Kornimate/medical-research-clean huggingface dataset:
extended remdesivir infusion combined with nirmatrelvir/ritonavir for persistent sars-cov-2 infection in immunocompromised patients

Conditions: COVID-19; SARS-CoV-2; Immunocompromised

Summary: to evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive sars-cov-2 pcr despite an oral antiviral agent prescription.

prolonged viral shedding is commonly observed in immunocompromised patients infected by sars-cov-2. until now, there is no successful clinical trial or guideline to guide optimal treatment for this clinical condition. here, we aimed to establish a clinical trial with combination of prolonged remdesivir infusion with nirmatrelvir/ritonavir among covid-19 patients recently receiving b-cell depletion therapy, to evaluate to clinical outcomes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * receive b-cell depletion therapy or bendamustine within 6months * laboratory confirmed sars-cov-2 infection * symptoms onset within 72 hours * niaid ordinal score 0-5 upon enrollment exclusion criteria: * prior use of any anti-sars-cov-2 agents within 2 weeks. remdesivir or nmv/r initiated within 24 hours is acceptable * life expectancy \&lt; 1 month * previous adverse effect related to remdesivir or nmv/r * concurrent use medicine with drug-drug interaction with nmv/r * patients receiving intubation and mechanical ventilation * egfr \&lt; 30 * child pugh score class c * any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.

Keywords: extended rdv infusion combination therapy for sars-cov-2 infection in immunocompromised patients
simvastatin in relapsing remitting multiple sclerosis (rrms) patients using avonex compared to placebo

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: patient with relapsing remitting multiple sclerosis taking avonex are included in this double blind randomized control trial. simvastatin is compared to placebo. end points of edss , total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.


Eligibility criteria:
inclusion criteria: 1. edss\<5 2. \>=1 attack in last year exclusion criteria: 1. \>2 attacks in study 2. drug complication

Keywords: edss attack
a phase i/ii study of aga111 for lumbar interbody fusion in patients with degenerative disc disease

Conditions: Degenerative Disc Disease

Summary: the objectives of the study are to evaluate the safety and preliminary efficacy of a single administration of aga111 for lumbar interbody fusion in patients with degenerative disc disease.

a randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and preliminary efficacy of single administration of aga111 for lumbar interbody fusion in patients with degenerative disc disease. a total of 60 participants will be enrolled and randomized to placebo, aga111 0.25 mg, or aga111 0.5 mg at 1: 1: 1 ratio. all participants will undergo lumbar interbody fusion and receive study treatment during the surgery.

Eligibility criteria:
inclusion criteria: 1. willing and capable of giving signed informed consent. 2. male or female, age between 40-80 years. 3. male or female of childbearing potential must agree to use a highly effective contraception throughout the entire study period, and female subjects must have a negative pregnancy test prior to the randomization. 4. has degenerative disc disease (ddd) of the lumbosacral(l3-s1) spine that results in back pain, with or without radiating leg pain. 5. has radiographic evidence (e.g. ct, mri, x-ray, etc.) of degenerative disc disease. 6. planning to receive single-level lumbar interbody fusion. 7. willing and capable of adhering to the protocol and visit schedule. exclusion criteria: 1. prior surgical procedure at the involved or adjacent spinal levels. 2. presence or prior history of inflammatory disease of the spine. 3. presence or prior history of neoplastic disease of the spine. 4. bmi \ 35. 5. documented titanium allergy or intolerance. 6. presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin). 7. presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study. 8. active local or systemic infection. 9. female subject who is pregnant or lactating. 10. serological evidence of positive human immunodeficiency virus (hiv) antibody. 11. hbsag positive or hbeag positive, along with positive hbv dna test. 12. serological evidence of hcv antibody, along with hcv rna \> lower limit of detection. 13. known drug or alcohol abuser.
study to assess if abp798 is safe & effective in treating non hodgkin lymphoma compared to rituximab

Conditions: Lymphoma, Non-Hodgkin

Summary: this was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of abp 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular b-cell nhl and low tumor burden. subjects were randomized in a 1:1 ratio to receive a 375 mg/m\^2 intravenous infusion of either abp 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.


Eligibility criteria:
inclusion criteria: * males and females 18 years of age and older * histological confirmed (by lymph node or extranodal region biopsy), grade 1, 2, or 3a follicular b-cell nhl expressing cd20 within 12 months before randomization * stage 2, 3, or 4 (per cotswold's modification of ann arbor staging system) with measurable disease (per international working group) * subjects must have a baseline scan (computed tomography \[ct\]) of the neck (if palpable lymph node \> 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 6 weeks before randomization * subjects must have had a baseline bone marrow biopsy within 12 months before randomization. previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening. * low tumor burden based on the groupe d'etudes des lymphomes folliculaires (gelf) criteria * largest nodal or extranodal mass ≤ 7 cm * no more than 3 nodal sites with diameter \> 3 cm * no splenomegaly \> 16cm by ct scan and no symptomatic splenomegaly * no significant pleural or peritoneal serous effusions by ct * lactate dehydrogenase ≤ upper limit of normal (uln) * no b symptoms (night sweats, fever \[temperature \> 38°c\], weight loss \> 10% in the previous 6 months) exclusion criteria: * diffuse large cell component and/or grade 3b follicular nhl * history or known presence of central nervous system metastases * malignancy other than nhl within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin) * recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection) * other investigational procedures that can impact the study data, results, or patient safety while participating in this study are excluded; participation in observational studies is allowed. * subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s) * previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for nhl (including rituximab or biosimilar rituximab, or other anti-cd20 treatments) * systemic corticosteroid use within 3 months before randomization (inhaled are allowable)

Keywords: cd20 positive b-cell non-hodgkin lymphoma abp 798
classification of ankle injury observed with x-ray combined with magnetic resonance imaging

Conditions: Ankle Injury

Summary: to verify whether x-ray combined with mri is able to carry out correct fracture classification and postoperative evaluation in patients with ankle fractures.

history and current related studies intraarticular fractures and ruptures of ligaments around the joint often occur after ankle injury. early correct treatment can effectively help joint repair, and reduce the incidence of serious complications. ankle fractures are one of the common orthopedic fractures. x-ray is a common method for detecting ankle injury, can determine the fracture site, type and extent. however, x-ray is difficult to display ankle fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate fracture classification or formulate treatment programs. magnetic resonance imaging (mri) can clearly show the ankle ligament, tendon, and cartilage injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can provide accurate imaging information. mri can provide accurate preoperative assessment of clinical indicators for the rational formulation of treatment programs to reduce complications. the observation of ankle contusion observed by mri is conducive to analyzing the mechanism of ankle joint injury. therefore, x-ray combined with mri would perfectly verify soft tissue injury after ankle fractures so as to make effective surgical program. adverse events adverse events including incision pain, incision nonunion, ankle pain, peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury. severe adverse events are events occurred during clinical trial, including requiring hospitalization, prolonged hospitalization, disability, inability to work, life-threatening, or fatalities. if severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours. data collection, management, analysis and open-access 1. case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected. 2. data were processed using epidata software (epidata association, odense, denmark), collated, and then recorded electronically. all data regarding this trial were preserved by the first hospital, hebei medical university, china. 3. the electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.

Eligibility criteria:
inclusion criteria: * ankle fractures patients detected by x-ray * highly suspected ankle ligament injury * history of obvious trauma * complete clinical data * irrespective of sex and age * sign the informed consent exclusion criteria: * cardiopulmonary function cannot tolerate anesthesia or surgery * open fractures of ankle joint * old fracture of the ankle joint
the effect of bone marrow stem cells harvested from the iliac crest versus mandibular ramus in alveolar cleft regeneration

Conditions: Cleft Lip and Palate

Summary: this comparative and prospective study was conducted on 10 patients with alveolar cleft defects. patients with alveolar cleft defects were randomly selected and randomly divided into two equal groups: group a: received autologous (bmmscs) harvested from the mandibular ramus and seeded on a collagen sponge in combination with nanohydroxyapatite. group b: received autologous (bmmscs) harvested from the lilac crest and seeded on a collagen sponge in combination with nanohydroxyapatite.

the utilization of mandibular ramus-derived bmscs presents a groundbreaking advancement in maxillofacial reconstruction. this approach offers numerous advantages, including reduced surgical complications, improved precision and localization, higher osteogenic potential, and lower risks of graft rejection. moreover, the combination of bmmncs, nanohydroxyapatite, and prf extracted from the mandible proves to be a viable alternative to traditional iliac crest grafting, promoting effective bone regeneration in alveolar cleft defects. by adopting this novel technique and harvesting site, it can can optimize surgical interventions, paving the way for enhanced standards of care and improving the quality of life for patients with maxillofacial challenges

Eligibility criteria:
inclusion criteria: * patient aged 8-15 years, not received any surgery for alveolar cleft defect, non-syndromic unilateral alveolar cleft with or without cleft palate, good oral hygiene and good compliance with the plaque-control instructions, medically fit for major surgical oral procedure. exclusion criteria: * pre-existing infection at the cleft site, patients with systemic diseases may affect bone healing.
rct on ketorolac and tramadol in bone fractures pain of child

Conditions: Fracture; Pain

Summary: randomized double blind trial with the aim to estimate effectiveness of two therapeutic regimes per os on pain due to not compound bone fractures in child 4-17 years old: * ketorolac 0,5 mg/kg (1 drop every 2 kg) * tramadol 2,5 mg/kh (1 drop every 2 kg) intensity of pain will be estimated with linear 1 to 10 or analogic mcgrath type scale every 20 min. the main objectives are the evaluation of pain decreasing in every group, the time of decreasing, the intensity of pain during procedures (ex. xray) and the occurrence of side effects secondary outcomes are comparison between the two groups on effectiveness on pain and on side effects


Eligibility criteria:
inclusion criteria: * children 4-17 years old with not compound bone fracture presenting in emergency room exclusion criteria: * compound fracture * occurring pain still treated * contraindicated ketorolac or tramadol use * informed consensus not obtained

Keywords: bone fracture ketorolac tramadol
antiretroviral speed access program

Conditions: HIV Infection

Summary: migrant populations represent an increasing proportion of newly referred people living with hiv in canada, particularly in quebec. timely hiv care of newly referred patients has important individual-level health benefits that can result in decreased transmission and benefit the society as a whole. yet, the timing of events in the hiv care cascade (from linkage to care to sustained viral suppression) together with the specific experience of care of these vulnerable populations (asylum-seekers, international students, patients with no status) who often face specific psycho-social and/or financial issues, has rarely been studied. in particular, little is known about their experience of hiv care whether they are referred to a multidisciplinary clinic or a physician-only clinic. in a context where b/f/taf will be provided free-of-charge to all enrolled participants including migrant populations, we aim to investigate what model of care can best address current deficiencies in the standard hiv care cascade for newly-referred patients, which often involves delays in linkage to care and starting art.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. newly referred at the study site 3. hiv-1 infected (fourth generation hiv ag/ab combination assay) 4. treatment-naïve to all anti-hiv therapy, except for the use for pre-exposure prophylaxis (prep) or post-exposure prophylaxis (pep), up to one month prior to screening 5. estimated gfr \>30 ml/min/1.73m2 according to the cockcroft-gault formula for creatinine clearance 6. must be willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to screening 7. female participants who are willing to use acceptable methods of birth control as defined in the protocol exclusion criteria: 1. have received anti-hiv therapy previously, except for prep or pep taken up to one month prior to screening 2. viral load \<100 copies/ml, high suspicion of non-reported art use or being a long-term nonprogressor or elite controller 3. concomitant use of drugs with contraindication or drug-drug interactions with b/f/taf 4. documented historic or baseline allergy to any of the components of b/f/taf 5. estimated egfr (by cockcroft-gault formula) \< 30 ml/min 6. pregnant, breast-feeding or planning or suspected to get pregnant 7. involvement in any other interventional hiv studies during the study period 8. has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving oral medications

Keywords: hiv multidisciplinary model of care patient-reported experience art initiation patient engagement
exercise adherence in a behavioral weight loss program

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to develop intervention strategies that improve long-term exercise adherence in obese adults in in order to improve long-term weight loss.

background: even though exercise improves long-term weight loss maintenance and reduces the risks of cardiovascular disease and type ii diabetes mellitus, obese adults are prone to drop out of exercise programs. dr. jakicic's prior findings suggest that exercise adherence can be enhanced and short-term weight loss can be improved by making exercise more convenient via prescribing exercise in multiple short bouts, rather than one bout per day. effects on long-term exercise adherence and weight loss have not been examined, however. his findings also suggest that providing more exercise options by placing exercise equipment in the home may also increase adherence, as evidenced by a significant correlation between the presence of home exercise equipment and physical activity. however, no experimental studies have tested whether placing exercise equipment in the home actually increases exercise adherence and weight loss. design narrative: the study tested the hypothesis that prescribing exercise in multiple short bouts would improve long-term exercise adherence and long-term weight loss, and that the addition of home exercise equipment would further improve these outcomes. a total of 148 overweight women were recruited and randomized to one of three treatments: 1) long-bout exercise; 2) short-bout exercise; 3) short- bout exercise + home exercise equipment. all subjects participated in an 18-month behavioral weight loss program, in which body weight was assessed at 0, 6, 12, and 18 months and exercise adherence was assessed throughout the 18 months. cardiorespiratory fitness and cardiovascular disease risk factors were measured at 0, 6, and 18 months. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
immunogenicity and safety of nbp608 compared to varivax in healthy children 12 months to 12 years of age

Conditions: Varicella

Summary: this study assesses non-inferiority by comparing seroconversion rate of nbp608 to varivax which are indicated for active immunization for prevention of varicella. total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

this is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of nbp608 compared to varivax which are indicated for active immunization for the prevention of varicella. total of 488 subjects of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. stratified randomization for age group is used to achieve the balance of treatment assignment within age strata. total of four visits are scheduled including two visits via telephone contact. blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at visit 1 and visit 3 respectively. safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through visit 2\*, visit 3 and visit 4\* (\* telephone contact)

Eligibility criteria:
inclusion criteria: * healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period * after menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination exclusion criteria: * those with hypersensitivity to any component of the ips(investigational products), such as gelatin or neomycin * those who have received a varicella vaccine previously * those with a history of hypersensitivity to vaccination, such as guillain-barre syndrome * those with congenital or acquired immunodeficiency * those with active untreated tuberculosis * those who have received or are expected to receive salicylates from 14 days prior to ip(investigational product) vaccination to visit 3 * those who have received or are expected to receive other vaccines from 1 month prior to ip(investigational product) vaccination to visit 3 * those who have received or are expected to receive other ips(investigational products) in another clinical study from 1 month prior to ip(investigational product) vaccination to visit 3

Keywords: prevention of varicella varicella-zoster vaccine
the effect of functional treatment of patients with backward positioned chins on the jaw joint and movements

Conditions: Malocclusion, Angle Class II; Retrognathism; TMJ

Summary: patients with class ii malocclusion and retrognathic mandibles will be treated using functional appliances and asses the remodeling that is expected to occur in the temporomandibular joint (tmj) using cone-beam computed tomography (cbct) images and we will register mandibular movements using electronic axiograph ( a specific apparatus used to record jaw movements in three dimensions). there are three groups : 1. activator group 2. twin block group 3. control group with no treatment. patients will be allocated to the three groups randomly. data will be collected using three different approaches: * cbct images before treatment and 12 months after treatment * axiograph registrations before treatment and 12 months after treatment

the main purposes of this project are: 1. to evaluate the remodeling effects that would take place in the bone structures of the temporomandibular joint (tmj) during functional treatment. 2. to evaluate the possible change that may occur in mandibular movements following functional treatment. 3. to evaluate the possible change in the spatial relationship between centric occlusion (co) and centric relation (cr) following functional treatment

Eligibility criteria:
inclusion criteria: class ii malocclusion skeletal class ii with retruded mandibles. old between 10-13 years healthy tmj horizontal or normal growth pattern exclusion criteria: patients who have been treated previously patients with syndromes or congenital deformities signs or symptoms of temporomandibular disorders.
diagnostic accuracy in sepsis

Conditions: Sepsis Syndrome

Summary: the sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.


Eligibility criteria:
inclusion criteria: * patients \>18 years old with suspected sepsis in the emergency department of oslo university hospital oslo exclusion criteria: * non