Kornimate/medical-research-clean huggingface dataset:
specific methylation profiles in hnscc

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: in the study, n-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas. with this study the investigators aim to validate these findings in a larger cohort.


Eligibility criteria:
cancer group: inclusion criteria: * written informed consent * verified head and neck squamous cell carcinoma exclusion criteria: * other active cancer * uncontrolled comorbidity * unable to give informed consent control group: inclusion criteria: * written informed consent * normal ent-examination exclusion criteria: * other active cancer * uncontrolled comorbidity * unable to give informed consent

Keywords: head and neck cancer squamous cell carcinoma methylation dna
expanded hiv care in opioid substitution treatment (ehost) trial

Conditions: Opioid Use Disorder; HIV

Summary: opioid substitution treatment (ost) provides a critical opportunity for hiv testing and linkage to antiretroviral treatment. the ehost study will evaluate a prescriber-focused intervention to increase hiv testing rates, and optimize antiretroviral treatment, re-engagement and retention outcomes among individuals engaged in ost. 46 ost sites in british columbia will be randomly allocated into three clusters. clusters will initiative the intervention at different time points, or steps, with every cluster receiving the intervention.

the public health response to the hiv/aids epidemic has turned its focus on means of optimizing health care delivery, and re-engineering delivery systems to maximize case identification, as well as access and sustained engagement in antiretroviral treatment. opioid substitution treatment (ost) provides a critical opportunity for hiv testing and linkage to antiretroviral treatment. the ehost study is a cluster-randomized, stepped-wedge trial to evaluate a prescriber-focused intervention to increase hiv testing rates, and optimize antiretroviral treatment re-engagement and retention outcomes among individuals engaged in ost. the study will encompass all drug treatment clinics currently admitting patients for the treatment of opioid dependence across the province of british columbia, which are thought to treat 90% of the ost caseload. the trial will be executed over a 24-month period, with groups of clinics receiving the intervention in 6-month intervals. evaluation of the effectiveness of the proposed intervention will be conducted entirely through existing data collection mechanisms, and focuses on three primary outcomes: (i) the hiv testing rate among those not known to be hiv positive; (ii) the rate of highly active antiretroviral (haart) initiation among those not on haart; and (iii) the rate of haart continuation among those on haart. despite the randomized delivery of the intervention, a difference-in-differences analytical framework will be applied to adjust for potential residual heterogeneity in patient case mix, volume, and quality of care across ost clinics. facilitated by established collaborations between key stakeholders across the province, we hypothesize that the ehost intervention will optimize hiv testing and care within this marginalized and hard-to-reach population.

Eligibility criteria:
inclusion criteria: * drug treatment clinic currently admitting patients for the treatment of opioid dependence across the province of british columbia exclusion criteria: * private office-based setting

Keywords: cost-effectiveness opioid substitution treatment integrated care hiv haart testing linkage to care treatment adherence
a study of detergents in the pathogenesis of eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this research is to determine if detergents in everyday products such as toothpaste make the lining of the esophagus leaky and cause allergic inflammation.


Eligibility criteria:
inclusion criteria: * normal, healthy volunteers. * able to swallow pills. exclusion criteria: * personal history of esophageal disease including but not limited to eosinophilic esophagitis, esophageal dysmotility, or gerd/reflux. * history of dysphagia (i.e., difficulty swallowing), chronic vomiting, chronic abdominal pain, unintentional weight loss. * celiac disease, inflammatory bowel disease, irritable bowel syndrome, esophageal varices, chronic aspiration, connective tissue disorder, or known parasitic infection. * gelatin allergy. * use of a toothpaste containing sls within 2 weeks of the study. * pregnancy.
patient perceptions of the relational empathy of healthcare practitioners from the department of emergency medicine during the covid-19 pandemic

Conditions: COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study investigates patients' perceptions of their doctor's or nurse's empathy during an in-person interaction with the doctor or nurse wearing personal protective equipment (ppe) compared to during a video interaction with the doctor or nurse without ppe. the goal of this research study is to learn whether patients who visit the acute cancer care center at md anderson believe they get better (more empathetic) care from doctors who visit them in person wearing ppe or from doctors who visit them by video call and do not wear ppe.

primary objective: i. to determine whether patients perceive their healthcare practitioner as more empathetic during an in-person interaction with the practitioner wearing personal protective equipment (ppe), or during a video interaction without the need for ppe. secondary objectives: i. to assess whether certain physicians perform better with video whereas others perform better in person. ii. to characterize generational differences in patient perception of healthcare practitioner empathy during an in person interaction with the practitioner wearing ppe, or during a video interaction without the need for ppe. outline: after initial visit, patients are randomized to 1 of 2 groups. group a (no ppe): patients receive standard of care via video call with treating physician. group b (wearing ppe): patients receive standard of care in-person physician visits.

Eligibility criteria:
inclusion criteria: * \>= 18 years old * able to speak and write in english * able to understand and willing to sign a written informed consent document * willing and able to complete the study assessment(s) exclusion criteria: * refuses to participate * too ill to participate, in the estimation of the patient's physician
a study of ly3532226 in participants with obesity

Conditions: Obesity

Summary: the main purpose of this study is to evaluate the safety and tolerability of the study drug known as ly3532226 in participants with obesity. blood tests will be performed to check how much ly3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. part a of the study will last approximately 16 weeks, excluding screening period. part b of the study will last approximately 20 weeks, excluding the screening period.


Eligibility criteria:
inclusion criteria: * have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (bmi) within the range of 30 to 40 kilogram per square meter (kg/m²) * have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment exclusion criteria: * have a lifetime history of a suicide attempt * have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years * have a baseline patient health questionnaire-9 (phq-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the phq-9 questionnaire * have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery * have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier * intend to use any weight-loss medications during study participation * have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
effect of high altitude exposure, acclimatization and re-exposure on right ventricular function in lowlanders

Conditions: Effect of High Altitude

Summary: prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude

low altitude baseline measurements will be performed in santiago de chile, 520 m, over the course of 3 days. participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the alma base camp located at 2900 m near san pedro de atacama, northern chile. participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. daily transports from 2900 to 5050 m will be by car (1 h ride, one way). after the first 7 day altitude sojourn participants will return to the santiago area (520 m) for a 7 day recovery period. a second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow. measurements on study subjects will be performed at baseline (lowland, santiago de chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. measurements will be conducted by qualified specialists using a portable ultrasound device.

Eligibility criteria:
inclusion criteria: * born, raised and currently living \<800m * no overnight stay at altitudes \>1500 m 4 weeks before the study exclusion criteria: * previous altitude intolerance to altitude \<3000 m * pregnancy * health impairment, which requires regular treatment
motivation to change, coping, and self-esteem in adolescent anorexia nervosa

Conditions: Personality Features in Anorexia Nervosa

Summary: by use of several questionaires, this study aimed at an investigation of the changes in motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia nervosa.. the psychometric properties of the anorexia nervosa stages of change questionnaire (ansocq) and its relation to coping style and self-esteem were assessed. after a treatment period of nine months, clinical an diagnosis and the body mass index (bmi) were re-assessed. besides construct validity of the ansocq, its predictive validity in terms of predicting the outcome of an was assessed.

n=92 adolescents referred to an eating disorders clinic meeting criteria for anorexia nervosa (an) gave written informed consent to participate in this study and completed the ansocq, the eating disorder inventory (edi-2), the eating attitudes test (eat), the body image questionnaire (biq), two questionnaires measuring self-related cognitions (src) and the coping across situations questionnaire (casq). after a treatment period of nine months, clinical an diagnosis and the body mass index (bmi) were re-assessed. exploratory factor analysis and logistic regressions were performed.

Eligibility criteria:
inclusion criteria: * consecutive cohort of patients aged 12-19 years with a certified diagnosis of anorexia nervosa exclusion criteria: * none

Keywords: eating disorders ansocq anorexia nervosa
study to evaluate the efficacy and safety of filgotinib in the treatment of small bowel crohn's disease (sbcd)

Conditions: Small Bowel Crohn's Disease

Summary: the primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as crohn's disease activity index (cdai) \< 150, at week 24 in participants with small bowel crohn's disease (cd). participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.


Eligibility criteria:
key inclusion criteria: * males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit * moderately or severely active cd * minimum duration of cd of at least 6 months * presence of diseased small bowel (sb) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum * patients with additional colonic involvement of cd are permitted in study as long as sbcd is present * previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): * corticosteroids * immunomodulators * tumor necrosis factor-alpha (tnfα) antagonists * vedolizumab * ustekinumab * willing and able to undergo magnetic resonance enterography (mre) per protocol requirements key exclusion criteria: * presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis. * presence of fistulae * evidence of short bowel syndrome * presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon * history of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study * use of any prohibited concomitant medications as described in the study protocol * active tuberculosis (tb) or history of latent tb that has not been treated note: other protocol defined inclusion/exclusion criteria may apply.
lidocaine on early cognitive dysfunction in shoulder arthroscopy

Conditions: Cognitive Dysfunction, Postoperative

Summary: the beach chair position (bcp) combined with deliberate hypotension impair cerebral perfusion pressure and oxygenation during arthroscopic shoulder surgeries and produce cerebral ischemia.

arthroscopic diagnosis and treatment of shoulder disorders have replaced open procedure as the primary treatment method. the beach chair (bcp) and lateral decubitus (ldp) positions are both considered as reliable techniques for performing effective arthroscopic shoulder surgeries. the usage of bcp for shoulder arthroscopic operations started from early 1980s. the advantages of bcp include lack of brachial plexus strain, good intra-articular visualization, with the ease of conversion to an open approach if required. the bcp combined with deliberate hypotension has been used to decrease intraoperative blood loss and allow a relatively blood-free surgical field. however, this combination has the risk to impair cerebral perfusion pressure and oxygenation during surgery and produce cerebral ischemia. lidocaine, a commonly used local anesthetic and class ib antiarrhythmic drug, that readily crosses the blood - brain barrier. evans et al. initially reported cerebral protection of lidocaine in a feline model of cerebral arterial gas embolism. later on, the effects of lidocaine on perioperative neuroprotection were detected. however, the mechanisms underlying lidocaine treatment-induced neuroprotection remain incompletely understood. lidocaine may provide cerebral protection through many mechanisms, including decreasing the cerebral metabolic rate, decelerating the ischemic transmembrane ion shift, and reducing the ischemic excitotoxin release.

Eligibility criteria:
inclusion criteria: * patients undergoing elective arthroscopic shoulder surgery under general anesthesia in beach chair position (bcp), * age 20 to 65 years old. exclusion criteria: * mini-mental state examination (mmse) score \< 23 before surgery * history of neurological disease (such as previous episodes of cerebral ischemia or stroke). * history of psychological disorder * suspected history of adverse reactions to lidocaine * drug or alcohol abuse * history of diabetes mellitus, sever hypertension, severe anemia, hepatic or renal dysfunction * unwillingness to comply with protocol.
appetite-related brain activity in women with anorexia nervosa

Conditions: Eating Disorders; Anorexia Nervosa

Summary: this study will use functional magnetic resonance imaging to compare appetite-related brain activity in women with anorexia nervosa before and after receiving treatment for the disorder.

anorexia nervosa (an) is a serious eating disorder that is characterized by an extreme loss of appetite. people with an view themselves as overweight and cannot bring themselves to eat, even though most are dangerously thin. functional magnetic resonance imaging (fmri) is a technique that can be used to determine which parts of the brain are activated by physical stimuli. when a certain stimulus is introduced, blood flow to the corresponding area of the brain increases. this increase in blood flow is depicted on the fmri scan. a person with an may have different responses to food when evaluated prior to treatment versus after treatment. this study will use fmri to compare appetite-related brain activity in women with an before and after receiving treatment for the disorder. participants in this study will undergo two fmri scans. participants with an will have one scan before entering the "weight gain phase" of treatment for an and another scan upon completion of treatment. healthy volunteers will undergo scans during a similar time frame. participants will not be allowed to eat from midnight on the night before the scan until after the fmri procedure, but they may drink water. during the scan, participants will be shown various objects and real foods; they will also be asked to touch the objects and food with their eyes closed. each visit will last approximately 45 minutes. ear protectors will be provided to reduce scanner noise.

Eligibility criteria:
inclusion criteria: for participants with an: * dsm-iv diagnosis of an (restricting or binge eating/purging subtype) * medically stable (not continuing to lose weight and vital signs stable) for healthy participants: * currently weighs 80-120% of ideal weight * no history of binge eating disorder or vomiting * no current or past psychiatric illness exclusion criteria: for participants with an: * currently taking medication * current substance abuse or dependence disorder * history of suicide attempt or other self-injurious behavior within 6 months prior to study entry * non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos) for healthy participants: * current or past psychiatric illness * history of binge eating or vomiting * any significant medical or neurologic illness * currently taking medication * history of drug or alcohol abuse within 3 months prior to study entry * non-removable metal on or inside the body (e.g., metal pacemaker, surgical clips, metallic-ink tattoos)

Keywords: eating disorders anorexia nervosa
efficacy and safety trial of pangramin slit hdm-mix in subjects with house dust mite induced rhinitis

Conditions: Allergic Rhinitis

Summary: primary aim is to evaluate the efficacy of specific immunotherapy with pangramin slit hdm-mix compared to placebo in the treatment of house dust mite (hdm) induced rhinitis with or without asthma. sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment. this study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy. this study aim also to contribute to the documentation of tolerability and safety profile of pangramin hdm mix.

extensive clinical experience has been gained due to the widespread use of pangramin® slit and other slit products as named patient products, both with respect to the types and the frequencies of the adverse events(aes) observed. no safety concerns have been found. the optimal therapeutic dose range regarding slit is not fully elucidated. the fate of the allergen after sublingual administration is not known in detail, i.e. to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume, excipients etc. the relationship between dose and effect is thus not fully elucidated. the general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events. as pangramin slit hdm-mix has a safety profile that allows a single daily intake by the patient at home, the dosage at this trial will be the same as marketed product.

Eligibility criteria:
inclusion criteria: * male or female ≥ 5 to ≤ 55 years of age. * a history hdm induced allergic rhinitis. * use of medication for the control of rhinoconjunctivitis symptoms. * positive skin prick test (spt). * positive specific ige. exclusion criteria: * pef ≤ 70% of predicted value. * history of significant symptomatic seasonal or perennial allergic rhinitis and/or asthma caused by an allergen to which the patient is regularly exposed, and sensitized (e.g. pollens, cat, dog, cockroach...except house dust mites). * severe asthma. * current symptoms of upper respiratory tract infection or other relevant infectious process. * current food allergies with oral allergy syndrome. * a clinical history of chronic sinusitis. * current severe atopic dermatitis. * concomitant or previous treatment by immunotherapy.

Keywords: house dust mite induced allergic rhinitis.
ql1706 in combination with neoadjuvant chemotherapy versus neoadjuvant chemotherapy for locally advanced, resectable esophageal squamous cell carcinoma

Conditions: Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Summary: this is a randomized, double-blind, placebo-controlled phase ii/iii clinical trial to evaluate the perioperative treatment with ql1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. the primary objective of the phase ii is to evaluate the pathological complete response rate of ql1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the phase iii is to compare event-free survival of ql1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance score of 0 to 1. * patients with thoracic esophageal squamous cell carcinoma diagnosed by pathologic histology or cytology and ct1-2n1-3m0 or ct3-4an0-3m0 according to ajcc/uicc 8th edition. * expected to undergo surgery after completion of neoadjuvant therapy and expected to achieve r0 resection. * have not receiv any anti-tumor therapy for esophageal cancer. * have adequate organ function. exclusion criteria: * significant tumor invasion into organs adjacent to the esophageal lesion; * a history of gastrointestinal bleeding or those with a high bleeding tendency; * the presence of supraclavicular lymph node metastases; * the presence of uncontrollable third interstitial fluid; * poor nutritional status.