Kornimate/medical-research-clean huggingface dataset:
preventing sexual aggression among high school boys

Conditions: Violence

Summary: the present research creates a partnership between researchers and a community agency to evaluate whether a sexual assault prevention program for high school students reduces perpetration of sexual violence among high school boys.

the present research advances the science of sexual assault prevention by creating a mutually beneficial partnership between well-established sexual assault prevention researchers and a cdc rape prevention and education program (rpe)-funded community agency to conduct a rigorous experimental evaluation of universal primary prevention programming designed to reduce sexual aggression among high school boys. the present research tests multi-session prevention programming that targets change at multiple levels of the social ecology (i.e., individual-, peer- and community-level) through social norms theory and bystander education. specifically, the present research evaluates your voice your view. your voice your view was developed and is currently administered in rhode island high schools by the cdc rpe-funded agency day one of rhode island. the program will be tested in a group randomized cluster trial among 10th graders at 30 high schools, with the aim of reducing perpetration of sexual aggression among high school boys. specifically, this research will conduct a randomized controlled trial with a sample of 10th grade students to demonstrate efficacy of the intervention in reducing rates of sexual aggression among high school boys, rates of dating violence involvement, and related risk and protective factors over a 2- and 6-month follow-up in comparison to a wait-list control group. thirty schools will be matched on demographic characteristics (i.e., % receiving subsidized lunch, racial/ethnic minority enrollment) and randomized to receive your voice your view or to the wait-list control group.

Eligibility criteria:
inclusion criteria: * adolescents at rhode island high schools will be eligible for enrollment according to the following criteria: 1) adolescent assent given; 3) passive consent of a parent/legal guardian is given. teachers will be eligible to participate in educator assessments if consent is given. exclusion criteria: * there are no exclusion criteria.
investigation of rate + extent of excretion of radioactivity in urine +faeces after oral administration of [14c]azd2066

Conditions: Pain

Summary: the aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of azd2066 in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent * clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ecg. exclusion criteria: * history of somatic disease/condition, which may interfere with the objectives of the study. * history of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder. * healthy volunteers who have been exposed to radiation levels above background (eg, through x-ray examinations).

Keywords: mass balance azd2066 pain pain conditions
personalized trial for chronic lower back pain

Conditions: Back Pain Lower Back Chronic

Summary: the personalized trial of chronic lower back pain will test the feasibility of employing technology to facilitate remote n-of-1 interventions to research participants with self-identified back pain. participants will spend 14 weeks alternating between massage, yoga, and usual care methods to treat their back pain, while answering daily questions and wearing an activity tracker. after 14 weeks, participants will have the ability to share their opinions about a personalized trials platform. we believe a personalized trials platform will be satisfactory to participants and feasible to scale to large randomized controlled trials, and eventually to clinical practice.

the personalized trial of chronic lower back pain will facilitate remote n-of-1 interventions to research participants with self-identified back pain persisting longer than 12 weeks. participants will be randomized in a multiple crossover design to receive swedish massage in-home by a commercial wellness service, yoga instruction in-home by a commercial wellness service, and no intervention/usual care. participants will evaluate their pain intensity, pain interference, fatigue and stress daily through self-reported questionnaires. online screening and enrollment methods, text-message reminders and questionnaire prompts, and wearable devices will be employed to collect data. at the end of the study, participants will receive a personalized report summarizing their observed data in each treatment period. participants will evaluate the system usability of personalized trials, will debrief their experience with a member of the research team, and will share their overall satisfaction with personalized trials.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * fluent in english * experiencing symptoms of low back pain for \> 12 weeks * self-reported pain intensity \> 8 on the promis pain intensity scale during screening * able to receive massage and yoga interventions (2x/week between 8 am and 10 pm) * owns and can regularly access a smartphone capable of receiving text messages * owns and can regularly access an e-mail account exclusion criteria: * pregnant women * history of spinal surgery * complex back pain (e.g. sciatica, spinal stenosis, or other pre-existing condition) * previous diagnosis of a serious mental health condition or psychiatric disorder * previous diagnosis of opioid use disorder or treatment for any substance use disorder * previously advised that yoga or massage is unsafe for their condition * current opioid use * current physical activity restrictions * planned surgery or procedures within 6 months of recruitment * planned travel outside the united states within treatment period time-frame * weight greater than or equal to 500 lbs.

Keywords: n-of-1 yoga massage pain low back pain lower back pain virtual swedish massage personalized trial personalized feasibility
outcomes of different treatment options in chronic venous disease

Conditions: Chronic Venous Disease

Summary: this study aims to describe conservative and invasive treatments for patients with chronic venous disease (cvd) in belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months.

this study is an observational, prospective, multicentre study to assess the effectiveness of conservative and invasive treatments in patients with cvd in belgium. the inclusion period of the study will last 6 months. patients will be followed until 2 years after inclusion into the study. during the inclusion period, after confirmation of eligibility, patients with cvd diagnosed by the general practitioner (gp) and requiring a treatment will be invited to participate in the study. about 140 gps across belgium will be included in the study. during the first visit, a treatment strategy will be proposed to the patient by the gp. the treatment can be conservative or invasive, depending on the severity of the disease. patients awaiting invasive treatment may receive conservative treatment to alleviate symptoms. the choice of treatment modality is left to the discretion of the treating physician, in agreement with the patient and according to local policies. as this is an observational study, there will be no interference in the choice of treatment, and no restrictions will be imposed.

Eligibility criteria:
inclusion criteria: \* patient visiting a gp with complaints related to cvd, * patient receiving the diagnosis of cvd from the gp during the v0, according to international guidelines and made on a clinical basis, * patient requiring and agreeing to receive conservative or invasive treatment, * french or dutch speaking patient, * patient signed informed consent and agrees to take part in the study and follow-up. exclusion criteria: * patient with coagulation disorders such as thrombophilia and/or taking anticoagulation drugs, * pregnant or breastfeeding patient, * patient with severe peripheral arterial occlusive disease (poad), with ankle brachial index (abi) \< 0.8, * patient with malignancy, * patient with neurological disorder or dementia, * patients taking regular treatment for cvd 3 months prior to inclusion (except painkillers or anti-inflammatory drugs if taken for reasons other than cvd), * patient in any other clinical study for any pharmaceutical product within 4 weeks preceding study inclusion, * patient with any comorbidity or situation preventing a follow-up of 2 years.
sensorimotor arm rehabilitation after stroke

Conditions: Stroke; Hemiparesis

Summary: hemiparesis is a frequently observed symptom of stroke. there are various therapy options that are used in the rehabilitation of patients. some studies have shown that, in addition to unilateral arm training, bilateral arm training can also lead to positive results in treatment and is a useful addition to therapy. the newly developed app requires the coordination of both arms in certain time sequences and intensities or rhythms and addresses different sensory modalities (visual, auditory and kinesthetic). the aim of the study is to examine whether tablet-based training improves bimanual coordination.


Eligibility criteria:
inclusion criteria: * diagnosis of an ischemic/hemorrhagic stroke * moderate upper extremity paresis: 30 to 60 cubes in the box-and-block test (bbt) * sufficient resilience / alertness (active participation possible for at least 30 minutes) * ability to give consent (written declaration of consent from the patient) exclusion criteria: * hemianopia and/or neglect * duration of illness \>3 months * pre-existing hemiparesis * participation in another clinical trial within the last 30 days * a pregnancy or breast-feeding period * contraindications for mri: claustrophobia; metallic or magnetic implants that contain iron, cobalt or nickel (e.g. pacemakers, brain pacemakers, automatic insulin pumps, electrodes, plates, clips, implanted hearing aids, dental implants, metal endoprostheses, metal parts or metal splinters in the body)
effectiveness of cervical osteopathic manipulation in patients with whiplash

Conditions: Whiplash

Summary: to determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the sat technique in patients with grade ii acute wl, comparing it with a conventional rehabilitation program.

a prospective, single-blind, parallel group, randomized, will be carried out in the physiotherapy service of the clinic hospital of terrassa with the participation of the rehabilitation, radiology, traumatology and surgery services. patients will be recruited from emergency services of the clinic hospital of terrassa and randomly divided into two groups man-group and rhb-group, using the random number generator of a statistical program (spss), to receive 3 and 20 treatment sessions, respectively. the treatment protocol was carried out during four weeks, and both interventions occurred over the same time period. in both treatment groups, patients started sessions during the first two week after the traffic car collision. man-group were treated with cervical spine manipulation with sat, after specialized physical therapists assessed there was no risk of vertebro-basilar injuries following the international framework. patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study). the rhb-group were treated with passive manual therapy (p-mt) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (a-te); and oculo-cervical exercises (oc-e). patients received a total of 20 sessions of 30 minutes each during 4 weeks. the exercises were performed five times (30 seconds interval each time) in a sitting position.

Eligibility criteria:
inclusion criteria: patients between 18-60 years of age who went to the emergency service after suffering a traffic car collision being the driver of the car. with acute wl grade ii wad diagnosis, made by physicians from the traumatology service (with neck pain by whiplash trauma with objective findings but no radiculopathy). referred to the hospital rehabilitation service exclusion criteria: any other symptomatology different to neck pain and other coexisting medical conditions which could severely restrict participation in the study.

Keywords: manual therapy manipulation physical therapy exercises
promoting patient-centered care through a heart failure simulation study

Conditions: Heart Failure

Summary: the initial aim of this study will be to assess current methods of heart failure (hf) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. the second aim will be to design and create a "living with hf at home" simulation session. the third aim will test the hypothesis that hospitalized hf patients who receive education in a simulation room in addition to usual hf education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.


Eligibility criteria:
inclusion criteria: 1. male or female \> 18 years of age. 2. ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. 3. documentation of hf of any etiology based on clinical assessment of the primary investigator, using standard-of-care criteria for diagnosis. 4. heart failure of either preserved or reduced ventricular function. exclusion criteria: 1. patients requiring icu monitoring 2. lvad candidate/recipient 3. cardiac transplant candidate/recipient 4. confusion 5. sepsis 6. terminal illness (other than hf) with expected survival of less than 1 year 7. enrollment or planned enrollment in another randomized clinical trial during this hospitalization 8. inability to comply with planned study procedures 9. active illicit drug use 10. participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study. 11. other conditions that in the opinion of the primary investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
acceptance-based intervention at colorectal cancer patients

Conditions: Colorectal Neoplasms; Acceptance Process; Pain, Procedural

Summary: taking into account the unavoidable effect of a major oncologic surgery commonly required for colorectal cancer patients and the recognized psychological and functional sequelae of the surgical treatment on their status, we will evaluate the influence of a psychological intervention, known as acceptance-based intervention, offered to those patients at the preoperative setting. reduction of anxiety and assessmemt of indices of post-intervention psychological and functional recovery will be the primary goals of the study.

introduction: uncertainty, fears and anxiety are common reactions to an upcoming colectomy for colorectal cancer patients and are related not only to cancer disease, but also to the inevitable change in colon anatomy, affecting their preoperative psychological and functional condition and their postsurgical recovery. purpose: we aim to evaluate the psychological and functional recovery of colorectal cancer patients, who undergo colectomy, after an acceptance-based nursing intervention. the scope of this brief preoperative intervention is to enable patients to cope more efficiently with the upcoming surgery and their health status, as it is expected to reduce anxiety and have positive effect on postsurgical psychological and functional recovery. methods: the study includes histologically diagnosed patients with colorectal cancer, regardless of stage, who are scheduled to undergo colectomy. patients will be divided into two groups-the experimental and the control group-by simple randomization. both groups are going to complete a set of same questionnaires regarding quality of life, sleep, anxiety, depression and functional status. patients in the control arm will then receive treatment-as-usual while patients in the experimental arm will also receive an acceptance-based intervention before surgery. postoperatively, for both groups, apart from the self-reported symptoms, we will assess objective recovery factors, such as postoperative complications

Eligibility criteria:
inclusion criteria: * patients with histologically proven colorectal adenocarcinoma * age \> 18 years exclusion criteria: * metastasis at time of diagnosis * recurrence at time of diagnosis * history of other malignancies * mental retardation * deafness * illiteracy * asa score\>3 * poor performance status
neuromusuclar adaptations in the rheumatoid arthritis disease

Conditions: Arthritis, Rheumatoid; Muscular Weakness

Summary: rheumatoid arthritis (ra) is a chronic autoimmune disease that causes joint inflammation and progressive joint destruction. rheumatoid cachexia is one of the structural manifestations of ra, and consists of a reduction in muscle mass, due to an increased muscle protein catabolism induced by inflammatory cytokines. this muscle mass loss generates an impairment in physical function and functional capacity in ra patients. the aim of study was to verify neuromuscular and functional responses in middle-aged women with ra compared to paired healthy women.


Eligibility criteria:
inclusion criteria: * ra patients with a class i and ii ra diagnosis according to the american rheumatism association's 1987 revised criteria, were recruited from a university hospital's rheumatology clinic. exclusion criteria: * presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility
leg fluid shift in patients with chronic heart failure and obstructive or central sleep apnea

Conditions: Obstructive Sleep Apnoea; Central Sleep Apnoea; Cheyne Stokes Respiration

Summary: this study aims to investigate the influence of a potential leg fluid shift (lfs) in patients with chronic heart failure (chf) and obstructive sleep apnea (osa) or central sleep apnea (csa).

chronic heart failure (chf) is a common disease in general western population with high levels of morbidity and mortality. prospective risk factors need to be identified and investigated. the prevalence for sleep disordered breathing (sdb) in patients with chf is higher compared to general population. especially the occurence of csa with its special breathing pattern of cheyne-stokes-respiration (csr) is frequent in chf patients.the pathophysiology and relation inbetween sleep apnea (sa) and chf isn´t completely identified yet. multiple theories with different strategies try to explain the pathophysics and development of sa. following one of these theories, patients with chf often develop edema in lower body compartments. the idea is a possible influence of retrograde nocturnal lfs from lower body to upper body compartments which could induce pulmonal congestion. therefore, an increased pulmonary capillary wedge pressure (pcwp) could irritate special pulmonal receptors resulting in csr with periods of hyperventilation, related hypocapnia and central apnea events. osa could be induced by fluid accumulation in the upper airway by retrograde fluid shift. patients with known chf receive fluid measurements by b multi frequency bioimpedance analysis (mfbia) the evening before and the morning after sleep is recorded using polygraphy (pg) or polysomnography (psg) in hospital. sleep results are analyzed by physicians using current guidelines of the american academy of sleep medicine (aasm). capillary blood gas (cbg) samples are taken before and after sleep to examine the relation of fluid shift and blood gas changes. a subgroup of the study group undergo additional investigation. hemodynamic effects (e.g. reduced cardiac output (co)) as a cause of a potential fluid shift is measured during wakefulness by using a tilting table. hemodynamically relevant parameters are recorded non-invasively.

Eligibility criteria:
inclusion criteria: * chronic heart failure * reduced left ventricular ejection fraction (lvef) ≤ 45% * nyha i - iv exclusion criteria: * current existing sleep apnoea breathing therapy * significant chronic obstructive pulmonary disease (copd) tiffenau-index: \<70% * respiratory insufficiency with need for a long time oxygen therapy * hypercapnic state in rest at day time * acute myocardial infarction at moment of study * instable angina pectoris at moment of study * cardiac surgery in last twelve weeks * stroke or tia in last twelve weeks * implantable cardioverter-defibrillator, if there is no security clearance of the fabricator * chronic kidney disease \> stage iii

Keywords: sleep-disordered breathing heart failure leg fluid shift
institut fuer diabetes-technologie surveillance program

Conditions: Diabetes

Summary: assessment of the system accuracy of different blood glucose monitoring systems available in europe

a variety of blood glucose monitoring systems (bgms) are available on the european market. for many of these bgms, the system accuracy is unknown or it has not yet been assessed in manufacturer-independent studies. the idt surveillance program aims at assessing the system accuracy of different bgms that are available in europe in a manufacturer-independent, investigator-initiated study. the initial study will cover 18 bgms from 18 different manufacturers. per bgms, one test strip lot will be assessed based on procedures stated in the international standard iso 15197:2013 / en iso 15197:2015.

Eligibility criteria:
inclusion criteria: * male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes * signed informed consent form * minimum age of 18 years * ubjects are legally competent and capable to understand character, meaning and consequences of the study. * if blood glucose values \ 300 mg/dl shall be measured after short term alteration in insulin therapy: * male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy. * signature of subjects to document consent with these procedures on informed consent form. exclusion criteria: * pregnancy or lactation period * severe acute disease (at the study physician's discretion) * severe chronic disease with potential risk during the test procedures (at the study physician's discretion) * current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) * being unable to give informed consent * \< 18 years * legally incompetent * being committed to an institution (e.g. psychiatric clinic) * language barriers potentially compromising an adequate compliance with study procedures * dependent on investigator or sponsor * if blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from: * coronary heart disease * condition after myocardial infarction * condition after cerebral events * peripheral arterial occlusive disease * hypoglycemia unawareness