Kornimate/medical-research-clean huggingface dataset:
randomized, placebo-controlled multicenter trial of lithium plus treatment as usual (tau) for acute suicidal ideation and behavior in patients with suicidal major depressive episode

Conditions: Suicidal Ideation/Behavior; Depression

Summary: the primary hypothesis of this confirmatory study is that lithium therapy will acutely decrease suicidal ideation and/or suicidal behaviour in inpatients with a major depressive episode (mde, unipolar and bipolar disorder according to dsm iv criteria). the specific aim is to test the hypothesis that lithium plus treatment as usual (tau), compared to placebo plus tau, results in a significantly greater decrease in suicidal ideation and/or behaviour over 5 weeks in inpatients with mde.

the study will consist of 254 adult patients, hospitalized for a major depressive episode with suicidal ideation and/or behaviour who will be randomized to two groups of each 127 participants. all study participants will receive treatment as usual in the hospital, including (psycho)pharmacological treatment and, if needed, psychotherapy plus a 5-week course of lithium or placebo. rating scales will be used daily resp. weekly to measure suicidal ideation and/or behaviour, depression, anxiety, mixed/manic features and impulsiveness. experienced clinicians will rate suicidal ideation and/or behaviour as well as depression twice a week and anxiety, mixed/manic features and impulsiveness once a week.

Eligibility criteria:
inclusion criteria: * major depressive episode; inpatient at screening visit; suicidal ideation/behaviour present defined by a clinical rating of 8 on the sheehan suicidality tracking scale (s-sts) and a rating of ≥20 on the montgomery asberg depression scale (madrs) at both screening and baseline visits; both gender, age 18 years. exclusion criteria: * contraindication for and history of lithium treatment within the past 6 months; patient unable to tolerate lithium treatment in the past; comorbid borderline/antisocial personality disorder, currently active substance dependency; patients with acute or unstable severe medical conditions, patients unable to understand the informed consent or involuntary inpatients, positive toxicology screen (illegal drugs), pregnancy and lactation

Keywords: anti-suicide lithium depression suicidal ideation/behavior
early assessment of myocardial tissue characteristics in obesity (early-myo-obesity)

Conditions: Obese

Summary: early-myo-obesity-cmr is a prospective, three-center, cardiac imaging study to investigate cardiac morphology, function, and tissue phenotypes in a cohort of non-diabetic obese adults, and compare with metabolically healthy non-obese controls.

1. transthoracic echocardiography was performed to analyze the lv morphology and function. 2. cmr was performed within 24 hours of the echocardiographic examination to assess the cardiac morphology , cardiac function, and myocardial tissue characteristics. standard cine images were acquired to quantify lv function and volume. t1 mapping-derived ecv values were used to detect subtle diffuse fibrosis , and late gadolinium-enhanced (lge) imaging was used to identify focal fibrosis. native t2 values were obtained to quantify myocardial edema . global longitudinal peak systolic strain (gls) and e' sr were assessed by tissue tracking analysis to detect subclinical systolic and diastolic dysfunction.

Eligibility criteria:
inclusion criteria: * age 18-75 years without cardiac symptoms or known cardiac diseas; * body mass index ≥25 kg/m2 exclusion criteria: * coronary artery disease (coronary artery stenosis \>50% on angiography or coronary computed tomography, documented myocardial infarction, or a history of coronary artery bypass graft surgery or percutaneous coronary intervention) * non-ischemic cardiovascular disease, such as idiopathic cardiomyopathy, valvular disease, congenital heart disease, or pulmonary heart diseas * a left ventricular (lv) ejection fraction of\<50% on echocardiography or a history of heart failure * arrhythmia or the presence of bundle branch block on electrocardiography * pacemaker or defibrillator implantation * renal dysfunction with an estimated glomerular filtration rate of \<60 ml/min/1.73 m2 * contraindications to cardiac magnetic resonance (cmr) imaging * malignancy or life expectancy of less than 2 year * inability to provide written informed consent
insomnia interventions in cancer survivors

Conditions: Insomnia

Summary: this study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

the purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including african-americans, latinos and caucasians. the results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.

Eligibility criteria:
inclusion criteria: * signed informed consent * age 18 and over * diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic * receiving treatment at one of the outpatient offices of the md anderson cancer center at cooper * self reported insomnia * not currently taking any medications to treat insomnia * no medical or psychological condition that would prevent successful protocol completion in the opinion of investigator.

Keywords: breast cancer prostate cancer colon cancer lung cancer gynecologic cancer
the use of visual feedback in airway clearance

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) patients perform airway clearance incorporating various breathing strategies, to clear secretions from their lungs. hand held devices may aid mucus expectoration, and also motivate the patient to manage by themselves. our aims was to study if resistive expiration through "volumetric incentive spirometer" (visex) can improve lung function in the short term in cystic fibrosis (cf) patients.


Eligibility criteria:
inclusion criteria: * cystic fibrosis patients exclusion criteria: * i.v. antibiotic therapy during the experiment day
a study to investigate the effect of a new postural bio-feedback device on low back pain

Conditions: Low Back Pain

Summary: a postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. the device records movement and muscle activity data relating to the lower back. bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).


Eligibility criteria:
inclusion criteria: 1. subject provides informed consent 2. age between 18 and 65 years of age 3. at least moderate intensity low back pain (lbp) and/or back related leg pain, as defined by a qvas score \> 3 (carragee, spine 2000). 4. initial qvas score of \> 3 out of 10 5. subjects must be assessed by the practitioner as sub acute (3 to 12 weeks post onset of low back pain (lbp) or chronic (\> 12 weeks post onset of low back pain (lbp). exclusion criteria: 1. lower back surgery within previous twelve (12) months. 2. females who are pregnant. 3. subjects with a severe hearing impairment. 4. evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder. 5. preceding chronic neurological changes (sub acute group only). 6. implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) 7. nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study. 8. significant medical abnormalities or conditions that in the opinion of the practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. 9. recent history of a significant medical-surgical intervention that in the judgment of the practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. 10. known allergic skin reaction to tapes and plasters. 11. subject who is currently enrolled in an investigational drug or device study.

Keywords: dorsavi vimove biofeedback objective movement data back pain
effects of low-intensity pulsed ultrasound on pain and functional disability in patients with lumbar spondylolysis

Conditions: Spondylolysis

Summary: low-intensity pulsed ultrasound (lipus) is effective in accelerating the healing of fractures, reduction in costs to the state, reduction in the numbers of those patients who progress from out-patient care to long term care who, in the process lose their ability to perform activities of daily living and consequently their independence.

aim of this study was to determine the effects of low-intensity pulsed ultrasound on pain and functional disability in patients with lumbar spondylolysis. thirty four (29 males \& 5 females) diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months aged between twenty to forty years were recruited. this randomized controlled trial was a part of phd physical therapy project conducted at department of physiotherapy, university of lahore teaching hospital, lahore, pakistan, from june 2020 to march 2021 by using non probability purposive sampling technique. subjects were divided randomly into two equal groups (group-a and group-b). lottery method was used to randomly assign patients into two groups. numeric pain rating scale (nprs) was utilized to measure pain intensity and oswestry disability index (odi) to measure functional disability. data was analyzed by using spss 21.

Eligibility criteria:
inclusion criteria: * both gender * diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months * age: 20-40 years exclusion criteria: * subjects with the history of neurological or autonomic deficits, * other fracture or bony abnormalities * rheumatic disease * other spinal problems * post-menopausal female * osteoporosis * osteopenia

Keywords: lumbar vertebra pain functional disability low-intensity pulsed ultrasound
effectiveness of nesa in the treatment of cancer survivors

Conditions: Cancer Survivors

Summary: cancer is a disease, or a set of diseases, that increased in our society. however, improvements in their detection and treatment increase the number of patients who survive. every year 2.6 million people are diagnosed in the european union and 1.4 million become cancer survivors. however, these people suffer the late adverse effects of treatment that can seriously affect their quality of life. the most common late effects are pain, fatigue, and sleeping difficulties. these are estimated between 58-90%. the autonomic nervous system (ans) appears to play an important role in the manifestation and perpetuation of these symptoms.

this study aims to evaluate nesa (or nesa non-invasive neuromodulation) to treat the most common long-term side effects in cancer survivors, due to the most used treatments. it will be compared between two groups of cancer survivors. the intervention group, with electrical stimulation, and the sham group, without electrical stimulation emission. the subjects will be assigned randomly. neither the patient, the therapist, nor the analysts/researchers will know the assignment. finally, this project aims to add a passive tool to the therapeutic arsenal of health professionals in the oncology field for the treatment of late side effects.

Eligibility criteria:
inclusion criteria: * be a cancer survivor (5 years after discharge) * have 1 of the 3 symptoms of the most common cluster: sleep problems, chronic fatigue, chronic neuro-muscular pain. exclusion criteria: * not have an active oncological process * present any of the contraindications of the nesa-xsignal device: pacemaker, internal bleeding, skin in poor condition (ulcerations or wounds), acute febrile processes, acute thrombophlebitis, pregnancy, phobia of electricity.

Keywords: cancer physical therapy modality electric stimulation therapy
dynamic position change in colonic adenoma detection

Conditions: Position; Colonoscopy; Adenoma

Summary: there was an only single operator study reporting dynamic position change during colonoscopy withdrawal significantly improved polyp and adenoma detection. so we designed a prospective, randomized multicenter study to verify the effect of dynamic position change in colonic adenoma detection. we think position change improve luminal distension and has the potential to improve adenoma detection rate.


Eligibility criteria:
inclusion criteria: * patient aged over 45 years who will be performed colonoscopy for the first time exclusion criteria: * polyposis syndrome * musculoskeletal problem * inflammatory bowel disease * previous bowel operation
efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination in treatment-naive and treatment-experienced subjects with chronic genotype 4 or 5 hcv infection

Conditions: Chronic Genotype 4 HCV; Chronic Genotype 5 HCV

Summary: this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) in participants with chronic genotype 4 or 5 hepatitis c virus (hcv) infection as measured by the proportion of subjects with sustained virologic response (svr12), defined as hcv rna \< lower limit of quantification (lloq) 12 weeks after discontinuation of therapy.


Eligibility criteria:
inclusion criteria: * hcv rna ≥ 10\^4 iu/ml at screening * chronic genotype 4 or 5 hcv infection * individuals may be treatment naive or treatment experienced * presence or absence of cirrhosis, a liver biopsy may be required * healthy according to medical history and physical examination with the exception of hcv diagnosis * agree to use two forms of highly effective contraception for the duration of the study exclusion criteria: * history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator * prior exposure to approved or experimental hcv specific direct acting antiviral(s) (daa) other than ns3/4a protease inhibitors * history of any other clinically significant chronic liver disease * evidence of or history of decompensated liver disease * hiv or chronic hepatitis b (hbv) infection * hepatocellular carcinoma (hcc) or other malignancy (with exception of certain resolved skin cancers) * chronic use of immunosuppressive agents or immunomodulatory agents

Keywords: hcv gt 4 hcv gt 5
ai-assisted ceeg diagnosis of neonatal seizures in neonatal intensive care unit

Conditions: Neonatal Seizure

Summary: a diagnostic accuracy study on artificial intelligence assisted continue eeg diagnostic tool is to carried out comparing with manually eeg interpretation as the golden standard for neonatal seizure.

the occurrence of neonatal seizures may be the first, and perhaps the only, clinical sign of a central nervous system disorder in the newborn infant. the incidence of neonatal seizures is variable based on gestational age. the etiology of seizures may indicate the presence of a potentially treatable etiology and should prompt an immediate evaluation to determine the cause and to initiate etiology-specific therapy. importantly, the earlier treatment of seizures positively affects the infant's long-term neurological development. however, even when continue electroencephalogram (ceeg) monitoring is available, the availability of on-site expertise to interpret ceeg signals is limited and in practice, the diagnosis is still based only on clinical signs. the previous study indicated that the reliable seizure detection was as little as 10% of seizure events. therefore, an early automated seizure detection tool has been developed based on machine learning. the lack of an automated seizure detection tool has been validated in the external neonatal seizures cohort. the evidence on the utility of the automated seizure detection tool remains uncertain. this is a prospective, continuous double-blind designed diagnostic accuracy study. the study aims to validate the accuracy of the artificial intelligence (ai)-assisted ceeg diagnostic tool comparing the manually ceeg interpretation as the golden standard of neonatal seizure in neonatal intensive care units. analysis of sensitivity and specificity is to evaluate the accuracy of ai-assisted ceeg diagnostic tool.

Eligibility criteria:
inclusion criteria: * postnatal age \< or = 28 days; * ceeg monitoring at least 12hours monitoring; * suspected seizures; * risk of intracranial hemorrhage; * abnormality of mri or ultrasound before ceeg; * neonates diagnosed with encephalopathy or suspected of encephalopathy; * hypoxic-ischemic encephalopathy or suspected hypoxic-ischemic encephalopathy; * metabolic disturbances (hypoglycemia, hypocalcemia, hypomagnesemia, inborn errors of metabolism); * central nervous system (cns) or systemic infections; * postsurgical neonatal within 3 days; * suspected genetic disease or positive genetic diagnoses; exclusion criteria: * the neonates with head scalp defect, scalp hematoma, edema and other contraindications which are not suitable for ceeg monitoring during hospitalization.
cll-1/cd33 targeted lcar-amdr cells in patients with relapsed or refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a prospective, single-arm, open-label, single dose-finding and dose-expansion study that evaluates the safety, tolerability, pk, and anti-tumor efficacy of lcar-amdr cells in subjects with relapsed/refractory acute myeloid leukemia who received adequate standard therapy.


Eligibility criteria:
inclusion criteria: 1. the subject voluntarily participates in the clinical study; fully understand and be informed of the study and sign the informed consent (informed consent form, icf)（for minors, the guardian shall also provide written informed consent ）; willing to follow and able to complete all test procedures; informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease; 2. age 14-60 years; 3. ecog score: ≤2; 4. relapsed/refractory aml must meet one of the following conditions: 1. twice or more relapse; 2. newly diagnosed aml patients who failed after 2 cycles of standard chemotherapy; 3. relapse within 12 months after cr, or relapse after 12 months with cr but failed to respond to conventional chemotherapy; 4. persistent extramedullary leukemia. 5. meet the requirements of allogeneic hsct 6. expected survival ≥ 3 months; exclusion criteria: 1. subject with apl/aml-m3:t(15;17)(q22;q12) 2. received any of the following treatments: * previous allo-hsct(subjects who received allo-hsct for more than 6 months, have stopped immunosuppressive drugs and have no active gvhd are not included in the exclusion criteria) * previous gene therapy * previous anti cd33/cll1 therapy * previous any target car-t cells therapy 3. prior antitumor therapy with insufficient washout period; 4. cns infiltration; except for patients with prior cns infiltration who are currently in remission; 5. hbsag, hbv dna, hcv-ab, hcv rna or hiv-ab positive; 6. pregnant or breast-feeding women;
comparison of viral particle dispersion following administration of an mdi or nebulizer in subjects with covid-19

Conditions: COVID-19

Summary: a randomized, 2-period crossover, single-center, open-label study for viral sample collection. after initiation of inhaled therapy with nebulizer or mdi, cascade impactors and surface samplers will be used to assess viral loads in rooms of subjects with covid-19.

observational study model = other \[non-treatment; impact on external location (rooms and surfaces)\] time perspective = other \[viral load samples taken at various time points after nebulization or mdi administered\] sampling method = non-probability sample \[to be described by study team\]

Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent, either themselves or via legally acceptable representative, prior to undergoing study procedures 2. willing and able to comply with study-related procedures/assessments 3. adults over 18 years of age 4. covid-19 infection as confirmed by pcr from nasopharyngeal, oropharyngeal swabs and/or saliva specimen taken within the previous 5 days exclusion criteria: 1. subjects currently receiving mechanical ventilation or noninvasive positive-pressure ventilation, or subjects who, in the opinion of the investigator, will require ventilatory support (i.e., mechanical ventilation or noninvasive positive-pressure ventilation) within the next 12 hours note: signs of impending need for ventilatory support include pronounced hypoxia despite supplemental oxygen \>6 l/min, prolonged respiratory rate (i.e., \>30 breaths per minute), signs of respiratory muscle fatigue, or paradoxical diaphragm. 2. presence of significant comorbidity that, in the opinion of the investigator, makes the subject unsuitable for participation in the study 3. known or suspected hypersensitivity to albuterol, history of paradoxical bronchospasm, or significant cough response to albuterol 4. participating in other clinical trials related to covid-19 thought to interfere with study interpretation (e.g., antivirals or antibodies that might change the viral load over the course of a day; subjects should not receive antibody therapy within 24 hours before the baseline period) 5. active or incompletely treated pulmonary infections, such as tuberculosis (or known history of nontuberculosis mycobacterium) over past 12 months 6. pregnant or currently breast feeding, or a positive urine pregnancy dip test performed at baseline (women only)

Keywords: nebulizer mdi meter dosed inhaler filter spacer covid-19 coronavirus disease 2019 sars-cov-2 aerosol viral transmission