Kornimate/medical-research-clean huggingface dataset:
postlicensure observational safety study of 13vpnc administered to infants and toddlers

Conditions: Pneumococcal Disease

Summary: the purpose of the study is to expand the understanding of the safety profile of 13vpnc in routine use following licensure and introduction of the vaccine.


Eligibility criteria:
inclusion criteria: * infants starting vaccination with 13vpnc in the first 6 months of life who are members of the northern california kaiser permanente healthcase system and who receive at least 1 dose of 13vpnc during the study observation period will be included. infants must not have had 7vpnc at the time of 13vpnc dose administration. exclusion criteria: * infants and children who were previously vaccinated with any number of doses of 7vpnc will be excluded.

Keywords: pneumococcal conjugate vaccine
the oh happy day class - digital connections (ohdc-dc): a pilot study

Conditions: Depression; Depressive Disorder; Depressive Symptoms

Summary: the goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to african americans who are depressed. the main question it aims to answer is if this treatment is effective in reducing symptoms of depression. participants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. participants can expect to be in the study for four months.

the oh happy day class-digital connections (ohdc-dc) is designed for african american adults experiencing clinical depression (cd). ohdc originally comprised of 13 treatment modules focused on culturally relevant strategies to increase knowledge of depression and healthy coping behaviors aimed at reducing symptoms of clinical depression and improving health outcomes. the oh happy day class-digital connections (ohdc-dc) comprise of 5 core elements of the ohdc-dc: 1. 90-minute-weekly cognitive behavioral psycho-education classes over a 6-week period. 2. six classes will be offered and facilitated online in the computerized ohdc-dc. 3. participants will be encouraged to stay engaged between classes by digitally connecting on the app with the class content. on the app they will receive reminders and messages from staff and participants to stay digitally connected and engaged. 4. embedded in the classes and content is psychoeducation with an emphasis on educating participants about depression, raising awareness of mental illness with the goal of normalizing it and reducing stigma, and increasing healthy coping behaviors, and. 5. the intervention will be delivered by a licensed mental health clinician.

Eligibility criteria:
inclusion criteria: * african-american * age 18 and older * experiencing depression (as evidenced by a score of 5 or higher on the phq-9) * own a mobile phone exclusion criteria: * individuals who are currently receiving psychotherapy * individuals who are presently experiencing suicidal ideation * individuals who started psychotropic medication less than three months prior to the start of the ohdc will be excluded from the study * participants scoring 25 or higher on the phq-9 will be screened out

Keywords: african american
v/q spect for diagnosis of pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the objective of the study was to assess diagnostic performance of v/q spect for the diagnosis of pulmonary embolism by comparing v/q spect results to a validated diagnostic strategy.


Eligibility criteria:
inclusion criteria: * pulmonary embolism suspicion
immunogenicity and safety study of fluarix™ vaccine in children who have previously been vaccinated with pandemrix™

Conditions: Influenza

Summary: this study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with gsk biologicals' fluarix vaccine in children who have previously been vaccinated with two doses of pandemrix at the age of 6 months-9 years.


Eligibility criteria:
inclusion criteria: * subjects having previously been immunized with two 0.25 ml doses of pandemrix, given at least 21 days apart, at the age of 6 months to 9 years inclusive at the time of first vaccination. * subjects having received the last dose of pandemrix at least six months prior to study enrolment. * subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/lar(s) of the subjects. * healthy subjects as established by medical history and clinical examination before entering into the study. * parent/lar with access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user device. exclusion criteria: * active participation in other clinical trials. * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * acute disease and/or fever at the time of enrolment. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study. * any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * history of seizures or progressive neurological disease. * subjects having received an h1n1v pandemic vaccine other than pandemrix or having received the 2010/2011 seasonal influenza vaccine. * child in care.

Keywords: influenza h1n1 fluarix pandemrix
dietary nitrates and vascular function in patients with peripheral artery disease

Conditions: Peripheral Artery Disease

Summary: the overarching question addressed in the current project is: does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (pad)? the investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. the proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.


Eligibility criteria:
inclusion criteria: * documented peripheral artery disease * ankle-brachial index (abi) \< or = to 0.90 exclusion criteria: * non-atherosclerotic vascular disease * critical limb ischemia * active ischemic ulceration * recent (within one year) revascularization * symptomatic coronary artery disease (angina pectoris) * heart failure * resting systolic blood pressure \> 180 mmhg or diastolic pressure \> 100 mmhg * hypotension (resting systolic bp \< 90 mmhg) * smoking or history of smoking within past one year * use of phosphodiesterase v inhibitor drugs * women with history of hormone replacement therapy within the past 6 months

Keywords: nitrates blood flow vascular function exercise
abnormal regulation, estimation and cognitive impacts of physical efforts as an endophenotype of anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing "too much") compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility. such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.

this is a three steps protocol. first, patients (with anorexia nervosa), controls (with no eating disorder) and first degree relatives (with no eating disorder) will be tested for emotional accuracy (seing faces on a screen with different core emotions), pain threshold (how long they can support a cold probe), body size (how they see themselves), appetite and cognitive flexibility (a test where the capacity to change rules during a game is done easily or not). then all subjects will do a standardized physical exercise which represents an effort with the equivalent level of energy for each participants as being chosen according to each level of competency (assessed through the "maximal aerobic power"). the third step consists in the repetition of (nearly) initial tests.

Eligibility criteria:
inclusion criteria: patients : * woman * 18 - 50 years * eating disorders (with or without bulimia) according to the edi-2 (eating disorder inventory) and the mini (mini international neuropsychiatric interview) * bmi (body mass index) between 14 and 17,5 * first degree relative without ed (eating disorders) first degree relatives : * woman * 18 - 50 years * mother or sister of patient with eating disorders * bmi (body mass index) upper to 17,5 * healthy of all ed (eating disorders) controls : * woman * 18 - 50 years * bmi \> 17,5 * without ed (eating disorders) exclusion criteria: all groups : * contraindication in the practice of an intensive sport * cardiovascular family history with risk of cardiovascular unwanted events * cardiovascular, surgical personal histories, ostéoarticulaires or musculo-tendinous against indicating to the practice of a sport * intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or acute) related and controls : diagnosis of ed (eating disorders) in the edi-2 and in the mini
a dose escalation/expansion study of oral op-1250 in subjects with advanced and/or metastatic hr+, her2- breast cancer

Conditions: Hormone Receptor Positive Breast Carcinoma; HER2-negative Breast Cancer

Summary: this clinical trial is a phase i dose escalation and dose expansion and phase ii monotherapy open-label, first-in-human, multicenter study of op-1250 in adult subjects with advanced and/or metastatic hormone receptor (hr)-positive, her2-negative breast cancer.

this is a phase i dose escalation and dose expansion and phase ii monotherapy open--label, first--in--human study to determine the dose limiting toxicity (dlt), maximum tolerated dose (mtd) and/or recommended phase ii dose (rp2d), to characterize the safety and pharmacokinetic (pk) profile, and to estimate the preliminary anti-tumor activity of op-1250 as a single agent in adult subjects with hormone receptor (hr)-positive/human epidermal growth factor receptor 2 (her2)-negative metastatic or locally advanced breast cancer. this study comprises 2 phases: phase i (part a \[dose escalation\] and part b \[dose expansion\]) and phase ii. additionally, all subjects (phase i and phase ii) will be eligible to participate in 1 of 2 sub-studies. patients must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease. patients will be evaluated for treatment emergent adverse events (aes) during study participation, and toxicity will be assessed according to the national cancer institute (nci) common terminology criteria for adverse events, version 5.0.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * must have received at least 1 prior hormonal regimen and at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic disease * must not have received prior oral endocrine therapy \< 2 weeks prior to first dose * must not have received prior, chemotherapy in 2 weeks or within 5 half-lives whichever is earlier, antibody therapy within 4 weeks or investigational therapy within 4 weeks or 5 half-lives whichever is earlier, prior to the first dose * adequate hepatic function * adequate renal function * normal coagulation panel * willingness to use effective contraception exclusion criteria: * gastrointestinal disease * significant renal disease * significant cardiovascular disease * significant ecg abnormalities * ongoing systemic bacterial, fungal, or viral infection (requiring antimicrobial therapy) * pregnancy or breastfeeding
cyberbullying among sohag university student

Conditions: Cyberbullying Among Sohag University Students

Summary: cyberbullying can be defined as intentional aggression through electronic routes, such as text messages, e-mails, chat rooms, online games, and social websites. in comparison with traditional bullying, cyberbullying has many unique characteristics that boost its harmful effects, including the inability to avoid bullying, presence of larger and more potential audience, the continuity of bullying regardless of time or place, and the anonymity of perpetrator in many occasions .

in egypt almost half of beni-sueif university students (48.2%) reported experiencing cyberbullying victimization. female students, students living in urban areas and those who spent more hours using the internet reported more exposure (p\<0.001). harassment was the main type stated by females (79.8%) while flaming was excessively reported by males (51.8%). students responded mostly by anger (63.1%), hatred (23.2%) and sorrow (22.6%) towards the worst victimization incidents. in this study i want to study the situation of cyberbullying among sohag university students . , study patterns of cyberbullying among sohag university students , determine of correlates of cyberbullying among sohag university students such as family factors and study the implications of cyberbullying on victims .

Eligibility criteria:
inclusion criteria: * students of the selected faculties exclusion criteria: * students who will refuse to participate in this study.

Keywords: cyberbullying
influence of education on acceptance of treatment for attention deficit hyperactivity disorder (adhd) among women

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the goal of this research study is to measure what percentage of women who suspect they have symptoms of adhd will go on to be diagnosed with adhd using accepted practice standards. the study will also evaluate the influence education on the genetics of adhd has on a woman in her deciding to receive behavioral health treatment for adhd.

attention deficit hyperactivity disorder (adhd) affects approximately 10-12% of school-aged children in the united states, making it one of the most common psychiatric disorders in children. it is characterized as inattention and hyperactivity-impulsivity, which has persisted for at least 6 months to a degree that is maladaptive and inconsistent with developmental level (dsm-iv-tr). adhd is a non-fluctuating illness unlike many other psychiatric co-morbid conditions.

Eligibility criteria:
inclusion criteria: * subjects must be females, 18 through 59 years of age * subjects must think they have adhd or have been previously diagnosed with adhd but may not have received any treatment for adhd * subjects must be able to participate in the informed consent process and give their written consent to participate in the study exclusion criteria: * subjects who have been treated (at any time) for adhd will be excluded from the study * potential subjects consuming greater than 21 units of alcohol (1 unit=12.0 ounces beer, 1.5 ounces hard liquor or 5.0 ounces wine) a week will be excluded from the study * potential subjects currently experiencing suicidal ideation or who have been hospitalized within the past six months for suicidal ideation will be excluded from the study
"blind" vs. fluoroscopy-guided steroid injections for knee osteoarthritis

Conditions: Osteoarthritis

Summary: to compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the procedure.


Eligibility criteria:
inclusion criteria: - adults with knee oa clinically deemed to qualify for steroid injection exclusion criteria: - children non-english speakers pregnant
teachers and parents as partners during middle school rct

Conditions: Behavior Disorders

Summary: there are two aims of this study (a) to examine the effect of teachers and parents as partners on student, parent, and teacher outcomes in middle school and (b) identify barriers and facilitators to implementing teachers and parents as partners in middle school for students with behavior concerns.

in the business-as-usual control condition, participants will have access to any services that a school would routinely provide (e.g., develop and implement a behavior support plan) as well as services families can access in the community (e.g., mental health support). teachers and parents as partners will occur in a series of stages comprised of approximately four structured meetings over approximately 8 weeks. a teachers and parents as partners consultant will meet together with a student's parent(s), teachers, other school personnel (as appropriate), and the student (as appropriate). the teachers and parents as partners team will collaboratively address behavior problem solving objectives. specific tapp objectives include: identifying strengths and specific behaviors of concern, specifying alternative prosocial behaviors, creating measurable behavior goals, co-constructing behavior intervention/support plans to address the target concerns, creating sustainable conditions to support plan implementation at home and school, and evaluating the plan to assess progress toward goals.

Eligibility criteria:
inclusion criteria: * students will be eligible if they have scores in the "elevated" or "extremely elevated" risk categories on the parent or teacher version of the behavior assessment scale for children (basc) 3 behavioral and emotional screening system (bess). parents, and primary teachers and school staff associated with an eligible student will be included. exclusion criteria: * students who do not meet the inclusion criteria will be excluded from participation, which includes their parent(s), teachers, and other school personnel. students also may not be eligible if they have mental health concerns or severe behavior problems that may not be appropriate for teachers and parents as partners or a research project (e.g., some internalizing problems, students who pose an risk of harming themselves).
dry needling and rehabilitatin carpal tunnel syndrome

Conditions: Dry Needling; Carpal Tunnel Syndrome; Myofacial Pain

Summary: dry needling is used for myofascial release. however, its effectiveness in carpal tunnel syndrome (cts) is not well known. it is thought that dry needling may also be an effective treatment for cts by providing relaxation in the fascial tissue. therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with cts.

carpal tunnel syndrome (cts) is the most common entrapment neuropathy in the society, which develops due to compression of the median nerve in the carpal tunnel. with the compression of the median nerve, a pain, numbness and tingling sensation spreading to the hand and wrist affects daily living activities and reduces the quality of life. thickening and myofascial restriction in the carpal tunnel area also contribute to this situation. for this reason, various treatment methods have been developed for cts, ranging from conservative treatment to surgery. dry needling is also an alternative treatment method that can be used for cts. dry needling allows the fascial tissue to loosen and re-enter the healing process, leading to a decrease in pain and an increase in quality of life. however, its effectiveness in patients with cts is unknown. this study aimed to examine the effectiveness of dry needling in patients with cts.

Eligibility criteria:
inclusion criteria: 1. volunteering to participate in the study. 2. being between the ages of 18-65. 3. being diagnosed with mild or moderate stage cts as a result of the electroneurophysiological test. exclusion criteria: 1. having additional neurological, rheumatological and orthopedic disorders. 2. having had previous hand surgery. 3. having an additional acute neck, shoulder, elbow and hand problem. 4. having a bmi of 40 kg/m2 and above. 5. being pregnant. 6. as a result of the electroneurophysiological test, the data related to the median nerve are at a severe level.
developing nursing students' intercultural sensitivity levels

Conditions: Nursing Caries; Education

Summary: this study; this is a randomized controlled experimental type study designed to improve the intercultural sensitivity levels of nursing students.

cultural sensitivity is extremely important for healthcare professionals. understanding cultural differences can help build a trusting relationship between patients and healthcare professionals. this increases patient satisfaction and improves the quality of health services. this work; this is a randomized controlled experimental type study designed to improve the intercultural sensitivity levels of nursing students. intercultural sensitivity training does not affect the intercultural sensitivity level of nursing students.

Eligibility criteria:
inclusion criteria: * being a student of aydın adnan menderes university nursing department * having successfully completed the basic practical courses of the first three classes * being enrolled in one of the public health nursing or mental health and diseases nursing courses from the fourth year * volunteer to participate in the study exclusion criteria: • not completing the training sessions of the research

Keywords: nursing student culture intercultural sensitivity education
a study of xeloda (capecitabine) in combination with xelox (oxaliplatin) in patients with metastatic nasopharyngeal cancer.

Conditions: Nasopharyngeal Cancer

Summary: this single arm study will assess the efficacy and safety of xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. patients will receive xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. the anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * history of nasopharyngeal cancer and distant metastases; * no previous chemotherapy in past 6 months; * recovery from previous radiotherapy; * ability to swallow and retain oral medication. exclusion criteria: * previous cytotoxic chemotherapy; * radiotherapy within 4 weeks of treatment start; * history of another malignancy within the last 5 years; * clinically significant cardiac disease.