Kornimate/medical-research-clean huggingface dataset:
effect of music therapy on the anxiety level of patients during the administration of ocular intravitreal injections

Conditions: Anxiety and Fear

Summary: introduction ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels. objective this study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety. methods this is a randomized, prospective, single blind, clinical trial. patients will be divided into two groups. group a patients will listen to classical music during the procedure (intervention). group b patients (control), will not listen to music during the procedure. all other aspects of the procedure will be the same for both groups. to analyze the impact music therapy, patients will fill in the stai anxiety questionnaire and will be evaluated with the pain visual analogue scale (vas) before and after the injection procedure. expected results subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. less pain perception is also expected.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years old. * patients must have been prescribed an intravitreal injections of an anti-vegf drug. * subjects must have undergone at least one previous intravitreal injection. * patients must fully understand the procedure and the project they will be participating in and agree on signing the informed consent. exclusion criteria: * patients with a psychiatric diagnosis with the need to take anxiety medication. * patients that before the intervention took medication to relax, such as benzodiazepines or anxiolytics. * subjects with hearing difficulty.

Keywords: music therapy anxiety intravitreal injection pain quality of life
predicting eons in pprom patients

Conditions: PPROM; Early-Onset Neonatal Sepsis

Summary: an eons occurred in nearly 14-22 % of the preterm infant of pregnant women with pprom. to this day no risk prediction is established. the main aim of this pilot study is generating primary data with a focus on the vaginal microbiome to set-up a prospective, multi-centre trial investigating the role of the vaginal microbiome for future eons risk prediction. the planned peons pilot trial is subdivided in three work packages: 1. recruitment, sample collection and routine clinical diagnostics 2. microbiome analysis by 16s rrna 3. microbiome/ metagenome analysis by "nanopore" (proof-of-principle) and will enroll women with a pprom event hospitalized between 22+0 and 34+0 weeks of gestation and neonates with signs of eons (subgroup 1) and without signs of eons (subgroup 2).


Eligibility criteria:
inclusion criteria: * full age pregnant woman with pprom and their born preterm infants * hospitalization between 22+0 and 34+0 weeks of gestation * multipara possible exclusion criteria: * hospitalization with pprom before limit of viability are reached * intrauterine fetal death * no study agreement * not able to consent
evaluation of the dexmedetomidine transdermal systems for postoperative analgesia following abdominoplasty

Conditions: Pain, Postoperative

Summary: the primary objective of this study is to evaluate the analgesic efficacy of dmts, compared with placebo, in subjects following abdominoplasty.

this is a randomized, double-blind, placebo-controlled, one-time application study of dmts or matching placebo over a 4-day treatment period (day 1 time 0 occurs when the dmts or matching placebo systems have been applied). subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. eligible subjects will be randomized equally to treatment with dmts or matching placebo. an independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.

Eligibility criteria:
inclusion criteria: * male or female, ≥ 18 years of age. * scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction). * have a physical status classification of 1 or 2 per the american society of anesthesiology. * have a body weight \> 58 kg, and body mass index of 20 to 38 kg/m2, inclusive. exclusion criteria: * known sensitivity to dexmedetomidine or any excipient in the dmts/placebo or to any peri- or postoperative medication whose use is required in this study. * skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the dmts/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery. * history of deep vein thrombosis or factor v leiden deficiency. * history of syncope or other syncopal attacks. * present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator. * evidence of a clinically significant 12-lead ecg abnormality.

Keywords: abdominoplasty pain transdermal dmts
maternal variables associated with adherence in children with asthma

Conditions: Asthma

Summary: a questionnaire will be used in order to find out the reasons for poor adherence for long-term treatment in children with asthma. the hypotheses is maternal factors including the knowledge that asthma is a chronic disease and fear to administer inhaled steroids are major obstacles for appropriate adherence.

parents to children aged 2 - 12 years with moderate to severe asthma who need long-term treatment with inhaled steroids will be included in the study. three weeks after their visit in the clinic, they will be requested to answer a questionnaire by telephone.

Eligibility criteria:
inclusion criteria: * parents to children aged 2 - 12 years with moderate to severe asthma to whom inhaled steroids was described for a period of at least 4 weeks. exclusion criteria: * parents who will not agree to sign the consent form and parents who do not speak and understand the hebrew language.

Keywords: asthma children adherence maternal factors
detection of helicobacter pylori infection by high resolution endoscopy

Conditions: Helicobacter-associated Gastritis

Summary: although endoscopic findings of h. pylori have been reported in the literature, there is still some debate over whether h. pylori-related gastritis can be diagnosed via endoscopic features alone. most studies concluded that it is not possible to diagnose h. pylori-related gastritis on the basis of endoscopic findings. however, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.

our study aimed to achieve the following: (1) describe the h. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for h. pylori detection; (3) find the optimal biopsy site for rapid urease test (rut); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.

Eligibility criteria:
inclusion criteria: * patients who underwent upper endoscopy exclusion criteria: * age \ 70 * severe systemic disease or advanced chronic liver disease * medication history of nsaid, ppi, h2 blockers or antibiotics * history of h. pylori eradication therapy * history of gastric surgery * recent history of upper gi bleeding * gastric or duodenal ulcer (including old scar change) during endoscopy * anemia (hemoglobin level \< 10mg/dl) * pangastritis
field-test and psychometric validation of the pectus excavatum evaluation questionnaire in the dutch pectus excavatum population

Conditions: Pectus Excavatum

Summary: a questionnaire that can measure disease severity from the patients perspective in patients with pectus excavatum already exists in english (pectus excavatum evaluation questionnaire; peeq). this questionnaire was recently translated into dutch. before this dutch version can be used, it needs to be tested by a number of patients. data will be collected at three moments: 1. preoperatively: the peeq will be completed on paper during the outpatient clinic visit. 2. postoperatively: the peeq will be completed electronically 2 months post-surgery. 3. test-retest reliability: the peeq will be administered electronically at least two weeks after a previous assessment.


Eligibility criteria:
inclusion criteria: * eligible participants will be pectus excavatum patients aged 12 to 18 years old who are scheduled for a nuss procedure. parents or legal guardians will also be invited to complete the parent section of the peeq. exclusion criteria: * exclusion criteria will be the inability of the patient or their parent/guardian to complete the corresponding section of the questionnaire due to language barriers.
gemox: oxaliplatin in pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: primary objective: * to evaluate overall response rate (based on recist criterion) secondary objective: * to evaluate time to progression, clinical benefit, quality of life and safety


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the pancreas * metastatic or locally advanced, non resectable disease(non resectable disease will be determined by the investigators with clinical data) * uni-dimensionally measurable disease as defined by recist (primary or secondary tumors\>2cm using conventional ct scan or ≥1cm with spiral ct scan) * no previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted * karnofsky performance status (kps) ≥60 * no known central nervous system metastases * no sensory neuropathy at inclusion * biological and hematological evaluation \< 2 weeks prior to treatment administration: * neutrophils ≥ 1500/ mm3 * platelets ≥ 100,000/mm3 * alkaline phosphatases\< 5x uln(upper limits of normal) and bilirubin \< 1.5x uln * sgot,sgpt \<2.5 x uln if no liver metastasis * sgot,sgpt \<5 x uln if liver metastasis * creatinine \< 1.5 x uln * baseline imaging (ct scan or magnetic resonance imaging) \<3 weeks before treatment administration * men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children exclusion criteria: * corticotherapy except for anti-emetic purpose * pregnant or breast feeding women (documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs) * uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia * uncontrolled or persistent hypercalcemia * history of significant neurologic or psychiatric disorders * vater ampulomas and biliary tract adenocarcinomas * other -non cured- malignancies the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
yoga for treating shortness of breath in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Pulmonary Emphysema; Chronic Bronchitis

Summary: the purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (copd). patients in this study must have moderate to severe copd and be primarily limited by shortness of breath.

management of dyspnea (shortness of breath) is a major concern for patients with copd. the efficacy of complementary exercises to manage dyspnea is unknown. complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. yoga practice is a complementary therapy that people use to manage their dyspnea. the aims of this study are to: 1) develop a safe and feasible yoga program for patients with copd; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice. patients in this study will be randomized to receive yoga training or usual care for 12 weeks. patients will be evaluated at study entry, after each session, and immediately after the training program.

Eligibility criteria:
inclusion criteria: * able to commit to a 12-week yoga class in san francisco, california * moderate to severe copd, clinically stable for at least 1 month prior to study entry * forced expiratory volume at one minute (fev1) \< 49% predicted after inhaled bronchodilator * activities of daily living limited by shortness of breath * ability to speak english and sign consent * patients receiving supplemental oxygen will be acceptable if their o2 saturation can be maintained at \> 85% on \< 6 l/min of nasal oxygen exclusion criteria: * symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness) * formal pulmonary rehabilitation training within 1 year prior to study entry
comparison of high flex and standard rotating platform total knee arthroplasty (tka)

Conditions: Knee Osteoarthritis

Summary: the goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform tka.


Eligibility criteria:
inclusion criteria: * age 40 to 75 years old * primary diagnosis of osteoarthritis of the knee * patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform tka. * patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments. exclusion criteria: * pregnant or lactating female subjects * patients with post-traumatic or inflammatory arthritis * patients with a fixed flexion contracture of greater than 20 degrees * patients with advanced hip, spine, or ankle disease * patients with a bmi greater than 40, where knee flexion may be limited by soft tissues

Keywords: total knee replacement high flexion range of motion rotating platform tka
the study of infliximab (cmab008 and remicade) in healthy subjects to compare the pk and safety

Conditions: Rheumatoid Arthritis

Summary: a phase 1, randomized, double-blind, parallel group, sing-dose study to compare the pharmacokinetics and safety of cmab008 and remicade in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy subject (male) between the ages of 18 and 45 years. * subject with a body weight of ≥50 kg and ≤ 80 kg and a bmi between 19.0\~26.0 kg/m2 (both inclusive); * healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram; exclusion criteria: * those who have surgered 4 weeks before signing the informed consent; * those with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor, blood, endocrine, nervous and other system diseases, or those with any previous immune diseases; * those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, traditional chinese medicine, vitamins, dietary supplements, etc.) and health care products within 4 weeks before signing the informed consent; * those who accepted biological drugs within 6 months before signing the informed consent, or accepted the tnf monoconal antibody drugs; * any one of hiv antibody, hbsag, hbeag, hbcag, hcv antibody and treponema pallidum antibody is positive; * either t cell immunospot test (t-spot) or antinuclear antibody is positive; * those who have infected within 30 days before administration, or serious infection associated with hospitalisation and/or which required inrravenous antibiotics within 3 months before administration. * vaccinated within 30 months before signing the informed conset, or plan to vaccinate during the trail; * those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior to the trail; those who have positive drug abuse test results; * those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 250ml per cup) every day; * those who have a blood donation history of 400 ml within 3 months, or 200 ml within 1 month; * those who have a history of drug or food allergy, or are known to be allergic to any component of the test drug or latex, etc. * those who are addicted to smoking or smoke more than 10 cigarettes per day on average within 6 months before signing the informed consent; * alcoholics or regular drinkers within 3 months before the trail, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive; * those who plan to donate sperm within 6 months after the adminstration of the test drug;
high-dose lymph node intensity modulated radiation therapy and hypofractionated prostate (sib)

Conditions: Prostate Cancer

Summary: the purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. these newer technologies are intensity modulated radiation therapy (imrt) and image guided radiation therapy (igrt).

in this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 gy (gy/gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 gy). the study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate. it is hoped that these newer technologies will: 1. allow a higher daily dose of radiation to the tumor and pelvic nodes 2. avoid nearby normal tissue and organs like the rectum and bladder 3. prevent the cancer from spreading or coming back

Eligibility criteria:
inclusion criteria: * histologically confirmed, adenocarcinoma of the prostate * t1-2n0m0 with risk of pelvic lymph nodes involvement \>25% by roach formula \[(2/3xpsa) + (gleason score - 6)x10\], or any t3-4n0m0 * karnofsky performance scale \> 70. * prostate tumor biopsy grading by gleason score classification is mandatory prior to registration. * no prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable. * patients must sign a study-specific consent form prior to registration. * no evidence of distant metastases (bone scanning) exclusion criteria: * clinical or pathological evidence of distant metastases (m1). * radical surgery for carcinoma of the prostate * history of prior chemotherapy * history of prior pelvic radiation therapy * children (age \< 18).
efficacy and safety of adjunctive pimavanserin for the treatment of schizophrenia (enhance-1)

Conditions: Schizophrenia

Summary: to evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia


Eligibility criteria:
inclusion criteria: 1. adults patients, between 18 and 55 years of age 2. a clinical diagnosis of schizophrenia with a minimum duration of 1 year 3. the main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below: * aripiprazole * aripiprazole long-acting injectables: * abilify maintena® * aristada® * risperidone * risperidone long-acting injection * olanzapine * lurasidone * cariprazine * brexpiprazole * asenapine 4. has had a partial but inadequate response to antipsychotic treatment 5. has a history of response to antipsychotic treatment other than clozapine exclusion criteria: 1. patient has a psychiatric disorder other than schizophrenia 2. patient has a history of resistance to antipsychotic treatment 3. a urine drug screen (uds) result at baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana a. patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation 4. patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program 5. patient has had a myocardial infarction in the last six months 6. patient is taking a medication or drug that prolongs the qt interval or has a family or personal history or symptoms of long qt syndrome patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).