Kornimate/medical-research-clean huggingface dataset:
mechanisms of pharyngeal collapse in sleep apnea, study c

Conditions: Sleep Apnea

Summary: in obstructive sleep apnea (osa), the upper airway recurrently closes during sleep. the mechanisms that lead to airway closure are not completely understood. models to study mechanisms of airway collapse have been proposed. however, these models have not been tested in the human upper airway. gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. in this study, subjects will breathe gas mixtures of different densities and viscosities for brief periods of time in order to test those models.

models to study mechanisms of airway collapse have been proposed. however, these models have not been tested in the human upper airway. gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. in this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. flow limitation will be induced by sustained reductions of continuous positive airway pressure (cpap). the investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.

Eligibility criteria:
inclusion criteria: * normal subjects or patients with osa exclusion criteria: * any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems. * any medication known to influence breathing, sleep/arousal or muscle physiology * concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia) * claustrophobia * inability to sleep supine * allergy to lidocaine or oxymetazoline hydrochloride * for women: pregnancy

Keywords: sleep apnea pathophysiology
clinical trial of exercise in patients with spinal muscular atrophy (sma)

Conditions: Spinal Muscular Atrophy; Neuromuscular Disease

Summary: this study is being conducted to test whether exercise can be effectively used as an intervention to treat spinal muscular atrophy (sma). in order to answer this question, the investigators will enroll 14 subjects with sma between ages 8 and 50 and ask them to complete an 18 month training schedule. at some points subjects will be asked to closely follow a specific training regimen and at other points they may be asked to exercise in the same manner they do normally. the exercises they will be asked to perform include biking on a stationary cycle and lifting hand weights. subjects will be asked to come in to the clinic seven times over the course of the study to perform tests. these tests include motor function measures, a physical exam, questionnaires, a exercise capacity test which involves riding a stationary bicycle, and test where the subject is asked to walk as far as they can in six minutes. the main goal of the study is to see if the subjects who participate in the exercise protocol have larger increases in the distance they can walk in six minutes than those who do not.


Eligibility criteria:
inclusion criteria: 1. weakness and hypotonia consistent with the clinical diagnosis of sma type 3, i.e. having achieved the ability to walk independently 2. laboratory documentation of homozygous absence of smn1 exon 7 3. ability to walk at least 25 meters without assistance 4. aged 8 to 50 years at the time of enrollment 5. ability to tread the stationary cycle ergometer 6. written informed consent of patient (if ≥ 18 years of age) or parents/guardian (if \< 18 years of age), and assent for participants who are of minor age. exclusion criteria: 1. inability to walk independently at least 25 meters 2. any acute co-morbid condition interfering with study participation in the judgment of the investigators within 7 days of enrollment including bacterial infection, viral infectious process, food poisoning, temperature \> 99.0ºf, need for acute treatment or observation due to any other reason, as judged by the investigator; patient can be included after resolution of the acute event 3. use of investigational medications intended for the treatment of sma including riluzole, valproic acid, hydroxyurea, oral use of albuterol, sodium phenylbutyrate, butyrate derivatives, creatine, carnitine, growth hormone, anabolic steroids, or agents with known or presumed histone deacetylase (hdac) inhibition, within 30 days prior to study entry. after signing informed consent, participants may discontinue prohibited medications and will then qualify for a screening visit after the 30 day wash-out period 4. inability to meet study visit requirements, or cooperate reliably with functional testing and exercise protocol 5. coexisting medical conditions that contraindicate travel, testing or moderate intensity exercise 6. pregnant or breastfeeding women, or those intending to become pregnant during the course of the study.

Keywords: spinal muscular atrophy exercise conditioning strengthening
clinical evaluation of a myopia control lens in slowing myopia progression.

Conditions: Myopia

Summary: this is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial nct05331378. a total of 40 children will be recruited.

as myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial (bao et al. 2022). a dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. this open clinical trial will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. the study population includes children in singapore aged 8 to 13 years (40 subjects) at the time of commencing treatment. axial length and spherical equivalent refraction will be the primary measure for myopia progression. visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses

Eligibility criteria:
inclusion criteria: * volunteer subject and guardian, fluent english spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * equal to or greater than 8 years and not older than 13 years at time of informed consent and assent. * spherical equivalent refractive error (ser) by manifest refraction between -0.75 and -4.75 d in each eye. * astigmatism, if present, of not more than 1.50 d. * difference in ser between the two eyes (anisometropia) by manifest refraction not more than 1.00 d. * best corrected visual acuity in each eye equal to or better than +0.10 logmar (≥ 20/25 as snellen) * be in good general health based on his/her and parent's/guardian's knowledge. absence of ocular disease with full ophthalmic examination. without any ocular or systemic condition known to affect refractive status. * absence of strabismus by cover test at near or distance wearing correction. * absence of amblyopia * without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. exclusion criteria: * vulnerability of subject * history of myopia control intervention * participation in any clinical study within 30 days of the baseline visit.

Keywords: refractive errors eye diseases
the effect of preoperative sodium ibuprofen on postoperative endodontic pain

Conditions: Irreversible Pulpitis

Summary: the aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.

oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. many pharmacological agents have been used to manage endodontic pain, including non-steroidal anti-inflammatory drugs (nsaids),.administration of nsaids before root canal treatment will reduce inflammatory process before it begins. nsaids are widely used to control post endodontic pain they act by blocking the activity of cyclooxygenase (cox 1 and 2) enzyme. in human dental pulps with irreversible pulpitis, a higher level of expression of cox 2.in cases of irreversible pulpitis nsaids can be administered preoperatively since they reduce the level of prostaglandine2(pge2) which is responsible for sensitization of nociceptors. ibuprofen is one of the most commonly used nsaids and a potent inhibitor of prostaglandin (pg) synthesis that can manage various pain types and has anti-inflammatory activity. enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. these ibuprofen salts.fast acting ibuprofen like sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations

Eligibility criteria:
inclusion criteria: * patients above 18 years old and below 66. * male or female * patients seeking root canal treatment * mandibular posterior molarteeth with symptomatic irreversible pulpitis . * spontaneous pain * systematically healthy patient(asa i,ii) exclusion criteria: * medically compromised patients having significant systemic disorders. (asa iii or iv) * history of intolerance to nsaids. * patients with two or more adjacent teeth requiring endodontic treatment. * external root resorption * internal root resorption * vertical root fracture * periapical lesion * pregnancy * use of ibuprofen in the last 12 hour * bleeding disorder * long term corticosteroid use * mobility grade ii or iii. * pocket depth more than 5mm. * previous root canal therapy. * non-restorability * temporomandibular joint (tmj) problems, bruxism, clenching or traumatic occlusion. * inability to perceive the given instructions.
hernia-prophylaxis in acute care surgery h-pacs

Conditions: Incisional Hernia

Summary: incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%. the gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. in the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly. the investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe . with a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.


Eligibility criteria:
inclusion criteria: * patients undergoing emergency midline laparatomy * emergency laparoscopy with expected conversion to midline laparatomy * written informed consent exclusion criteria: * asa ≥5 * septic shock * pregnant women * prior mesh implantation * known sensitivity for porcine material or polysorbate 20
observational study of thc concentrations in acute cannabinoid intoxication

Conditions: Acute Cannabinoid Intoxication

Summary: this observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (thc) and its metabolites, 11-oh-thc and thc-cooh, in plasma of subjects who visit the emergency department due to acute cannabinoid intoxication.

this is a multi-center, prospective, cross-sectional observational study to determine the concentrations of tetrahydrocannabinol (thc) and its metabolites (and/or other cannabinoids) in the plasma of subjects admitted to emergency departments with acute cannabinoid intoxication the study will explore the relationships between these concentrations and parameters such as demographics, symptom severity, time to symptom resolution, and clinical outcomes. samples will be collected as part of standard clinical procedure without requiring study participants to spend additional time in the hospital.

Eligibility criteria:
inclusion criteria: 1. subject visits emergency department for acute cannabinoid intoxication as evidenced by the following criteria: 1. recent cannabis use within the last 12 hours 2. clinically significant physiological abnormalities associated with cannabis use or problematic behavioral or psychological changes (e.g., altered perception, impaired motor coordination, euphoria, anxiety, a sensation of slowed time, impaired judgment, social withdrawal) that developed during, or shortly after, cannabis use 2. subject (and/or parent/lar when required) has the ability to communicate with comprehension with the study personnel at the time of consent/assent and the gathering of data other than plasma samples. 3. subject (and/or parent/lar when required) is willing and able to provide informed consent/assent. exclusion criteria a potential subject who meets any of the following criteria will be excluded from participation in this study: 1. anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. 2. individuals under the age of 18 who do not have a parent or legal representative present during the time at the ed. 3. patients presenting with signs or symptoms attributable to another medical condition or better explained by another mental disorder. 4. patient presenting with cannabis hyperemesis syndrome (chs) or cannabis withdrawal syndrome (cws) 5. patients who are brought in by law enforcement, i.e., cannabis intoxication associated with a vehicle accident (driving under the influence).
halt growth of liver tumors from uveal melanoma with closure of liver artery following injection of gm-csf

Conditions: Uveal Melanoma; Liver Metastases

Summary: patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. gm-csf (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, ethiodol. this is followed by blockage of the artery with small pieces of gelatin sponge (embolization). it is hoped with this novel approach that: * tumor cells will die due to a loss of their blood supply, * local inflammatory reactions induced by gm-csf will kill remaining tumor cells, and * a systemic immune response against tumor cells may develop.

patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. gm-csf (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, ethiodol. this is followed by blockage of the artery with small pieces of gelatin sponge (embolization).

Eligibility criteria:
inclusion criteria: * metastatic uveal melanoma in the liver with histological confirmation * ability/willingness to give informed consent * ecog performance status of 0 or 1 * adequate renal, liver and bone marrow function exclusion criteria: * solitary liver metastasis that is amenable to surgical removal * presence of symptomatic liver failure including ascites and hepatic encephalopathy * presence of extra-hepatic metastases * untreated brain metastases * uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry * presence of any other medical complication that imply survival of less than six months * uncontrolled sever bleeding tendency or active gi bleeding * significant allergic reaction to contrast dye or gm-csf * immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks * previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis * active hepatitis with serum glutamic oxaloacetic transaminase (sgot) and serum glutamic pyruvic transaminase (sgpt) greater than 5 x normal * hiv infection positive by elisa * pregnancy or breast feeding women * biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy * significant arteriovenous shunt identified on angiography of the hepatic artery * occlusion of main portal vein or inadequate collateral flow around an occluded portal vein
a physician-inititated trial investigating the ivolution nitinol stent

Conditions: Peripheral Arterial Disease

Summary: the objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding ivolution nitinol stent in symptomatic (rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.


Eligibility criteria:
inclusion criteria: 1. de novo lesion located in the femoropopliteal arteries suitable for endovascular treatment 2. patient presenting with a score from 2 to 4 according to the rutherford classification 3. patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals 4. patient is \>18 years old 5. patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study 6. prior to enrollment, the target lesion was crossed with standard guidewire manipulation one target lesion is located within the native sfa: distal point 3 cm above knee joint 7. the target lesion has angiographic evidence of stenosis or occlusion 8. length of the target lesion is ≤ 15 cm by visual estimation 9. target vessel diameter visually estimated is ≥4 mm and ≤7 mm 10. there is angiographic evidence of at least one vessel-runoff to the foot exclusion criteria: 1. presence of a stent in the target vessel that was placed during a previous procedure 2. presence of an aortic thrombosis or significant common femoral ipsilateral stenosis 3. previous bypass surgery in the same limb 4. patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics 5. patients who exhibit persistent acute intraluminal thrombus at the target lesion site 6. perforation at the angioplasty site evidenced by extravasation of contrast medium 7. patients with known hypersensitivity to nickel-titanium or other study device components 8. patients with uncorrected bleeding disorders 9. female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding 10. life expectancy of less than 12 months 11. ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30% 12. use of thrombectomy, atherectomy or laser devices during procedure 13. any patient considered to be hemodynamically unstable at onset of procedure 14. patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
prospective study to evaluate safety of deb-tace with 100µ beads in patients with non resectable hcc

Conditions: Hepatocellular Carcinoma

Summary: this is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (deb-tace) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (hcc). the hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of deb-tace.

in this observational, prospective study patients will undergo deb-tace and subsequent follow up procedures according to standard clinical practice. the primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in deb-tace. as a secondary end-point a description of efficacy parameters will be obtained.

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of hcc according to european association for the study of the liver (easl) and american association for the study of liver diseases (aasld) criteria and staged by bclc criteria 2. indication for receiving transarterial chemoembolization deb-tace with 100 µ microspheres according to usual clinical practice. 3. able and willing to participate and give their written informed consent. 4. both genders and ≥ 18 years old. 5. eastern cooperative oncology group (ecog) 0 6. preserved hepatic function (child-pugh ≤ b7). 7. no evidence of tumoral invasion in portal vein or main biliary ducts. 8. able to go through image diagnostic techniques such as ct or mri. 9. preserved cardiac and renal function. 10. no concomitant active infections that require antibiotic treatment. 11. measurable disease according to mrecist criteria. 12. life expectancy over 6 months. exclusion criteria: 1. ecog ≥ 1 2. child-pugh ≥b8. 3. presence of ascitis or encephalopathy 4. extrahepatic tumoral disease. 5. tumoral vascular invasion 6. serum bilirubin\>3 mg/dl. 7. cr clearance ≤ 60 ml/min 8. if any of the following is contraindicated: 1. administration of doxorubicin 2. iodated contrasts 3. ct or mri procedures 4. transarterial embolization procedures 5. white blood cells (wbc) \< 2000 /mm3 6. neutrophil count \< 1500 /mm3 7. ejection fraction \< 50 % 8. platelet count \ 2,0) 9. transaminases (ast and/or alt) \> 5x upper limit of normal or \>250 u/l 10. known hepatofugal portal vein flow 11. a-v intrahepatic macroscopic fistula 9. pregnant or breast feeding women. 10. tumor burden involving more than 50% of the liver. 11. active bacterial or fungal infection. 12. other concomitant tumors. 13. any other condition that according to investigator criteria, contraindicates deb-tace. 14. patients not willing to participate and/or give their written informed consent.

Keywords: hepatocellular carcinoma tace
comparative bioavailability in healthy elderly volunteers

Conditions: Alzheimer's Disease

Summary: a randomised four way crossover design in which each subject will receive two dose levels of trx-0037 and two doses of trx-0014 over approximately a four week period in randomised order.


Eligibility criteria:
inclusion criteria: * male and female 55 and over * no clinically important abnormal physical finding * no clinically significant lab results * normal ecg, normal bp and hr,bmi between 19 and 32 * weight 50 to 100 kg, able to communicate * provide written informed consent * non smokers * males to use contraception * females to be surgically sterile or post menopausal exclusion criteria: * administration of any imp other than study drug within 12 weeks before entry * use of any prescribed meds, st john's wort, over the counter meds as described in the protocol * surgical or medical condition that might interfere with imp * history of drug or alcohol abuse * clinically significant allergy requiring treatment * loss of greater than 400ml of blood within 12 weeks. * serious adverse reaction or hypersensitivity to any drug * prescence of hep b, hep c or hiv-1 or hiv-2 at screening * presence of g6pd at screening * history of methaemoglobinaemia * partner who is pregnant of lactating * positive pregnancy test