Kornimate/medical-research-clean huggingface dataset:
outcomes related to covid-19 treated with hydroxychloroquine among in-patients with symptomatic disease

Conditions: Coronavirus; Acute Respiratory Infection; SARS-CoV Infection

Summary: orchid is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with covid-19. patients, treating clinicians, and study personnel will all be blinded to study group assignment.

effective therapies for covid-19 are urgently needed. hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against sars-cov-2, the virus that causes covid-19. preliminary reports suggest potential efficacy in small human studies. clinical trial data are needed to determine whether hydroxychloroquine is effective in treating covid-19. study aim: to compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the covid ordinal outcomes scale at day 15, among adults with covid-19 requiring hospitalization. study hypothesis: among adults hospitalized with covid-19, administration of hydroxychloroquine will improve clinical outcomes at day 15. .

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. currently hospitalized or in an emergency department with anticipated hospitalization. 3. symptoms of acute respiratory infection, defined as one or more of the following: 1. cough 2. fever (\> 37.5° c / 99.5° f) 3. shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as spo2 \<92% on room air, new receipt of supplemental oxygen to maintain spo2 ≥92%, or increased supplemental oxygen to maintain spo2 ≥92% for a patient on chronic oxygen therapy). 4. sore throat 4. laboratory-confirmed sars-cov-2 infection within the past 10 days prior to randomization. exclusion criteria: 1. prisoner 2. pregnancy 3. breast feeding 4. symptoms of acute respiratory infection for \>10 days before randomization 5. \>48 hours between meeting inclusion criteria and randomization 6. seizure disorder 7. porphyria cutanea tarda 8. diagnosis of long qt syndrome 9. qtc \>500 ms on electrocardiogram within 72 hours prior to enrollment 10. known allergy to hydroxychloroquine, chloroquine, or amodiaquine 11. receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol 12. receipt of \>1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment 13. inability to receive enteral medications 14. refusal or inability to be contacted on day 15 for clinical outcome assessment if discharged prior to day 15 15. previous enrollment in this trial 16. the treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient

Keywords: covid-19
italian registry of arthritis on biologic therapy

Conditions: Rheumatoid Arthritis

Summary: the biologic drugs targeting tnfa, il-6, il-1, t cells, b cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. these biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis * patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine) * patients eligible to begin conventional biologic therapy exclusion criteria: * any criteria excluding treatment with biologic drugs according to international guidelines

Keywords: rheumatoid arthritis seronegative polyarthritis biologic drugs safety efficacy biologics polyarthritis
aquabeam india study for the treatment of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: single-arm prospective, interventional clinical trial. results will be compared to a historical control in the treatment of benign prostatic hyperplasia


Eligibility criteria:
inclusion criteria: * male * 50 - 80 years * moderate to severe bph * subjects who have failed standard medical therapy exclusion criteria: * size and width of prostate * medical condition or co-morbidities where bph intervention would be contraindicated

Keywords: aquablation aquabeam bph luts
efficacy and safety of auriclosene (nvc-422) in the treatment of bacterial conjunctivitis

Conditions: Bacterial Conjunctivitis

Summary: the purpose of this study is to evaluate the microbiological and clinical efficacy of auriclosene compared to its vehicle for bacterial conjunctivitis. adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. subjects will be randomly assigned to receive either auriclosene ophthalmic solution or vehicle ophthalmic solution.

this is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: auriclosene ophthalmic solution 0.3% ("auriclosene") and auriclosene vehicle ("vehicle"). subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits: * visit 1: screening, day 1 * visit 2: day 3 (±1) * visit 3: day 5 (+1) test of cure/exit ip will be dosed ou (both eyes) qid for 4 days. microbiological specimens will be collected from each eye at each visit. visual acuity will be assessed ou at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.

Eligibility criteria:
inclusion criteria: * 1 year of age and older * bulbar conjunctival injection * conjunctival discharge/exudate * signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less * other inclusion criteria per protocol exclusion criteria: * suspected fungal, viral, chlamydia or acanthamoeba co-infection based on clinical diagnosis * any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment * other exclusion criteria per protocol

Keywords: pink eye
a multiple dose study of repeat intravitreal injections of gem103 in neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration; Retinal Disease; Retinal Degeneration; Macular Degeneration

Summary: this study is designed to investigate the safety and tolerability of gem103 ivt injection + standard of care vs. sham + standard of care.

this is a phase 2a, multi-center, multiple dose study in subjects with neovascular age-related macular degeneration (namd) to investigate the safety and tolerability of gem103 ivt injection + standard of care vs. sham + standard of care. subjects will undergo clinical and ophthalmic assessments for determination of inclusion in the study and who meet all eligibility criteria will be enrolled.

Eligibility criteria:
inclusion criteria: 1. at least 50 years old at the time of signed informed consent 2. choroidal neovascularization (cnv) related to namd with the following features, as determined by the image reading center 1. maximum cnv lesion size of 12 disc areas 2. subretinal hemorrhage less than or equal to (\<=) 50% of lesion size 3. on aflibercept treatment prior to day 1 4. best corrected visual acuity (bcva) in the study eye between 24 to 75 letters using edtrs exclusion criteria: 1. presence of the following ocular conditions in the study eye: 1. any active ocular disease or condition that impact the subject to participate in the study or be a contraindication of ivt injections 2. any intraocular surgery 3. aphakia or complete absence of the posterior capsule 4. prior corneal transplant 5. scar or fibrosis greater than or equal to (\>=) 50% of cnv lesion or involving center of fovea 2. presence of any of the following ocular conditions in either eye: 1. history of herpetic infection, idiopathic polypoidal choroidal vasculopathy (pcv), pathologic myopia, central serous chorioretinopathy (cscr), adult onset foveal pattern dystrophy 2. concurrent disease that could require medical or surgical intervention during the study period 3. active/suspected ocular/periocular infection or active intraocular inflammation 4. history of idiopathic or autoimmune-associated uveitis 3. any prior or ongoing medical condition or clinically significant screening laboratory value that may present a safety risk, interfere with study compliance, interfere with consistent study follow-up, or confound data interpretation throughout the longitudinal follow-up period 4. has experienced a cardiovascular or cerebrovascular event within 12 months of informed consent 5. females must not be pregnant or lactating 6. current use of medications known to be toxic to the lens, retina or optic nerve 7. use of any investigational new drug or other experimental treatment in the last 6 months prior to day 1, and/or receipt of any prior gene therapy or ocular device implantation
prospective comparative study between ultrasound-guided continuous erector spinae plane block and the use of intravenous patient controlled analgesia for management of pain in patients with multiple fracture ribs

Conditions: Multiple Fracture Ribs

Summary: rib fractures are common after blunt injury to the chest. present in 10% of blunt trauma admissions. pain associated with rib fractures can result in compromise of pulmonary function causing hypoxaemia or pneumonia, which may require mechanical ventilation. adequate relief of rib fracture pain allows the patient to breathe deeply, avoid intubation and clear secretions effectively, which will minimise the pulmonary complications . pain control is essential for not only primary pain relief but also preventing secondary complications such as atelectasis or pneumonia as well as the transition to chronic pain. accordingly, further steps are now being taken from the conventional pain control medication and techniques by the introduction of more aggressive pain control measures .traditional regional anaesthesia (ra) techniques such as paravertebral, intercostal and epidurals injections are resource-intensive and time-consuming, limited to single dermatomes; provide incomplete analgesia of the hemithorax; and are associated with significant potential complications such as local anaesthetic intoxication, vasovagal syncope, hemi diaphragmatic paresis and pneumothorax . the erector spinae plane block (espb) is a novel fascial plane block. its use has been documented in numerous instances with positive outcomes in controlling acute as well as chronic pain. the most popular technique was the continuous infusion through a catheter . fascial plane blocks that can be used for rib fracture pain management are serratus anterior plane block, erector spinae plane block and the rhomboid intercostal and subserratus (riss) block. the procedure is more simple to use with a lower incidence of complications ,less time consuming , more superficial than others so it can be used in patients on anticoagulant therapy . providing analgesia for patients with rib fractures continues to be a management challenge. therefore, further studies are needed comparing between different techniques to prove their efficacy in pain management


Eligibility criteria:
inclusion criteria: * • age 18:60 years * patient with 2 or more unilateral rib fractures. * asa 1 , asa 2 exclusion criteria: * • patient refusal * history of chronic pain or daily use of analgesics * history of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (vas) for pain measurement * severe renal or hepatic dysfunction * allergy to any required drug * second thoracic surgery * local infection at the injection site * spinal deformity * head injury * lung complications related to trauma ( pneumothorax , haemothorax , lung collapse). * need of mechanical ventilation
observational, postmarketing surveillance study of spinraza injection (nusinersen sodium)

Conditions: Muscular Atrophy, Spinal

Summary: the primary objective is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in korea. the secondary objective is to evaluate the effectiveness of nusinersen sodium injection in the postmarketing setting in korea.


Eligibility criteria:
key inclusion criteria: * currently receiving or about to initiate treatment with commercial spinraza in the postmarketing setting * genetic documentation of 5q-linked sma key exclusion criteria: * hypersensitivity to the active substance or any of the excipients of spinraza * ongoing participation or participation within 6 months or 5 half-lives of the agent (whichever is longer) of enrollment in other interventional clinical trials for the treatment of sma * inability to comply with study requirements note: other protocol defined inclusion/exclusion criteria may apply.
kineret in the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: objective of the study is to gain knowledge about the administration of kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. in the current survey, the investigation of the response rate of kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.


Eligibility criteria:
inclusion criteria: * informed consent by the patient * rheumatoid arthritis * previous methotrexate therapy with inadequate response exclusion criteria: * pregnancy
sct-i10a plus sct510 versus sorafenib as first-line therapy for advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to assess the safety and effectiveness of sct-i10a in combination with sct510 in patients with hcc who have not received prior systemic therapy.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of hcc not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment. * no prior systemic therapy for hcc(end of postoperative adjuvant chemotherapy for more than 6 months allowed). * child-pugh ≤7 , no history of hepatic encephalopathy. * barcelona clinic liver cancer stage b, not suitable for local treatment and bclc c. * at least one measurable lesion based on recist1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate hematologic and organ function. exclusion criteria: * local treatment or surgery for liver lesions within 4 weeks. * prior liver or other organ transplantation. * active central nervous system (cns) metastasis or leptomeningeal metastases. * gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment. * hemorrhage tendency or high-risk for bleeding , severe coagulation disorders. * active known, or suspected autoimmune disease. * any condition that is not suitable for participate in this study as determined by investigator.
affective learning in disabled health training

Conditions: Learning Disabilities

Summary: this study was conducted to determine the effect of the learning method based on transformative learning theory to improve sensitivity towards the disabled on the empathic tendency, attitude and alexithymia levels of nursing students.

this randomized, controlled and experimental study was conducted between october and december 2019. the sample of the study consisted of 70 2nd grade nursing students (34 people in the experimental group and 36 in the control group). the learning method based on transformative learning theory was applied to the experimental group. the data were collected using a demographic information form, the empathic tendency scale, attitudes towards disabled person scale, and toronto alexithymia scale. the mann-whitney u test, wilcoxon signed ranks test, paired sample test, and pearson's chi-squared test were used to determine the differences between the groups.

Eligibility criteria:
inclusion criteria: * being 18 years old or above, * to study in the second year, * taking the theoretical course of disabled health exclusion criteria: * having attended any training for disabled people before * to have any disabled person in the family members with whom they live.

Keywords: nursing students transformative learning disabled
osseodensification and implant survival and success

Conditions: Missing Teeth

Summary: approximately 40 implants from patients seeking treatment at the university of oklahoma, college of dentistry will be recruited for this study. osteotomies will be prepared using the osseodensification technique and implants will be placed immediately after. the implants will be from a single manufacturer (roxolid® sla® bone level tapered; straumann®, institut straumann ag, basel, switzerland). volumetric analysis of alveolar ridge will be studied using intra-surgical direct measurements and cbct imaging. a custom stent will be fabricated to standardize the clinical and radiographic measurements at 2mm, 3mm, and 4mm apical to the alveolar crest. changes in peri-implant bone density will be analyzed on standardized periapical and bitewing radiographs, using the imagej software (national institute of health, bethesda, maryland, usa). implant stability quotient (isq) values will be recorded with a resonance frequency analysis system (osstell®, gothenburg, sweden). calibrated examiners will assess implant survival and biological or restorative complications and failures. sites will be evaluated throughout osseointegration and one year after final restoration is delivered.


Eligibility criteria:
4. inclusion / exclusion criteria the inclusion criteria include: 1. adult patients ≥18 years old 2. able to understand and sign a written informed consent form and willing to fulfil all study requirements 3. healed edentulous ridge that is planned for an implant restoration. 4. experimental site has not been previously augmented with xenograft 5. experimental site has at least 2 mm of cancellous bone the exclusion criteria include: 1. uncontrolled systemic disease 2. currently smoking \>10 cigarettes/day 3. history of head/neck radiotherapy within the past five years 4. current use of oral bisphosphonates or history of iv bisphosphonate use 5. pregnant, expecting to become pregnant, or lactating women 6. presence of active periodontal disease 7. poor oral hygiene 8. previous history of implant failure at the site the early termination criteria include: 1. the researcher believes that it is not in the patient's best interest to stay in the study 2. based on the exclusion criteria, the patient becomes ineligible to participate 3. patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc) 4. patient does not follow study related instructions 5. the study is suspended or canceled
olfaction and inflammation in chronic rhinosinusitis with nasal polyps

Conditions: Nasal Polyps; Chronic Rhinosinusitis With Nasal Polyps; Olfaction Disorders

Summary: impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. in case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. in addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with tnf alpha, a pro-inflammatory molecule.


Eligibility criteria:
inclusion criteria for patients : * patients with nasosinus polyposis requiring nasosinus surgery * patient affiliated or entitled to a social security * signed consent inclusion criteria for control group : * patients with an indication for septoplasty * patient affiliated or entitled to a social security * signed consent exclusion criteria for patients : * patients with nasosinus polyposis secondary to another disease * patients with hyposmia or anosmia prior to naso-sinus polyposis * patients with diagnosed neurodegenerative disease * patients who are mentally or physically unable to perform olfactory tests * patients on anti-tnf-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy. exclusion criteria for control group : * patients with nasosinus polyposis * patients with chronic rhino-sinusitis * patients with hyposmia or anosmia * patients with diagnosed neurodegenerative disease * patients who are mentally or physically unable to perform olfactory tests * patients on anti-tnf-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.

Keywords: tnf alpha
risk for subsequent osteoradionecrosis in a transferred fibula flap in head and neck cancer patients undergoing segmental mandibulectomy: a cohort study

Conditions: Head and Neck Cancer; Fibula Flap; Osteoradionecrosis; Mandibulectomy

Summary: a retrospective analysis of 329 patients at one single institution between january 2014 and december 2019 who underwent free fibula flap reconstruction was conducted. a variety of clinicopathological postoperative parameters were identified and assessed.

the study was conducted as a monocentric, retrospective study. patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through january 2014 to december 2019 at one single institution in taiwan were identified. all charts including surgical records, progress notes, nursing records, clinic notes, imaging study after surgery were reviewed. data extraction was performed for the following variables: patient demographics, primary diagnosis, cancer location and staging, treatment prior to index surgery, postoperative hemoglobin and albumin, operating time, flap type, mandibular defect length, type of the defect according to jewer's classification, ischemia time, number of fibula segments, plate type, re-exploration, time of hospitalization, postoperative radiotherapy and/or chemotherapy, orn cases, identification time of orn and management for orn. the patients were then organized into two groups: orn and non-orn. this research was approved by the institutional review board of our hospital (no. 201800172b0), which was available until 2022/02/28. the investigators completed data analysis before 2022/02/28 and then initiated manuscript preparing.

Eligibility criteria:
inclusion criteria: * patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through january 2014 to december 2019. exclusion criteria: * cases with incomplete medical records. * patients who did not attend at least 6 months of follow ups.