Kornimate/medical-research-clean huggingface dataset:
clonal evolution of b cells in high-risk cll after idelalisib-rituximab

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of the study is to assess the evolution of b cells at a genetic and surface-marker level in high-risk cll after idelalisib-rituximab treatment. the targeted population includes 20 subjects ages 18 or older diagnosed with high-risk cll. this will include patients with relapsed or refractory disease who require therapy with idelalisib and rituximab as per fda label. this is an observational study for peripheral blood samples of these patients collected at pre-determined time points.


Eligibility criteria:
inclusion criteria: * age over 18 * ability to provide informed consent * ability to provide peripheral blood samples * diagnosis of cll * indication(s) for cll therapy * at least one criterion for high-risk disease * disease refractory (e.g., no response) to at least one round of chemotherapy * disease that has relapsed (i.e., returned) after at least one round of chemotherapy * proven presence of the 17p deletion within cll cells * planned receipt of idelalisib-rituximab as per fda guidelines and patient's oncologists exclusion criteria: * patients who do not meet the diagnostic criteria for cll or at least one indication for treatment. * patients who are receiving idelalisib with an off-label indication * patients who do not or cannot provide informed consent to donate peripheral blood tumor samples to our stem cell core facility * patients who do not provide informed consent to collect clinical, prognostic, and outcomes data during the time period that they are treated with idelalisib-rituximab
physical therapy intervention for puerperal mastitis

Conditions: Mastitis

Summary: puerperal mastitis is one of the most commonly reported problems during breastfeeding. women frequently report breast pain, tenderness, redness, engorgement, fever, malaise, chills, lethargy, sweating, headache, nipple damage and a hot spot on the affected breast. these highly distressing symptoms may severely impact on a woman's daily activities and quality of life and might lead to the premature cessation of exclusive breastfeeding, which may have significant impact on infant health and survival. the role of physical therapy in reducing pregnancy/postpartum-related disorders including breast problems is gaining momentum and importance in obstetrics. however, to date, only low-level evidence has shown positive effects of breast massage, a physical technique, on pain, milk supply and symptom relief in women with breastfeeding problems. this is encouraging, however further research is needed to explore whether physical therapy is effective to reduce symptoms of puerperal mastitis. the investigators will conduct a prospective, assessor blinded single-center randomized controlled trial to assess the effectiveness of an individualized physical therapy program with therapeutic ultrasound, education and massage for patients with puerperal mastitis, compared to patients receiving usual obstetric care and sham ultrasound treatment.

the high incidence of mastitis in breastfeeding women places health professionals working with postpartum women in key positions for managing women for symptoms of mastitis. this study aims to investigate the effectiveness of a physical therapy program for mastitis. the data the investigators collect from this study will provide evidence on effective and targeted strategies to achieve the goals of acceptable, effective and low risk physical therapy treatment of mastitis in postpartum women. once these perspectives are known, recommendations on mastitis management can be made.

Eligibility criteria:
inclusion criteria: * have given birth at national cheng kung university hospital (nckuh) * are breastfeeding * are aged 21-35 * are diagnosed with early stage mastitis * have sufficient chinese/mandarin language skills to participate exclusion criteria: * history of breast reduction or augmentation * an abscess * severe physical/psychiatric impairments * presence of any malignancies
study of the evolution profile of the renal doppler in the perioperative hepathic transplantation

Conditions: Acute Renal Failure

Summary: liver transplantation is associated with a modification of the perfusion pressures of the abdominal organs (preoperative portal hypertension in connection with liver pathology, and normalization of the perfusion pressures during surgery). this abrupt change in the infusion regime is probably responsible for an alteration in renal function in some patients, and the identification of renal vascular profiles using doppler could point to pathological profiles, which should be diagnosed early.


Eligibility criteria:
inclusion criteria: * patient of full age (≥18 years) * patient operated on at the hus for a liver transplant, between july 1, 2019 and june 30, 2020. * patients having undergone an evaluation of hepatic and renal vascular profiles perioperatively. * patients hospitalized in the surgical intensive care unit after hepatic transplant surgery. * patient not having expressed, after information, the reuse of his data for the purposes of this research exclusion criteria: * patient who expressed his opposition to participating in the study * patient with suspected obstructive acute renal failure * stenosis of renal arteries known at the time * end-stage renal disease on dialysis * impossibility of giving the subject informed information (difficulties in understanding the subject, etc.) * subject under safeguard of justice

Keywords: acute renal failure chronic renal failure liver transplant renal vascular profiles intraoperative hemodynamic instability acute tubular necrosis renal doppler
validating the matadoc against best practice standard external reference standard

Conditions: Brain Injuries

Summary: the purpose of this project is to further develop a standardized music-based measure used in music therapy with adults who have emerged from coma following profound brain injury, but are not able to demonstrate responsiveness to their environment due to complex clinical needs. building on previous work, the project aims to strengthen the psychometric properties (e.g. concurrent validity, responsiveness) of the measure for its use with adults with profound brain damage.

adult patients with prolonged disorders of consciousness (pdoc), but who have not been diagnosed as minimally conscious or vegetative state, will be recruited. all participants will be assessed using the music therapy assessment tool for awareness in disorders of consciousness (matadoc) standardized protocol. assessment intervention will take place in four individual clinical contacts, over a 16 day period. data will be collected using the matadoc rating form and scored according to the matadoc manual. participants will concurrently be assessed with coma recovery scale-revised (crs-r). the matadoc is implemented by music therapists who have been trained in its use and who are experienced in working with adults with pdoc. crs-r data will be collected by members of the treatment team who are experienced or trained in its use. matadoc and crs-r assessors will remain blinded to the data collected. analysis will compare diagnostic outcomes of the two measures as well as explore the function of comparable items of each measure across similar domains (e.g. auditory, visual).

Eligibility criteria:
inclusion criteria: * medically stable patients (i.e. not currently suspected of or under investigation for infection)who have a prolonged disorder of consciousness i.e. has persisted for longer than 4 weeks * between the ages of 18 and 70 years of age * a diagnosis of awareness (i.e., vs, mcs or emergent) is not confirmed or is under investigation * fluent in english language comprehension as reported by the family exclusion criteria: * known pre-morbid hearing impairments * the patient has a previous diagnosis of musicogenic epilepsy * the patient had previously refused music therapy intervention * patients with a suspected diagnosis of locked-in syndrome * non-fluent in english comprehension as reported by family.

Keywords: vegetative state (vs) minimally conscious state (mcs) brain injuries
propofol versus midazolam for upper endoscopy in cirrhotic patients

Conditions: Cirrhosis

Summary: upper gi endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. the purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper gi endoscopy.

background : upper gi endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. aim: the purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper gi endoscopy. methods: 60 outpatients who has known chronic liver disease (child-pugh class a or b) (cirrhosis) and are undergoing variceal screening will be randomized to receive propofol or midazolam for sedation. administration of sedation was performed by a anesthesist. outcome measures studied are induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function and subclinical hepatic encephalopathy (number connection test), and saturation of oxygen. expected results: the mean time to achieve adequate sedation will be shorter for for the propofol group in comparison to midazolam group. the level of sedation achieved by the propofol group will be greater. time to full recovery will be faster in the propofol group. propofol do not exacerbate subclinical hepatic encephalopathy as compared to midazolam. patients receiving propofol will express greater overall mean satisfaction with the quality of their sedation at the time of discharge. conclusions: propofol sedation is expected not to exacerbate subclinical hepatic encephalopathy in cirrhotics.

Eligibility criteria:
inclusion criteria: * known chronic liver disease (child-pugh class a or b) who presented for upper gi endoscopy for routine variceal screening. * the diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available. * staging of cirrhosis will be determined by meld score and by child-pugh score . all patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites. exclusion criteria: * exclusion criteria will include the following: * known allergy or adverse reaction to sedative or component thereof * patients with known significant respiratory disease or airway abnormality) * active neurological impairment including clinically detectable hepatic encephalopathy * advanced or decompensated liver disease ( cp score \>10, meld \>24) (child-pugh class c) * active alcohol consumption or illicit drug abuse * active prescription for sedation or narcotics

Keywords: propofol midazolam sedation cirrhosis endoscopy recovery time efficacy and safety of sedation patient satisfaction return to baseline function saturation of oxygen
efficacy and safety of insan bamboo salt on improvement of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of insan bamboo salt on improvement of helicobacter pylori infection. the investigators measured improvement of helicobacter pylori infection parameters , including 14c-ubt(urea breath test), and subjects' symptoms, and monitored their blood pressure.


Eligibility criteria:
inclusion criteria: * males and females 19-65 years old * 14c-ubt test ≥ 100 cpm * endoscopy results showing gastritis * able to give informed consent exclusion criteria: * diagnosed of gastrointestinal disease such as ulcer, cancer, more than 10 erosions * taken antibiotics and stomach medicines such as steroid, bismuth compound, h2-receptor antagonist and proton pump inhibitor within 2 weeks * allergic or hypersensitive to any of the ingredients in the test products * history of reaction to any of the test products or of gastrointestinal diseases such as crohn's disease or gastrointestinal surgery * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnant or lactating women etc.
fecal continence outcomes and quality of life after excision of sacrococcygeal teratoma (retrospective study)

Conditions: Sacrococcygeal Teratoma

Summary: sacrococcygeal teratoma is one of the most common tumors that occur in the neonatal period. it presents either as a mass protruding from the sacrococcygeal region or as a pelviabdominal mass according to the type. surgical excision is the main treatment, most masses are benign, however some are malignant and require radiotherapy or chemotherapy. complications may occur due to pressure resulting from the tumor growth in the fetal period, or due to damage to important near tissues during surgical excision. postoperative complications may be urinary as neurogenic bladder, lower gastrointestinal as constipation, soiling or incontinence. in this work we study the outcomes of fecal continence through a questionnaire and its effect on the quality of life of the affected children.


Eligibility criteria:
inclusion criteria: * all patients with sacrococcygeal teratoma operated after july 2010 and older than 3 years old. exclusion criteria: * patients lost to follow up before 6 months after surgery. * patients with currarino triad.
stockholm3 use prior to mri for prostate cancer detection in a clinical care pathway: a multi-centered validation

Conditions: Prostate Cancer

Summary: men meeting local clinical standard of care to undergo a prostate mri for suspicion of prostate cancer will be included. blood sample will be drawn on the day of mri or immediately prior to mri for measurement of the prostate cancer biomarker stockholm3. specifically, the stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results. the patients will not receive the results of the stockholm3 assay. a stockholm3 score will be reported for each patient. the primary aim is to show superior specificity of stockholm3 (at different thresholds) for mri selection compared to psa (at different thresholds) (i.e., the proportion of men with a negative stockholm3 test or a negative psa test among those with a normal mri). additional aims: 1. to show non-inferior relative sensitivity in detection of cspc of stockholm3 compared to psa (the proportion of men with a positive stockholm3 test (at different thresholds) or a positive psa test (at different thresholds) among those diagnosed with cspc will be calculated). 2. to evaluate stockholm3 risk thresholds to determine if it can be used to further reduce mri, biopsy and gleason grade group 1 cancers without reducing sensitivity of cspc detection.


Eligibility criteria:
inclusion criteria: * men with age range (40.0 - 80.0 years) * already scheduled to undergo mri for prostate cancer screening (both negative and positive mri included). exclusion criteria: * psa \< 1.5 ng/ml * any known diagnosis of prostate cancer (patient on active surveillance) * men that have undergone digital rectal exam (dre) immediately before blood draw (dre within 5 days of study blood draw are excluded). * men who in the three (3) months prior to study participation received any invasive urologic procedure such as thermotherapy, microwave therapy, laser therapy, transurethral resection of the prostate (turp), urethral catheterization, and lower genitourinary tract endoscopy (cystoscopy) * no history of new treatment for bph in three (3) months prior to study participation.
propofol-enhanced assessment of ketamine for chronic pain and depression

Conditions: Chronic Pain; Depression

Summary: the goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during iv sedation in adults with chronic pain and depression. we do not know whether ketamine will be more effective than placebo under these circumstances. this study aims to: * evaluate whether placebo is non-inferior to ketamine in treating chronic pain and depression, when delivered under propofol sedation * confirm that propofol sedation is a safe way to keep participants blinded to treatment * assess patients' comfort with the sedation process to improve future studies * explore whether patient expectations affects their pain and depression participants will: * need to qualify for the study based on stringent medical criteria * undergo sedation with propofol * randomly receive either a ketamine or a placebo (saline) infusion during sedation * complete several study assessments over 5-7 weeks

ketamine is a dissociative anesthetic that has been in clinical use for more than 50 years. in addition to its well-known anesthetic and pain-relieving properties, ketamine has been found to have fast-acting antidepressant effects in patients with depression. however, the mechanisms underlying ketamine's ability to treat chronic pain and depression are poorly understood. a most basic question regarding ketamine's therapeutic mechanism is still unresolved: do patients need to consciously experience and recall ketamine's acute dissociative effects to receive lasting analgesic and antidepressant benefits? in this clinical trial, participants will receive either ketamine or a placebo when they are under sedation with propofol. a n=6 pilot feasibility phase will precede the fully-powered n=34 randomized controlled trial.

Eligibility criteria:
inclusion criteria: * age 18 to 70 years old * comfortable speaking and writing in english * chronic pain present daily for at least 3 months * currently experiencing depression * able to comply with the study protocol and communicate with study personnel about adverse events and other clinically important information exclusion criteria: * pregnant or breastfeeding * one or more health conditions that makes study unsafe or unfeasible, determined by study physicians * regular use of medications that may have problematic interactions with the study drugs * participating in another clinical trial which may conflict with this one

Keywords: chronic pain depression ketamine propofol sedation psychotropic drugs hypnotics and sedatives dissociative anesthetics
construction of special disease cohort database and biological sample holographic database of severe pneumonia

Conditions: Severe Pneumonia; Special Disease Cohort Database; Holographic Library of Biological Samples

Summary: the incidence rate and mortality of lung infection are high worldwide. it is a common and frequently occurring disease which seriously threatens human health. severe pneumonia accounts for 18-36% of all pneumonia. severe pneumonia has caused serious economic and medical burden. therefore, it is urgent to carry out the real-world cohort study of severe pneumonia. big data and sample library will provide useful clinical guidance and scientific research reserves for clinicians. through further research, we can improve the treatment success rate and reduce the mortality. the purpose of this study is to provide reliable biological samples and related data information for the relevant basic and clinical trials in the field of severe pneumonia by carrying out the construction of special disease cohort database and biological sample holographic database, and to establish a long-term sharing platform for the transformation of research results into clinical practice, improve the prognosis of severe pneumonia,and provide the evidence for improving the diagnosis and treatment of severe pneumonia suitable for china's national conditions.


Eligibility criteria:
inclusion criteria: * recent cough, expectoration or aggravation of original respiratory diseases, with or without purulent sputum / chest pain / dyspnea / hemoptysis * fever * signs of pulmonary consolidation and / or moist rales * peripheral blood leukocytes \>10×10\^9/l or less than 4×10\^9/l, with or without nucleus shifting to the left. * new patchy infiltration, consolidation of lobes / segments, ground glass opacity or interstitial changes, with or without pleural effusion on chest imagings * positive etiological examination * age \> 18 years old * need mechanical ventilation; septic shock need vasoactive drug treatment. meet one of them. * ① respiratory rate ≥ 30 beats / min; ② oxygenation index (pao2 / fio2) ≤ 250; ③ multilobar infiltration; ④ disturbance of consciousness / disorientation; ⑤ azotemia (bun ≥ 20mg / dl); ⑥ cytopenia (wbc \< 4.0 × 109 / l); ⑦ thrombocytopenia (platelet \< 10.0 × 109 / l); ⅷ low body temperature (t \< 36 ℃); ⅸ hypotension, requiring strong fluid resuscitation. meet the above three requirements at the same time. exclusion criteria: ● cannot understand and / or implement the investigation protocol.
the impact of successful quitting smoking after intensive smoking cessation interventions on morbidity and mortality among smokers with severe mental disorders - a nationwide cohort study from the danish smoking cessation database

Conditions: Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention

Summary: we evaluate intensive smoking cessation interventions (gsp) on morbidity and mortality in terms of assessing the impact among quitters and non-quitters with severe mental disorders (smd)


Eligibility criteria:
inclusion criteria: * f20-f29, f30-f39, f60-f69, f10-f16, f18, f19 * participation in the gsp in denmark exclusion criteria: * dual diagnosis (f00-f99 and a co-occurring substance-use disorder (f10-f16, f18, f19) * \< 18 years * no consent to follow-up * no baseline smoking status