Kornimate/medical-research-clean huggingface dataset:
optical brain pulse monitor: validation of cerebral oximetry monitoring (obpm:vocom) study.

Conditions: Hypoxia

Summary: the purpose of this study is to calibrate and validate a cerebral oximeter product from cyban pty. ltd. the study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.

the primary objective of the study is to measure the absolute and relative accuracy of the sto2 device by comparing the nirs-derived brain tissue oxygen saturation with blood-referenced co-oximeter oxygen saturation values. the co-oximeter oxygen saturation values from paired arterial and jugular bulb blood samples are combined into a weighted-equation to derive the reference savo2. accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.

Eligibility criteria:
inclusion criteria: * healthy, male or female subjects between the ages of 18 to 45 years; * completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant; * minimum weight 40kg; * bmi within range 18.0 - 35.0; * assigned american society of anesthesiologists (asa) physical status 1 by principal investigator or delegate exclusion criteria: * prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., novocain) \[self- reported\]; * prior known severe allergies to medical grade adhesive/tape (band-aid) \[self-reported\]; * taking any medication other than birth control\[self-reported\]; * is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self- reported\]; * has a negative allen\&#39;s test to confirm non-patency of the collateral artery \[clinical assessment by pi or delegate\]; * has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]; * is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding; * has anemia \[lab values specific for gender\]; * has heparin allergy * has a history of sickle cell trait or thalassemia \[self-reported\]; * has an abnormal hemoglobin electrophoresis result \[lab measurement\]; * has a positive urine cotinine test or urine drug screen or oral ethanol test; * has a room air saturation less than 95% by pulse oximetry \[measurement by pi or delegate\] * has a clinically significant abnormal ekg \[assessment by pi or delegate\]; * has a clinically significant abnormal pulmonary function test via spirometry \[assessment by pi or delegate\]; * has a cohb greater than 3%, or methb greater than 2% \[measured by venous blood sample co- oximetry\]. * students and employees under the direct supervision of pi or sub-i.

Keywords: cerebral oximetry hypoxia
effects of a high intensity resistance training in muscular strength, agility, and body composition of anorexia nervosa restricting type patients

Conditions: Anorexia Nervosa Restricting Type

Summary: the aim is to test the hypothesis that high-resistance training for 8 weeks, following the recommendations for healthy adolescents, is capable of eliciting increases in muscle strength, agility, skeletal muscle mass, and functional capacity without losing weight, body mass index (bmi) or fat mass in anorexia nervosa restricting type patients. further, we hypothesize that the effects produced by the high-resistance training program will be maintained 4 weeks following the completion of the training program.


Eligibility criteria:
inclusion criteria: * diagnosed with anorexia nervosa restricting type * age ≤16 years * receiving psychological therapy 3 days/week, and daily life tracing (including diet) * bmi \>14.0 kg/m2 exclusion criteria: * being excessive exercisers (6 hours per week moderate to vigorous physical activity \[1952 counts/min\] upon admission) * not being able to perform physical activity.

Keywords: anorexia nervosa restricting type muscle strength exercise body composition physical activity
investigating the pharmacokinetics and pharmacodynamics of recombinant human insulin administered by dry powder inhaler

Conditions: Diabetes Mellitus

Summary: evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

explorative, single-center, randomized, open label, 4-way crossover study to evaluate the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Eligibility criteria:
inclusion criteria: * male * non smoking for at least 12 months * bmi equal to or less than 28 * no clinically significant abnormalities * fvc and fev1 equal to or more than 80% * willing to participate and to sign informed consent form exclusion criteria: * positive results for insulin antibodies at screening * history of substance abuse or dependency within last 5 years * positive screening test for substance abuse * positive blood test for hiv, hepatitis b or hepatitis c antibody * fasting blood glucose of more than 126mg/dl * any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication * history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality * has received investigational medications within 21 days prior to receiving the first dose of study medication * has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication * has taken or used any otc medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication * health that may be adversely affected by procedures or medications used in the study * unwillingness or inability to understand or to follow required study restrictions and procedures

Keywords: pharmacokinetics pharmacodynamics inhaled recombinant human insulin
long-term use of viltolarsen in boys with duchenne muscular dystrophy in clinical practice (vilt-502)

Conditions: Duchenne Muscular Dystrophy

Summary: the vilt-502 study is non-interventional study(united states)/low-intervention clinical trial (canada) of viltolarsen administered intravenously once weekly for 10 years to boys with dmd who complete the ns-065/ncnp-01-202 study.

the vilt-502 study is an open-label, single-arm study to assess the long-term safety and effectiveness of viltolarsen, an exon skipping therapy for the treatment of dmd. patients who complete the phase ii long-term extension study and meet the additional inclusion and exclusion criteria of the present protocol will be invited to enroll. viltolarsen will be administered through weekly iv infusions, at the study site or at home. the vilt-502 study will be conducted as a non-interventional study in the us, and as a low-intervention clinical trial in canada where viltolarsen is not yet commercially available, owing to differences in the stage of regulatory approval in the two countries.

Eligibility criteria:
inclusion criteria: 1. patient, patient's parent or legal guardian have provided written informed consent/medical record release authorization prior to any extension study-specific procedures, and the patient has provided assent appropriate for his age and developmental status. 2. patient completed the ns-065/ncnp-01-202 study and was judged by the investigator as appropriate to participate in the vilt-502 study. 3. patient and parent or legal guardian are willing and able to comply with scheduled visits, study treatment administration plan, and study procedures. exclusion criteria: 1. patient has an allergy or hypersensitivity to the study drug or to any of its constituents. 2. patient has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator. 3. patient has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and observation will be correctly completed or impair the assessment of study results, in the opinion of the investigator. 4. patient had a treatment which was made for the purpose of dystrophin or its related protein induction after completing the ns-065/ncnp-01-202 study. 5. patient took any other investigational drugs after completing the ns-065/ncnp-01-202 study. 6. patient plans to participate in another clinical trial. 7. patient was judged by the investigator and/or the sponsor as not appropriate to participate in the study for reasons other than #1 - #6 above.
a mechanistic evaluation of the nociceptive desensitizing properties of topical capsaicin

Conditions: Capsaicin; Ultaviolet B Light Burn; Neuropathic Pain; Lidocaine

Summary: the aim of this project is to study the role of transient receptor potential (trp-) channel v1 (trpv1+) fibers in the development of cutaneous inflammation induced by epidermal ultraviolet-b damage. moreover, in this project the investigators want to evaluate if the capsaicin-desensitization action can still be induced in a skin area pretreated with topical, local anesthetic lidocaine.

in this project the ultraviolet- b pain model, a model using type b ultraviolet rays to induce a first-degree sunburn, will be used to induce a non-specific inflammation in the skin. this model is well-known to produce both peripheral and central hyperalgesia through sensitization of peripheral and central nociceptors. capsaicin, the active substance in chili peppers, is currently used to treat peripheral neuropathic pain, and prolonged application of 8% capsaicin patch causes profound desensitization to painful heat stimuli and itch provocations. therefore, the investigators would like to monitor the development of unspecific uvb-cutaneous inflammation and consequent neurogenic flare in a capsaicin pre-treated area. moreover the investigators want to test if pre-treating the skin with lidocaine can reduce the pain associated with the capsaicin application without affecting its desensitization action.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * caucasian descent (only in sub-study 1) * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other drugs * previous or current neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate * current use of medications that may affect the trial * skin diseases * consumption of alcohol or painkillers 24 hours before the study days and between these * moles or tattoos in the area to be treated or tested. * exposure of the irradiated area to uv radiation (e.g., sun) 48 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials) * known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.
miyoperi̇cytoma of oral mucose: case report

Conditions: Myopericytoma

Summary: miyopericytoma (mpc) is defined as a benign tumor consisting mostly of oval-spindle-shaped myoid-appearing cells with perivascular growth. it may involve a single or multiple anatomical regions and may be multifocal and tends to occur mainly in the extremities, dermal and superficial soft tissues of adults. cases of miyopericytoma due to trauma have been reported.histological features and clinical course are generally benign, but features suggestive of low-grade malignancy were seen in mpcs. myopericytoma in the oral and maxillofacial region is rare and a limited number of cases have been reported in the literature. a 42-year-old female patient was admitted to our clinic with an enlarging lesion on the lingual aspect of the anterior mandible, which she noticed 2 years ago. as a result of the examination, a smooth-surfaced, off-white, pedunculated, fibrotic, painless, and non-bleeding lesion was detected in the lingual aspect of the anterior mandible. the lesion was removed by excisional biopsy.


Eligibility criteria:
inclusion criteria: patient with a fibrotic lesion in the mouth exclusion criteria: patient without fibrotic lesions in the mouth.

Keywords: oral pathology mıyopericytoma
efficacy/safety of ha inhalation solution for hereditary emphysema in patients with alpha-1 antitrypsin deficiency

Conditions: Emphysema; Alpha 1-Antitrypsin Deficiency

Summary: the purpose of the study is to evaluate the safety and efficacy of administering repeated doses of hyaluronic acid inhalation solution to subjects with emphysema that have alpha-1-antitrypsin deficiency

the study primarily aims to establish desmosine and isodesmosine concentrations in plasma, sputum and urine measured as markers of elastin degradation systemically in the lung and also markers of inflammation and fibrinogen. assessment of vital signs, lab tests, carbon monoxide diffusing capacity, oxygen saturation, pulmonary function tests, ecgs, physical exams and adverse events.

Eligibility criteria:
inclusion criteria: 1. able and willing to provide written informed consent and comply with study requirements 2. men or women aged 18 through 80 years at the time of consent 3. diagnosis of emphysema at screening consistent with national institutes of health guidelines 19 gold copd classification stages i, ii or iii 4. evidence of emphysema on radiographic imaging. 5. a ratio of pre-bronchodilator fev1 to forced vital capacity (fvc) of ≤ 80% at screening 6. fev1 ≥ 30% and ≤ 79% (post-bronchodilator) of predicted normal at screening 7. clinical laboratory tests (complete blood count, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the pi and sponsor at screening 8. women of childbearing potential and men who are sexually active must agree to use an adequate method of contraception (oral contraceptives, depot progesterone, condom plus spermicidal, or iud) during the study and for 1 month after the final dose of study drug. 9. evidence of alpha-1 antitrypsin deficiency (aatd) with any genotype except pimz deficiency. individuals with pimz deficiency are not allowed in the study. 10. patients must have stopped using intravenous alpha-1 antitrypsin protein (aat) augmentation therapy at least 3 months before entering study. exclusion criteria: 1. subjects with measured dlco of ≤ 35%, or unable to perform a reproducible dlco 2. subjects unable to perform 3 reproducible spirometry tests after 8 attempts 3. upper or lower respiratory tract infection within 2 weeks prior to screening and baseline (day1) 4. presence of clinically relevant abnormality on chest x-ray (other than evidence of emphysema) within the previous 12 months 5. use of supplemental oxygen therapy 6. requirement for ventilator support within the last year 7. exacerbation requiring treatment with systemic corticosteroids within the last 3 months 8. history of lung transplant or liver transplant. 9. presence of clinically relevant abnormality on electrocardiogram (ecg) 10. any medical condition that, in the investigator's judgment, would compromise study participation or the evaluation of the study drug 11. women who are pregnant or breastfeeding 12. receipt of an investigational drug within 30 days prior to screening 13. patients who are current smokers or have smoked within the last 3 months -

Keywords: emphysema copd alpha-1 antitrypsin deficiency
individualized carbon-ion radiotherapy for patients with locally recurrent nasopharyngeal carcinoma

Conditions: Locally Recurrent Nasopharyngeal Carcinoma

Summary: this is a randomized phase 2 trial with 2 groups (control group vs experimental group). patients with locally recurrent nasopharyngeal carcinoma (lr-npc) assigned to the control group will receive standardized carbon-ion radiotherapy (cirt). for patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. the primary endpoint of the study is to compare the 2-year progression-free survival (pfs) between 2 groups.

this is a randomized phase 2 trial with 2 groups (control group vs experimental group). patients with locally recurrent nasopharyngeal carcinoma (lr-npc) assigned to the control group will receive standardized cirt with a dose of 63 gray equivalent (gye) in 21 fractions (fx). this regimen was obtained from our previous phase 1 (dose escalation) study. for patients assigned to the experimental group, a predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. a dose of 60 gye/20 fx, 63 gye/21 fx and 66 gye/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively. the primary endpoint of the study is to compare the 2-year progression-free survival (pfs) between 2 groups. the secondary endpoints include 2-year overall survival (os), local progression-free survival, regional progression-free survival, distant metastasis-free survival, toxicities and quality of life.

Eligibility criteria:
inclusion criteria: * aged between 17-70 years. * pathologically diagnosed as who type 2/3 nasopharyngeal carcinoma. * failed previous definitive radiotherapy at least 6 months ago. * only had 1 previous course of radiotherapy. * eastern cooperative oncology group score: 0-1. * adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \ 60ml/min. * willing to accept adequate contraception for women with childbearing potential. * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial. exclusion criteria: * presence of distant metastasis. * without measurable lesion. * previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors. * accompanied with severe major organ dysfunction. * presence of mental disease that may influence the understanding of informed consent.

Keywords: locally recurrent nasopharyngeal carcinoma individualized carbon-ion radiotherapy predictive model of mucosal necrosis survival toxicity
validity of the french version of the child's vestibular disorder symptoms questionnaire

Conditions: Dizziness

Summary: there is currently no score in french for evaluating disorders of the child's balance. only one questionnaire was validated in the child in english in 2016, the " pediatric vestibular symptom questionnaire ". the objective of the research is to validate the french translation of this questionnaire.

balance disorders are the most common cause of dizziness in children with a prevalence of 0.7 to 15%. vestibular migraine, benign paroxysmal positional vertigo of the child, post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are the most common causes. however, these disorders are often undiagnosed in children as many doctors may attribute these symptoms to behavioural disorders or clumsiness. this is probably because of the difficulty children may have in expressing or describing their dizziness symptoms without specific questioning, but also because of the tendency of children to accept the terminology that an adult offers them or even tend to cling to their parents when they experience a balance disorder or vertigo. vestibular disorders can also have secondary psychological symptoms with an impact on school learning and quality of life. a precise interrogation to check the symptoms, to look for the triggers and to trace the installation of the symptoms is fundamental to diagnose and make a therapeutic decision. thus, it is very important to help the child express his or her feelings by proposing different descriptions and formulations to determine the etiology and diagnosis. while a number of international questionnaires validated and translated into french exist in the adult to assess the presence, severity and impact of vestibular symptoms, there is currently no score in french for evaluating disorders of the child's balance. only one questionnaire was validated in the child in english in 2016, the " pediatric vestibular symptom questionnaire ". the objective of the research is to validate the french translation of this questionnaire.

Eligibility criteria:
inclusion criteria: * non-opposition of the holders of parental authority and the subject to participation in the study * subjects between 7 and 17 years of age * patients : patients followed in the clinic at necker hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder. * controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background. exclusion criteria: - absence of diagnosis after etiological assessment.

Keywords: pediatric vestibular symptom pediatric vestibular symptom questionnaire in french
scg142 tcr-t cells for human papillomavirus-associated carcinomas

Conditions: Human Papillomavirus Associated Carcinomas; Cervical Cancer; Head and Neck Cancers; Anal Cancer; Vulva Cancer; Vaginal Cancer; Penile Cancer; HPV-Related Malignancy

Summary: a multicenter, open, single arm dose escalation and dose expansion phase i study to evaluate the safety, tolerability, and efficacy of scg142 tcr-t cells in subjects with advanced hpv associated carcinomas.


Eligibility criteria:
key inclusion criteria: 1. greater than or equal to 18 years of age 2. hpv associated carcinomas 3. patients must have at least one measurable lesion defined by recist 1.1 4. eastern cooperative oncology group (ecog) performance status 0 or 1 key exclusion criteria: 1. active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory. 2. patients with active autoimmune diseases. 3. patient has a known active hepatitis b or hepatitis c. 4. other severe medical conditions that may limit subject\&#39;s participation in this trial.