bioihbjkbjnl/mcl2 huggingface dataset:
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Failure; Hepatic Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it
      can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that
      Ulinastatin can improve survival in HCC patients or not.
    

Detailed description: 
      Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad,
      still shows a rising trend. Postoperative hepatic failure remains a major reason of liver
      resection's failure.

      • As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of
      hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain
      inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce
      the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to
      assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular
      carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can
      improve survival in HCC patients or not.
    

Intervention name(s): Ulinastatin; Diammonium glycyrrhizinate
Intervention type(s): Drug; Drug
Intervention description(s): Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
Intervention MeSH terms: Glycyrrhizic Acid; Urinastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Ulinastatin; Hepatic Failure
The Effects of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers
Condition: Military Training
Study type: Interventional

Summary: 
      The study will determine whether acute ingestion of a probiotic combined with
      beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers
      during 8-weeks of advanced infantry training.
    

Detailed description: 
      Up to sixty soldiers from an elite infantry unit will perform a parallel design
      investigation. Soldiers will be randomly assigned to one of four groups. Group 1 will consume
      the probiotic plus HMB, group 2 will consume HMB only, group 3 will consume only the
      probiotic, and group 4 will consume only placebo. All four groups will be garrisoned
      together, eat the same meals, and perform the same activity. All groups will be tested before
      as well as after an 8-week advanced infantry training program. During each testing session
      resting blood samples will be obtained to assess cytokine, inflammatory, and muscle damage
      markers. Additionally, questionnaires will be used to determine digestive health.
      Anthropometric, performance, and muscle volume measures will also be assessed prior to and
      immediately following the supplementation and training protocol.
    

Intervention name(s): Placebo; HMB; BC30
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo capsules similar to the experimental treatments.; Capsules containing calcium HMB.; Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Study on Knee Immobilization and Pain Levels After an Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

Summary: 
      The purpose of the study is to determine if there is difference in immediate postoperative
      pain levels (48 hours) between patients who wear a knee immobilizer splint compared to
      patients who do not wear a knee immobilizer splint after an anterior cruciate ligament
      reconstruction surgery.
    

Detailed description: 
      This study will attempt to evaluate the efficacy of knee immobilization on patient
      postoperative pain levels following an ACL reconstruction. There is a lack of consensus in
      the area of postoperative knee bracing/immobilization. A survey of Canadian surgeons
      indicates that the primary reason for postoperative knee immobilization is to reduce pain. To
      the investigators' knowledge, there are no studies comparing the use of immediate (0-48
      hours) postoperative knee immobilization versus no immobilization and pain control in this
      patient population.
    

Intervention name(s): knee immobilization splint
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: anterior cruciate ligament reconstruction; knee immobilization; postoperative pain
Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, double-blind, parallel-group, randomized, placebo-controlled,
      multiple-ascending oral dose study to investigate the safety, tolerability, pharmacokinetics,
      and pharmacodynamics of ACT-389949 in healthy subjects.

      Part A of the study will evaluate the safety and tolerability following once a day oral
      dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and
      pharmacodynamics.

      Part B of the study will evaluate the safety and tolerability of ACT-389949 following a
      maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13
      days or every 2 days for 9 days (5 doses for each regimen).

      Part C of the study, if required, will provide additional information to that obtained from
      Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of
      ACT-389949.
    


Intervention name(s): ACT-389949 40 mg; ACT-389949 200 mg; ACT-389949 800 mg; ACT-389949 (Group C1 dose to be selected); ACT-389949 (Group C2 dose to be selected); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Predicted dose; Predicted dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ACT-389949
Study to Assess the Safety and PK of GSK573719 and GSK573719/GW642444(VI) Combination in Healthy Subjects and Subjects With Severe Renal Impairment
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and pharmacokinetics of inhaled GSK573719 and
      GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal
      impairment. The results of the study will provide guidance on the use of this product in
      subjects with severe renal impairment.
    

Detailed description: 
      GSK573719 monotherapy and GSK573719/vilanterol combination are currently under development
      for the treatment of COPD. This study will assess the pharmacokinetics and safety of inhaled
      GSK573719 and GSK573719/vilanterol (VI) in healthy subjects and in subjects with severe renal
      impairment. Nine subjects with severe renal impairment (as defined by a Clcr<30mL/min) will
      be recruited along with healthy control subjects (as defined by a Clcr>80mL/min matched to
      the severe renal impairment subjects based on gender, ethnicity, body mass index (±15%) and
      age (±5 years)). The results from this study will provide guidance on the use of GSK573719
      and GSK573719/VI in severe renally impaired patients.
    

Intervention name(s): Inhaled GSK573719; Inhaled GSK573719/vilanterol
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will receive a single dose of GSK573719 (125mcg) in treatment period 1; All subjects will receive a single dose of GSK573719 (125mcg)/vilanterol (25mcg) in treatment period 2
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: pharmacokinetics; GW642444; GSK573719; vilanterol; renal impairment; safety; COPD
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug
      effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing
      potential.
    


Intervention name(s): BMS-986166; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BMS-986166; Japan
Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer
Condition: Gastric Cancer; Enteral Immunonutrition
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune
      and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are
      poorly investigated. The aim of this study was to assess the effect of EIN on immune
      function, inflammation response and nutrition status when compared to standard enteral
      nutrition (SEN).

      The investigators believe that the proportion of cluster of differentiation 4
      T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of
      CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin
      M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and
      TNF-α were lower and nutritional status was similar.
    


Intervention name(s): enteral immunonutrition
Intervention type(s): Dietary Supplement
Intervention description(s): Enteral nutrition was started within 12h at an infusion rate of 20ml per hour for SEN group and 16ml per hour for EIN group in the first 24h. The rates of flow were gradually increasing with 50ml/h in SEN versus 40ml/h in EIN on day 2, 70ml/h versus 56ml/h on day 3 and 100ml/h versus 80ml/h until the 7th day depending on the feeding tolerance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized to receive enteral immunonutrition or standard enteral nutrition in postoperative day 1 by enteral feeding.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: gastric cancer; enteral nutrition; enteral immunonutrition; immune function; inflammation response
A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This will be a Phase I, open-label, nonrandomized, single dose study in healthy male
      subjects.

      Potential subjects will be screened to assess their eligibility to enter the study within 28
      days prior to the dose administration. Subjects will be admitted into the study site on Day
      -1 and be confined to the study site until at least Day 8. On the morning of Day 1, all
      subjects will receive a single oral dose of [14C]-SKI-O-703. Subjects will be discharged if
      the following discharge criteria are met: plasma radioactivity levels below the limit of
      quantitation for 2 consecutive collections, ≥ 90% mass balance recovery, and ≤ 1% of the
      total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive
      24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the
      study site up to Day 15.
    

Detailed description: 
      SKI-O-703 is being developed by Oscotec Inc. and is currently being studied for the treatment
      of adult patients with moderately to severely active rheumatoid arthritis and for the
      treatment of patients with persistent and chronic immune thrombocytopenia. SKI-O-592 (the
      free base of SKI-O-703) has demonstrated high selectivity and potency against spleen tyrosine
      kinase in a biochemical assay. For immunoreceptor activation linked to SYK, the effect of
      SKI-O-592 on the anti-inflammatory response consisting of tumor necrosis factor alpha,
      β-hexosaminidase, and CD69 expression was greater than the effects of first-generation SYK
      inhibitors (eg, R406) in several immune cell lines and in human primary cells. This
      anti-inflammatory activity was responsible for the selective inhibition of p-SYK (Y525/526),
      which led to the sequential inhibition of downstream effectors. In vitro studies revealed
      excellent SYK selectivity of SKI-O-592 that led to no inhibition of SYK-independent signal
      pathways, indicating that SKI-O-592 shows more potent anti-inflammatory activity to allow
      continuous administration of SKI-O-703 compared with the first-generation SYK inhibitors.
      SKI-O-703 is currently not approved or marketed in any country.
    

Intervention name(s): .[14C]-SKI-O-703
Intervention type(s): Drug
Intervention description(s): Single oral dose of 200 mg (100 μCi in 200 mg salt [0.5 μCi/mg as salt], equivalent to 100 μCi in 142 mg active [0.7 μCi/mg as active]) of [14C]-SKI-O-703 containing approximately 100 μCi of [14C]-SKI-O-703 per capsule after an overnight fast.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Male Subjects
The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life
Condition: Pelvic Floor Muscle Weakness; Urinary Incontinence
MeSH terms: Muscle Weakness; Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This physiotherapist-guided group training programme should be performed in both the supine
      and the sitting positions; it is investigated, which is better and more cost-effective in
      patient motivation.
    

Detailed description: 
      Here we aimed to investigate whether-based on trunk muscle synergism-the condition and
      functioning of the pelvic floor muscle would improve in the sitting and supine postures or in
      the control group during pelvic floor muscle training with forced exhalation. We enrolled
      nulliparous women in supine (n = 22), sitting (n = 19) and control (n = 14) groups. We
      performed the 8-week combined pelvic floor muscle training programme. We examined the effect
      of training on the parameters with the Kruskal-Wallis test, and the pairwise comparisons with
      the Mann-Whitney U-test and the Wilcoxon-rank test with the Bonferroni correction.
    

Intervention name(s): Pelvic floor muscle training
Intervention type(s): Other
Intervention description(s): The treatment for the sitting group comprised 8 sessions, with a 1-hour combined pelvic floor muscle training (cPFM-T) session each week in a group and 15 minutes of individual home training, six times a week for a total of 8 weeks of treatment. All training sessions comprised warming-up, gradual muscle strengthening and relaxation exercises. In the study, before and after the training programme, we used a self-administered questionnaire.We measured changes in pelvic floor muscle activity with a vaginal surface electromyographic instrument. We performed the transversus abdominis measurements at the same time as the vaginal measurements and pelvic floor muscle tasks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic floor muscle training; transverse abdominal muscle; ultrasound measurement; urinary incontinence; vaginal surface electromyography
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a
      cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.
    


Intervention name(s): Placebo; Trazodone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Klimadynon® in Comparison to Conjugated Oestrogens in Women Suffering From Menopausal Complaints
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate, relative to placebo and conjugated oestrogens, the efficacy, safety and
      tolerability of a 12 weeks peroral treatment twice daily with a cimicifuga racemosa extract
      corresponding to 20 mg, 75 mg or 150 mg plant material on menopause-related neurovegetative
      and mental complaints
    


Intervention name(s): Low dose of Klimadynon®; Medium dose of Klimadynon®; High dose of Klimadynon®; Oestrofeminal®; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of an Incubator Cover on Term and Preterm Neonates' Vital Signs
Condition: Neonatal Disease; Nursing Caries
MeSH terms: Infant, Newborn, Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of an incubator cover on the vital signs of
      term and preterm neonates hospitalized in a neonatal intensive care unit. Methods: 91
      neonates presenting to a neonatal intensive care unit who met the inclusion criteria were
      included in the study. Vital signs of neonates were measured with and without incubator
      cover. Measurements were performed three times (0th, 15th, and 30th minute).
    

Detailed description: 
      Term and preterm are exposed to many stimuli during their stay in the neonatal intensive care
      unite (NICU). These stimuli; operation and alarm sounds of devices, continuous and high level
      ambient lighting. These stimuli can cause deviations in the physiological indicators of
      newborns, and hearing and vision loss. The aim of this study is to evaluate the effect of an
      incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal
      intensive care unit. Methods: This study is a prospective repeated measure pretest-posttest
      repeated-measures design. 91 term and preterm newborns who were hospitalized in the neonatal
      intensive care unit and met the inclusion criteria were included in this study.

      Neonates were admitted to the study if they satisfied all of the following criteria: (1) term
      and preterms, (2) admitted to NICU, (3) clinically stable, (4) verbal and written consent
      from the parent. Term and preterm neonates were randomized into two groups (term group = 44,
      and preterm group = 47 neonates). Vital signs of both groups were measured with and without
      incubator cover. Measurements were performed three times (0th, 15th, and 30th minute).
    

Intervention name(s): use an incubator cover
Intervention type(s): Other
Intervention description(s): Vital signs of term and preterm newborns were measured separately and with and without an incubator cover.
Intervention model: Single Group Assignment
Intervention model description: A Pretest-Posttest Repeated Measures Design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: term; preterm; vital signs; incubator cover
Metabolic Study of Sleep Apnea in Men and Women
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to look at the metabolic (use of energy) and hormonal features
      of sleep problems in men and women.
    

Detailed description: 
      Obesity is a major risk factor for obstructive sleep apnea (OSA), a condition characterized
      by repetitive respiratory disturbances, intermittent hypoxia, sleep fragmentation by frequent
      microarousals and low amounts of deep slow wave sleep (SWS). Today, more than 10 million
      American women suffer from OSA. OSA has been identified as an independent risk factor for the
      metabolic syndrome. Because OSA is more prevalent in men than in women, a disproportionate
      number of studies of OSA and its consequences have been conducted in men. Thus, OSA has been
      characterized as a disorder associated with gender-based health care inequity. Recent
      evidence, including data from our group, suggests that reduced amounts and intensity of SWS
      (i.e. slow-wave activity [SWA]) may play a pivotal role in the development of metabolic and
      cardiovascular disturbances in obese men and women, particularly those with OSA. This project
      will focus on sex differences in SWA and their relationship with daytime sleepiness and
      metabolic vulnerability in obese men and women with and without OSA. We propose to
      simultaneously characterize: 1. sleep-wake regulation; 2. measures of diabetes risk; 3.
      measures of cardiovascular risk; and 4. profiles of sex steroids, cortisol and adipokines in
      a. obese men without OSA, b. obese men with OSA before and after treatment with continuous
      positive airway pressure (CPAP), c. obese pre-menopausal women without OSA, and d. obese
      pre-menopausal women with OSA before and after CPAP treatment. The completion of these
      interdisciplinary studies will provide a unique data set contrasting in obese women versus
      obese men the relationships between sleep and the metabolic syndrome, OSA and the metabolic
      syndrome and the impact of CPAP treatment on the metabolic syndrome. This work will provide
      important insights regarding the pathophysiology of OSA and its adverse consequences in obese
      men and women, and the basis for the development of effective sex-specific prevention and
      treatment strategies.
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): CPAP (continuous positive airway pressure) treatment at home for 6 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; Diabetes; Metabolism; Gender