bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Study of Rimazolam and Propofol Combined With Etomidate in Gastroenteroscopy in Elderly Patients
Condition: Elderly Patients; Gastrointestinal Endoscopy; Remimazolam Besylate; Etomidate Combined With Propofol
Study type: Interventional

Summary: 
      Studies have shown that etomidate combined with propofol in gastroscopy has high safety and
      lower incidence of hypoxia and hypotension, suggesting the advantages of etomidate combined
      with propofol in elderly patients.

      Remimazolam Besylate is a 1.1 class new drug that acts on GABA receptors and is metabolized
      by plasma esterase with fast metabolism time, only 1/7 of midazolam, which may be more
      suitable for elderly patients. Therefore, this study intends to explore the safety and
      effectiveness of two sedation schemes in gastroenteroscopy for elderly patients.
    

Detailed description: 
      Before starting the endoscopy procedures, patients were randomly assigned to either
      Remimazolam Besylate group or propofol combined with etomidate group. The onset time,
      recovery time, vital signs, postoperative recovery, cognitive function and adverse events
      were compared.
    

Intervention name(s): Remimazolam Besylate; etomidate combined with propofol
Intervention type(s): Drug; Drug
Intervention description(s): Remazolam 7mg for the first time (push time 1min), 2.5mg can be added after 2min according to MOAA/S score, no more than 5 times within 15min; Etomidate 0.1mg/kg+1% propofol 0.5mg/kg for the first time ,etomidate0.05mg/kg+ 1% propofol 0.25 mg/kg can be added according to MOAA/S score
Intervention MeSH terms: Propofol; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Remimazolam Besylate; Etomidate combined with propofol; Gastrointestinal Endoscopy
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
Condition: HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS
      in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as
      measured by p24 antigen levels. Effect on relative HIV infectivity.
    


Intervention name(s): Fat Emulsion 2%; Fat Emulsion 20%
Intervention type(s): Drug; Drug
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Primary purpose: Treatment
Keywords: Weight Loss; Parenteral Nutrition, Total; AIDS-Related Opportunistic Infections; Liposyn; Acquired Immunodeficiency Syndrome
Alcohol and Innate Immunity
Condition: Binge Drinking
MeSH terms: Binge Drinking
Study type: Observational

Summary: 
      Alcohol leads to a leaky gut and translocation of bacterial products. This may lead to
      inflammation and immune dysfunction as well as the typical hangover symptoms.
    

Detailed description: 
      Alcohol binge drinking, defined as 5 or more drinks for men and 4 or more drinks for women at
      one time, is the most frequent form of alcohol consumption worldwide, especially in younger
      people. This drinking pattern is popular and leads to increased mortality and morbidity.
      Therefore binge drinking is a major public health issue. The behavioural and neurological
      consequences of binge drinking are well characterized.

      Less is known about the systemic effects on the gut as the first organ in contact with
      alcohol. Chronic alcohol intake can lead to increased gut permeability, bacterial
      translocation and alterations in the gut microbiome in animal models. Recently bacterial
      translocation has been shown in healthy volunteers after a single alcohol binge. On immune
      cells, acute alcohol intake seems to have dichotomous effects. On the one hand
      immunosuppressive and anti-inflammatory effects have been described, however, alcohol induced
      liver injury is driven by pro-inflammatory reactions. These immune effects seem to be driven
      by endotoxin or other bacterial products via Toll-like receptors that are translocated to the
      circulation via a defective gut barrier. Immune effects of alcohol have also been linked to
      hangover symptoms after an alcohol binge.

      Furthermore there is evidence that endotoxemia might also contributes to alcohol dependence
      by promoting prolonged and increased voluntary alcohol intake in mice. On the other hand
      mutant mice lacking important genes for immune responses exhibit decreased alcohol
      consumption. This indicates that immune signaling promotes alcohol consumption. Therefore it
      is tempting to speculate that increased gut permeability leading to increased bacterial
      translocation after an acute alcohol binge could promote the desire for further alcohol
      consumption.

      The investigators aim to test in this pilot trial whether one alcohol binge damages gut
      barrier function, increases bacterial translocation and causes innate immune dysfunction.
      Furthermore the effect of glucose and fructose will be studied too.
    

Intervention name(s): Alcohol; Glucose; Fructose; vehicle
Intervention type(s): Other; Other; Other; Other
Intervention description(s): every participant will drink vodka at a dose of 2ml/kg bodyweight; oral Glucose tolerance test; oral fructose tolerance test; control (water)
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers selected from a database
      
Biospecimen description: 
      Serum, Plasma, Urine, Stool
Psychological Treatment of Overweight Binge Eaters
Condition: Binge Eating Disorder; Cognitive Therapy/Methods; Mental Disorders/Epidemiology; Obesity/Epidemiology; Obesity/Therapy
MeSH terms: Obesity; Overweight; Bulimia; Feeding and Eating Disorders; Mental Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating
      disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but
      its long-term impact and time course on other BED-related symptoms remain largely unknown.
      This study compares the effects of group CBT and group IPT across BED-related symptoms among
      overweight individuals with BED.
    

Detailed description: 
      Cognitive-behavioral therapy (CBT) has documented efficacy for the treatment of binge eating
      disorder (BED). Interpersonal psychotherapy (IPT) has been shown to reduce binge eating but
      its long-term impact and time course on other BED-related symptoms remain largely unknown.
      This study compares the effects of group CBT and group IPT across BED-related symptoms among
      overweight individuals with BED. METHODS: One hundred sixty-two overweight patients meeting
      DSM-IV criteria for BED were randomly assigned to 20 weekly sessions of either group CBT or
      group IPT. Assessments of binge eating and associated eating disorder psychopathology,
      general psychological functioning, and weight occurred before treatment, at posttreatment,
      and at 4-month intervals up to 12 months following treatment. RESULTS: Binge-eating recovery
      rates were equivalent for CBT and IPT at posttreatment (64 [79%] of 81 vs 59 [73%] of 81) and
      at 1-year follow-up (48 [59%] of 81 vs 50 [62%] of 81). Binge eating increased slightly
      through follow-up but remained significantly below pretreatment levels. Across treatments,
      patients had similar significant reductions in associated eating disorders and psychiatric
      symptoms and maintenance of gains through follow-up. Dietary restraint decreased more quickly
      in CBT but IPT had equivalent levels by later follow-ups. Patients' relative weight decreased
      significantly but only slightly, with the greatest reduction among patients sustaining
      recovery from binge eating from posttreatment to 1-year follow-up. CONCLUSIONS: Group IPT is
      a viable alternative to group CBT for the treatment of overweight patients with BED. Although
      lacking a nonspecific control condition limits conclusions about treatment specificity, both
      treatments showed initial and long-term efficacy for the core and related symptoms of BED.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT); Interpersonal Therapy (IPT)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Body Mass Index; Bulimia/therapy; Comorbidity; Interpersonal Relations; Psychotherapy/methods
Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor
Condition: Induced Labor; Cervical Ripening; Obstetric Labor; Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose:

      To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal
      dinoprostone insert for induction of labor in women with post-term pregnancies.

      Methods:

      The investigators designed a prospective, randomized, open-labeled, blinded for the end-point
      evaluators trial including women of at least 41 weeks of gestational age with uncomplicated
      singleton pregnancies and Bishop score lower than 6. Participants were randomized into
      dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal
      outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours
      was the primary outcome variable.
    


Intervention name(s): Misoprostol 25 mcg; Dinoprostone 10mg
Intervention type(s): Drug; Drug
Intervention description(s): To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.; To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Other intervention name(s): Misoprostol induction; Dinoprostone induction
Intervention MeSH terms: Misoprostol; Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dinoprostone; Misoprostol
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics
      and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.
    


Intervention name(s): AR882 Single Dose; AR882 Multiple Dose
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of AR882; AR882 taken once daily for 14 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Healing at Non-submerged Implants Installed With Different Insertion Torques.
Condition: Edentulous; Alveolar Process, Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The objective of the study is to evaluate histomorphometrically the healing at implants
      installed with standard or very low insertion torque values.
    

Detailed description: 
      Very high insertion torque values have been recommended when immediate loading is applied to
      implants.1 However, it has been shown that similar clinical outcomes may be achieved even
      with insertion torque values ≤15 Ncm when implants are splinted together. Due to the
      contradictory outcomes on the influence of the torque on osseointegration and a lack of
      histological data in humans, there is a need of more evidences that may support the
      clinicians in the decision making when an unintentional low insertion torque occur at
      implants during the daily practice. So the aim of the study i evaluate histomorphometrically
      the healing at implants installed in Twelve volunteer patients that will be recruited. Two
      screw-shaped titanium devices will be installed in the distal segments of the mandible using
      insertion torque values of either <10 Ncm or ~30 Ncm. The implants were left to heal in a
      non-submerged fashion. After 8 weeks, biopsies will be retrieved and ground sections will be
      prepared for histological evaluation.
    

Intervention name(s): implant installation
Intervention type(s): Procedure
Intervention description(s): All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.
Other intervention name(s): implant surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Affection of Two Chest Management for Enhanced Recovery Program After Video-assisted Thoracoscopic Lobectomy.
Condition: Chest Tube
Study type: Interventional

Summary: 
      Comparing the influences of different chest tube managements for enhanced recovery program
      after video-Assisted thoracoscopic lobectomy.
    

Detailed description: 
      The Enhanced Recovery Program has a series of observation data contains hospitalization days,
      adverse events, drainage, extubation, visual analogue scale(VAS) scores and the number of
      analgesic using.The investigators plan to enroll 60 patients and divide them into two groups
      to compare the influences of different chest tube managements for enhanced recovery program
      after video-assisted thoracoscopic lobectomy.
    

Intervention name(s): Large size tube; Drainage ball
Intervention type(s): Other; Other
Intervention description(s): Patients in Group A are inserted the large size tube (28F).; Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).
Other intervention name(s): Upper tube; Upper tube
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Total 60 patients accept video-Assisted thoracoscopic lobectomy are divided into two groups(Group A and Group B) equally and randomly.Different group takes different chest tube managements.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERAS(Enhanced Recovery After Surgery); Video-assisted thoracoscope lobectomy; Non-Small Cell Lung Cancer (NSCLC); Chest tube
Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans
Condition: Cardiovascular Diseases; Hypertension; Diet, Healthy
MeSH terms: Hypertension; Cardiovascular Diseases
Study type: Observational

Summary: 
      The role of diet in preventing hypertension and cardiovascular diseases in African Americans,
      who have a much higher risk of developing these diseases, is not well understood. Therefore,
      this project will investigate whether African Americans following a 100% plant-based diet
      have more optimal blood pressure, vascular function, and blood lipid profiles, along with
      lower systemic inflammation relative to African Americans following a typical American diet.
    


Intervention name(s): Typical American Diet; Plant-Based Diet
Intervention type(s): Other; Other
Intervention description(s): Participants self-reported adherence to a typical American diet prior to enrolling in the study. This factor determined cross-sectional group allocation.; Participants self-reported adherence to a 100% plant-based diet prior to enrolling in the study. This factor determined cross-sectional group allocation.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample from the greater Dallas-Fort Worth Metroplex area.
      
Biospecimen description: 
      stored serum
    
Keywords: health disparity; endothelial function; hypertension; vegan diet; Black Americans; inflammation
Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab
      followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk
      patients with DLBCL Non-Hodgkin's lymphomas.
    

Detailed description: 
      Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of
      lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic
      survival curve with patients in complete remission (which can be considered cured) and
      patients that relapse. This last group of subjects have only 25%-33% chance of long free
      disease survival if treated with a second line therapy with high dose chemotherapy plus
      autologous transplant of PBPC.

      Therefore in order to achieve an improvement of the overall survival in patient with DLBCL,
      it is necessary to increase the number of complete remission after first line therapy.

      The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare
      the efficacy and safety of an intensive conditioning regimen with high intensity
      chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen
      plus Rituximab in patients with unfavorable prognosis at diagnosis.
    

Intervention name(s): Rituximab-HDS; Rituximab-CHOP
Intervention type(s): Drug; Drug
Intervention description(s): Rituximab-HDS; Rituximab-CHOP
Other intervention name(s): Rituximab supplemented high-dose sequential chemotherapy.; Rituximab/Cyclophosph/doxorubic/vincrist/prednis
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL; R-HDS; R-CHOP14
Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the feasibility of recording fast-ripples, a
      potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by
      Dixi-Medical.
    

Detailed description: 
      Partial epilepsies are refractory to medical treatment in 30% of the cases (Refractory
      Partial Epilepsy or RPE). Patients with RPE suffer from social and occupational disability,
      an increased risk associated with seizures (traumatic brain injury, accidents), but also a
      higher risk of sudden unexplained death (2 to 3 times higher) than the general population.
      Moreover, the medical and social burden of these patients is heavy, representing a
      significant cost to society.

      In some cases, surgical treatment with resection of the epileptogenic zone (EZ) can be
      proposed. The presurgical evaluation includes various investigations seeking to clarify the
      location of the EZ; but this approach is sometimes insufficient and the definition of the EZ
      then requires invasive exploration through intracerebral EEG recording (stereo-EEG, SEEG).
      This latter technique is currently the preferred standard to define the EZ. It involves
      implanting electrodes in the brain areas suspected to belong to the seizure network. 50 to
      70% of patients investigated with this technique will have epilepsy surgery.

      In recent years, a series of studies in animals and humans have suggested that some
      oscillations, very short and at very high frequency (> 250 Hz), called "fast ripples" (FRs)
      could be a good biomarker of the EZ (for a review see Zijlmans et al, 2012). The FRs are more
      easily recorded from microelectrode (diameter: 20-40 microns).

      The purpose of this study is to evaluate a new medical device designed by DixiMedical to
      record FRs, combining micro and regular clinical electrodes.
    

Intervention name(s): intracerebral micro-macroelectrodes
Intervention type(s): Device
Intervention description(s): All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Safety; Electrodes; Device; StereoElectroencephalograph; Epileptogenic zone; Fast ripples
BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This protocol will developed an assessment of the T-FLEX device controlled by Brain-Computer
      Interface in patients with Stroke.
    

Detailed description: 
      Brain-Computer Interface (BCI) remains an emerging tool that seeks to improve the patient
      interaction with the therapeutic mechanisms and to generate neuroplasticity progressively
      through neuromotor abilities. Motor Imagery (MI) analysis is the most used paradigm based on
      the motor cortex's electrical activity to detect movement intention. It has been shown that
      motor imagery mental practice with movement-associated feedback may offer an effective
      strategy to facilitate motor recovery in brain injury patients. This protocol will study a
      BCI system associated with visual and haptic feedback to facilitate MI generation and, to
      control a T-FLEX ankle exoskeleton. In this study, a group of five post-stroke patients will
      test four different strategies using T-FLEX: Passive movement, Active movement, Motor
      Imagination with Visual stimulation and Motor Imagination with Visual-Haptic stimuli. The
      quantitative characterization of BCI performance will be made by using statistical analysis
      of electroencephalographic data. Finally, the patient's satisfaction will be evaluated by a
      questionnaire.
    

Intervention name(s): Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.
Intervention type(s): Device
Intervention description(s): The participants will carry out 4 tasks with a BCI system integrated to the T-FLEX device. The task consists of 1 session that includes 4 conditional experiments: Active ankle movement, passive ankle movement, Motor Imagery Detection with Visual cue, and Motor Imagery Detection with Tactile Stimulation and visual cue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Brain-Computer Interface; Exoskeleton