Kornimate/medical-research-clean huggingface dataset:
a trial to assess the safety, tolerability, and pharmacokinetics of mdt-637 in healthy volunteers

Conditions: Drug Safety; Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to determine the range of single inhaled doses of a new dry powder product, mdt-637, that are safe and well-tolerated. this includes monitoring effects on pulmonary function and determination of blood levels of mdt-637 following inhalation.


Eligibility criteria:
inclusion criteria: * males and/or surgically sterile or post-menopausal females (confirmed by fsh test); males must agree to practice barrier contraception until they are discharged from the study * willing to give written informed consent * 18 to 50 years of age * bmi of 19-30 kg/m2 * non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study * good general health as determined by medical history, physical examination, ecg and clinical laboratory tests * willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing exclusion criteria: * uncontrolled, clinically significant disease which in the opinion of the principal investigator and mdt would place the subject at risk through study participation or would confound the assessment of the safety of mdt-637 * evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis * history of significant nasal irritation from nasal inhalation of medication * history of malignancy * history of clinically significant alcohol or drug abuse * positive drug screen for drugs of abuse * positive test for hiv, hepatitis b or hepatitis c * allergy to lactose, or lactose intolerance * use of prescription medication within 14 days of visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of visit 2 * positive serum pregnancy test at visit 1 * inability to perform reproducible spirometry * abnormal fev1, fvc, or fev1/fvc (fev1and fvc \< 85% of predicted and variability of \<5% or fev1/fvc ratio \< 0.7) * abnormal qtc interval at visit 1(\>450 msec in males or \> 470 msec in females) * significant blood donation (or testing) in previous 8 weeks

Keywords: rsv
psychodynamic internet treatment versus cognitive behavioral therapy (cbt) for generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the objective is to test if internet-delivered cognitive behavior therapy (icbt) or internet-delivered psychodynamic therapy (ipdt) performs better for a population with generalized anxiety disorder (gad), compared to a wait-list control condition.

this was a non-inferiority trial within the context of a parallel group study with unrestricted randomisation in 1:1:1 ratio conducted in sweden. outcome assessors were blind to treatment status.

Eligibility criteria:
inclusion criteria: * fulfill the diagnostic criteria for gad according to dsm-iv * have access to the internet * have good knowledge of the swedish language exclusion criteria: * recent (during last 6 weeks) change in psychiatric medication * presently in any other psychological treatment * severe depression * suicidal ideation

Keywords: internet treatment gad guided self-help
percutaneous electrical nerve stimulation for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: there is evidence supporting that physical therapy interventions can be effective for the management of patients with cts. no consensus on the best approach exist. it seems clear that the median nerve is affected in several ways (compression, inflammation, excursion) in carpal tunnel syndrome. percutaneous electrical nerve stimulation is a treatment approach consisting of the application of an electrical current throughout needling filaments placed close to the nerve, in this case the median nerve. the purpose of this clinical trial is to compare changes in function, symptom severity and the intensity of pain after the application of percutaneous electrical nerve stimulation vs. endoscopic surgery in women with cts at short- and long-term follow-up periods.


Eligibility criteria:
inclusion criteria: * pain and paresthesia in the median nerve distribution * positive tinel sign, * positive phalen sign, * symptoms had to have persisted for at least 6 months * deficits of sensory and motor median nerve conduction according to guidelines of the american association of electrodiagnosis, american academy of neurology, and the american physical medicine and rehabilitation academy exclusion criteria: * any sensory/motor deficit related to the ulnar or radial nerve; * older than 65 years of age; * previous surgical intervention, steroid injections or physical therapy intervention * multiple diagnoses of the upper extremity (eg, cervical radiculopathy); * history of neck, shoulder, or upper limb trauma (whiplash); * history of any systemic disease causing cts (eg, diabetes mellitus, thyroid disease); * history of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia); * pregnancy;
cost talk: discussing cancer care costs

Conditions: Prostate Cancer

Summary: the purpose of this study is to investigate whether an encounter decision aid (used during a consultation) containing cost information about options, combined with clinician training about cost discussions and available financial resources, influence surgeon-patient cost conversations, referrals to address costs, patients' financial stress, and high-quality decision-making for patients with slow-growing prostate cancer.

the study will use a stepped wedge design to evaluate the encounter decision aid. each participating urologic surgeon will begin in the usual care arm of the study. subsequently, the surgeons will be randomized to the intervention arm at staggered time points to undergo training and begin using the decision aid intervention with patients who are diagnosed with slow-growing prostate cancer. this study will consist of two aims. the first aim is to examine the use of an encounter decision aid with cost information on the presence and impact of out-of-pocket cost conversations. the investigators will train participating clinicians on how to use the decision aid intervention and available financial resources. with patient and clinician consent, the investigators will audio record clinical encounters and measure cost conversations using a previously-developed checklist to code transcripts derived from the audio recordings. patients can still participate if they do not consent to audio recording as these topics will be assessed in the self-report survey after their clinic or virtual visit. the second aim will examine the impact of an encounter decision aid with cost information on high-quality decision-making. the investigators will collect a post-visit questionnaire from participating patients, including patient-reported measures of decisional conflict, decision regret, and the shared decision-making process. participants will be sent a follow-up questionnaire 3 months after their initial study enrollment to assess decision regret and financial toxicity.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * visiting a participating urologist/urologic surgeon to discuss treatment options * slow growing prostate cancer defined as gleason score of 6 or 7 (3+4) and/or psa (prostate-specific antigen) level less than 10ng/ml or at surgeon's discretion * must be patients of one of the participating providers exclusion criteria: -patients who cannot give informed consent due to cognitive or emotional barriers

Keywords: prostate cancer treatment costs
a real-world study to assess safety and effectiveness of secukinumab in pediatric plaque psoriasis patients in china

Conditions: Moderate to Severe Chronic Plaque Psoriasis

Summary: this is a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in chinese pediatric patients with moderate to severe plaque psoriasis treated with cosentyx® for up to 52 weeks.

patients who are about to initiate cosentyx® or have started cosentyx® within the last 4 weeks and meet the eligibility criteria will be enrolled. patients will be followed via routine visits in real clinical practice up to 52 weeks. data from medical records, including safety and effectiveness information of cosentyx® (e.g., ae, sae, physical examinations, laboratory tests, disease assessments, etc.) will be collected at each visit. no additional study visits, examinations, laboratory tests or procedures will be mandated throughout the study.

Eligibility criteria:
inclusion criteria: patients meeting all of the following criteria are eligible for inclusion in this study: * written assent and informed consent must be obtained as per local regulations prior to any study procedures. * diagnosed with moderate to severe plaque psoriasis. * initiating treatment with cosentyx® or having started cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study. * aged 6 to less than 18 years at the time they are prescribed cosentyx®. * have valid pasi and iga mod 2011 score at the time they are prescribed cosentyx®. exclusion criteria: patients meeting any of the following criteria are not eligible for inclusion in this study: * patients previously treated with other biologics. * patients participating in other clinical trials or who previously participated in clinical trials within 30 days before cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer. * patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.

Keywords: chronic plaque psoriasis china nis cosentyx secukinumab
short-term effects of sound-bed music therapy in healthy caregivers of a hospital oncology ward (mto_03)

Conditions: Healthy Adults (Hospital Oncology Ward); Physiological Phenomena (e.g.HRV Parameters); Morphology

Summary: the purpose of this study is to determine the effects of live sound-bed music on physiological and psychological parameters in staff of a hospital oncology ward.


Eligibility criteria:
inclusion criteria: * signed informed consent of the participant * affiliation to the staff of the hospital oncology ward exclusion criteria: * insufficient knowledge of the german language * alcohol, caffeine or nicotine less than 3 hours before the beginning

Keywords: oncology psychology cancer music sound-bed
elena cohort: a long-term longitudinal study in a pediatric sample with autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the objective of the elena french cohort is to study the developmental trajectories of children and adolescents with asd and their risk or protective associated factors. this is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with asd recruited from services specialized in the assessment of developmental disorders.

multidisciplinary cohort studies of children with autism spectrum disorders (asd) followed from childhood to adulthood exist abroad but not in france. the objective of the elena french cohort is to study the developmental trajectories of children and adolescents with asd and their risk or protective associated factors. this is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with asd recruited from services specialized in the assessment of developmental disorders. the patients will be monitored every 18 months for at least 36 months and during a maximum of 10 years. clinical, social, environmental, and genetic data, as well as data relating to the parental quality of life will be collected. the primary endpoint will be the adaptive level in three domains of the vineland ii (communication, socialization and daily living skills). the secondary endpoints will be parental quality of life, comorbidities, interventions and severity of asd. the inclusion of 900 patients over a 10-year period is expected. this cohort should contribute to a better knowledge of the child with asd's development, taking into account his physical, social and familial environment, the type of interventions and some genetic components. it should also lay the foundations for a national network of professionals working in the field of autism research by offering them a common tool for promoting translational studies.

Eligibility criteria:
inclusion criteria: * age between 2 and 16 years * diagnosis of asd formally established during a multidisciplinary assessment, according icd 10 criteria and adi * patient who benefited in the last 12 months: vineland, ados, intellectual level * parents consent exclusion criteria: * subject refusal to participate * parental refusal to participate

Keywords: cohort
role of methylation test triage in hpv positive women

Conditions: Precancerous Cervical Lesion

Summary: the pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (astn1 dlx1, itga4, rxfp3, sox17, znf671) in triaging high-risk human papillomavirus infection. the sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.

the study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. women who meet the clinical endpoint (i.e. histopathologically confirmed ≥cin2 after baseline colposcopy/biopsy) are withdrawn from the study. participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. participants included in the follow-up phase are underwent hpv, cytology, and methylation tests at 6 months and 1 year after baseline.similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and hpv tests result is positive.

Eligibility criteria:
inclusion criteria: * aged 25\~65 years undergoing cervical cancer screening * normal for cytology and positive for hrhpv * informed consent was obtained exclusion criteria: * pregnant * with a known history of ablation or treatment with cervical excision within 12 months * hysterectomy * chemoradiotherapy * planning to participate or taking part in another cancer screening, treatment, or vaccination study * do not meet the inclusion criteria * give up the trial or naturally dropped out of the follow-up during the observation process * people who asked to withdraw

Keywords: human papillomavirus high-grade squamous intraepithelial lesion methylation cervical cancer screening triage adenocarcinoma in situ cytology
ultrasound guidance for interscalene brachial plexus block

Conditions: Shoulder; Orthopedic Surgery; Nerve Block

Summary: this study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery. the ultrasound technique will be compared with the current gold standard, electrical nerve stimulation. the aim of this study is to define which technique is better in terms of time to onset of anesthesia.

the study will compare real-time ultrasound (us) guidance and electrical nerve stimulation (ens) in terms of onset time for interscalene brachial plexus anesthesia. the main hypothesis is that direct visualization of neural structures under us guidance will grant better local anesthetic (la) disposition around the roots of the plexus, thus improving onset times. perineural catheters will be used to maintain regional analgesia for 48 hours after surgery. we hypothesize that us guidance may also help physicians place perineural catheters more precisely, thus improving analgesia in the following hours to days. finally, we will investigate for possible differences in minor adverse events such as vascular puncture, pain during the anesthetic procedure.

Eligibility criteria:
inclusion criteria: * asa physical status class i-iii * elective surgery of the shoulder * informed consent to regional anesthesia exclusion criteria: * inability to effectively communicate * chronic opioid use * absence of informed consent to participation to the study * ipsilateral upper limb neurological deficits * known allergy to study medications * contraindications to continuous block placement

Keywords: analgesia, patient-controlled anesthesia, regional ultrasound postoperative pain brachial plexus
fat absorption and metabolism after roux-en-y gastric bypass

Conditions: Bariatric Surgery

Summary: using intravenous and oral administration of stable isotope tracers, we will investigate the importance of altered fat absorption and altered whole body fat metabolism for the reduced postprandial systemic tag concentrations in non-diabetic patients in weight stable phase after rygb.


Eligibility criteria:
inclusion criteria, rygb * age \> 18 years * rygb \> 12 months prior to inclusion * weight stable (± 3 kg during the last month) * hba1c \< 48 mmol/mol before surgery, and no history of diabetes * hba1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion inclusion criteria, con * age \> 18 years * no former bariatric surgery * weight stable (± 3 kg during the last month) * hba1c \< 48 mmol/mol, fasting plasma glucose \< 6.1, and no history of diabetes exclusion criteria * thyrotoxicosis or inadequately treated hypothyreosis * haemoglobin \< 6.5 mmol/l at inclusion * pregnancy (pregnancy test in fertile woman before enrolment) or breast feeding * medication affecting the planned examinations which cannot be paused during the study period. * adherence to extreme diets with excessively high or low contributions from certain macronutrients (e.g. ketogenic diet) * complications restricting eating behavior (e.g. postprandial hypoglycemia, vomiting or strictures) * mr contraindications

Keywords: fat triglyceride triacylglycerol roux-en-y gastric bypass malabsorption
the effect of psychological first aid intervention on stress and resilience in volunteers working in kahramanmaraş centered earthquakes

Conditions: Psychological Resilience; Stress; Earthquake

Summary: purpose: it was aimed to compare the effectiveness of online psychological first aid intervention on stress and psychological resilience in volunteers who took part in earthquakes. method: this is a single-blind randomized controlled experimental study conducted to determine the effect of online psychological first aid intervention on the stress and resilience levels of volunteers who took part in the earthquake.

in this study, it is aimed to compare the effectiveness of the online psychological first aid intervention on stress and psychological resilience given to the volunteers working in various provinces (11 provinces) affected by the kahramanmaraş centered earthquakes.

Eligibility criteria:
inclusion criteria: * volunteering in the earthquake zone, * not having a perception disorder that will prevent communication, * to volunteer to participate in the research. exclusion criteria: * having a communication barrier, * not wanting to be involved in the study.

Keywords: post traumatic stress disorder psychological first aid psychological resilience earthquake victims
safety and immunogenicity of a/h1n1-soiv (swine flu) vaccine with and without adjuvant in children (3 to < 9 years)

Conditions: Influenza

Summary: this study will evaluate the safety and immunogenicity of different combinations of a/h1n1 s-oiv (swine flu) vaccine in healthy young children.


Eligibility criteria:
inclusion criteria: * children 3 to \< 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months. exclusion criteria: * history of serious disease. * history of serious reaction following administration of vaccine or hypersensitivity to vaccine components. * known or suspected impairment/alteration of immune function. * receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination. for additional entry criteria, please refer to protocol.

Keywords: swine flu flu vaccine children adjuvant
safety and acceptability of deferiprone delayed release tablets in patients with systemic iron overload

Conditions: Iron Overload Due to Repeated Red Blood Cell Transfusions

Summary: safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (dr) tablets in patients with systemic iron overload.

this study is looking at the safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (dr) tablets in patients with systemic iron overload who are currently taking deferiprone immediate-release tablets (ferriprox) three times a day. ferriprox doses range from 75 milligrams per kilogram of body weight (mg/kg) per day to 100 mg/kg per day. half the patients in the study will be on a dosage that is closer to the low end of the range, and half will be on a dosage that is closer to the high end. both groups will be switched for one month to deferiprone dr tablets at approximately the same total daily dosage that they have been taking for ferriprox.

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥ 18 years. 2. diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a regular regimen of red blood cell transfusions. 3. on a stable regimen (≥3 months) of ferriprox tablets for the treatment of systemic iron overload. 4. absolute neutrophil count ≥1.5 x 10\^9/l at screening. 5. a record of at least 12 measured alanine aminotransferase (alt) and aspartate aminotransferase (ast) levels. exclusion criteria: 1. receipt of any iron chelator other than ferriprox (i.e., combination therapy) in the last 3 months, or planning to receive it at any time during the period of the study. 2. alt and/or ast value \> 5 times the upper limit of normal (uln) at screening 3. active case of hepatitis b or c at screening.

Keywords: iron overload chelation deferiprone ferriprox
an interview study with injured workers concerning their experiences with the social systems and psychosocial health consequences

Conditions: Work-related Injury; Occupational Disease; Workers' Compensation; Psychological; Policy

Summary: objective: in addition to physical discomforts, work-related injuries and illnesses often result in various forms of hardships, including economic hardship, labor conflicts and legal disputes. the physical and psychological health conditions are likely to be worsen when the social supporting systems are not well functioning. in this study, the investigators aim to conduct in-depth interviews with injured workers to study their experiences with the social systems, including employment protection system, workers' compensation system, health care system and other social welfare systems, and to explore how the systems may affect workers' physical and psychological health. methods: face-to-face interviews will be conducted with a semi-structured questionnaire. subjects who had ever experienced work-related injuries or diseases (including muscular skeletal disorders and work-related cardiovascular or cerebrovascular diseases) over the past 3 years are invited. the investigators anticipate to recruit a total of 60\~100 cases, whom will be recruited through the assistance of occupational physicians, occupational health centers, labor groups and unions. interview time will be limited to 1 hour. anticipated results and contribution: findings of this study will help to advance our knowledge concerning the functions of current social systems and the hardships of workers who suffer from work-related injuries and diseases. suggestions will be provided for the improvements of current systems. keywords: work-related injury, occupational disease, workers' compensation, psychological, policy.


Eligibility criteria:

Keywords: work-related injury occupational disease workers' compensation psychological policy