Kornimate/medical-research-clean huggingface dataset:
a randomized controlled trial about teaching parents how to manage childhood immunization pain

Conditions: Mothers of Newborn Infants

Summary: there is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

over 90% of young children demonstrate severe distress during vaccination. pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. lack of time is reported as a secondary barrier. an educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

Eligibility criteria:
inclusion criteria: * new mothers with health full-term infants * 5 minute apgar 7 or more exclusion criteria: * non-english speaking mothers * mothers with psychiatric conditions * infants admitted to intensive care unit

Keywords: randomized controlled trial parent education pain management infant immunization
neoadjuvant of tislelizumab combined with chemotherapy followed by surgery in unresectable stage ⅲ nsclc

Conditions: NSCLC, Stage III

Summary: the purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for stage iii unresectable locally advanced nsclc.


Eligibility criteria:
inclusion criteria: * written informed consent provided. * unresectable stage iii non-small cell lung cancer confirmed by histopathology or cytology. * ecog score is 0 or 1. * adequate hematological function, liver function and renal function. exclusion criteria: * previously received systemic anti-tumor therapy for non-small cell lung cancer. * history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment. * history or active pulmonary tuberculosis. * active infections that require systemic treatment. * history or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy. * untreated active hepatitis b. * has a known history of human immunodeficiency virus (hiv) infection (hiv 1/2 antibody positive). * grade 3 or above peripheral neuropathy. * severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs. * underlying severe or uncontrolled disease. * malignant tumors other than nsclc within 5 years. * any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.
myopia control spectacle lens cessation study

Conditions: Myopia; Myopia Progression; Juvenile Myopia

Summary: to quantify myopic progression (cycloplegic spherical equivalent refraction - cser) following the cessation of use of specific spectacle lenses. to quantify axial length progression following cessation of use of specific spectacle lenses.


Eligibility criteria:
inclusion criteria: * previously a successfully completed participant in the cypress extension study; * agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); * willingness to participate in the trial for up to 12 months without contact lens wear; * the subject's parent(s) or legal guardian(s) must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. exclusion criteria: * known allergy to proparacaine, tetracaine, or tropicamide.
evaluation of immediately placed dental implants with local application of injectable prf in periodontally compromised sites

Conditions: Bone Density; Bone Loss, Alveolar

Summary: the present study is a human, prospective, parallel, randomised controlled clinical trial conducted to explore the efficacy of injectable prf around dental implants. the trial is in accordance with the consolidated standards of reporting trials (consort) criteria, 2010.

ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. a detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. all patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. all the patients were treated with immediate implants. the injectable -prf was coated on implants as well as injected in the socket in both the maxillary and mandibular anterior region. the clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively.

Eligibility criteria:
inclusion criteria: 1. cooperative patients willing to participate in the study 2. at least two maxillary or mandibular anterior teeth indicated for extraction due to chronic periodontitis (chronic or aggressive) 3. patients above 18 years of age 4. patients with esthetic concerns 5. patients with good oral hygiene maintenance 6. adequate bone height apical to alveolus of the failing teeth (more than or equal to 5mm) to accommodate an implant - exclusion criteria: 1. persistent \& unresolved infection at implant site 2. teeth with close proximity to anatomical structure and adjacent roots 3. patients on radiotherapy 4. patients with systemic disorders 5. patients with parafunctional habits 6. patients with history of alcohol, drug dependency and smoking

Keywords: injectable platelet rich fibrin bone density crestal bone loss immediate implants
the effect of osteopathic manipulative treatment on recovery of coronary bypass patients

Conditions: Cardiovascular Disease

Summary: the purpose of the study was to determine the effect on recovery after surgery of patients who received a standardized daily protocol of osteopathic manipulative treatment.patients undergoing elective coronary artery bypass surgery were voluntarily enrolled in the study and assigned to one of three groups.one group received a standardized daily treatment protocol along with conventional care, another received daily similar placebo treatment with conventional care, and a final group received only conventional post surgical care.the research hypothesis was that daily treatment with osteopathic manipulative treatment would reduce hospital stay and hasten recovery from surgery.persons in the treatment group had earlier discharge, and faster recovery of bowel function and basic mobility.

fifty-three persons were voluntarily enrolled into this randomized, double-blinded placebo controlled trial to examine the effects of osteopathic manipulative treatment (omt) on the post operative recovery of persons undergoing elective coronary artery bypass graft (cabg) surgery. participants were assigned randomly to one of three cohorts: one with only conventiobnal treatment, one with a daily standardized protocol of omt and a third with a daily time matched placebo omt protocol.all patients received standard state of the art care consistent with national standards of post cabg care. the study showed favorable trends in terms of hospital length of stay , return of bowel function, and mobility.

Eligibility criteria:
inclusion criteria: * adults undergoing elective coronary artery bypass graft surgery who were patients of the same surgeon exclusion criteria: * prior coronary artery bypass graft procedure * unstable psychiatric illness * chronic pain * open chest phenomenon * unforeseen peri or postoperative complications

Keywords: coronary artery bypass graft osteopathic manipulative treatment cardiovascular disease
sahara: a randomized controlled trial

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the sahara trial will clarify the role of treating anemia with red blood cell (rbc) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. it will guide best practice standards and clarify the optimal rbc transfusion strategy in patients with asah.

we hypothesize that in adult patients suffering from asah and anemia, a liberal rbc transfusion strategy as compared to a restrictive rbc transfusion strategy decreases the combined rate of death and severe disability at 12 months (using the modified rankin scale)

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old at time of sah 2. first ever episode of aneurysmal sah 3. diagnosis of asah as confirmed by treating physician (eg: neurosurgeon or neuro- interventionalist) and supported by blood in subarachnoid space (e.g. cranial imaging or cerebrospinal fluid positive for xanthochromia, surgical visualization) that is the result of a ruptured aneurysm (e.g. direct visualization, cranial imaging or catheter angiogram) 4. hb ≤100g/l within 10 days following asah (defined by first day of hospital presentation) exclusion criteria: 1. physician and or family decision to withdraw/withhold active medical care at time of enrolment 2. active bleeding with hemodynamic instability at time of enrolment 3. patients with contraindication or known objection to blood transfusions 4. sah due to mycotic aneurysm, infundibulum and vascular malformations.

Keywords: aneurysmal subarachnoid hemorrhage (asah) red blood cell transfusion (rbc) vasospasm intracranial hemorrhages cardiovascular diseases
jackson heart study women's hypertension study

Conditions: Hypertension

Summary: high blood pressure is a powerful risk factor for heart disease. black women are more likely to have high blood pressure than white women or hispanic women. even when they are aware they have high blood pressure, many people struggle to keep their blood pressure controlled. research shows a connection between life stress and high blood pressure and heart disease outcomes. mindfulness training programs can help people regulate their emotions and cope with stress. research shows that mindfulness programs can also lower blood pressure. this study will compare two programs: mind-bp, a zoom-based mindfulness training group; and boost, a zoom-based support group. the aims of the study are to test if the mind-bp program leads to greater reductions in blood pressure, stress and depressive symptoms than the boost program in black women with high blood pressure who are participating in the jackson heart study. the primary outcome measure is 6-month change in systolic blood pressure. the secondary outcome measures are 6-month changes in perceived stress and depressive symptoms.


Eligibility criteria:
inclusion criteria: * female participant in jackson heart study * willing to be randomized and comply with all aspects of protocol * willing to be audio-recorded during group sessions. exclusion criteria: * positive cognitive screen (mmse \<19) * severe depressive symptoms (ces-d ≥16) * pregnant or planning to become pregnant in the next 6 months * current participation in another trial * arm circumference \>45 cm and \<22 cm
osteomyelitis: procalcitonin to diagnose and monitor osteomyelitis

Conditions: Diabetes; Foot Ulcer; Osteomyelitis

Summary: the investigator plans a cohort study of 80 subjects admitted to hospital with a diabetic foot infection in order to compare serial bone biopsies (the current "gold standard") and procalcitonin to diagnose and monitor the effectiveness of therapy for osteomyelitis. the investigator will collect specimens as part of an existing trial to evaluate negative pressure wound therapy in diabetic infected wounds. a high proportion of these patients have osteomyelitis and will receive standard therapy including repeat bone biopsy and parenteral antibiotics. the investigator expects repeated measurement of procalcitonin will be highly correlated with repeated bone biopsy after antibiotic treatment has been completed to determine if therapy has been successful or if additional antibiotic therapy is needed.

there is a world-wide epidemic of diabetes. as part of the epidemic lower extremity amputations are dramatically increasing. soft tissue and bone infections are one of the most common reasons for amputation. it is often difficult to determine if diabetic foot ulcers have an underlying bone infection. inaccurate diagnosis of osteomyelitis leads to unnecessary antibiotic treatment, surgery, and amputation. in addition, we do not have good diagnostic tools to determine when osteomyelitis has been treated successfully. the role of biomarkers specific to bone turnover (resorption and formation) in relation to bone infections is poorly understood. we know that remodeling is an essential function in bone physiology with increased osteoclast production leading to resorption of old bone coupled with increased osteoblast production associated with new bone formation. the balance between these two functions is known to be disrupted in disease states including osteoporosis, but has not been examined specifically in infected bone. procalcitonin has been suggeasted as a tool to both diagnose and monitor the effectiveness of therapy for various infections, but there is very little work in diabetic foot osteomyelitis. aim 1. to evaluate the role of procalcitonin as a screening tool to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis. aim 2. to determine the role of procalcitonin as a management tool to determine osteomyelitis treatment success versus treatment failure (indicated by bone biopsy) after completing a standard course of antibiotics for 6 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus * age ≥ 21 years * infectious disease society of america stage 3 infection exclusion criteria: * history of previous bone infection in the study foot * unable to provide informed consent * hiv, hepatitis, osteomyelitis at other sites

Keywords: procalcitonin biomarkers osteomyelitis diabetes foot ulcer(s) infectious disease society of america stage 3 infection
adherence in patients receiving pegintron and rebetol for hepatitis c in conjunction with a patient assistance program (study p04206)

Conditions: Hepatitis C, Chronic; Hepacivirus

Summary: patients receiving a patient assistance program during therapy for hepatitis c will be enrolled into this study. all patients will receive pegintron and rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. this study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase iv studies.


Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c naive to treatment exclusion criteria: * none
microwave imaging in neurotrauma

Conditions: Craniocerebral Trauma

Summary: the study aims to investigate whether microwave-based technology can be used as a bedside decision-making aid to identify patients who may have a bleed in their head. the md100 is a microwave-based head scanner, developed for the purpose of detecting strokes. in clinical trials, it was noticed that the device performed better when the patient suffered a stroke due to a bleed. it was believed that this device had wider applications in trauma care. the md100 has demonstrated a very high level of accuracy in detecting bleeds in small clinical trials in the non-acute setting. the device is supported by software that determines the presence of a bleed. this study will be set in the emergency department of major trauma centres. patients that have sustained a head injury will be considered for enrollment into the study. following a head ct scan, patients will be scanned by the md100. the trial will run in two phases. in phase one: the findings from the patient's head ct scan will be used to trial the device and teach the software what it is scanning. in phase two: the md100 will be tested to see whether it can concur with the findings of the patient's ct scan, this will be used to determine the accuracy and reliability of the device.


Eligibility criteria:
inclusion criteria: * patients 18 and over. * blunt head trauma * the patient has had a ct head scan exclusion criteria: * patients with head injuries penetrating the skull * patients with radiologically confirmed cervical spine fracture * patients with radiologically confirmed depressed skull fracture and/or dislocation * patients with implanted metal in or around their skull (including titanium places and surgical staples) * confirmed pregnancy * per the investigator's judgement, any condition or symptoms preventing the patient from entering the trial.

Keywords: head injury traumatic brain injury
novel stretching device versus night splints

Conditions: Plantar Fasciitis

Summary: a set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. the participants will use each device for 6 weeks. at the end of those 6 weeks, they will return for a follow up questionnaire. the answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.

the attached recruitment brochure will be distributed to physician's offices, and possibly placed as an ad in the newspaper. potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in carterville, il. during their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. the research participants will then stand on the tssfad1 device for 5 to 10 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period. the investigators will then use a random number generator program from www.random.org to generate a number between 1 and 100. participants with an odd number will be assigned home use of standard night splints. those with an even number will be provided with a tess unit to be used at home a minimum of 5 minutes twice per day. the participants will use their device for 6 weeks. they will receive a check in phone call at the 3 week mark of their participation. contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device. participant's random number will be used to link data in the study to the participant. the investigators will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of plantar fasciitis * ability to understand the purpose of the study * ability to safely use the device they are assigned after education and return demonstration. exclusion criteria: * patients with ankle fusion or significant balance impairment which would prohibit safe use of the tess device
the p53 colorectal cancer trial

Conditions: Colorectal Cancer Metastatic; Colorectal Cancer Stage IV; TP53 Gene Mutation

Summary: single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense cyclophosphamide every second week based on tp53 mutation status; i.e. only patients with tp53 mutated tumors may be included in the treatment arm.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer patients for whom conventional therapy has failed; defined as 2 lines of chemotherapy including oxaliplatin or irinotecan- containing regimens as well as an egfr inhibitor if applicable. * tumor lesion suitable for biopsy * age \>18 years * clinically or radiologically measurable tumor deposits according to the recist criteria * who performance status 0-1 * radiology studies (ct thorax/abdomen/pelvis) and echo cor and ecg must be performed within 28 days prior to registration. * before patient registration in the trial, written informed consent must be given according to national and local regulations. * blood test requirements: neutrophils \> 1.0 e9/l platelets \> 75 e9/l bilirubin \< 20 µmol / l. serum creatinine \< 1.5 x uln exclusion criteria: * co-morbidity including, but not limited to, impaired renal-, liver or bone marrow function, that based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses. * known hypersensitivity to the study drug, its metabolites or any excipients in the infusion solution. * psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * pregnant or lactating patients cannot be included. * clinical evidence of serious coagulopathy. prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist. * patient not able to give an informed consent or comply with study regulations as deemed by study investigator.

Keywords: cyclophosphamide colorectal cancer metastatic tp53 gene mutation
pharmacokinetics of levosimendan in pediatric intensive care units

Conditions: Acute Heart Failure

Summary: to describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ecmo, crrt)

levosimendan is a calcium sensitiver wih inotropic effects. it's use in the context of acute or chronic heart failure in children has yet to be defined. due to physical proprieties of levosimendan and metabolites, we hypothesized that concomitant use of extracorporeal devices such as ecmo will cause major pharmacokinetic variations. furthermore, pharmacokinetics of levosimendan in children with multiple organ failure has to be specify.

Eligibility criteria:
inclusion criteria: * all children admitted in pediatric intensive care units with planned infusion of 0.2 mcg/kg/min of levosimendan over 24h in context of routine care * arterial line or central venous catheter inserted for blood sampling procedures in context of routine care. exclusion criteria: * absence of clear parental status or information

Keywords: levosimendan pharmacokinetics children acute heart failure