Kornimate/medical-research-clean huggingface dataset:
evaluating the effectiveness of the acute respiratory infection smart form

Conditions: Respiratory Tract Infections

Summary: to evaluate the effectiveness of the acute respiratory infection smart form

specific aim 1: to design and implement an integrated documentation-based clinical decision support and physician feedback system, provided in an electronic health record (ehr), to improve the management of patients with acute medical conditions. hypothesis 1: a documentation-based clinical decision support tool (cdss) "smart form" physician feedback system, can be designed and implemented to facilitate documentation and physician order-entry, provide individualized, evidence-based recommendations for the management of patients acute respiratory infections (aris), and are usable by primary care physicians. specific aim 2: to determine the effectiveness of documentation-based cdss and physician feedback on documentation and the clinical management of patients respiratory tract infections. hypothesis 2a: a documentation-based cdss "smart form" will increase the documentation of important clinical data in patients with ari when compared to usual practice. hypothesis 2b: a documentation-based cdss "smart form" will increase adherence with guidelines for the management of patients with ari when compared to usual practice.

Eligibility criteria:
inclusion criteria: acute respiratory infection visit exclusion criteria: any patients who are not part of a panel of a participating physician

Keywords: upper respiratory infections respiratory tract infections tree number c01.539.739 tree number c08.730 unique id d012141
motion sifnos: a study to investigate the efficacy of tradipitant in subjects affected by motion sickness

Conditions: Motion Sickness

Summary: randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive); * body mass index (bmi) of ≥18 and \<40 kg/m2; * history or symptoms consistent with motion sickness exclusion criteria: * chronic nausea due to condition other than motion sickness; * a positive test for drugs of abuse at the screening or evaluation visits; * clinically significant deviation from normal clinical laboratory results
a multi-center diagnostic stewardship program to improve respiratory culture utilization in critically ill children

Conditions: Ventilator Associated Pneumonia; Tracheobronchitis

Summary: the objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.

the bright star collaborative, or testing stewardship to reduce antibiotic resistance collaborative, is a prospective multicenter quality improvement (qi) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods. greater than or equal to 10 institutions will participate in this collaborative. participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (qi) program in their pediatric intensive care unit (picu). specific aim 1: evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use. specific aim 2: to determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock. variables: total respiratory culture rates, culture results, icu length of stay, mortality rates, hospital and icu readmission, cause of death, ventilator-associated infection/ventilator-associated condition rate, sepsis, septic shock. analysis: the analytic approach equates to estimating and comparing the respiratory culture incidence during the "baseline/pre-implementation" and "post-implementation" periods, using a generalized linear mixed model (glmm) assuming a poisson distribution for the monthly number of respiratory cultures with the monthly number of ventilator days as an offset. similar analyses will be performed for secondary outcomes.

Eligibility criteria:
inclusion criteria: * institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their pediatric icus exclusion criteria: * institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their pediatric icus

Keywords: diagnostic stewardship pediatric respiratory culture test
effects of a physical rehabilitation program using the nintendo wii on children with osteogenesis imperfecta (oi)

Conditions: Osteogenesis Imperfecta

Summary: children with osteogenesis imperfecta are described as extremely sedentary and therefore fatigable, which strongly impacts their daily activities. the physical rehabilitation of these children is a fundamental aspect of treatment. it has been shown that playing wii console causes the same increase in energy expenditure than practicing moderate exercise, while ensuring user safety. this type of physical exercise with this type of fun game console might have a role in the treatment of oi children on the physical side but also on the psychological side.


Eligibility criteria:
inclusion criteria: * - children affiliated to a social security scheme * children diagnosed oi by a competent physician of one of the french specialist centers; * oi children type 1 or type 4; * stable oi (far from a fractional episode of at least two months); * children without regular activity on the nintendo wii console or other interactive console; * boy or girl\> 6 to 18 years * parents or person having parental authority affiliated to a social security scheme * parents or person having parental authority who signed the consent form for the study. exclusion criteria: * - children who can not walk; * children with severe oi other than type 1 or type 4; * fracture during the last two months; * surgical intervention within the last 8 months; * inability to understand and follow the protocol; * participation in another clinical study; * children, parents or holder of parental authority refusing the written consent.

Keywords: osteogenesis imperfecta physical exercise training wii muscular strength
brief behavioral weight loss treatment vs. weight watchers

Conditions: Obesity; Overweight

Summary: the purpose of this study is to compare the effectiveness of weight watchers, brief behavioral treatment, and a combination treatment. we hypothesize that a combination treatment will achieve greater weight losses than weight watchers alone.

weight watchers is a popular nonmedical commercial weight loss program. recent studies suggest that people enrolled in weight watchers lose approximately 3-5 kg in 6 months of treatment. these outcomes are substantially lower than average weight losses achieved in 6 months if university/hospital-based standard behavioral treatment (approximately 10 kg). however, standard behavioral weight loss programs are expensive and have limited accessibility to most people seeking weight loss. therefore, the purpose of the current study is to investigate whether enhancing weight watchers by adding an 8-week group-based behavioral weight loss program prior to participation in weight watchers will improve weight loss outcomes at 6 months. comparison: 6 months of weight watchers vs. combination treatment (2 months of standard behavioral weight loss treatment followed by 4 months of weight watchers) vs. 2 months of standard behavioral treatment.

Eligibility criteria:
inclusion criteria: age 21-65 years bmi 27-45 kg/m2 able to sign informed consent exclusion criteria: women who are pregnant, nursing, less than 6 months postpartum, or plan to become pregnant during course of study individuals who report a medical condition that would affect the safety and/or efficacy of a weight management program involving dietary change and physical activity (e.g., heart disease, cancer) individuals with major psychiatric illness that would interfere with protocol adherence individuals who are currently participating in a weight loss program or taking weight loss medication or lost \>=5% of body weight during 6 months prior to screening recent (within the past 12 months) participation in weight watchers

Keywords: behavioral weight loss treatment brief behavioral treatment commercial weight loss programs weight watchers
paracervical pouch in placenta accreta spectrum

Conditions: Placenta Accreta

Summary: the study objective is the significance of the ultrasound detection of the paracervical pouch in placenta accreta spectrum. it aimed to evaluate its relation to the degree of placenta accreta spectrum, amount of the blood loss and the number of packed red blood cells transfused.

the study will be carried on patients diagnosed with placenta previa or placenta accreta spectrum and had at least one caesarean section. the study will be divided into 2 groups of 70 patients at least per each. the first group will include patients in whom a paracervical pouch is detected, and the second group will include patients in whom the pouch is not detected by transvaginal ultrasound. paracervical pouch is defined ultrasonographic as the downward displacement of the uterine serosa from the level of the cervical internal os

Eligibility criteria:
inclusion criteria: * • patients between 19 to 40 years old * patients had at least one cesarean section. exclusion criteria: * • patients who request hysterectomy. * patients diagnosed with hepatitis b, c, or hiv, * those with bleeding diathesis. * patients whose bmi is more than 40 kg/m2. * patients who need an emergency cesarean section.

Keywords: placenta adherence
efficacy and safety study of certolizumab pegol (czp) versus active comparator and placebo in subjects with plaque psoriasis (pso)

Conditions: Psoriasis; Plaque Psoriasis

Summary: the purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.

this study consists of the following periods: * initial treatment period from week 0 to week 16 * maintenance treatment period from week 16 to week 48 * open-label extension treatment period (96 weeks) * safety follow-up (10 weeks)

Eligibility criteria:
inclusion criteria: * provided informed consent * adult men or women \>= 18 years * chronic plaque psoriasis for at least 6 months * baseline psoriasis activity and severity index \>= 12 and body surface area \>= 10 % and physician's global assessments score \>= 3 * candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy * other protocol-defined inclusion criteria may apply exclusion criteria: * erythrodermic, guttate, generalized pustular form of psoriasis * history of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol * congestive heart failure * history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease * concurrent malignancy or a history of malignancy as described in the protocol * history of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis) * female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug in the uk, czech republic, germany, and france, and within 3 months for all other countries. male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in france and within 10 weeks in all other countries * any other condition which, in the investigator's judgment, would make the subject unsuitable for participation in the study * other protocol-defined exclusion criteria may apply

Keywords: certolizumab pegol cimzia psoriasis
the additional effect of different taping applications in patients with lumbar radiculopathy

Conditions: Low Back Pain, Recurrent; Kinesiotape; Quality of Life; Physiotherapy

Summary: our study aims to compare the therapeutic effects of different taping materials and techniques on pain, functionality, and tissue temperature in patients with lumbar radiculopathy.

pain occurs due to the intervertebral disc; ligaments in the region; or degeneration, strain, and sprains in the muscles, neurogenic, inflammatory, infectious, or neoplastic problems caused by structures in and around the spine . low back pain is a serious health problem, with a lifetime prevalence of 84% . according to the american society of pain's clinical practice guidelines, low back pain is classified into three categories: nonspecific low back pain, radiculopathy-induced low back pain, and low back pain associated with another specific cause. a multidisciplinary approach is recommended for the treatment of low back pain. before pharmacological treatments, cognitive behavioral therapy, physiotherapy exercise programmes, electrical physical therapy modalities, manual therapy, and psychological therapy are frequently referenced treatment options. taping is one of the conservative physical therapy methods that is often a preferred treatment in clinics. rigid (athletic) taping and kinesiological taping are the most preferred taping techniques . non-elastic taping material is used in the rigid taping application. it is used to position soft tissue and ensure that the tissues come together, are protected from contact, create compression, and prevent local swelling. studies supporting the sensorimotor and proprioceptive sensory enhancing effects of rigid tape, which provides very good sensory input over the skin, are found in previous studies \[7-9\]. unlike rigid tape, kinesio tape can be stretched up to 140% of its resting length due to its structure, which is the approximate stretching capacity of normal skin . although there are various studies related to this topic, there is still no consensus on the effectiveness of taping in patients with low back pain who have disc degeneration. the reason for this is that some studies show the positive effect of kinesio taping on the reduction of low back pain, but some cannot show the effect of taping or find any changes . the healing mechanisms of different taping treatments have not been fully clarified. moreover, local temperature, which is one of the indicators of vascularization and tissue healing, has not been investigated widely. our study aims to examine the effects of different taping materials and techniques on pain, functionality, and local tissue temperature in patients with lumbar radiculopathy.

Eligibility criteria:
inclusion criteria: * the criterion for inclusion in the study for volunteers was low back pain due to lumbar radiculopathy. exclusion criteria: * exclusion criteria were skin disease, central nervous system damage, tumour in the spine, surgical operation of the spine, pregnancy, and rheumatic disease

Keywords: low back pain kinesiotape quality of life skin temperature physiotherapy
dextromethorphan in treating patients with fatigue caused by cancer

Conditions: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: dextromethorphan may help relieve fatigue in patients with cancer. purpose: this clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.

objectives: primary * assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue. secondary * correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate. outline: this is a multicenter, open-label, pilot study. patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7. treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of malignancy * must be undergoing active treatment for malignancy which may include hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate), but not radiotherapy alone * fatigue score ≥ 4 on a verbal analogue scale of 0 to 10 * no untreated cancer-related anemia patient characteristics: * hemoglobin \> 10 g/dl * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * able to swallow pills * no known allergy to dextromethorphan hydrobromide * no patients known to be phenotypically poor metabolizers of cyp2d6 * no untreated hypothyroidism prior concurrent therapy: * see disease characteristics * prior single-dose inhibitors (e.g., ranitidine or cimetidine) for hypersensitivity prophylaxis allowed * erythropoietic growth factor therapy of \> 8 weeks duration allowed * no concurrent cyp2d6 inducers or inhibitors * no concurrent monoamine oxidase inhibitors * no other concurrent medications containing dextromethorphan hydrobromide * no concurrent over-the-counter medication, herbal product, vitamin, food supplement, or any other type of special product unless permission to continue use is obtained from the principal investigator * no other concurrent anticancer investigational agents or therapies

Keywords: unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific fatigue
the effect of bms-986195 combined with an oral contraceptive (ethinyl estradiol/norethindrone) in healthy female patients

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to investigate the effect of bms-986195 in combination with an oral contraceptive in healthy female patients.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.0 and 32.0 kg/m2 inclusive, * weight ≥ 50 kg * negative result for tuberculosis (tb) as evidenced by a quantiferon-tb gold plus test at screening, or documentation of a negative result within 4 weeks before cycle 1, day 1 * women of childbearing potential with intact ovarian function, on a stable regimen of combination birth control containing ee without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to cycle 1 day -1 * subjects aged 21 years or older must have a normal pap smear result within 3 years before cycle 1 day 1 (a pap smear may be performed at screening if no result is available); a finding of abnormal squamous cells of unknown significance (ascus) is allowed provided it is an initial finding and not a follow up from an initial finding of ascus exclusion criteria: * exposure to an investigational agent within 12 weeks before cycle 1 day 1 * subjects who are pregnant or breastfeeding * any significant acute or chronic medical illness including infection, any active infection, febrile illness within 7 days before cycle 1, day 1, or any condition that could predispose the subject to infection * history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic urinary tract infection is 2 episodes within 6 months) * any serious acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening * known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (eg, history of splenectomy, primary immunodeficiency, etc) other protocol defined inclusion/exclusion criteria could apply
safety and efficacy study of tnx-102 sl in patients with military-related ptsd

Conditions: PTSD

Summary: this is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg tnx-102 sl (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years of age, who have served in any branch of the military. * diagnosed with current ptsd as determined by the clinician-administered ptsd scale (caps-5) for dsm-5. * index trauma(s) resulting in ptsd must meet dsm-5 criterion a for ptsd as described in caps-5, have occurred in 2001 or later, be military service related. * willing to refrain from use of all other formulations of cyclobenzaprine. * willing and able to refrain from antidepressants and other excluded medications. * capable of reading and understanding english and able to provide written informed consent. * if female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study. * willing and able to comply with all protocol-specified requirements. exclusion criteria: * increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol. * significant (e.g., moderate or severe) comorbid traumatic brain injury (tbi) by history. * severe depressive symptoms at screening or baseline. * clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion. * use of antidepressant medication within 2 months of baseline. * female patients who are pregnant or lactating. * history of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients. * seizure disorder. * patients with a body mass index (bmi) \> 45. * has received any other investigational drug within 30 days before screening. * previous participation in any other study with tnx-102 sl. * family member of investigative staff.

Keywords: ptsd military-related ptsd