma * the tumor which has been in proliferative or plateau phase * there is no indication for systemic treatment * informed consent is obtained from the parent of the patient exclusion criteria: * patient who has the indication for systemic therapy * patient who is treated by the other modality such as laser treatment * patient who has underlying disease treated by beta blocker, corticosteroids, interferon, cyclophosphamide or vincristine * patient who has history of hypersensitivity reaction to beta blocker, asthma, cardiac condition prove to heart block
a study of rbd1016 in chb participants

Conditions: Chronic Hepatitis B

Summary: this study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, pk and immunogenicity of rbd1016 injection on nas background treatment in chb participants.

the study consists of screening period, treatment period, and fu period. it is divided into 3 dose groups, namely 100 mg q4w, 200 mg q4w and 200 mg q12w. each group will enroll 16 eligible participants, with 12 participants receiving rbd1016 injection and 4 participants receiving placebo.

Eligibility criteria:
inclusion criteria: 1. willing and able to give written informed consent for study participation; 2. male or female participants aged 18-65 years; 3. body mass index (bmi) within the range of 18-34 kilograms/square meter (kg/m2); 4. documented history of chronic hepatitis b virus (hbv) infection, by positive hbsag and/or hbv dna tests ≥ 6 months before screening; 5. hbeag positive or negative at screening; 6. on a stable regimen (≥ 12 months before screening) of any approved first-line oral nas; 7. hbv dna level \<100 iu/ml at screening; 8. hbsag level ≥50 iu/ml at screening; 9. serum alanine aminotransferase (alt) ≤ 1.5 times the upper limit of normal (uln); 10. liver transient elastography (fibroscan) results within 12 months before screening or at screening showing that the liver stiffness measurement (lsm) level is less than 9 kpa; or with liver biopsy within 24 months before screening showing that the metavir score is f0-f2; exclusion criteria: 1. diagnosed with other liver diseases other than hepatitis b; 2. history of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening; 3. history of organ transplantation or previous or concurrent with hepatocellular carcinoma (hcc), or imaging findings suggesting a possibility of malignant liver lesions; 4. concurrent hepatitis c virus (hcv), human immunodeficiency virus (hiv), or diagnosis of syphilis, acute hepatitis a or acute hepatitis e; 5. laboratory results at screening as follows: serum alpha-fetoprotein (afp) \>50 μg/l; serum albumin concentration \ 1.5; platelet count \ 2×uln; serum creatinine concentration \>1.5×uln or creatinine clearance \<60 ml/min (according to the cockcroft-gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this study; 6. those who the investigator believes are not suitable to participate in the study due to other factors.
glaucoma screening to enhance at-risk californians' health

Conditions: Glaucoma

Summary: the vast majority of glaucoma cases in the united states go undetected and untreated until the late stages of the disease. open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. this study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.

specific aim 1: to determine the effectiveness of a telemedicine-based glaucoma screening program for detecting glaucoma. the investigators hypothesize that a mobile screening intervention incorporating optical coherence tomography (oct), fundus photography, and tonometry will result in a greater number of new glaucoma diagnoses compared to education alone or delayed treatment. specific aim 2: to determine whether a telemedicine-based glaucoma screening program provides benefits beyond glaucoma detection. the investigators hypothesize that (a) individuals randomized to the screening intervention will have higher rates of cataract surgery and distance vision correction one year after screening, and (b) those in the screening intervention will report higher vision-related quality of life one year after screening.

Eligibility criteria:
inclusion criteria: * black people aged 50 years or older * hispanic people aged 65 years or older * people with diabetes aged 50 years or older * must have been seen at the federally qualified health center (fqhc) within the past month exclusion criteria: * patients without a valid phone number or mailing address * patients who have had an optometry appointment within the past year

Keywords: optical coherence tomography tonometry glaucoma screening
point-spectroscopy trial

Conditions: Wound; Wound of Skin

Summary: evaluation and characterization of autofluorescence signals of tissue in and around wounds as identified by moleculight fluorescence image.

evaluate and characterize autofluorescence signals of tissue components in and around wounds identified by moleculight fl images using a point spectrometer. the fluorescence spectroscopy data will yield quantitative spectral information, including the relative intensity and emission peak of the biological autofluorescence signatures.

Eligibility criteria:
inclusion criteria: * patients presenting with acute or chronic wounds * 18 years or older * willing to consent exclusion criteria: * treatment with an investigational drug within 1 month of enrolment * any contra-indication to regular wound care * inability or unwillingness to consent
sufentanil intranasal

Conditions: Emergencies; Pain, Acute; Analgesia; Sufentanil

Summary: study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.

in this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm. the patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal sufentanil. pain is then measured using the visual analogue pail scale at 15-20 minutes and at 60 minutes. at both these time points, adverse effects and vitals are also assessed.

Eligibility criteria:
inclusion criteria: * posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more exclusion criteria: * pregnant * \<18 years * prisoners * lesions of head, face or abdomen * no consent given or possible * pain not scorable * known drug abuse or substitution therapy * chronic level 3 pain medication * intake of level 3 \< 8 hours * intoxicated patient * allergy or intolerance to opiates * renal or hepatic insufficiency * \< 50kg body weight * hemodynamic instability

Keywords: emergency pain analgesia intranasal sufentanil
evaluating weight stability of pancreatic cancer cachexia patients

Conditions: Pancreatic Neoplasms; Pancreatic Cancer; Cachexia; Weight Loss

Summary: eligible patients will have a diagnosis of both pancreatic adenocarcinoma and cachexia defined as greater than 5% unintentional weight loss within 6 months prior to screening visit. patients must be greater than 18 years of age; and have greater than 3 months life expectancy. this study will observe a standard of care intervention (tube feeding) for potential benefit. peptamen will be administered through a jejunal or a gastrojejunal feeding tube and dosing will be calculated using the mifflin st. jeor equation. it will be administered daily for the duration of the protocol.

in this study, we will prospectively evaluate advanced pancreatic adenocarcinoma patients with cachexia, who are receiving enteral feeding, with a peptide based diet (medical food), through a jejunal or gastrojejunal feeding tube. we plan to collect serum samples routinely and establish a cohort of patients with this clinical syndrome. our aims are to establish the feasibility and efficacy of enteral nutrition and its relationship to meaningful clinical outcomes. furthermore, we will assess for a correlation between cachexia, activity, and patient reported outcomes on domains of quality of life in an optional activity tracker sub-study.

Eligibility criteria:
inclusion criteria: * advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to socci-csmc for chemotherapy * cachexia defined as greater than 5% unexplained weight loss within 6 months prior to screening visit or consultation with medical oncologist * candidate for enteral feeding with peptamen, a peptide based formula. must have jejunal or gastrojejunal tube either previously placed or at least prior to day 1 of study * age ≥ 18 years. * ecog performance status 0-2 * greater than or equal to 3 month life expectancy * ability to understand and the willingness to sign a written informed consent * may have received prior anti-cancer treatment, complete or partial resection of primary tumor * patients must be ambulatory and have access to a smart phone to participate in the activity tracker sub-study exclusion criteria: * patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * malignant ascites requiring paracenteses * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * bowel obstruction, partial or total * pregnancy
oral immunotherapy in young children with food allergy

Conditions: Food Allergy

Summary: the goal of this clinical trial is to learn about oral immunotherapy in food allergic children \< 30 months of age. the main question it aims to answer is: what is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.

primary objective: what is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care? secondary objective: what is the effect of early low-dose oral immunotherapy in children under the age of 30 months with an established food allergy on (allergy specific) quality of life of parents and children compared to routine care? study design: randomized controlled superiority trial study population: children between 9 and 30 months old with an ige-mediated food allergy to peanut, tree nuts, cow's milk and/or hen's egg as proven by an oral food challenge. intervention: 1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared to strict avoidance in the control group. main study parameters/endpoints: long-term tolerance as assessed by an exit oral food challenge at 4 weeks after discontinuation of the oral immunotherapy, combined with uncomplicated consumption of a full dose of the specific food at 6 months after discontinuation of the therapy.

Eligibility criteria:
inclusion criteria: * an ige-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/or hen's egg as proven by sensitization to the specific allergen (sige \> 0.35ku/l) and a positive oral food challenge. * the fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s). exclusion criteria: * (suspected) eosinophilic oesophagitis * uncontrolled asthma/ viral wheeze. * the inability of parents to follow instructions, recognize allergic reactions or administer emergency medication. * participation in any other intervention study at the time of the oit study, with the exception of studies on guided early introduction of highly allergenic foods.

Keywords: oral immunotherapy infants food allergy
tubeless versus standard upper pole percutaneous nephrolithotomy

Conditions: Pleural Effusion

Summary: comparison of complications between standard upper pole percutaneous nephrolithotomy (pcnl) with nephrostomy placement and double j stent and pcnl with double j placement only without nephrostomy.

measurement of complications in and comparison between two groups of patients undergoing upper pole pcnl. first group consists of patients left with nephrostomy and double j stent and the second group includes patients left with double j stent only without nephrostomy.

Eligibility criteria:
inclusion criteria: * patients undergoing upper pole percutaneous nephrolithotomy older than 18 years of age and willing to participate exclusion criteria: * patients younger than 18 years of age * patients unwilling to participate in the study * patients that nephrostomy tube placement was a prerequisite at the end of the procedure

Keywords: percutaneous nephrolithotomy (pcnl) nephrostomy double j stent pleural effusion
improving syncope risk stratification in older adults

Conditions: Syncope

Summary: syncope (temporary loss of consciousness) is a frequent reason for an emergency department (ed) visit among older adults. the current ed evaluation of syncope frequently leads to hospitalization, results in low diagnostic yield, and is enormously costly. the purpose of this protocol is to improve risk prediction for syncope. improved risk prediction will inform the design of interventions to safely reduce unnecessary health service use. this is a multi-center, prospective, observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting). the primary outcome is a composite of 30-day cardiac death and serious cardiac events. study aims and hypotheses are: specific aim 1. describe serious outcomes after unexplained syncope; rates and reasons for admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic tests. h1: current patterns of care representing a diversity of practice settings and patient populations are costly with low clinical benefit. specific aim 2. derive and validate a novel risk prediction model for 30-day cardiac death and serious cardiac outcomes after unexplained syncope. h2: explicit criteria including contemporary cardiac biomarkers will improve risk stratification compared to unstructured physician assessment and published risk models. specific aim 3. assess safety and costs of a risk-tailored diagnostic algorithm compared to existing care for unexplained syncope. h3: a risk-tailored diagnostic algorithm can safely reduce the costs of evaluating unexplained syncope in older adults.


Eligibility criteria:
inclusion criteria: 1. age≥60 years; and 2. a complaint of syncope or near-syncope. syncope is defined as a transient loss of consciousness (loc), associated with loss of postural tone, with immediate, spontaneous, and complete recovery. near-syncope is the sensation of imminent syncope without loss of consciousness. exclusion criteria: * seizure as presumptive cause of loc * stroke or transient ischemic attack as presumptive cause of loc * loc after head trauma confusion from baseline mental status * intoxicated (alcohol or other drugs) * medical or electrical intervention to restore consciousness * hypoglycemia as presumptive cause of loc * inability to provide follow-up information, including patients who do not speak english (or spanish, if applicable for study site), lack phone access, or lack a permanent address * inability or unwillingness of individual or legal guardian/representative to give written informed consent

Keywords: risk stratification syncope geriatric
study evaluating temsirolimus (cci-779) in mantle cell lymphoma (mcl)

Conditions: Lymphoma

Summary: this is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * mantle cell lymphoma (mcl) confirmed with histology, immunophenotype, and cyclin d1 analysis * received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance) * prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following: * primary disease refractory to at least 2 regimens; * refractory to at least 1 regimen after first relapse; * refractory or untreated after second or greater relapse; * refractory to first line and relapsed after second line. chemotherapy combinations may include, but are not limited to: chop (cyclophosphamide, doxorubicin, vincristine, prednisone), r-chop (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), fcm (fludarabine, cyclophosphamide, mitoxantrone), r-fcm (rituximab,fludarabine, cyclophosphamide, mitoxantrone), ice(ifosfamide, carboplatin, etoposide), dhap (dexamethasone, cisplatin, cytarabine) and hyper-cvad (cyclophosphamide, doxorubicin, vincristine, dexamethasone). exclusion criteria: * subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease * prior investigational therapy within 3 weeks of first dose. investigational therapy is defined as treatment that is not approved for any indication. * active central nervous system (cns) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (treated cns metastases must be stable for \> 2 weeks prior to day 1.)

Keywords: lymphoma
investigation of clinical spectrum, bacterial pathogens and immune response in acute pharyngotonsillitis

Conditions: Tonsillitis

Summary: acute pharyngotonsillitis is one of the most common infections encountered by pediatricians. most children with acute pharyngotonsillitis have symptoms that can be attributed to viral infection. however 30-40% of cases is of bacterial etiology. the purpose of this study is to examine frequency, age distribution, clinical picture and pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.

according to the us vital health statistics report, acute pharyngotonsillitis is responsible for more than 6 million office visits each year by children younger than 15 years of age. approximately 30% of cases is of bacterial etiology and group a beta-hemolytic streptococci(gabhs) are responsible for most bacterial cases, although other pathogens, such as neisseria gonorrhoeae, arcanobacterium haemolyticum, mycoplasma pneumoniae, and chlamydia pneumoniae, may be the causative agents in sporadic cases. an accurate diagnosis of gabhs infection is important because it is the only common form of acute pharyngotonsillitis for which antibiotic therapy is definitely indicated. effective antibacterial treatment can shorten the clinical course of gabhs pharyngotonsillitis, reduce the rate of transmission, and prevent suppurative and nonsuppurative complications, such as peritonsillar abscess and acute rheumatic fever. this study enrolls patients who will present with acute fever and clinical signs of pharyngotonsillitis at three primary pediatric ambulances. a rapid a beta-hemolytic streptococcus (gabhs)-detection test will be performed in these patients. in one office, additional throat cultures are obtained of all patients, and blood is taken in a subgroup of 60 gabhs-positive and 60 gabhs-negative cases. in gabhs-positive patients, a second blood sample will be obtained at day 7th and day 28th, and stored until specific antibody response to gabhs will be measured.

Eligibility criteria:
inclusion criteria: * age 3 months to 18 years * clinical signs of tonsillopharyngitis * informed consent exclusion criteria: * age more than 18 years * diagnosed chronic disease or infection (e.x. hiv, tuberculosis, malignancy) * current participation in another research projects that may interfere with this study * incapability to perform all study procedure

Keywords: upper airway infections pharyngotonsillitis gabhs
atazanavir or lopinavir in hiv post-exposure prophylaxis

Conditions: HIV Infections

Summary: the study compares the adherence of 240 hiv-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to hiv.


Eligibility criteria:
inclusion criteria: * age \> 18 * hiv exposure requiring prophylaxis under current guidelines exclusion criteria: * pregnancy * suspected drug resistance in source case * contraindications to the study drugs

Keywords: hiv seronegativity