Kornimate/medical-research-clean huggingface dataset:
a feasibility study evaluating a novel mask (nasal reservoir cannula)

Conditions: Pneumonia Childhood

Summary: this study evaluates the addition of a novel mask (nasal reservoir cannula) to a standard nasal cannula during supplemental oxygenation for the treatment of hospitalized pediatric patients with hypoxemia due to severe pneumonia. half of patients (group a) will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (period 1), followed by a 1-hour period of continued use of the standard nasal cannula delivery (period 2). half of patients (group b) will receive oxygen for 1 hour using a standard nasal cannula (period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (period 2).

pneumonia is the leading infectious cause of death among children less than 5 years of age. hypoxemia is a major fatal complication of pneumonia, and the risk of death increases with increasing severity of hypoxemia. improving oxygen delivery and extending oxygen supplies to children with hypoxemia due to severe pneumonia could reduce mortality in resource-limited settings. global good has developed a low cost oxygen mask (nasal reservoir cannula) to more efficiently deliver oxygen to the pediatric patient by increasing dead space to recapture a portion of expelled oxygen using the spatial distribution of the nasal reservoir cannula volume and length of surface seal. this nasal reservoir cannula fits over a standard nasal cannula (also termed prong). the system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (fio2) per oxygen delivered (l/min) compared with a standard nasal cannula alone.

Eligibility criteria:
inclusion criteria: 1. age ≥ 1 and ≤ 6 years. 2. severe pneumonia based on who criteria 3. spo2 ≥ 85% and \< 94% by pulse oximetry on room air 4. hospital admission based on clinician judgment 5. written informed consent from parent(s)/guardian(s) of subjects must be obtained before any study procedure is performed 6. body weight ≥ 8 kg and ≤ 26 kg exclusion criteria: 1. hypercapnia (pco2 \> 55 mm hg or 7.32 kpa) on room air 2. acidosis / lactic acidosis (ph \ 6 mg/dl) on room air 3. spo2 \< 85% or ≥ 94% by pulse oximetry on room air 4. sick score \> 2.4 5. hemoglobin \< 7 g/dl 6. facial abnormalities or trauma precluding use of mask and nasal prongs. 7. requirement of intubation or non-invasive or invasive positive-pressure ventilation 8. suspected or known pneumothorax 9. body weight \ 26 kg 10. hemodynamic instability based on clinician judgment 11. spo2 \< 90% by pulse oximetry on oxygen, measured at the end of the enrollment and before initiation of period 1

Keywords: pneumonia hypoxemia oxygen therapy oxygen mask
respiratory muscle training and intermittent hypoxia: additive health effects?

Conditions: Pre-Hypertension

Summary: the prevalence of pre-hypertension and hypertension in the elderly is very high. apart from medication, physical exercise training is a potential strategy to reduce blood pressure, however, the ability to perform exercise can be limited in the elderly. hence, alternative non-pharmacological strategies to reduce blood pressure are necessary. two interventions that have been shown to positively influence blood pressure are respiratory muscle training (rmt) and intermittent hypoxia (ih). whether a combination of rmt and ih yields even better effects is currently unknown. therefore, in this study, the effect of a single session of rmt with and without ih on blood pressure and associated cardiovascular parameters will be investigated in elderly subjects with pre-hypertension.


Eligibility criteria:
inclusion criteria: * age: 65-80 years * systolic blood pressure between 130-139 mmhg and diastolic blood pressure lower than 90 mmhg * non smoking * normal body-mass-index (bmi): 18.5-24.9 kg·m-2 * normal lung function * willing to adhere to the general study rules exclusion criteria: * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * previous enrolment into the current study * enrolment of the investigator, his/her family members, employees and other dependent persons * intake of blood pressure medication * intake of medications affecting sleep or the performance or the respiratory, cardiovascular or neuromuscular system * acute or chronic illness other than prehypertension
patients with acl injury and varus knee will undergo acl reconstruction alone, or combined with high tibial osteotomy in the same session.

Conditions: ACL - Anterior Cruciate Ligament Deficiency; Varus Deformity of Tibia (Disorder); ACL Injury; Knee Deformity

Summary: the purpose of this study is to compare the results of single-stage anterior cruciate ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament reconstruction alone in knees with varus malalignment and anterior cruciate ligament deficiency. evaluation will be clinically, radiologically and time needed to return to pre injury activity level. our hypothesis: simultaneous anterior cruciate ligament reconstruction and high tibial osteotomy provides good functional scores, low rate of graft failure and early return to pre injury activity level with minimal added morbidity.


Eligibility criteria:
inclusion criteria: * age between 20 and 50. * knee varus malalignment 7-10°. * acl injury with clinical anterior instability confirmed by mri. exclusion criteria: * osteoarthritis (kellgren-lawrence grade iv). * inflammatory joint disease. * knee flexion \< 120° * knee fixed flexion deformity \> 10°. * bmi \>30 * any ligamentous or meniscal knee injury other than acl injury.
evaluation of vgx-3100 and electroporation alone or in combination with imiquimod for the treatment of hpv-16 and/or hpv-18 related vulvar hsil (also referred as: vin 2 or vin 3)

Conditions: Vulvar High Grade Squamous Intraepithelial Lesion (HSIL); Vulvar Dysplasia; Vulvar Intraepithelial Neoplasia (VIN); VIN2; VIN3; Pre-cancerous Lesions of the Vulva; Human Papillomavirus (HPV)

Summary: the purpose of this study is to test the safety and efficacy of an investigational immunotherapy vgx-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (hsil) \[vulval intraepithelial neoplasia 2 or 3 (vin 2 or vin 3)\] associated with human papilloma virus (hpv) types 16 and/or 18. vgx-3100 is being assessed as an alternative to surgery with the potential to clear the underlying hpv infection. for more information visit our study website at: www.vinresearchstudy.com


Eligibility criteria:
inclusion criteria: * women aged 18 and above; * have high grade squamous intraepithelial lesion (hsil) of the vulva (vin2 or vin3) caused by infection with hpv types 16 and/or 18 confirmed at screening visit; exclusion criteria: * biopsy-proven differentiated vin; * any previous treatment for vulvar hsil within 4 weeks prior to screening; * allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream; * pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product; * immunosuppression as a result of underlying illness or treatment; * significant acute or chronic medical illness.

Keywords: hpv-16 hpv-18
laser treatment in early wound healing to promote physiological skin remodeling

Conditions: Scar Improvement by Laser

Summary: the primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (nafl) to reduce scar formation in a randomized controlled trial. thus, nafl will be applied during 1) inflammation phase (0-3 days) as represented by nafl-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by nafl-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by nafl-treatment six weeks after surgery.

this is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. the study will be performed on patients undergoing an excision at bispebjerg dermatological department. one randomly allocated part of each included wound will receive three nafl-treatments and the other part will serve as untreated control wound. scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after nafl-treatments. the clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.

Eligibility criteria:
inclusion criteria: * o subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (nmsc) lesions. * the length of postoperative wound should be estimated to minimum 2.5 cm and may be located on any region of the body * minimum 18 years old * presenting full medical record report at study initiation * fitzpatrick skin type i-iii * non-smokers * written informed consent obtained from subject * understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation exclusion criteria: * o history of or presenting with a keloid scar * a subject with a systemic disease not yet stabilized * if the patient is pregnant * visible recent sun exposure in test area * significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study * current use of topical treatment and lack of willingness to refrain from future use of topical treatment, such as i.e. silicone products, that potentially can interfere with the test results * unable to follow the outlined study protocol

Keywords: scar nafl laser
solo-symbicort® in the treatment of persistent asthma in adolescents & adults

Conditions: Asthma

Summary: the purpose of this study is to compare symbicort single inhaler treatment with the best conventional practice in patients with persistent asthma


Eligibility criteria:
inclusion criteria: * diagnosis of asthma \< 3 months * prescribed daily use of glucocorticosteroids for at least 3 months prior to visit 1 exclusion criteria: * smoking history \> 10 pack-years * asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion * any significant disease or disorder that my jeopardize the safety of the patient. additional inclusion and exclusion criteria will be evaluated by the investigator.
feasibility study of a vaginal ring for delivery of tmc120 (dapivirine)

Conditions: HIV Infections

Summary: the purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide tmc120 (dapivirine). twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. they then underwent 7-day exposure to a ring containing 120 mg of tmc120 (dapivirine). feasibility was assessed in terms of safety and tolerability as well as drug delivery.


Eligibility criteria:
inclusion criteria: * female, 18-50 years, inclusive * willing and able to provide written informed consent * hiv-uninfected and otherwise healthy * willing to abstain from sexual activity and use of vaginal products while participating in the trial * currently using oral contraceptives for pregnancy prevention * willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial exclusion criteria: * history of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements. * history of allergy to tmc120 or to the constituents of the vaginal ring. * history of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation * history of diagnosis of and/or treatment for a sexually transmitted disease within the last three months. * history of genital tract surgery within the last month * currently pregnant or breastfeeding, or within two months of last pregnancy outcome * currently or within one month of participating in any other clinical research trial * current (during screening) diagnosis of any genital infection * current vulvar of vaginal symptoms * current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption

Keywords: hiv-i reverse transcriptase inhibitors hiv seronegativity
study evaluating the safety, tolerability and preliminary pharmacokinetics and pharmacodynamics of myk-461

Conditions: Hypertrophic Cardiomyopathy

Summary: the purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of myk-461 in human subjects. this is a sequential group, single ascending (oral) dose study in nyha class i, ii, or iii patient volunteers aged 18-65 years.


Eligibility criteria:
inclusion criteria: * diagnosed with hcm * normal left ventricular ejection fraction (lvef) * nyha class i, ii or iii exclusion criteria: * inherited metabolic disorders, myocardial infiltration or cardiofaciocutaneous syndrome (e.g., noonan's, fabry's). * history of clinically important atrial or ventricular arrhythmias * history of positive human immunodeficiency virus (hiv) test and/or seropositive for hepatitis c virus (hcv) or hepatitis b virus (hbv)..
dlbs1033 for the treatment of acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of dlbs1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.

patients included into the study will be randomized into two groups and receive either standard therapy alone (as control group) or standard therapy plus dlbs1033 at a dose of 490 mg three times daily (as dlbs1033 group). standard therapy used in the study will consist of: aspirin 80 mg, simvastatin 20 mg, vitamin b complex, and citicholine 250 mg/2 ml twice daily. after hospital admission and diagnosis, patient will be handled according to the standard management for acute ischemic stroke applicable in the hospital. right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study's regimens. clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline, day 4, and day 8 of treatment (end of study); while safety examinations will be performed at baseline and end of study.

Eligibility criteria:
inclusion criteria: * male or female subjects with age of 18-75 years . * has been diagnosed with acute ischemic stroke clinically confirmed by ct scan. * modified national institutes of health stroke scale (mnihss) score \>= 5. * patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms. * able to take oral medication. exclusion criteria: * for females of childbearing potential: pregnancy and lactation period. * history of or current hemorrhagic stroke (within the last 3 months). * transient ischemic stroke (tia). * patients with seizure at the onset of stroke. * history of serious head injury within the last 3 months. * history of major surgery within the last 3 months. * serious cardiovascular conditions, such as myocardial infarction, chf grade iii and iv (nyha classification), aorta dissection, and atrial fibrillation within the last 6 months. * presence of severe renal or hepatic dysfunction * presence of acute or chronic infections. * thrombocytopenia (thrombocytes level \< 150.000/ul). * patients with higher risks of bleeding. * uncontrolled hypertension (systolic blood pressure \> 185 mmhg or diastolic blood pressure \> 110 mmhg). * random plasma glucose \>= 200 mg/dl. * current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines. * hypersensitive to the investigational product(s).

Keywords: dlbs1033 acute ischemic stroke mrs mnihss
a study of stro4 in patients amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study intends to evaluate the safety and efficacy of str04 administered intravenously in participants with amyotrophic lateral sclerosis.

this study is a 69 week open label study of autologous bone-marrow-derived mesenchymal stem cells (str04) in participants with als. participants will undergo a screening visit, followed by collection of peripheral blood and bone marrow for the manufacture of str04. once manufacturing is successfully completed, participants will have a baseline visit followed by 4 doses of str04, one dose every 12 weeks. participants will have a final assessments 12 weeks after the 4th dose.

Eligibility criteria:
inclusion: * "definite" or "probable" als according to the revised el escorial criteria (airlie house) * als severity grade 1 or 2 according to the japan als severity classification. * alsfrs-r scores of 2 or more for all items, with scores of 4 for all breathing- related items (i.e., dyspnea, orthopnea, respiratory insufficiency). * within 2 years of als onset. * %fvc of 80% or more. * aged 18 to ≤75 years at the time of informed consent. exclusion: * current viral infection (e.g. hbv, hcv, hiv, htlv-1, hpvb19, syphilis, covid- 19). * current low blood cell counts * history of cancer, congenital malformations, or chromosomal abnormalities * history of allergy to penicillin or streptomycin, or other serious allergies. * current poor medical condition, due to endocrine disease, metabolic disease, immune disease, blood disease, psychiatric disorders, neurological diseases, cardiovascular diseases, respiratory diseases, gastrointestinal diseases, musculoskeletal or connective tissue diseases, renal or urogenital diseases. * history of intracranial lesions, or stenosis, dissection or severe atherosclerotic disease of a blood vessel in the head or neck. * current uncontrolled hypertension. * prior treatment with a cell or gene therapy. * currently participating in any other clinical trial. * women who are pregnant, breastfeeding, or plan to become pregnant during study participation * men with plan for their partner to become pregnant during study participation.

Keywords: als
application of cad-cam technology in orbital bone reconstruction

Conditions: Orbital Bone Fracture; Maxillary Cyst; Maxillary Neoplasms; Zygomatic Fractures; Orbital Neoplasms; Facial Deformity

Summary: reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone.... etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. innovation of cad-cam technology and its application in maxillofacial surgery will markedly improve the surgical outcome. this study will assess the accuracy of orbital reconstruction using cad-cam technology and to compare two different modalities for orbital reconstruction based on this technology.

this study will be a prospective cohort study. it will include patients treated with the custom-made implants for orbital blow out fractures, zmc fractures or tumors. the sample will consist of 34 patients who will need orbital reconstruction and will be operated in maxillofacial, head and neck unit, general surgery department, faculty of medicine, sohag university, egypt. the patients will be randomly divided into two groups, group (a) reconstructed with patient specific implant and group (b) reconstructed with preformed plate preoperatively bended on stereolithographic model. the reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. all patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (ct) then virtual surgical planning and custom-made patient implant will be manufactured. post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by ct scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.

Eligibility criteria:
inclusion criteria: * fracture of the orbital floor and/or medial wall and/or lateral wall. * complex fracture of the zygomatic bone (those affecting orbital volume). * old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry. * periorbital neoplasm affecting orbital volume and need surgical resection exclusion criteria: * injury to the globe that restricts surgical reconstruction. * neurological diseases with influence on eye motility or sight. * patients with special needs. * medically compromised patients who are not fit for surgery. * patients refused participation in this study.

Keywords: orbital bone reconstruction zygomaticomaxillary complex fracture (zmc) patient specific implant preformed plates cad-cam
fesoterodine flexible dose study

Conditions: Overactive Bladder

Summary: this phase 3b study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (oab) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.


Eligibility criteria:
inclusion criteria: * overactive bladder symptoms for greater than or equal to 3 months. * mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary. * mean number of urgency episodes greater than or equal to 3 per 24 hours in bladder diary. exclusion criteria: * contraindication to fesoterodine (antimuscarinics). * known etiology of oab (e.g., neurogenic, local urinary tract pathology). * previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline. * unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Keywords: overactive bladder
topical bromfenac for intraoperative miosis and pain reduction

Conditions: Cataract

Summary: to evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.

this prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. the patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.

Eligibility criteria:
inclusion criteria: * male and female * subjects 18 years or older * patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (pc) iol implantation. exclusion criteria: * presence of corneal abnormalities * history of intraocular surgery * history of ocular or systematic diseases (glaucoma, diabetes, uveitis * regular, systemic use of steroid or nsaids during the previous 3 months

Keywords: phacoemulsification femtosecond laser bromfenac nsaid pupil