Kornimate/medical-research-clean huggingface dataset:
clinical trial for surgery of the ulnar nerve (sun) at the elbow

Conditions: Neuropathy Ulnar

Summary: this research is studying two surgical procedures in a large group of people to learn about how well these procedures work as a treatment for ulnar neuropathy at the elbow (une). researchers want to see which surgery is more helpful for people with ulnar neuropathy. this research will determine if one surgery is better than the other to alleviate symptoms.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis or suspected diagnosis of isolated ulnar neuropathy at the elbow * confirmation of ulnar neuropathy using the american association of electrodiagnostic medicine criteria for electrodiagnostic studies at the elbow. (participants must meet at least 1 of the criteria to be enrolled (absolute motor nerve conduction from above elbow (ae) to below elbow (be) of less than 50 m/s; an ae to be segment greater than 10 m/s slower than be to wrist segment; a decrease in compound muscle action potential (cmap) negative peak amplitude from be to ae greater than 20%) * stated willingness to comply with all study procedures and availability for the duration of the study * able to read, understand and complete the questionnaires in english exclusion criteria: * previous elbow fracture requiring surgical fixation * patients who have not attempted conservative management for une (e.g. night splinting) * subluxation of ulnar nerve on preoperative exam * recurrent une after previous surgery * concomitant neuropathic conditions such as carpal tunnel syndrome or cervical or brachial plexus abnormalities * participants with severe comorbid conditions that prohibit surgery

Keywords: decompression anterior subcutaneous transposition elbow ulnar nerve
the arhinasd (allergic rhinitis in pediatric subjects with nasal septum deviation) project

Conditions: Rhinitis, Allergic

Summary: allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%. it is among the most common chronic inflammatory diseases globally and is caused by ige-mediated reactions to inhaled allergens, often co-occurring with asthma and causing severe burdens and disabilities worldwide. allergic rhinitis can in fact seriously compromise the quality of life, significantly influencing school performance, social life and the quality of sleep. it is known that the most common symptoms characterizing allergic rhinitis (itching of the nose, sneezing, rhinorrhea and nasal/sinus obstruction) are partly overlapping with those due to a condition of deviation of the nasal septum and a recent study has shown how 87 % of patients with persistent allergic rhinitis are affected by at least 1 of the 7 types of nasal septum deformity. deviation of the nasal septum is a very frequent anatomical disorder and is present in up to 48% of children and adolescents in the general population. the deviation narrows the affected nostril canal, reducing the flow of air that passes through the nostrils, predisposing to chronic mucosal inflammation with inflammatory infiltrate and in turn increasing the risk of developing chronic rhinitis and sinusitis. there are no data in the literature that correlate nasal septum deviation with an increased risk of developing allergic rhinitis. given these premises, the arhinasd (allergic rhinitis in pediatric topics with nasal septum deviation) study was designed with the primary objective of evaluating the presence of allergic rhinitis in a sample of patients with and without deviation of the nasal septum.


Eligibility criteria:
inclusion criteria: * caucasian ethnicity * both sexes * age between 6 and 14 years * written informed consent. exclusion criteria: * non-caucasian ethnicity * age \ 14 years concomitant presence of: * chronic diseases * malignancies * immunodeficiency * chronic infections * autoimmune diseases * chronic inflammatory intestinal diseases * celiac disease * genetic diseases * metabolic diseases * cystic fibrosis * chronic pulmonary diseases * malformations of the cardiovascular system * malformations of the respiratory system * malformations of the gastrointestinal system * neuropsychiatric disorders * neurological diseases * obesity * eosinophilic diseases * antibiotics use in the last 7 days * cortisone use in the last 7 days * antihistamines use in the last 7 days
great - good response with appropriate treatment

Conditions: Cancer Pain; Neoplasms

Summary: the symptoms associated in advanced cancer patients and adverse events due to use of opioids have major influence on the state of health and quality of life of patients. the pain, in particular, is a symptom with severe negative impact and with a prevalence ranging between 33% and 64%, according to the stage of the disease, with values around 70-90% in advanced stages and metastatic. the use of opioids, however, is usually associated with the appearance of common adverse events as drowsiness/sedation, constipation, nausea/vomiting, and dizziness. some effects are self-limiting in the time for the appearance of tolerance while others, as constipation persist. several clinical studies have demonstrated that the association oxycodone-naloxone (oxn), which consists in the union between a molecule agonist and an antagonist of opioid receptors, reduced the constipation in the presence of unchanged analgesic efficacy compared to oxycodone alone.


Eligibility criteria:
inclusion criteria: * patients with diagnostic (histological or cytological) evidence of locally advanced or metastatic solid tumour; * with average pain intensity \> 4, measured with nrs and related to the last 24 hours, due to the cancer, requiring oxn for the first time; * with life expectancy \> one month; * strong opioid naïve; * eligible to take any of the medications under evaluation; * with age ≥ 18 years. exclusion criteria: * with presence of other diseases, including psychiatric/mental illness, severe senile or other form of dementia, that can interfere with participation and compliance with the study protocol or can contraindicate the use of the investigational drugs; * diagnosis of primary brain tumor or leukaemia; * diagnosis of chronic renal failure; * patients with antalgic radiotherapy or radio-metabolic therapy in progress or completed less than 14 days before study; * patients starting a first line chemotherapy simultaneously to the beginning of the study; * other types of analgesic treatments, including local-regional anesthetic techniques or neurosurgical /ablative methods; * patients who cannot guarantee regular follow-up visits for logistic or geographic reasons.
development of charcot marie tooth disease (cmt) pediatric scale for children with cmt

Conditions: Charcot Marie Tooth Disease

Summary: the primary goal of this project is to develop and test a charcot marie tooth disease (cmt) pediatric scale for use in evaluation in natural history cmt study.

this project is to develop a new cmt pediatric scale (cmtpeds) for children with cmt. although there is a validated score (the cmtns) which measures disease severity for cmt, it is not always applicable to children due to their limited ability to relay information about their symptoms. the cmtpeds scale is being developed and validated in order to measure disease severity in children and have outcome measures available for future clinical trials. children (defined as 21 and under) being evaluated will be asked to perform functional tasks such as using stairs, walking in a hallway, and performing hand function tests. this information will be used to validate the cmtpeds score. it is important to have validated instruments to measure disease severity in childhood so these can be used with clinical treatment trials are available.

Eligibility criteria:
inclusion criteria: all patients must be seen in person at one of the participating centers for enrollment in this study. * children (\< 21 years of age) * known or probable inherited neuropathies classified as cmt1, cmt2, or cmt4 exclusion criteria: * known diagnoses of acquired neuropathy including toxic (e. g. medication related neuropathies); metabolic (e.g. diabetic), immune mediated or inflammatory \[acute inflammatory demyelinating polyradiculoneuropathy (aidp) or chronic inflammatory demyelinating polyneuropathy (cidp)\] polyneuropathies; neuropathy related to leukodystrophy, congenital muscular dystrophy; and patients with severe general medical conditions. * entirely normal conduction velocities of upper and lower limbs as this suggests that the subject may not have a neuropathy.
efficacy and safety of ghx02 in the treatment of acute bronchitis

Conditions: Acute Bronchitis

Summary: this study is a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of ghx02, compared with placebo, for acute bronchitis. one-hundred and fifty patients will be included in this trial and randomly assigned to either a high-dose ghx02 group(1920mg/day), standard-dose ghx02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio. patients will take one of the medications three times a day for 7 days, with 3 visiting days(screening, day0, day7). on the screening day, the korean standard tool of pattern identification of cough and sputum, a diagnostic system that determines therapy in traditional korean medicine, will be used to allocate patients into three groups of wind-heat, wind-cold or others.


Eligibility criteria:
inclusion criteria: 1. age 19-75 years 2. bss ≥ 5 points at visit2 due to acute bronchitis 3. symptoms starting within 2 weeks before study inclusion 4. patients who consent to participate exclusion criteria: 1. pregnant or breast-feeding 2. treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion 3. treatment with antitussives or expectorants during the last 7 days before study inclusion 4. history or presence of confounding respiratory disease that may affect evaluation of the efficacy of clinical medicine (e.g. chronic bronchitis, chronic obstructive pulmonary disease (copd), bronchiectasis, asthma, pneumonia, cystic fibrosis, lung cancer, or active pulmonary tuberculosis) 5. liver or renal impairment (alanine aminotransferase(alt), aspartate aminotransferase(ast), alkaline phosphatase(alp) ≥ 3 times the normal upper limit, or creatinine\> 3.0 mg/dl at screening) 6. history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery) 7. history of alcoholism or substance abuse 8. participation in other clinical drug(medicine) trials during the last 30 days before study inclusion 9. judged by the investigators to be inappropriate for the clinical trial.

Keywords: acute bronchitis, herbal medicine
bonding quality and gene expression in fullterm infants compared to late preterm infants and preterm infants with early skin to skin or visual contact

Conditions: Premature Infant

Summary: recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born \<32 weeks of gestational age) with early skin to skin contact after birth compared to infants with visual contact at six months corrected age. we hypothesize that these differences are still identifiable at the age of 6 to 8 years and that quality of bonding in preterm infants born \<32 weeks of gestation differs significantly from late preterm infants and full-term infants.

quality of bonding in former preterm infants born 2012 to 2015 who participated in the "delivery room skin to skin study" (deisy), moderate to late preterm infants born 2010 to 2011 who participated in the "trauma and depression in late preterm parents study" (tradelpp) and full-term infants at 6 to 8 years of age is assessed using the german version of the attachment story completion task (asct). additionally, gene expression of six key molecules involved in stress response and neurobehavioral development (the corticotropin releasing hormone receptor 1 and 2 genes (crhr1 and crhr2), arginine vasopressin gene (avp), the glucocorticoid receptor gene (nr3c1), the serotonin receptor 2a gene (htr2a), and the serotonin transporter gene (slc6a4)) are quantified in in mucosal epithelial cells from buccal swabs of children of all four groups. maternal and infant co-factors such as maternal depression, perceived social support, parental stress, infant health development and behavior are assessed by self-reporting questionnaires.

Eligibility criteria:
inclusion criteria: * first child, singleton, former participant of "deisy" or "tradelpp" study for preterm infants, uncomplicated vaginal birth for fullterm infants exclusion criteria: * maternal mental health problems, resuscitation after birth, malformations or severe underlying disease

Keywords: bonding gene expression stress response neurodevelopment
fixed bearing versus mobile bearing patient satisfaction and clinical outcome study

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine if there is a patient satisfaction preference of fixed bearing versus mobile bearing unicompartmental knee arthroplasty (uka) in patients who are at a minimum two years post operative. patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a fixed bearing or a mobile bearing uka in one or both knees.


Eligibility criteria:
inclusion criteria: 1. must be able to read, understand and provide written informed consent on the institutional review board (irb) approved informed consent form (icf) 2. ability to understand and provide written authorization for use and disclosure of personal health information. 3. subject who are able and willing to comply with the study protocol and follow-up visit. 4. must be 18 years or older to participate. 5. subjects must have a clinically documented osteoarthritis in a knee, single or multiple compartments, 6. subjects must have undergone a fb uka or mb uka in one and or both knees. mb uka or fb uka patients revised to total knee arthroplasty (tka) are eligible to enroll. 7. must be a minimum 2 year (24 months) post-surgery on the knee. 8. the uka operation must have been performed by the investigator. 9. subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with pro's, questionnaires, physical exam and imaging studies. exclusion criteria: 1. subjects with bicompartmental uka (i.e. medical or lateral uka combined with patello femoral joint (pfj) (uka) 2. women who are pregnant.

Keywords: unicompartment knee replacement
effects of table tennis for people with parkinson's disease

Conditions: Parkinson Disease

Summary: quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games).

quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games). interventions in both groups will take place twice a week for 6 weeks (12 sessions in total). the main variables to be assessed will be motor and cognitive. as secondary variables, clinical and daily life aspects will be assessed. as results, it is expected that the experimental group will obtain improvements in motor variables compared to the control group after receiving the interventions. however, improvements in cognitive variables and secondary variables are expected to be similar in both groups.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease based on the uk pd society brain bank criteria * stage i to iii on the hoehn and yahr scale * ability to walk for 10 minutes unassisted exclusion criteria: * score of under 23 on the mini-mental state examination * severe visual or auditory deficits * cardiovascular conditions that impede physical activity * brain surgery
microcirculatory perfusion in patients with coma after out-of-hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: the hypothesis is: in patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°c) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°c.

the purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (ohca). the microcirculation is measured in this study by sublingual side stream darkfield (sdf) imaging and near infrared spectroscopy (nirs) at admission and after 12 and 24 hours.

Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest * \> 18 years * informed consent * rosc (return of spontaneous circulation) \< 4 hours exclusion criteria: * recent maxillofacial surgery * participation in other clinical trials

Keywords: cardiac arrest therapeutic hypothermia microcirculation
incidence of hiv infection in screening indian men who have sex with men

Conditions: HIV Infection

Summary: this research trial studies the incidence of human immunodeficiency virus (hiv) infection in screening indian men who have sex with men (msm). gathering health information over time from indian msm may help doctors determine how many indian msm develop new cases of hiv infection.

primary objectives: i. to determine the one-year incidence of hiv among high-risk msm in india. secondary objectives: i. to test the feasibility and acceptability of recruiting a sample of 150 high-risk hiv-uninfected msm using respondent-driven sampling (rds) and following them every six months for one year. ii. to produce preliminary descriptive data on the prevalence and incidence of human papillomavirus (hpv) infection and hpv-associated disease and sexually transmitted infections (stis) other than hpv in hiv-seronegative msm in india. iii. to produce preliminary descriptive data on sexual risk behaviors with men and women, as well as data on other potential confounders. outline: participants receive a questionnaire, undergo a targeted physical and anal clinical exam, undergo blood collection and urethral swab for stis, and a penile skin cell and anal swab for cytology and hpv deoxyribonucleic acid (dna) at months 0, 6, and 12. participants also undergo high-resolution anoscopy (hra) and penile clinical exam at month 12.

Eligibility criteria:
inclusion criteria: * hiv seronegative, as documented by any licensed hiv test according to national acquired immunodeficiency syndrome (aids) control organization (naco) guidelines * participants report any sex with a man in the past 6 months * participants must speak hindi, marathi, or english * participant should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months exclusion criteria: * active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements * participants with impairments that, in the opinion of the site investigator, are temporary, will be asked to return another day for enrollment * inability to provide informed consent * history of a sex change operation that would preclude collection of penile or scrotal specimens
prehospital triage of patients with suspected non-st-segment elevation acute coronary syndrome: the triage-acs study

Conditions: ACS; NSTEMI - Non-ST Segment Elevation MI; Unstable Angina

Summary: with the emergency medical services (ems), no prehospital risk stratification and triage is performed for patients suspected of having an non-st-segment elevation acute coronary syndrome (nste-acs). while the latest esc guidelines recommend an early invasive strategy within 24 hours for all high risk nste-acs patients and same-day transfer to a pci (percutaneous coronary intervention) center. with the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an nste-acs. the recently validated preheart score makes it possible to stratify patients in a low-risk and high-risk group for having a nste-acs and gives the ems the opportunity to make triage decisions in the prehospital setting. patients with a high risk for having an nste-acs are transferred directly to an pci-center for further diagnostic work-up. patients with a low risk for having nste-acs and transferred to the ed of the nearest hospital without pci facilities (non-pci center) for further diagnostic work-up, resulting in an optimization of the regional care utilization. this is the first study to focus on patients who are at a high risk of having an nste-acs and to assess if whether prehospital triage using the preheart score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.


Eligibility criteria:
inclusion criteria: * chest pain suspected for nste-acs * age ≥ 18 years * intention to transfer patient to emergency department exclusion criteria: * st-segment elevation acute coronary syndrome * post resuscitation patients * hemodynamic instability defined as killip class iv * suspected other life treating pathology * pregnancy * no informed consent for data usage

Keywords: prehospital risk stratification triage emergency medical services
study of muscle effects of bym338 in mechanically ventilated patients

Conditions: Mechanical Ventilation

Summary: the purpose of this study is to evaluate the effect of bym338 on muscle mass and function in group iii failure to wean patients, as compared to placebo controls.


Eligibility criteria:
inclusion criteria: * adults on mechanical ventilation for at least 7 days with a tracheostomy in place for \>24 hours. * expected to survive at least 14 days. * receiving adequate nutritional support, defined as at least 20 kcal/kg and 0.6 g/kg protein per day (unless lower protein intake required by clinical status). exclusion criteria: * patients deemed to be terminal wean patients. * patients who have progressive neuromuscular degenerative disorders. * patients who are comatose. * evidence of unstable medical status.

Keywords: muscle, anabolism, cachexia, respiratory failure, diaphragm