Kornimate/medical-research-clean huggingface dataset:
tenofovir in hiv/hbv coinfection

Conditions: HIV Infection; Hepatitis B Coinfection

Summary: the purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the hepatitis b virus in patients infected with hiv and hepatitis b (co-infection)

a randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with hiv/hbv co-infection over 48 weeks (clinical trial a). plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on clinical trial a with a group of therapy naïve hbv mono-infected subjects (substudy a1)

Eligibility criteria:
inclusion criteria: * written informed consent * documented hiv infection (positive serology for hiv-1 and detectable hiv-1 rna) * age 18 - 70 years * hbv dna \> 105 copies/ml * hbsag positive \>6 months or hbsag positive and anti hb core igm negative * creatinine \<= 2.0mg/dl (\<= 0.2 mmol/l) * platelet count \>= 50,000/mm * hiv-1 antiretroviral therapy naïve * no prior exposure to anti-hbv agents (lam, adefovir, tdf) although prior ifn treatment allowed exclusion criteria: * hcv-rna positive or anti-hav igm positive * acute hepatitis (serum alt \> 1000 u/l) * active opportunistic infection * other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, wilsons disease, alfa-1-antitrypsin deficiency) * concurrent malignancy requiring cytotoxic chemotherapy * decompensated or child's c cirrhosis * alfa-fetoprotein (afp) \> 3x uln (unless negative ct scan or mri within 3 months of entry date) * pregnancy or lactation * any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study

Keywords: hepatitis b hiv treatment naive
bgs neonatal pilot study

Conditions: Pain From Heel Sticks

Summary: this is a pilot, randomized, safety and efficacy study of an investigational device (i.e. babygentlestick™; bgs, actuated medical, inc). the primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * medically stable late preterm/term neonates with a gestational age at birth of \> 35 weeks gestation at birth * sex: male or female exclusion criteria: * congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements * known risk for bleeding (i.e. hemophilia, blood clotting or protein disorders) * prolonged labor or delayed birth with evidence of perinatal depression (e.g. infant apgar scores below 5) * identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (nas) * critical illness in the mother preventing the ability to obtain informed consent from parents
rad001 for non-clear cell renal cell carcinoma (rcc)

Conditions: Renal Cell Carcinoma

Summary: to assess the efficacy and safety of rad001 (everolimus) in non-clear cell renal cell carcinoma


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly) 2. subjects with metastatic legion 3. subjects aged 18 years or older 4. subjects whose ecog performance status is 0 or 1 5. subjects who have laboratory value below; hematology * neutrophil \>= 1.5 x 109/l * platelet \>= 75 x 109/l * hemoglobin \>= 9 g/dl liver function tests * total bilirubin ≤ 1.5 xuln * ast, alt ≤ 2.5 xuln * alkaline phosphatase ≤ 2.5 xuln renal function tests * creatinine clearance \>= 30 ml/min 6. subjects who understand and provide a written informed consent exclusion criteria: 1. subjects who have been administered an mtor inhibitor 2. pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative 3. subjects who participated in a clinical study using the study medication within 30 days before randomization 4. subjects with clinically uncontrolled central nervous system (cns) metastasis 5. subjects with life expectancy of less than 3 months 6. subjects with interstitial pulmonary disease 7. subjects whose qtc interval is prolonged (qtc \> 450 msec for male or \> 470 msec for female) 8. other serious diseases or medical conditions heart disease unstable despite treatment history of myocardial infarction within six months before the study history of serious neurological or psychological disorder including dementia or seizure active peptic ulcer which cannot be controlled by a drug

Keywords: renal cell carcinoma non-clear cell rad001 metastatic, non-clear cell, renal cell carcinoma
pain perception and the autonomic nervous system

Conditions: Autonomic Nervous System Modulation; Pain Perception; Pain Sensitivity; Central Sensitization; Vagus Nerve Stimulations

Summary: in this study, we want to investigate how pain processing and sensation are related to a certain part of the nervous system, the so-called autonomic nervous system. for this purpose, we apply heat and pressure stimuli to the skin and test pain processing by means of ratings scales and sensory tests. breathing, heart rate and sweat response are also measured. to assess the spinal cord level, we measure muscle response (measured by electromyography, emg) to electrical stimulation. additionally, sensory nerves will be stimulated at the ear and participants will also be given various questionnaires to complete.

this study investigates the effects of autonomic regulation on pain perception and experimentally induced pain sensitivity. participants come for one or two study visits, that will last approximately 3 hours. the study is divided into two phases: the pilot phase and the main experimental phase. during the pilot phase, the perception of pressure and heat stimuli, as well as spinal excitability, will be assessed before and during different types of electrical stimulation of sensory nerves at the outer ear. during the main experimental phase, skin sensitivity and spinal excitability will be assessed before and after repetitive heat stimulation and stimulation of sensory nerves at the outer ear. in both study phases, the activity of the autonomic nervous system will be assessed throughout the experiment, and questionnaires will be completed.

Eligibility criteria:
inclusion criteria: 1. over 18 and below 40 years of age 2. good general health 3. able to give informed consent exclusion criteria: 1. any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any acute pain at time of study 2. inability to follow study instructions, e.g. due to language problems 3. pregnancy (female participants will be asked if pregnancy could be possible) 4. increased alcohol (\&gt;2 (for women)/4 (for men) standard glasses per day or \&gt;5 (for women)/4 (for men) glasses at least once a month within a few hours) or caffeine consumption (≥ 400mg per day) 5. consumption of alcohol, drugs, analgesics within the last 24 h 6. consumption of more than 100 mg of caffeine within the last 8 h 7. scar tissue or generally reduced sensitivity in the designated testing site areas 8. shoe size \&lt; 38 (if experiment is conducted at the feet) 9. history of cardiovascular disease or carotid artery disease 10. medication or substances inferring with the autonomic nervous system or with pain sensitivity (e.g. benzodiazepines, nicotine)
breath samples collection clinical trial, for development of the tera biostation t101, intended for cov-19 exhalation products detection.

Conditions: COVID-19

Summary: the sponsor has developed a rapid screening tool intended to determine if the subject tested has covid-19.

according to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples. the proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'infected' and 'healthy' can be demonstrated in terms spectroscopic measurements. indication for use: rapid detection of the novel sars-cov-2 (covid-19) virus in breath samples. the study is aimed to collect data in order to assess whether a patient's covid -19 status can be identified by a unique spectrophotometric pattern.

Eligibility criteria:
inclusion criteria: general: 1. male or female subject aged 18 years and above 2. subject is able and willing to provide informed consent 3. subject is able to complete the breath test. arm a: 4. requiring a diagnostic or screening rt-pcr test for covid-19. arm b: 5. positive to covid-19 in rt-pcr test performed up to 48 hours before screening. exclusion criteria: 1. male of female subject under the age of 18. 2. subject is unable to provide and informed consent, for any reason.
clinical efficacy of erythropheresis in high altitude polycythemia

Conditions: High Altitude Polycythemia

Summary: the clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia.

the clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia. people reside in highland diagnosed as high-altitude polycythemia were included and randomly divided into two groups. in one group, routine therapy including oxygen inspiration would be performed, while in another erythropheresis would be added. symptom relief, blood oxygenation, and 6-minute walk test would be assessed and compared in the above two groups.

Eligibility criteria:
inclusion criteria: 1. \>=18 years old;2.high altitude polycythemia; 3.han nationality who have been in highland for over 12 months; 4. no other complications indicated by general examinations such as chest x-ray, electrocardiogram; 5. patients who are informed and informed consent form are acquired. exclusion criteria: 1. hypoxemia caused by other respiratory or cardiac diseases or polycythemia vera; 2. acute or subacute mountain sickness ; 3. acute or chronic infections and medication history ; 4. psychiatric disorders or severe neurosis; 5. malignant myeloproliferative disease; 6. any contraindications to erythropheresis.
postoperative pain management on uvulopalatopharyngoplasty patients

Conditions: Pain, Postoperative; Obstructive Sleep Apnea-hypopnea Syndrome; Pain, Acute

Summary: this is a randomized controlled study, aimed to investigate the effects of dinalbuphine sebacate (ds) on patients having uvulopalatopharyngoplasty (uppp). ds is a prodrug of nalbuphine, a mixed agonist-antagonist opioid. the mean absorption time for the complete release of ds into systemic circulation is approximately 145 h, which could theoretically provide extended analgesic effects for up to 6 days. patients diagnosed with obstructive sleep apnea are generally associated with higher risks towards opioid side effects, especially respiratory depression. post-uppp pain managing should be cautiously arranged and executed. we hypothesize that the combination of our routine practice and ds will improve the outcomes after uppp.

within 4 weeks before uvulopalatopharyngoplasty, patients are invited for this study. after written informed consent gained, the eligibilities are checked. eligible patients are arrogated into experimental or control group randomly prior to surgery. experimental group receives the ds administration at least 12 hours before surgery. during peri-operative period, pain management are conducted following our routine practice. pain intensity, consumption of analgesics, adverse events, swallow function and life quality are all assessed and recorded within 14 days after surgery.

Eligibility criteria:
inclusion criteria: * aged between 20 and 65. * diagnosed with obstructive sleep apnea. * arranged to undergo uvulopalatopharyngoplasty. * classified as asa i, ii, or iii. exclusion criteria: * can not comply with study protocol. * bmi \> 34 kg/m2. * history of chronic pain. * history of narcotics or alcohol abuse. * allergic to nsaid. * diagnosed as diabetes mellitus with poor glycemic control. * diagnosed with severe cardiovascular or respiratory diseases. * judged as an unsuitable subject by investigators.

Keywords: dinalbuphine sebacte nalbuphine naldebain uvulopalatopharyngoplasty
change of gut microbiome in the treatment of graves' disease

Conditions: Graves' Disease

Summary: graves' disease is the main cause of hyperthyroidism. graves' disease has a prevalence of 0.5% in the general population. as a non-surgical treatment, antithyroid drug (atd) and radioactive iodine treatment have been proposed and atd is the first-line treatment in korea. however, atd has a rare but fatal side effect of agranulocytosis. furthermore only half of its users maintain long-term remission and frequent recurrence is a problem to this disease. therefore it is essential to distinguish between patients who respond well to atd and those who resist it. the aim of this study is to verify the changes in gut microbiome in graves' disease patients before and after six-month treatment with atd. patients first diagnosed with graves' disease will participate in the study. the study design is a prospective longitudinal trial. the patients are asked to have their gut microbiome analyzed before and after the treatment of graves' disease with atd. primary endpoint is the changes of analyzed gut microbiome before and after atd treatment. secondary outcome is to find species that can be used as a biomarker to differentiate the patients refractory to atd.


Eligibility criteria:
inclusion criteria: * more than 19 years and lesser than 70 years * first diagnosed as graves' disease and planned to have antithyroid drug exclusion criteria: * pregnancy and lactating women * inflammatory bowel disease * active malignancy * autoimmune disease * immune-deficiency patients
the role of sedation technique in ebus-tbna

Conditions: Lung Cancer

Summary: there is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) on diagnostic accuracy. the aim of this retrospective study is to compare diagnostic accuracy of ebus-tbna in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar). the first consecutive patients at the university hospital zurich undergoing ebus-tbna for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. diagnoses based on ebus-tbna were compared with those on surgical or radiological follow-up.

between september, 2007 and january 31, 2014, all consecutive patients who undergo ebus-tbna at the university hospital zurich for selective assessment of enlarged (≥ 1 cm by ct or ultrasound) or suspected (enhanced fluorodeoxyglucose (fdg) activity in pet/ct) lymph nodes were enrolled. demographic and clinical data, procedural reports and cytological findings were collected from medical records. computed tomography (ct) or pet/ct scans were prospectively reviewed to gather the size and standardized uptake value (suv) of fdg of each sampled lymph node. the cytological findings obtained with ebus-tbna were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following ebus-tbna, or alternatively by clinical and radiological follow-up data.

Eligibility criteria:
inclusion criteria: * ebus-tbna exclusion criteria: * no exclusion criteria

Keywords: bronchial endoscopy ultrasound ebus anesthesia lung cancer diagnosis including staging
robotic assisted cochlear implantation feasibility study

Conditions: Sensory Hearing Loss

Summary: a first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

a first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.

Eligibility criteria:
inclusion criteria: * geographically and physically able to attend scheduled evaluations and follow-up appointments * indicated for cochlear implantation * age 18 years or older * fluent in german or french * sufficient facial recess size ( \> 2.5 mm between the facial nerve and chorda tympani) exclusion criteria: * pregnancy * anatomical malformation of the middle or inner ear or unusual facial nerve course * lack of compliance with any inclusion criteria

Keywords: cochlear implantation robotics image guidance
a school program for children exposed to violence

Conditions: Stress Disorders, Post-Traumatic; Depression

Summary: this study will develop a program to help school children deal with violence-related trauma.

the number of children who have been indirectly or directly exposed to violence has dramatically increased in the last decade. the emotional and behavioral consequences of violence exposure can be particularly devastating to children. interventions are needed that can reduce symptoms related to traumas already experienced and enhance children's skills for handling extreme stress that might be experienced in the future. the cognitive-behavioral intervention for trauma in schools (cbits) program was developed between 1998 and 2001 to help children in the los angeles school district deal with traumatic events. although promising, the program required a school-based mental health clinician for implementation. this study will evaluate the effectiveness of a program adapted for the los angeles cbits program that can be used by school staff in a middle school setting. the adapted cbits program will be compared to a wait list to determine which is more effective in reducing trauma-related stress and depression among sixth grade students. students who have experienced violence-related trauma will be randomly assigned to receive either 10 weekly sessions of group cognitive behavioral therapy or to wait 3 months. self-report scales and interviews will be used to assess the emotional states of participants at study entry and study completion. no follow-up visits will be required.

Eligibility criteria:
inclusion criteria: * students in 6th and 7th grade in two participating los angeles area schools * exposure to severe violence, as either a victim or witness, within 1 year prior to study entry * have symptoms of post-traumatic stress disorder at study entry * able to speak and understand english * parent or guardian willing to give informed consent exclusion criteria: * post-traumatic stress disorder symptoms that are not related to a traumatic event * mental retardation * conduct disorder that would interfere with the participant's ability to engage in group therapy

Keywords: trauma violence adolescent schools cognitive behavioral therapy
pharmacokinetics of ch14.18 in younger patients with high-risk neuroblastoma

Conditions: Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Neurotoxicity Syndrome; Pain; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma

Summary: this research trial is studying how ch14.18 acts in the body of younger patients with high-risk neuroblastoma. studying samples of blood from patients with cancer receiving ch14.18 may help doctors learn more about how this drug is used by the body to develop better ways to give the drug to potentially improve its effectiveness and lessen its side effects.

primary objectives: i. describe the pharmacokinetics of ch14.18 (monoclonal antibody ch14.18) in children with high-risk neuroblastoma. ii. quantify the degree of inter-patient and intra-patient variability in the clearance of ch14.18, and correlate ch14.18 clearance with patient characteristics, the presence of human anti-chimeric antibody (haca), tumor burden (assessed on scans), and plasma gd2 levels to identify sources of variability in the clearance. iii. develop a pharmacokinetic model to describe the pharmacokinetic profile of ch14.18 and derive pharmacokinetic (pk) parameters. secondary objectives: i. correlate plasma concentrations of ch14.18 with the severity of neuropathic pain, which is being quantified using an observational pain scale, and the total dose of morphine administered to control pain. ii. develop a limited sampling strategy that will accurately quantify the area under the curve (auc) of ch14.18. iii. simulate alternative dosing strategies with the pharmacokinetic model in order to reduce variability and simplify drug administration. outline: patients undergo blood sample collection at baseline and during and after course 1, 3, or 5 of treatment for pharmacokinetic analysis. some patients undergo blood sample collection at baseline and during and after two treatment courses (1 and 3, 1 and 5, or 3 and 5).

Eligibility criteria:
inclusion criteria: * diagnosis of high-risk neuroblastoma * enrolled on the cog protocol anbl0032 or anbl0931 and eligible to receive ch14.18 according to the criteria on these primary treatment protocols * parental informed consent and verbal assent of the subject when appropriate exclusion criteria: * prior testing demonstrating the presence of haca * anaphylactic reaction to ch14.18 on a prior treatment cycle
pilot study about tamoxifen therapy for breast cancer patients

Conditions: Breast Cancer

Summary: the aim of this study are to to evaluate the knowledge and understanding on tamoxifen theraphy for breast cancer patients and examine the decision conflict scale and satisfaction with decision scale while making decision to take tamoxifen.

the knowlege questionnaire about tamoxifen was developed by the medication guides that provide for patients taking tamoxifen and hormone therapy for breast cancer fact sheet from national cancaer institute. several experts in the field of breast cancer and gynecologic cancer are going to review and indicate the questionnaire.

Eligibility criteria:
inclusion criteria: * the breast cancer patients who take tamoxifenexclusion criteria: exclusion criteria * the patients who do not agree to participate in this study * the paitents who have trouble with understanding and reading korean.

Keywords: tamoxifen breast cancer knowkedge
evaluation of a ionic silver and honey preparation to treat chronic wounds of the lower legs

Conditions: Leg Ulcer

Summary: in this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. evaluation will be based on standardised photographs and clinical data. the secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.


Eligibility criteria:
inclusion criteria: * adult * chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and * written informed consent exclusion criteria: * refuse to give written informed consent. * patient suffering from mental disorder that may interfere with the treatment. * known allergy or intolerance to any of the products used in the formulation. * having received systemic antibiotics within 7 days of starting treatment with honey based formulation. * arterial insufficiency stage iv of the lower limbs.

Keywords: wound healing granulation tissue varicose ulcer