Kornimate/medical-research-clean huggingface dataset:
a study investigating the utilization, effectiveness and quality of life in clinical practice in germany for participants with relapsing-remitting multiple sclerosis treated with ozanimod (zeposia®)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to collect real-world data and to gain insights about long-term usage of ozanimod (zeposia ®), its effect on well-defined outcome parameters comprising participant-relevant outcomes, as well as quality of life, effectiveness, and incidence of adverse events.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of relapsing-remitting multiple sclerosis (rrms) * the decision upon treatment with ozanimod must have been made before enrollment and independently of this non-interventional observational study * all data on ozanimod treatment are collected prospectively. the retrospective documentation of ozanimod therapy and enrollment of participants that are already on ozanimod therapy is not allowed exclusion criteria: * special warnings, precautions and contraindications specified in the current version of the summary of product characteristics (smpc) * hypersensitivity to the active substance(s) or to any of the excipients of ozanimod as specified in the prescribing information must not be enrolled * participation in any other clinical studies other protocol-defined inclusion/exclusion criteria apply

Keywords: multiple sclerosis relapsing-remitting ozanimod zeposia®
thyroid screening protocol during pregnancy: a multi-center prospective controlled study

Conditions: Subclinical Hypothyroidism

Summary: estimate the proper thyroid screening method during pregnancy. evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.

the investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(ft4) and thyroid peroxidase antibody (tpoab). women were assigned to a screening group in pumch (in which measurements were obtained immediately) or a control group in hmchh (in which serum was stored and measurements were obtained shortly after delivery). each group enrolled 1000 pregnant women separately. women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. compare the pregnancy outcomes, iq at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.

Eligibility criteria:
inclusion criteria: * all of the pregnant women who receive prenatal care in pumch and hmchh * sign the consent form * agree to follow-up the pregnancy outcome and child exclusion criteria: * the pregnant women who do not agree to enter the study

Keywords: antenatal thyroid screening subclinical hypothyroidism thyroid function thyroid antibody pregnancy outcome childhood cognitive function
hemostasis in kocher-langenbeck approaches for acetabular surgery using a topical surgical hemostat (vitagel)

Conditions: Fracture Fixation; Intra-Articular Fractures; Acetabulum

Summary: the purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile kocher-langenbeck surgical approach. since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. the investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.


Eligibility criteria:
inclusion criteria: * acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons. * fixation must require a single non-extensile posterior approach (kocher-langenbeck) * posterior wall, posterior column, certain simple transverse and transverse associated with a posterior wall, t-type, and posterior wall-posterior column fracture types * ages 18-65 * patient or family must consent to the research protocol exclusion criteria: * not meeting the aforementioned inclusion criteria * unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources) * revision surgery * surgery occurring more than two weeks post-injury * history of blood dyscrasias or immunocompromised patients * patients with medical conditions requiring anticoagulation or international normalized ratio (inr) above 1.5 * obese patients (bmi \>35) * known ongoing infection (local or systemic) * pregnant women

Keywords: acetabulum fracture hemostatis vitagel fibrin sealant
connecting national guard service members through education in crisis line facilitation training

Conditions: Suicide

Summary: national guard (ng) are affected by suicide at a much higher rate than civilians. the military and veterans crisis line (mvcl) is not being used as often as we would expect. the purpose of this study is to find out whether a group-based training session will impact awareness and use of the military and veterans crisis line (mvcl) among members of the national guard.


Eligibility criteria:
inclusion criteria: * michigan army national guard member * associated with a unit with more than 25 members exclusion criteria: - unable to provide informed consent

Keywords: training crisis line
quantifying radiation-induced skin reactions: establishing the foundation for future prediction models

Conditions: Breast Cancer

Summary: breast cancer has the highest incidence rate among female cancers, and breast radiotherapy plays an essential role in the treatment of breast cancer. however, the acute and chronic skin reactions caused by radiotherapy, especially radiation dermatitis, have a significant impact on the physical and mental health of breast cancer patients. severe acute radiation dermatitis can affect the patient's quality of life and may even lead to treatment interruption, thereby affecting treatment efficacy. chronic radiation dermatitis can lead to irreversible skin problems, such as "radiation-irritated skin" and skin pigmentation, which can affect the quality of life of breast cancer patients after treatment. this study aimed to evaluate and examine the skin reactions of 30 breast cancer patients who underwent whole-breast radiotherapy after breast conserving surgery. the subjects returned to the hospital for evaluation every week during radiotherapy, and in the second and sixth weeks after the end of the treatment, they received physical examinations and surveys, including questionnaire surveys, skin observations and measurements. the study lasted for 3 months. skin observation items included physiological parameters such as skin moisture, temperature, melanin, transepidermal water loss (tewl), and clinical evaluation of skin reactions by physicians. through statistical analysis of skin physiological parameters, scientific instruments can quantify the radiation skin reactions traditionally judged by clinical physicians by visual examination and can perform real-time clinical prediction monitoring, which can be used to establish a skin reaction prediction model in the future.


Eligibility criteria:
inclusion criteria: * participants must be males or non-pregnant females at least 18 years of age. * diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which will be treated by radiotherapy after operation. * patient had unilateral breast conservation surgery with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment. * patients were scheduled to receive at least five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 gy per session) for total dose of at least 45 gy. * participant must give informed consent. exclusion criteria: * bilateral breast cancer * previous radiotherapy to the chest * prior breast reconstructions, implants, and/or expanders * known radiosensitivity syndromes (e.g. ataxia-telangiectasia) * collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (sle) * participation in any clinical trial in the prior 30 days from baseline. * any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Keywords: radiation-irritated skin radiation therapy
a study of ipatasertib (gdc-0068) in combination with fluoropyrimidine plus oxaliplatin in participants with advanced or metastatic gastric or gastroesophageal junction cancer

Conditions: Gastric Cancer

Summary: this multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified folfox6 \[mfolfox6\]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (gej) cancer. participants will be randomized to receive either ipatasertib or placebo orally daily on days 1 to 7 of each 14-day cycle in combination with mfolfox6 on day 1 of each cycle.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically documented, inoperable locally advanced or metastatic or recurrent gastric/gej adenocarcinoma, not amenable to curative therapy * measurable disease, according to recist v1.1 * life expectancy greater than or equal to (\>/=) 12 weeks * adequate hematologic and organ function exclusion criteria: * previous chemotherapy for inoperable locally advanced or metastatic gastric/gej adenocarcinoma. participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced gastric/gej adenocarcinoma, provided all treatments were completed \>/= 6 months prior to randomization. * known human epidermal growth factor receptor 2 (her2)-positive gastric/gej adenocarcinoma * radiation treatment within 28 days of randomization. participants who have received palliative radiation treatment to peripheral sites (eg, bone metastases) within 28 days of randomization may be enrolled in the study if they have recovered from all acute, reversible effects and with notification of the medical monitor. * previous therapy for gastric/gej adenocarcinoma with akt, phosphatidylinositol 3-kinase (pi3k), and/or mammalian target of rapamycin (mtor) inhibitors * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
community characteristics and physical activity among adolescent girls - ancillary to taag

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to investigate the role of community characteristics in physical activity levels of adolescent girls.

background: the nhlbi-funded multi-centered trial of activity for adolescent girls (taag) is a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years. design narrative: because environmental factors can influence the likelihood that a person will engage in physical activity, the study investigates the role of community characteristics in physical activity levels. the research forms an ancillary study to the nhlbi-funded multi-centered trial of activity for adolescent girls (taag), a group (school)-randomized controlled intervention trial to increase physical activity among a cohort of sixth grade girls over 2.5 years. the parent taag study will be collecting measures of physical activity using both self-report and csa accelerometers, small monitors worn at the hip that record acceleration and deceleration of movement without the need for any reporting from the participants. using a radius of 5 miles around each participating taag school and around the homes of each study participant, the investigators plan to use geographic information systems (gis) to gather information documenting proximity of recreational facilities, street design, population density, population mix (ethnic/age distribution), crime, availability of mass transit, neighborhood socioeconomic status (ses), geographic elevations and topography and types of land use. using hierarchical linear modeling, with girls nested within neighborhoods, while controlling for individual level factors such as race and socioeconomic status, they plan to investigate the relationship of the environment to individual physical activity. in addition, by following girls over time, they plan to investigate whether the effect of the taag intervention will be modified by community characteristics. this study will be unique in its scope of exploring the role of community environments in physical activity across six very different urban, suburban, and rural areas: san diego, ca, minneapolis, mn, baltimore, md, new orleans, la, tucson, az and columbia, sc.

Eligibility criteria:
no eligibility criteria

Keywords: built environment parks retail outlets adolescent girls physical activity
morphine for dyspnea in pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: "determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"


Eligibility criteria:
inclusion criteria: * ipf diagnosis in accordance with guidelines * period of stable disease * dyspnea rated 3 to 4 in mmrc scale * current non-smoker * other potential causes of breathlessness such as kidney or heart failure optimally treated in the opinion of the principal investigator * able to complete questionnaires and trial assessments * ability to give informed consent * if female, must be: 1. postmenopausal (no menses for 12 months without an alternative medical cause) 2. sterile 3. using acceptable contraception and agree to exclude pregnancy with pregnancy test in the beginning of the hospitalization exclusion criteria: * - other coexisting severe chronic lung diseases * absolute contraindications to six-minute-walking-test according to polish respiratory society guidelines: * \< 7-10 days since coronary interventions due to stemi * \< 24 h since planned coronary intervention * myocarditis/pericarditis * symptomatic rhythm and conduction abnormalities * acute deep vein thrombosis, pulmonary embolism, pulmonary infarction * decompensated heart failure * acute infection and other diseases which can significantly impact the test result (eg. severe anemia, acute kidney or liver failure, hypo- or hyperthyroidism, etc) - contraindications to morphine hydrochloride: * previous history of respiratory depression after opioid administration * previous history of allergic reactions to opioids * severe ventilation impairment due to e.g. asthmatic state, airway foreign body * severe kidney or liver failure * increased intracranial pressure * head injury * cerebral edema * coma * seizure disorders * acute alcohol poisoning * acute abdomen * acute diarrhea caused by infection or food poisoning; * patients at risk of paralytic ileus; * biliary colic; * phaeochromocytoma; * simultaneous mao inhibitor treatment and immediate 2-week period following its discontinuation - ongoing opioid treatment for any indication
effect of soft tissue mobilization with and without neural mobilization in cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: this study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.

soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently. soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance. neural mobilization technique is different for all 3 nerves i.e radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.

Eligibility criteria:
inclusion criteria: * patients with age 18 to 55years * patients having pain more than 3months * radiating pain in one of the upper limb * spurling's test positive exclusion criteria: * traumatic injury of upper limb or cervical spine * vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc) * patient asymptomatic for pain but symptomatic for tingling and paraesthesia * circulatory disturbance of upper extremity * known history of high level of spinal cord injury and malignancy * thoracic outlet syndrome

Keywords: cervical radiculopathy, soft tissue mobilization, neural mobilization
icu nutrition study bern

Conditions: Critical Illness; Starvation; Enteral Nutrition

Summary: nutritional treatment has become an essential component of the management of critically ill, due to better knowledge about positive impact of nutritional support. malnutrition among icu patients is associated with increased morbidity, mortality, length of stay (los) and therefore higher costs.several studies however suggest, that early implementation of nutritional support is associated with improved clinical outcome, shorter los, and decreased infection rates. one of the objectives of this study is to determine if an nutrition protocol can improve the delivery of enteral tube feeding in the icu.


Eligibility criteria:
exclusion criteria: * \<18 years of age * stay less than 72 hours on icu * die within 72h after admission * patients admitted for palliative care

Keywords: critical care intensive care unit early enteral nutrition nutritional management protocol
regulation of intracerebral pressure during electroconvulsive therapy

Conditions: Depression; Intracranial Pressure

Summary: the purpose of this study is to determine whether electroconvulsive therapy (ect) has an influence on pressure within the human brain before, during and after ect.

1. aim: 1. our main objective concerning this study is to determine to what extent ect does lead to an increase of the pulsatility index (as an indicator of intracerebral pressure) measured by a transcranial doppler device (tcd). 2. as a secondary objective we want to compare the pi measurements with simultaneously measured systemic blood pressure. 2. study design: a.observational study: cohort study 3. treatment: a. treatment as usual, pi and blood pressure measurement at baseline, just before ect, during and 5 minutes after ect. data will be collected during unilateral treatment during 3 consecutive ect treatments. 4. endpoints: 1. a minimum of sixteen patients are needed according to the power analysis.

Eligibility criteria:
inclusion criteria: * temporal window to measure pi * major depression * psychotic depression exclusion criteria: * under 18 years of age

Keywords: depression electroconvulsive therapy ultrasonography doppler transcranial intracranial pressure
neoadjuvant chemotherapy in borderline resectable and locally advanced pancreatic cancer (norpact-2)

Conditions: Locally Advanced Pancreatic Adenocarcinoma; Chemotherapy Effect; Borderline Resectable Pancreatic Adenocarcinoma; Pancreatectomy

Summary: this is a norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. eligible patients are treated with neoadjuvant chemotherapy possibly followed by surgical exploration and resection. all norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. the assignment of the medical intervention is not at the discretion of the investigator, but follow the national norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up.


Eligibility criteria:
inclusion criteria: * borderline resectable or locally advanced adenocarcinoma of the pancreas (nccn, version 2, 2015) * nx, m0 (uicc 8 th version, 2016) * cytological or histological confirmation of adenocarcinoma * age \> 18 year and considered fit for major surgery * written informed consent * considered able to receive the study-specific chemotherapy exclusion criteria: * co-morbidity precluding pancreatectomy * chronic neuropathy ≥ grade 2 * who performance score \> 2 * granulocyte count \< 1500 per cubic millimetre * platelet count \< 100 000 per cubic millimetre * serum creatinine \> 1.5 unl (upper limit normal range) * albumin \< 2,5 g/dl * female patients in child-bearing age not using adequate contraception, pregnant or lactating women * mental or physical disorders that could interfere with treatment of with the provision of informed consent * any reason why, in the opinion of the investigator, the patient should not participate
high-resolution lower dose dedicated breast computed tomography (ct)

Conditions: Breast Cancer

Summary: this study is being performed to find out if a new kind of breast imaging (called dedicated breast ct or bct) can help doctors to see the small structures in breast tissue more clearly. the investigators also want to find out if using the bct will provide a more accurate diagnosis of breast cancer.

the breast imaging device that will be used in this study (breast computed tomography or bct) is not fda-approved for this use so this is a research study. the machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose. the breast ct device will take multiple pictures of the subject's breast and create a 3-d image of the breast. it does not compress or squash the breast like a mammogram.

Eligibility criteria:
inclusion criteria: all subjects that are eligible to participate in the study will be women who satisfy all of the inclusion criteria stated below: * who are 40 years of age or older (typical screening age range) * who are undergoing or scheduled for screening or diagnostic imaging, or need a biopsy to investigate an abnormality in the breast. exclusion criteria: subjects that present with any of the criteria listed below will be excluded: * males, * women less than 40 years old, * women unable to self-consent, * prisoners, * pregnant, suspected to be pregnant, or lactating women (self-reported) * women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker; * women who are unable to tolerate study constraints, frail, or unable to cooperate; * women who weigh more than 440 lbs (200 kg), which is the weight limit for the patient support table of the bct system; * women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for hodgkin's disease; * women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram; * women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.