Kornimate/medical-research-clean huggingface dataset:
detection of lipoarabinomannan in urine evaluation of the standardtmf tblamfia and its impact on the initial tb diagnosis

Conditions: Tuberculosis; Diagnoses Disease

Summary: evaluation of the performance of an in vitro test, the standardtm f tb lam ag fia (sd biosensor, inc.) for the early diagnosis of tuberculosis (tb) infection. this test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. the test will be used according to the instructions for use (ifu).

standardtm f tb lam ag fia is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample. the test evaluated in this study may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier to collect biological samples. the study can therefore be relevant for updating who guidelines for tb diagnosis. the results of the standardtm f tb lam ag fia will be interpreted according to the manufacturer´s instructions and will be compared to the results of the test performed to confirm the pulmonary tb, the extrapulmonary tb or the pulmonary ntm diagnosis (intention to treat assay). the test will be repeted at the end of the anti-tb therapy to evaluate if the test can be used as marker of treatment response. healthy subjects without exposure or risk for tb factors will serve as a proxy for specificity; subjects with confirmed tb will serve as control group to estimate sensitivity.

Eligibility criteria:
inclusion criteria: inclusion criteria for ptb, pntm and extraptb: * adult subjects with documented active pulmonary tb, pulmonary ntm or extrapulmonary tb * subjects who have signed informed consent * aged ≥18 years inclusion criteria for hc: * healthy donors who have signed informed consent * aged ≥ 18 years * no tb or ntm risk factors or exposure exclusion criteria: exclusion criteria for ptb, pntm and extraptb: * do not have active pulmonary tb, ntm or extrapulmonary tb * do not sign the informed consent * are aged \< 18 years exclusion criteria for hc: * have active pulmonary tb or ntm * do not sign the informed consent * are aged \< 18 years
pilot mammography reader study to assess breast cancer detection in ffdm plus dbt versus ffdm alone

Conditions: Breast Cancer

Summary: the purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

this pilot reader study was to determine the following: 1. the radiologist's performance metrics for the two reading modalities, i.e., "ffdm read on the aspire bellus workstation" and "ffdm read in conjunction with dbt read on the aspire bellus workstation",; 2. the magnitude and direction of differences between performance metrics for the two modalities; and 3. variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.

Eligibility criteria:
inclusion criteria: * female subjects participating in fmsu004a protocol with known clinical status exclusion criteria: * subjects with unknown clinical status not participating in fmsu004a protocol.

Keywords: mammography
train your sleep; treating adolescent insomnia with cognitive behavioral therapy for insomnia (cbt-i)

Conditions: Insomnia; Chronic Pain

Summary: the primary aim of this study is to understand how insomnia contributes to chronic pain in youth. specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. it is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. in this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation. study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (cbt-i) intervention, and a follow-up assessment. investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (qst). participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. qst will assess pain inhibition via conditioned pain modulation (cpm) and pain facilitation via temporal summation (ts).


Eligibility criteria:
youth inclusion criteria: * aged 12 to 17 years. * meets criteria for insomnia with or without comorbid chronic musculoskeletal pain. * parent/guardian available to provide consent. * patient and a primary caregiver are able to independently read and understand english well enough to provide informed consent and complete study procedures. * access to email, internet, and audio and video call capabilities. parent/guardian inclusion criteria: * parent/legal guardian of a child meeting above eligibility criteria * able to independently read and understand english well enough to provide informed consent and complete study questionnaires. youth exclusion criteria: * history of cardiac or neuromuscular disorder * parent-report of child's use of opioid medications (i.e., fentanyl, morphine, hydromorphone, methadone, hydrocodone, oxycodone) that cannot be discontinued for 7 days prior to study visits. * inadequate proficiency in english or a developmental disability that interferes with informed consent/assent or completion of study procedures. * history of obstructive sleep apnea, restless leg syndrome, or narcolepsy. * history of bipolar disorder and/or manic episodes * diagnosis of epilepsy. * currently in foster care or considered a ward of the state. * history of raynaud syndrome. * active suicidal ideation, intent or plan in the past month. parent exclusion criteria: • inadequate proficiency in english or a developmental disability that interferes with informed consent or completion of questionnaires.
no-commercial enteral diet for patients in home nutritional therapy: effects on anthropometric and biochemical indices

Conditions: Malnutrition

Summary: the objective is to evaluate the effect of no-commercial enteral diet for patients in home nutritional therapy in anthropometric and biochemical indices comparing to patients using commercial enteral diets.


Eligibility criteria:
inclusion criteria: * patients in home nutritional therapy receiving no-commercial enteral diets exclusion criteria: * baseline diseases others than neurological
staged versus simultaneous bilateral knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to assist surgeons and patients in answering the question "should i have both knees replaced at the same time, or should i just do one and wait to do the second one?"

this is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral ka. the primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs. this trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.

Eligibility criteria:
inclusion criteria: * patients considering bilateral knee arthroplasty * patients must sign the consent form * patients must be willing to complete the study questionnaires for the duration of the study exclusion criteria: * patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee * patients who are unable to complete the questionnaires

Keywords: bilateral, staged, simultaneous
standard versus oesophago-gastric junction complex myotomy for treatment naïve type 2 achalasia patients

Conditions: Esophageal Diseases

Summary: - consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. randomization is done according to the computer-generated algorithm. a clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. written informed consent will be obtained from all participants. in this study, the participants and the care-provider assessing the clinical response to the poem procedure at 3months will be blinded to the allocation.

. primary objective - • to study the incidence of true reflux on 24 hour ph analysis with manual study. secondary objective - * to analyse treatment success which is defined as eckdart score \< 3 at follow up assessment ( 3rd month) * to analyse the recovery of peristalsis after poem using high resolution manometry * to study total procedure time , intra operative adverse effects and duration of hospital stay. * severity of oesophagitis * presence of gerd symptoms based on gerd questionnaire \& quality of life questionaire post procedure.

Eligibility criteria:
inclusion criteria: * adult \>18 years * diagnosis of type 2 achalasia cardia based on high resolution manometry. exclusion criteria: * patients with type 1 \& 3 achalasia cardia * patients with previous endoscopic or surgical treatment for achalasia * patients with standard exclusion criteria for poem procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio \> 1.5, platelet count \< 50 000/μl), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
sitagliptin comparative study in patients with type 2 diabetes (0431-049)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes


Eligibility criteria:
general inclusion criteria: * patient has type 2 diabetes mellitus (t2dm) * patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy general exclusion criteria: * patient has a history of type 1 diabetes mellitus or history of ketoacidosis * patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months
alterations of functional activities and leg stiffness after hamstring lengthening in cerebral palsy children

Conditions: Cerebral Palsy; Crouch Gait

Summary: cerebral palsy (cp) is the most prevalent physical disabilities originating in childhood. crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. this surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand.

cerebral palsy (cp) is the most prevalent physical disabilities originating in childhood. crouch gait is a common gait abnormality in patients with cerebral palsy, which is common treated with hamstring lengthening. this surgery can alter mechanical property of lower limb and affected ability of generating force in hamstring, leading changes in functional activities. therefore, the first aim of this study is to investigate the effects of hamstring lengthening on pelvis and hip control while performing functional activity, including level walking and sit-to-stand. gait or motion analysis has been used widely in the diagnosis of patients with locomotor pathology and the subsequent planning and assessment of treatment. ten subjects diagnosed with spastic diplegic cerebral palsy and crouch gait will be recruited and ten healthy controls will be recruited in this study with inform consents. detailed physical examination and motion analysis experiments will be performed in normal group and in spastic diplegic patients before the hamstring lengthening and follow ip after six months. the subjects would be asked to perform level walking with self-selected pace and sit-to-stand from an armless chair. for each test, subjects would repeat at least 5 times, with their kinematic, kinetic and emg data collected simultaneously. with thorough analysis and comparison of these data, it is hoped that a reference in clinical decision of hamstring lengthening can be established, and a complete knowledge of the effects after hamstring lengthening, which will be helpful for future clinical rehabilitation.

Eligibility criteria:
inclusion criteria: * cerebral palsy * couch gait exclusion criteria: -
pet imaging of solid tumors using 124i-humanized 3f8: a pilot study

Conditions: Melanoma; Neuroblastoma; Sarcoma

Summary: the purpose of this study is to find out how an antibody called hu3f8 travels through the body and to tumors. antibodies, like hu3f8, are proteins that help attack tumors or fight infections. antibodies can be made by your own body or in a laboratory. the target of an antibody is called an antigen; antibodies fit their antigen like a lock fits a key.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of neuroblastoma must meet both of the following criteria: * diagnosis confirmed by histological assessment by mskcc department of pathology or by the presence of bm metastases plus elevated urinary catecholamines * relapsed or refractory stage 4 disease or relapsed or refractory stage mycn-amplified 2b or 3 disease. * patients with tumors other than neuroblastoma must meet both the following criteria: * have one of the following diagnoses (these tumors are known to express gd2 on cell surface): * melanoma * osteogenic sarcoma * leiomyosarcoma * ewing sarcoma * liposarcoma * fibrosarcoma * malignant fibrous histiocytoma * spindle cell sarcoma * small cell lung cancer * medulloblastoma metastatic to extracranial sites * paraganglioma * have refractory or relapsed or metastatic disease * patients with solid tumors with diagnoses other than neuroblastoma or those listed above will be eligible if they meet both of the following criteria: * immunohistochemical demonstration of gd2 expression on cell surface (tumor assessment by immunohistochemistry is required for this group of patients) * have refractory or relapsed disease or metastatic disease. all patients must have measurable or evaluable disease * age 3-90 years * prior treatment with anti-gd2 monoclonal antibody is permitted only if human anti-human antibody titer is ≤1300 assay developed by dr. nai-kong cheung. * negative serum pregnancy test in women of childbearing potential * women of child-bearing potential must be willing to practice an effective method of birth control while on study * signed informed consent indicating awareness of the investigational nature of this study. exclusion criteria: * existing major organ dysfunction \> grade 2, with the exception of myelosuppression (neutrophil count \> or = 500/μl and platelet count \> or = 25,000/μl are acceptable) and hearing loss. * acute life threatening infection * requirement for sedation for pet/ct scans * pregnant women or women who are breast-feeding. * inability to comply with protocol requirements. * hypersensitivity to potassium iodide or lugols products * prior development of positive human antimouse antibody response (hama) or human antihuman antibody response (haha) * positive human anti-hu3f8 antibody titer.

Keywords: 124i-humanized 3f8 pet imaging 13-147
role of basal ganglia and thalamus in perceptual consciousness and metacognition

Conditions: Parkinson Disease; OCD; Dystonia

Summary: the term perceptual awareness refers to subjective experience... or the phenomenology associated with the processing of a sensory stimulus. the term metacognition refers to our ability of introspection, knowledge and control of our own cognitive processes. the objective of this research is to establish the contribution of the basal ganglia and thalamus to the perceptual awareness and meta-cognition, using deep brain stimulation coupled with electroencephalography.


Eligibility criteria:
inclusion criteria: * major patient in need of brain stimulation therapy for motor disorders (parkinson's disease, tremor, dystonia) or psychiatric disorders (ocd). * outpatient or inpatient follow-up * fluent in french and able to understand the study procedures * informed consent * patient affiliated to social security * written agreement to participate in the patient's study * intellectual abilities compatible with the performance of cognitive or motor tasks exclusion criteria: * persons referred to in articles l1121-5 to l1121-8 of the csp (pregnant women, parturient women, mothers, etc.) who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure * patients in whom transient cessation of stimulation is not tolerated * subject in period of exclusion from another study * subject cannot be contacted in case of emergency * subject under administrative or judicial supervision

Keywords: metacognition consciousness deep brain stimulation
the effect of a music intervention on postictal agitation in electroconvulsive therapy patients

Conditions: Music Intervention; Electroconvulsive Therapy Treated Patients; Agitation on Recovery From Sedation

Summary: this study will investigate the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.

postictal agitation (pia) is a fairly common adverse effect after electroconvulsive therapy (ect) treatment that, when present, predicts other complications such as retrograde amnesia. multiple studies have suggested that a music intervention in the context of surgery significantly reduces pre-operative anxiety, as well as the need for sedatives and analgesic medication. pretreatment anxiety is common for ect patients and is a known predictor of pia. currently, there is no preventative treatment for pia. given the beneficial effects of music demonstrated in similar hospital settings combined with its easy implementation and lack of side effects, the investigators hypothesize that music listening can lower the incidence and severity of pia among patients undergoing ect therapy, thereby also reducing post-treatment cognitive impairment. therefore, the objective of the study is to assess the effect of music on postictal agitation when played peri-interventionally for patients undergoing electroconvulsive therapy for severe depression.

Eligibility criteria:
inclusion criteria: * patients undergoing ect treatment for depression (including depression as part of bipolar disorder) * adult patients (≥18 years) * hypnotic agent used is etomidate * sufficient understanding of the dutch language (in judgement of the attending physician or researcher) * written informed consent by patient or legal representative exclusion criteria: * significant impaired hearing (defined as unable to communicate verbally or listen to music) * severe neurological condition (defined as interfering with the ability to process music) * patients receiving ect for treatment of schizophrenic disorders

Keywords: music postictal agitation electroconvulsive therapy
a case-control study on the differentiation between cough variant asthma and chronic cough

Conditions: Asthma

Summary: this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model.

the investigators retrospectively collected information from patients with chronic cough who underwent pulmonary tests at the first affiliated hospital of zhejiang chinese medical university from january 2019 to december 2019. data of external test were also from the first affiliated hospital of zhejiang chinese medical university, and time period was from january 2023 to april 2023.pulmonary function test and methacholine challenge test was performed by professional technicians. characters between patients with cough variant asthma and chronic cough were compared to establish a diagnostic model.

Eligibility criteria:
inclusion criteria: * (1) age from 18 years old to 65 years old; (2) clinical diagnosis of cva and cc . exclusion criteria: * exclusion criteria for cva were: a history of copd, bronchiectasis, bronchitis, cystic fibrosisor pneumonia, interstitial lung disease, pulmonary tuberculosis, lung cancer; cough caused by drugs or treatments; patients with upper airway cough syndromes (uacs) and gastroesophageal reflux-related cough (gerc) or other apparent causes of cough; patients who used corticosteroid (ics) in the previous four weeks; exclusion criteria for cc were: a history of variable airway limitation.

Keywords: small airway dysfunction cough variant asthma chronic cough
a study of ly3303560 in healthy participants and participants with alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of the study drug, ly3303560. side effects and laboratory results will be monitored. this study will involve single doses of ly3303560 administered intravenously (iv), meaning into a vein or subcutaneously (sc), meaning under the skin. screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for ad participants. the study requires about 16 weeks of each participant's time including a 4 day clinical research unit (cru) admission and 10 follow-up appointments. this is the first time that this study drug is being given to participants. this study is for research purposes only, and is not intended to treat any medical condition.


Eligibility criteria:
inclusion criteria: * overtly healthy males or females of non-childbearing potential and who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * ad participants must be at least 50 years of age and have diagnostic criteria consistent with either mild cognitive impairment due to ad or mild-to moderate ad and have a positive florbetapir positron emission tomography (pet) scan exclusion criteria: * have known allergies to ly3303560, related compounds or any components of the formulation, or history of significant atopy * have an increased risk of seizures * for ad participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by magnetic resonance imaging (mri)
post operative adjuvant chemotherapy followed by adjuvant tamoxifen vs nil for patients with operable breast cancer

Conditions: Breast Cancer

Summary: post operative adjuvant chemotherapy followed by adjuvant tamoxifen vs nil for patients with operable breast cancer


Eligibility criteria:
inclusion criteria: * patients with operable breast cancer