Kornimate/medical-research-clean huggingface dataset:
oral iron for erythropoietic protoporphyrias

Conditions: Erythropoietic Protoporphyria; EPP; X-linked Protoporphyria; XLP

Summary: in the medical literature there are conflicting reports on whether iron improves symptoms in patients with epp and xlp. giving iron to people who are iron deficient is thought to improve epp symptoms. however, this has never been systematically tested. therefore, the purpose of this study is to determine the effect of oral iron for epp and xlp patients.

this is a clinical trial, which means its purpose is to study an intervention or treatment. in this study all patients with epp or xlp will be given a standard dose of iron pills and monitored for one year. there is currently no effective food and drug administration (fda) approved treatment for epp or xlp in the us. giving iron to patients with low ferritin (a measure of body iron stores) levels may help improve their epp symptoms by decreasing erythrocyte protoporphyrin levels. patients will be asked come to the study site once every three months over the course of a year for a total of five visits. at these visits the study doctors will check in with participants and some blood and urine samples will be taken. participants will not be charged for any of the lab tests that are being done for part of this study alone. in between these study visits there will be phone call to check in and see how participants are doing. all patients in this study will receive iron pills at no cost to them.

Eligibility criteria:
inclusion criteria: * enrollment in the longitudinal study of the porphyrias * male or female age ≥18 years * history of nonblistering cutaneous photosensitivity * biochemical findings - a marked increase in erythrocyte protoporphyrin (total erythrocyte protoporphyrin \>400 ug/dl) with a predominance of metal-free protoporphyrin * serum ferritin ≤30 ng/ml at baseline * able to tolerate oral iron exclusion criteria: * history of liver or bone marrow transplant or clinically significant liver dysfunction as determined by the investigator * known or suspected allergy to oral iron based on patient report * clinical evidence of active and ongoing gi bleeding * use of any other clinical or experimental therapy in the past 3 months * individuals with elevations of porphyrins in plasma or erythrocytes due to other diseases (i.e. secondary porphyrinemia) such as liver and bone marrow diseases * patients with any clinically significant comorbid conditions, which in the opinion of the investigator, precludes participation

Keywords: interventional open-label epp xlp porphyria
cervical erector spinae block for shoulder surgery

Conditions: Postoperative Pain; Shoulder Surgery

Summary: arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life. in addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are associated with the use of opioids to manage postoperative pain. erector spinae plane block (espb) has been used in many different indications for acute pain treatment at different thoracic and lumbar levels. recently, staining the roots of the brachial plexus has been reported in a cadaveric study of the cervical espb (1). however, there are only few case reports related to efficiency and safety of this newly defined cervical espb technique (2) . the primary objective of this randomized controlled is investigate the post-operative analgesic effectiveness of ultrasound guided single-shot cervical espb for patients undergoing arthroscopic shoulder surgery in comparison to those receiving conventional parentheral opioid analgesia alone. secondary objective is testing the safety of this newly defined block in terms of incidence of complications.

60 patients will be enrolled to in this study between june 2020 - october 2020. all patient will be randomly selected who will be operated for shoulder surgery. age, weight, asa score, body mass index, additional dissease status will be recorded. the patients will be divided in two groups. one group will have cervical espb before the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. both groups will receive identical anaethesia protocols. perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. in postoperative period, the pain scores of the patients will be recorded according to the numeric rating scale (nrs) in every three hours. if pain score raises over 3/10 on nrs the patient will receive tramadol 100mg as rescue analgesia. in case of persisting pain first, meperidine 50 mg will be applied and other multimodal analgesic drugs will be added to protocol. at the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Eligibility criteria:
inclusion criteria: * 18 -65 years of agge * asa i-ii * undergoing elective shoulder surgery exclusion criteria: * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy * recent use of analgesic drugs * obesity (body mass index \>35 kg/m2)

Keywords: cervical erector spinae plane block postoperative pain shoulder surgery
study of the safety and immunogenicity of nasovax extension

Conditions: Influenza

Summary: this study is an extension to study alt-103-201, a phase 2a, randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of nasovax in healthy adults 18 to 49 years of age.

this study is an extension to study alt-103-201 to evaluate immunogenicity of nasovax administered by intranasal spray at a single dose of 1×1011 vp at day 366 (± 60 days). up to 15 subjects who received nasovax at the 1×10(11th) vp dose in study alt-103-201 will be screened, and a serum sample will be collected from each eligible subject for evaluation of influenza hai assay against influenza a/california/07/2009(h1n1), a strain homologous to the one used for nasovax (monovalent adcoca09.ha). ad5 antibody neutralization assay may also be performed.

Eligibility criteria:
inclusion: 1. receipt of nasovax at the 1×10(11th) vp dose in study alt-103-201 2. adequate venous access for phlebotomy 3. provision of written informed consent exclusion: 1. any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the investigator would interfere with the subject providing an adequate blood sample or the subject's ability to give informed consent
vasculux-examination of the pulmonary vascular barrier in patients during lung transplantation

Conditions: End Stage Chronic Obstructive Airways Disease

Summary: lung transplantation is a well established method for surgical therapy for patients with end stage pulmonary disease. the investigators seek to determine to which extent the pulmonary vascular barrier gets harmed during lung transplantation and whether pulmonary edema after reperfusion can be monitored with measurement of extravascular lung water index (elwi). additionally the investigaors are going to evaluate the correlation between elwi and shedding of the endothelial glycocalyx. the study is designed as a prospective observational cohort study.

this study is designed as a single center prospective observational cohort study including only patients who are undergoing lung transplantation due to endstage pulmonary disease. it is well known that pulmonary edema is one of the major problems following reperfusion of the new organ. the glycocalyx is located on the apical surface of vascular endothelial cells which line the vascular lumen. the endothelial glycocalyx consists of mainly proteoglycans that covers, among others, leukocyte and thrombocyte receptors and fulfills its principal role in maintaining plasma and vessel wall homeostasis. in patients undergoing cardiac surgery studies showed regional as well as global ischemia causing an increase of syndecan-1 and heparansulphate in plasma during reperfusion. the extent of the pulmonary vascular barrier's damage might serve as predictor for postoperative complications as reperfusion edema of the lungs. to quantify the extent of damage the investigators seek to evaluate the correlation between elwi and the damage to the vascular barrier. elwi will be assessed using transpulmonary thermodilution. components of the vascular barrier will be quantified using elisa-technique. 10 ml full blood will be drawn at 7 different predifined measurement points named t0-t7 as follows: * t0 before induction of anesthesia * t1 before reperfusion of the first lung * t2 5 min after reperfusion of the first lung * t3 before reperfusion of the second lung * t4 5 min after reperfusion of the second lung * t5 before admission to the intensive care unit * t6 6h after reperfusion of the last lung * t7 12h after reperfusion of the last lung for statistical analysis student's t-test, friedman or wilcoxon rank test will be used, as indicated. expected length of the study is 2 years enrolling 30 patients undergoing lung transplantation.

Eligibility criteria:
inclusion criteria: * at least 18 and younger than 65 years of age * scheduled for lung transplantation exclusion criteria: * pregnancy * necessity of ecmo implementation before induction of general anesthesia * mechanical ventilation before lung transplantation
evaluation of a diagnostic device for detection of nasal staphylococcus aureus

Conditions: Staphylococcus Aureus

Summary: to establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal staphylococcus aureus colonization against clinical microbiology laboratory culture methods.


Eligibility criteria:
inclusion criteria: 1. subjects 18 years of age or older, male or female and from any race or culture. 2. subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery. exclusion criteria: 1. subjects who are on the nasal topical antibiotic mupirocin (bactroban® nasal ointment) within the last 4 weeks. 2. subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. cpap = continuous positive airway pressure or nasal cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.

Keywords: staphylococcus aureus nasal colonization pre-surgical patients sensitivity specificity nasal staphylococcus aureus in pre-surgical patients
picoway™ 730 resolve fusion for benign pigmented lesions and wrinkles

Conditions: Benign Pigmented Lesions; Facial Wrinkles

Summary: evaluation of the picoway™ laser system with 730nm and resolve™ fusion handpieces for treatment of benign pigmented lesions and wrinkles.

subjects will receive up to 4 study treatments with the picoway™ 730 nm laser wavelength, picoway™1064nm fractional handpiece and/or picoway™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. primary efficacy assessed by masked photographic evaluation. optional biopsy collection for histological analysis of laser tissue effects.

Eligibility criteria:
inclusion criteria 1. willing to provide signed informed consent 2. adults age 21 to 80 3. fitzpatrick skin type (fst) i to vi 4. presence of benign pigmented lesions assessed at baseline as pigment severity score (pss) of "2" or higher and/or wrinkles assessed at baseline as fitzpatrick wrinkle score (fws) of "2" or higher 5. willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study 6. willing to abstain from any other procedures for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including surgery, light, laser, ultrasound or radiofrequency treatments 7. willing to abstain from use of prescription cosmetic products for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including injections of neurotoxins or dermal fillers, skin lightening creams, and wrinkle creams 8. willingness to adhere to study treatment and follow-up visit schedules exclusion criteria 1. pregnant, planning pregnancy or breast feeding 2. allergy to topical or injectable lidocaine or similar medications 3. allergy to topical steroid or similar medications 4. unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area 5. history of melanoma in the intended treatment area 6. history of keloid or hypertrophic scar formation 7. use of topical or systemic retinoid therapy during the past six (6) months 8. use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study 9. use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study 10. severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment. 11. open wound or infection in the intended treatment area 12. history of light induced seizure disorders 13. dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months 14. the subject is not suitable, in the opinion of the clinician, for participation in the study due to medical or other reasons that could compromise the study integrity or subject safety
effect of deep breathing on balance in patients with chronic mechanical low back pain

Conditions: Chronic Mechanical Low Back Pain

Summary: the primary purpose of this study is to investigate the effects of deep breathing pattern on dynamic balance in patients with chronic mechanical low back pain versus healthy controls. secondary to compare between dynamic balance control during deep versus regular breathing patterns in patients with chronic mechanical low back pain and healthy controls. further, to detect whether pain intensity differs during balance testing applying either deep or regular breathing in patients with chronic mechanical low back pain.

diaphragm has been reported as a contributor in postural control and respiration. however, the integrated function of postural control and respiration is a complex process, especially evident during activities that increase demands on one or both functions . previous research reports noticed that breathing pattern is altered in cases of chronic mechanical low back pain during tasks that challenges the trunk muscles function, and trunk stability . dynamic balance control is one of the functional tasks that burdens the trunk muscles, and requires high degree of integration. dynamic balance is disturbed in cases of chronic mechanical low back pain, and reports indicate that balance deficits extends after the painful episodes in those who have history of low back pain in patients with chronic mechanical low back pain regular respiratory movements results in greater disturbances to balance than healthy subjects . accordingly, in this study will attempt to emphasize the role of the deep breathing pattern during dynamic balance testing in chronic mechanical low back pain patients and matched healthy control subjects. as it is suggested that activity of the diaphragm will be focused upon through introducing deep breathing during dynamic balance testing; it is expected to enhance dynamic balance through its dual integrating its dual function of postural control and respiration.

Eligibility criteria:
inclusion criteria: * participants in both groups should fulfill the criteria set for age and bmi ranges. * patients in study group should complain of pain in the lower back for a period of more than 3 months. * referred from an orthopedist . * participants in control group should haven't complained of back pain exclusion criteria: * patients complain of radiculopathy . * patients complain of any other musculoskeletal disorder other than chronic mechanical low back pain . * any previous or current complains of pain involving other regions of the spine. * have history of respiratory dysfunction due to current or previous respiratory condition. * suffer from any condition that affect balance control, including neurological, vestibular, visual or somatosensory deficits. * use drugs that might compromise their balance control
evaluation of the feasibility and safety of laryngoscopic microsurgery under non-intubation anesthesia

Conditions: Spontaneous Breathing; Laryngomicrosurgery; Superior Laryngeal Nerve Block

Summary: nonintubated anesthesia applied in combination with high-flow nasal oxygen (hfno) is an alternative strategy for laryngeal microsurgery (lms). lms is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (slnb) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during lms with nonintubated anesthesia.

laryngeal microsurgery (lms) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal co2. nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (hfno) is another option for lms. lms with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. furthermore, lms with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. current practice in lms with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. however, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. therefore, the investigators investigated the use of a superior laryngeal nerve block (slnb) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during lms with nonintubated anesthesia.

Eligibility criteria:
inclusion criteria: * the patient who needed to undergo lms. exclusion criteria: * severe airway obstruction. * severe airway disease. * american society of anesthesiologists (asa) physical state \> iii. * pregnancy or body mass index (bmi) ≥ 40 kg/m2.

Keywords: nonintubated spontaneous breathing laryngomicrosurgery superior laryngeal nerve block
assessing the level of disability and fear avoidance beliefs in bankers of karachi

Conditions: Neck Pain

Summary: an observational study will be conducted to determine the level of pain and disability among bankers working in different banking setups for past 2 years by using neck disablity pain index and fear avoidance belief questionnaire. the participant will be recruted fromdifferent private and public banking sectors of karachi, including habib bank limited, silk bank,js bank and other.

a cross-sectional study with a total sample size of 100 participants will be recruited for the purpose of the survey. the participants will be given neck disability pain index questionnaire and fair avoidance belief questionnaire in order to determine the level of pain and disability among bankers who are performing their duties in bank from atleast two years.

Eligibility criteria:
inclusion criteria: * bankers with neck pain exclusion criteria: * neck surgery

Keywords: fear avoidance belief musculoskeletal disorders neck pain
comparison of tazarotene and minocycline therapies for maintenance of facial acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of the study is to compare the efficacy of three maintenance regimens (topical tazarotene, oral minocycline, or both) in sustaining improvement in acne.

for many years antibiotic therapy has been the backbone of therapy for inflammatory acne. however, topical retinoids also offer efficacy against inflammatory acne and the combination of a topical retinoid and an antibiotic can result in faster and more complete clearing of inflammatory lesions than either drug alone. the reduced sensitivity of propionibacterium acnes to antibiotics is a growing problem. resistance is a major issue not only because it can result in treatment failure but also because of concerns that it may potentially be transferred to other bacteria that anti-acne antibiotics are used used against. one of the most important factors predisposing to the development of resistant strains of propionibacterium acnes is the prolonged use of antibiotics. therefore, in order to help minimize the development for such resistance, it is evident that maintenance strategies for acne should aim to minimize the long-term use of antibiotics. topical retinoids are a rational choice for maintenance therapy due to their activity on microcomedones (the precursor for all acne lesions). nevertheless, there is a paucity of data evaluating this use in a maintenance setting. the aim of this study was to determine whether patients with moderate to severe inflammatory acne who have achieved a good level of clearance (eg\>/= 75%) can maintain the improvement in their acne using maintenance therapy. the study compared the efficacy of three maintenance therapies (topical tazarotene, oral minocycline, and topical tazarotene plus oral minocycline) in sustaining the clinical improvement attained after initial topical tazarotene plus oral minocycline therapy.

Eligibility criteria:
inclusion criteria: moderate facial acne vulgaris 25-60 facial inflammatory acne lesions 10-100 facial comedos no more than 2 facial nodular cystic lesions (no more than 5 mm in diameter) for females of child bearing potential, a regular menstrual cycle negative urine pregnancy test exclusion criteria: uncontrolled systemic disease acne vulgaris known to be resistant to antibiotics for females: pregnancy, breastfeeding, or planning pregnancy use of estrogens or birth control pills for 12 weeks or less any skin disease that may interfere with diagnosis or evaluation of acne vulgaris known hypersensivity to any components in tazarac gel or to any tetracyclines use of any systemic retinoids in past 2 years use of any systemic antibiotics, or participation in another drug or investigational study, in past 30 days use of topical anti-acne medication in past 14 days

Keywords: acne, tazarotene, minocycline, maintenance, retinoid, efficacy, combination