Kornimate/medical-research-clean huggingface dataset:
clinical trial on palliative cancer patients with constipation

Conditions: Constipation

Summary: it is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. for the treatment group, mazirenwan 10g plus huangqi 20g are chosen as the core prescription. furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. the primary end point is the global symptom improvement. secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (cvas) (0=none to 7=most severe) and individual assessment of constipation related symptoms. for the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.


Eligibility criteria:
inclusion criteria: * severity of constipation \> 3 points (an 8-point scale from 0 to 7) * palliative performance scale ≥60% * relatively stable liver and renal function within 3 months * patients who can read and speak chinese exclusion criteria: * inability to communicate * presence of a colostomy, or gastrointestinal obstruction * presence of loose or watery stool (bristol stool scale 6-7) or bowel movement \> 3/day under routine laxative treatment * history of chinese herbal medicine allergies * estimated life expectancy less than 1 month

Keywords: chinese herbal medicine formula mazirenwan randomized controlled trial constipation palliative care in cancer
haplo-identical hsct versus chemotherapy for adult acute lymphoblastic leukemia patients

Conditions: Acute Lymphoblastic Leukemia

Summary: the survival of adult patients with standard-risk acute lymphoblastic leukemia(all) need to improve. we want to compare the efficacy of haplo-identical hematopoietic stem cell transplantation (hsct) with chemotherapy for adult(age:18-39 years old) all patients in first phase of complete remission (cr1)

although the high complete remission rate (80%-90%) can be achieved, the long-term survival rate of standard-risk adult patients with acute lymphoblastic leukemia(all) is only 25%-55% when they receive chemotherapy alone. the survival rate can be further improved uo to 50%-75% when they receive hla-matched hsct however, the chance of finding a hla-matched donor is low, especially in china. alternative donor such as halpo-identical related donor might be an choice. our retrospective analysis showed about 59% overall survival could be achieved when standard-risk adult all patients received halpo-identical hsct.therefore, we start this randomization controlled trial to compare the efficacy of haplo-identical hsct with chemotherapy for adult(age:18-39 years old) all patients in cr1.

Eligibility criteria:
inclusion criteria: * acute lymphoblastic leukemia * 18-39 years old * in first complete remission -adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional upper limit of normal (uln); alanine aminotransferase (alt) and aspartate aminotransferase(ast) ≤2.5 times the institutional uln - * adequate renal function defined as creatinine ≤3 times the institutional uln * no uncontrollable infection * performance status(ps)score 0-2(who) * subjects able to provide written informed consent exclusion criteria: * having hla-matched donor * high-risk all: (1)ph+all (2)hypodiploidy (3)t(v;11q23) (4) complex karyotype（≥5 chromosome abnormalities）（5）high white blood cell (wbc) count (b-all≥30×109/l;t-all ≥100×109/l). * pregnancy * loss of ability to freely provide consent due to psychiatric or physical illness

Keywords: acute lymphoblastic leukemia hematopoietic stem cell transplantation chemotherapy
epidemiology and clinical features of uveitis in a tertiary referral

Conditions: Uveitis

Summary: the aim of the study is to report the pattern of uveitis in patients attending a tertiary referral center at the university hospital in montpellier. the patients seen at the specialized consultation for uveitis between 2002 and first semester 2018 were included. data about demography, clinical features and final diagnoses were collected and updated during the differenet visits. the medical records were restrospectively rewieved and analyzed.


Eligibility criteria:
inclusion criteria: * patients seen at the specialized consultation for uveitis between 2002 and first semester 2018 exclusion criteria: * patients under 18

Keywords: epidemiology clinical features etiology tertiary center
bacterial colonization of suction drains following spine surgery

Conditions: Surgical Site Infection, Closed Suction Drains

Summary: closed suction drains are commonly used following surgery, if the wound is expected to discharge significant amounts of fluid. to this date, no evidence base exists as to the exact post operative time period or discharge volume necessitating presence of a drain. in orthopedic common practice, drains are removed on the second post operative day, fearing the drain will serve as a point of entry for nosocomial infection. in this study, drains will be left in place as long as daily discharge volume exceeds 50cc, regardless of the amount of days following surgery. daily cultures and antibiotic levels will be taken from the drains receptacle, to determine if and when the drains is colonized by aerobic bacteria.


Eligibility criteria:
inclusion criteria: * all patients undergoing spine surgery that requires suction draining,and do not meet the exclusion criteria for this study. exclusion criteria: * known active infection in the spine or elsewhere.
prospective trial of the effect of preoperative forced-air warming on perioperative body temperature following neuraxial anesthesia in total hip arthroplasty patients

Conditions: Perioperative Hypothermia

Summary: the purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * patients undergoing total hip arthroplasty under neuraxial anesthesia, * age 55-85, * bmi 18-40 exclusion criteria: * allergy to local anesthetics, * patients electing to have general anesthesia for their total hip arthroplasty, * pregnancy, * prisoners, * patients unable to give informed consent, * english as a second language, * active infectious or febrile illness (measured temperature \> 37.5 degrees celsius).
assocaiton between uric acid trajecteries and remission of nafld in nafld individuals

Conditions: Non-Alcoholic Fatty Liver Disease; Hyperuricemia

Summary: uric acid is the end product of dietary or endogenous purines degradation, and hyperuricemia is one of the most common metabolic disorders. a growing body of evidence, comprising a great deal of cross-sectional studies and several prospective ones, also indicates that hyperuricemia is associated with increased prevalence, incidence, and disease severity of non-alcoholic fatty liver disease (nafld). capitalizing on a cohort study in china, the investigators are aimed to assess the associations of sua trajecteries with remission of nafld in nafld individuals and examined whether the association differs across subpopulations.

a cohort study was conducted to evaluate the relationship between the sua trajecteries and remission of nafld. the study enrolled employees who were attending their annual health examination. furrhermore, the investigators are aimed to explore whether the association differs across subpopulations.

Eligibility criteria:
inclusion criteria: 1. age \>=18 years; 2. agree to be enrolled in this study. exclusion criteria: 1. those taking antihypertensive or antidiabetic agents, lipid-lowing agents, or hypouricemic agents; 2. those with alcohol consumption greater than 140 g/week for men and 70 g/week for women; 3. those with a history of other known causes of chronic liver disease such as viral hepatitis or autoimmune hepatitis, and those using hepatotoxic medications.
glutamatergic modulation of cocaine-related deficits

Conditions: Cocaine Dependence

Summary: cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. despite promising preclinical findings with n-methyl-d-aspartate receptor (nmdar) modulators, studies with human subjects have been unsuccessful to date. the purpose of this investigation is to examine the effects of the nmdar antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.

in this study, volunteers will undergo a 9 day inpatient trial during which they will receive three counter-balanced infusions (two doses of ketamine and a dose of lorazepam) on three separate days in a within-subject, double-blind, controlled design. of the various glutamate antagonists available for human use, ketamine will be utilized because its safety profile, pharmacokinetics, and range of tolerable sub-anesthetic dosings have been very well studied. also, ketamine has shown promise in managing opiate and alcohol use disorders in certain studies, and may therefore be the most likely glutamate antagonist to dampen cue reactivity and increase motivation in cocaine users. if ketamine significantly improves these deficits, this would suggest that the drug should be investigated further for potential utility as a treatment for cocaine dependence.

Eligibility criteria:
inclusion criteria 1. active free-base cocaine dependence (at least 4 days of use over the past month, with at least 1 use per week); if the participant uses through another route (in, iv), then the fb route is dominant (\> 80% of occasions). 2. physically healthy 3. no adverse reactions to study medications 4. 21-52 years of age 5. normal body weight 6. responsive to drug cues 7. capacity to consent exclusion criteria: 1. seeking treatment or abstinence 2. dsm iv criteria for substance dependence (other than methamphetamine, cocaine, cannabis, or nicotine), or dsm iv criteria for abuse of ketamine or lorazepam 3. dsm-iv criteria for other axis i psychiatric illness that may make participation hazardous such as schizophrenia, schizoaffective disorder, psychosis nos, mdd, psychosis secondary to substances, or bipolar disorder 4. delirium, dementia, amnesia, cognitive disorders, or dissociative disorders 5. current suicide risk or a history of suicide attempt within the past 2 years 6. current use of prescribed psychotropic medication 7. pregnancy, nursing, or had a baby within the past 6 mo. 8. heart disease as indicated by history, abnormal ecg, previous cardiac surgery. 9. unstable physical disorders which might make participation hazardous such as end-stage aids, hypertension (\>140/90), anemia, active hepatitis or other liver disease, or diabetes 10. "bad" reaction/experience with prior exposure to ketamine or lorazepam 11. history of significant violence 12. first degree relative with a psychotic disorder
comparison of gadobutrol and gadobenate dimeglumin for delayed enhancement cardiac mri

Conditions: Subacute/Chronic Myocardial Infarction

Summary: this study aims at evaluating the diagnostic efficacy of gadobutrol versus gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac magnetic resonance imaging


Eligibility criteria:
inclusion criteria: * diagnosis of myocardial infarction * age ≥ 18 years and ≤ 80 years * informed consent * male patients as well as female patients using contraceptives exclusion criteria: * patients with a heart pacemaker, with magnetic material or other magnetic implants. * renal failure (gfr \<30ml/min) * patients with known allergy to a gadolinium-containing contrast agent * drugs or alcohol addiction, dementia
improved diagnostics of celiac disease in children

Conditions: Celiac Disease; Eosinophilic Esophagitis

Summary: the main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.

prevalence of celiac disease is on a steep rise in western countries, but due to difficult diagnosis the majority of patients remain unrecognized. undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. on the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. at present the natural history and benefits of an early diagnosis in such individuals is poorly known. further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. new serology-based diagnostic criteria have been suggested but prospective data is lacking. aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. in addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. the study and patient collection are to be conducted at the pediatric clinics in finland and in romania. all children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. the total duration of the study is 10 years but data will be analyzed on-line.

Eligibility criteria:
inclusion criteria: * suspicion of celiac disease or gluten sensitivity * age below 18 years exclusion criteria: * study refusal * age 18 years or more

Keywords: celiac disease eosinophilic esophagitis endomysial antibodies transglutaminase antibodies small-bowel
the influence of oral probiotic on the vaginal flora and microenvironment alteration in the vaginosis infection women

Conditions: Probiotic, Human Papillomavirus Infection, Pap Smear, Microbiome

Summary: a single-blind, randomized, and probiotic-treatment including adult women with vaginitis and/or hpv positive. after oral probiotics, all participants will be followd-up cervical swabs and vaginal microbiome alteration till the end of the study.


Eligibility criteria:
inclusion criteria: * diagnosed as vaginal viginitis * willing to sign permit * willing to regular follow up exclusion criteria: * pregnant * virgin * severe cervix pathology cinii or cin iii * confirmed cervical cancer * under long term antibiotics due to other physical condition
long-term safety and efficacy of plozasiran in adults with hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: this is an open-label study to be conducted in adults with hypertriglyceridemia (htg) and severe hypertriglyceridemia (shtg). each participant must have completed all required visits per protocol in the parent study aroapoc3-3001 (nct05089084), aroapoc3-3003 (nct06347003), aroapoc3-3004 (nct06347016) or aroapoc3-3009 (nct06347133). all eligible participants will receive plozasiran administered subcutaneously (sc) approximately every 3 months for 24 months. participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.


Eligibility criteria:
inclusion criteria: * adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures * completed all required study visits per protocol in the parent study aroapoc3-3001, aroapoc3-3003, aroapoc3-3004 or aroapoc3-3009 * female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the end of study (eos) or the last dose of plozasiran, whichever is later. male subjects must agree to use a condom during the study and for at least 90 days after the eos or last dose of plozasiran whichever is later. subjects must not donate sperm or eggs during the study and for at least 90 days after the eos or last dose of plozasiran, whichever is later. female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \>1 menstrual cycle prior to day 1. exclusion criteria: * subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (ast) or alanine aminotransferase (alt) or due to hba1c elevation that did not respond to antidiabetic regimen * subject withdrew consent for continued study treatment in the parent study * known hypersensitivity to the active substance or to any of the excipients of plozasiran * any new condition or worsening of existing condition or any other situation that in the investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk * unwilling to limit alcohol consumption to within moderate limits for the duration of the study. note: other inclusion/exclusion criteria may apply per protocol
exparel administered by infiltration into the tap for prolonged postsurgical analgesia in lower abdominal surgeries

Conditions: Pain

Summary: the purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of exparel as a foundation in postsurgical pain therapy in transversus abdominis plane (tap) infiltration in lower abdominal surgical procedures.

the purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of exparel as a foundation in postsurgical pain therapy in transversus abdominis plane (tap) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.

Eligibility criteria:
inclusion criteria: * males and females \>18 years of age * american society of anesthesiologists (asa) physical status 1-3 * undergoing either lower abdominal surgery defined as laparoscopic hysterectomy (female), laparoscopic myomectomy (female), laparoscopic colectomy (male/female) * physically and mentally able to give full informed consent to participate in this study and complete all study assessments within the timeframes required (including electronic diaries should patient be discharged prior to day 4) * capable of returning the diary after pod 4 by mail (preferably) or upon follow up visit. exclusion criteria: * history of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. * any patient whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful local administration of exparel. * patients who have received any investigational drug within 30 days prior to exparel administration, or planned administration of another investigational product or procedure during their participation in this study. * any chronic condition requiring use of opioids for treatment of a medical condition for 2 weeks or more prior to surgery. * confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential). * patients that would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements. * any patient with diagnosed or potential metastatic disease. * any condition that in the investigator's opinion might be harmed or be a poor candidate for participation in the study (such as patients requiring long acting opioids as part of the induction medications). * initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (ssris), selective norepinephrine reuptake inhibitors (snris), gabapentin, pregabalin (lyrica®), or duloxetine (cymbalta®) * history of suspected or known addiction to, or abuse of, illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
effects of different support surfaces on the properties skin after loading

Conditions: Pressure Ulcers

Summary: pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. there is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. the overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).


Eligibility criteria:
inclusion criteria: * healthy, female volunteers * 60 to 80 years * body mass index between 18.5 and 29.9 kg/m2 * non-smoker of at least one year * absence of skin diseases or scars in the skin areas of interest * ability to move independently and to maintain supine and prone positions * able to give written informed consent * no use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement * skin phototype i to iii according to fitzpatrick classification * willing and able to fulfil the study requirements exclusion criteria: * disability to maintain in supine or prone position * acute diseases * acute or chronic diseases with increased or decreased body temperature (≤ 35°c or ≥ 38,5°c, measured in the ear) * history or establishment of diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (copd) * acute or chronic wounds in the skin areas of interest * any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites * participation in another clinical study 4 weeks before inclusion visit * current participation in any other clinical study