bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Thalidomide in Preventing Chemotherapy-induced Delayed Nausea and Vomiting
Condition: Neoplasms
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was aimed to evaluate efficacy and tolerability of thalidomide in improving
      prevention of chemotherapy-induced delayed nausea and vomiting in chemotherapy-naive patients
      after highly emetogenic chemotherapy.
    

Detailed description: 
      This is a prospective, randomized, multi-center, double-blind, placebo-controlled clinical
      trial, aimed to evaluate efficacy and tolerability of thalidomide in improving prevention of
      chemotherapy-induced delayed nausea and vomiting (CINV) in chemotherapy-naive patients after
      highly emetogenic chemotherapy(HEC) (cisplatin-based regimen or cyclophosphamide combination
      with doxorubicin/epirubicin). A total of 820 patients are planned to be enrolled into the
      study. Patients treating with highly emetogenic chemotherapy will be randomized into two
      groups, and be treated with Thalidomide+ Palonosetron+ Dexamethasone or Placebo +
      Palonosetron+ Dexamethasone, respectively. The primary end point is complete response rate
      (CRR) for delayed CINV, and the secondary end points include the safety and quality of life
      (QOL).
    

Intervention name(s): Thalidomide; Placebo for thalidomide; Palonosetron and Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1; Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1; Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
Other intervention name(s): Placebo tablet for thalidomide
Intervention MeSH terms: Thalidomide; Dexamethasone; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: solid tumor; chemotherapy-induced delayed nausea and vomiting; thalidomide; prevention
Reducing Fall Risks for Adults With Obesity
Condition: Obesity; Bariatric Surgery Candidate; Gait, Unsteady
MeSH terms: Gait Disorders, Neurologic; Obesity
Study type: Interventional

Summary: 
      The objective of the clinical study was to examine if practice could improve walking patterns
      associated with fall risks before patients with obesity underwent weight loss surgery. We
      hypothesized that patients would show improvements in their walking after completing the
      intervention. For the intervention, patients walked under five conditions: on flat ground at
      the beginning of the study, crossing three obstacle heights, and on flat ground at the end of
      the study for a total of 25 times.
    

Detailed description: 
      Obesity has a negative impact on aspects of walking associated with fall risks. After weight
      loss surgery, adults show improvements in walking. However, those who undergo surgery still
      show deficits in walking and an additional group of individuals do not undergo the procedure.
      Our objective was to examine if practice could improve gait patterns associated with fall
      risks before patients underwent weight loss surgery. Adults with obese body mass index
      between 30 to 60 years old who were eligible to undergo the Roux-en-Y weight loss surgery
      procedure walked under five conditions: initial baseline walking on flat ground, crossing
      three obstacle heights, and final baseline walking on flat ground for a total of 25 trials.
      Spatio-temporal gait parameters were collected using a gait carpet and body-worn sensors. The
      GAITRite mat was a 4.9 m long x 0.6 m wide pressure-sensitive mat with a temporal resolution
      of 120 Hz and a spatial resolution of 1.3 cm. LEGSysTM includes five wearable sensors
      containing triaxial gyroscopes, accelerometers, and magnetometers. Dependent variables
      selected included velocity (cm/s), cadence (steps/minute), step length (distance between
      consecutive steps), step width (lateral distance between feet), single limb support time
      (amount of time spent on one leg during the walking cycle), and double limb support time
      (amount of time spend on two legs during the walking cycle).
    

Intervention name(s): Obstacle crossing intervention for adults with obesity
Intervention type(s): Behavioral
Intervention description(s): The obstacle crossing intervention will be done for reducing falls risks in obesity. The intervention will provide gait practice to individuals with obesity who are eligible for and prior to weight loss surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; gait; bariatric surgery; walking; obstacles
Symptom-limited Stair Climbing Test in Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Aims: To assess the efficacy of symptom-limited stair-climbing test (SLSCT), in determining
      the exercise capacities of patients with chronic heart failure (CHF) in comparison with
      cardiopulmonary exercise test (CPET) and 6-minute walk test(6MWT) and to interpret the
      results according to the clinical status of the patients.

      Methods: Thirty-one patients, aged 50-75 years, with stage II-III CHF according to the New
      York Heart Association Classification and left ventricular ejection fraction (LVEF) of ≤45%
      were included. The demographic and clinical characteristics of the patients were recorded.
      Exercise capacity was assessed by SLSCT, 6MWT, and CPET. The duration of patients'
      performance in the test, reasons for ending the test and predicted maximal oxygen consumption
      (VO2max) were recorded. Heart rate (HR), blood pressure (BP), dyspnoea severity [Modified
      Borg Scale (MBS)] and peripheral oxygen saturation were recorded. Pulmonary functions were
      assessed by spirometry.
    


Intervention name(s): Exercise Test
Intervention type(s): Other
Intervention description(s): Tests were conducted to evaluate exercise capacity.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Thirty-one patients age 65.52±7.57 years with stage II-III according to the NYHA
        classification, diagnosed with CHF, with a LVEF of 45% or less admitted to study.
      
Keywords: chronic heart failure; exercise capacity; symptom-limited stair-climbing test
Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation
      containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects.
      Participants will take 1 capsule of the test product and reference product in 2 periods and 2
      sequences (either test after reference or reference after test). There will be a washout of
      at least 14 days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Duloxetine of 1 capsule formulation with Duloxetine 60 mg to demonstrate bioequivalence of
      both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Cymbalta[Trademark], product of Eli Lilly, Puerto Rico. The 90%
           confidence intervals for the intra-subject coefficient of variation (Test versus
           Reference Product) for the main pharmacokinetic parameters area under the plasma
           concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72
           hours (AUC0-72), and maximum plasma concentration (Cmax) for total Duloxetine will be
           determined.

      Participants will be confined in the study site for approximately 25,5 hours during each
      study period (for 10 hours pre-dosing and for 15,5 hours post dosing) during which
      pharmacokinetic (PK) blood samples will be obtained. 17 blood samples will be taken up to 24
      hours after the administration in each period. Participants will return to the site to
      provide additional blood samples at 48 h, and 72 h postdose.The washout period between the
      two study periods will be at least 14 days.

      The samples from each participant will be analyzed with 2 methods of high performance liquid
      chromatography-tandem mass spectrometry bioanalytical assays to quantify total Duloxetine in
      plasma.

      The safety objective is to evaluate the tolerability of both formulations in subjects by
      collecting adverse events.
    

Intervention name(s): Duloxetine 60mg Test Drug Enteric Coated Granules; Duloxetine 60mg Reference Product Enteric Coated Granules
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Cymbalta (Eli Lilly)
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464
      p.o once daily in a rising dose group-comparison (placebo controlled, double blind,
      randomized per dose level).

      Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual
      comparison), preliminary assessment of food effects (interindividual comparison)

      Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and
      Subsequent Randomised, Open Parallel Group Phase).

      MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative
      Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial
      Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent
      Randomised, Open Parallel Group Phase).
    


Intervention name(s): BIBB 1464 MS tablet; BIBB 1464 MS solution; BIBB 1464 MS placebo; Standard dinner
Intervention type(s): Drug; Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy Evaluation of the Probiotics Containing Skincare Products on Skin
Condition: Skin Problems
Study type: Interventional

Summary: 
      Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many
      years, including prevention of skin diseases and improvement of skin conditions. In this
      clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus
      plantarum cream on skin health.
    

Detailed description: 
      To evaluate the efficacy of applying probiotic cream in the ameliorationof the whole face
      skin conditions such as moisturizing, whitening, anti-wrinkle and so on.
    

Intervention name(s): Emulsion base with probiotics; Emulsion base
Intervention type(s): Combination Product; Other
Intervention description(s): Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10^9 cells/ g-cream); Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide
Other intervention name(s): Active Group; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Parallel, Open Label Study
Masking: None (Open Label)
Primary purpose: Supportive Care
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
Condition: Scoliosis; Adolescent Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Inflammatory markers have been analyzed in several diseases of unknown etiology, in the
      expectation of increasing therapeutic perspectives. This possibility arises from the
      different levels of tissue injury with low-grade chronic inflammation that have been observed
      in studies in which the markers were not evaluated traditionally, and today have influenced
      clinical management.

      The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS
      before and after aerobic and combined exercise training.
    

Detailed description: 
      Inflammatory markers have not been evaluated in adolescent idiopathic scoliosis (AIS), but
      this deformity potentially involves various musculoskeletal structures permanently, which
      justifies the analysis. A low-grade chronic inflammation may be related to the lower capacity
      in exercise performance observed in this population, which must be stimulated to perform
      standardized physical activity.
    

Intervention name(s): aerobic exercise; combined exercise; treadmill
Intervention type(s): Other; Other; Device
Intervention description(s): aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate); aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate); resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent idiopathic scoliosis; inflammatory markers; exercise
Pulmonary Evaluation With Ultrasound in Different Levels of PEEP
Condition: Atelectasis; Hypertension; Lung Edema
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Patients submitted to general anesthesia and artificial ventilation almost always develop
      pulmonary atelectasis, which can determine adverse consequences both intraoperatively and
      postoperatively. It is recommended to use physiological tidal volume (6 - 8 mL / kg of ideal
      body weight) during the intraoperative period in order to minimize the risk of lung injury.
      To prevent the formation of atelectasis, minimizing the risk of complications, the use of
      PEEP has been recommended. At present, there is no way to make an optimal adjustment of PEEP
      to the needs of each patient, seeking a value that keeps the alveoli open without forming
      atelectasis and also without areas of hyperdistension.

      The aim of this study was to evaluate the agreement between the ultrasound and the electrical
      impedance tomography - Timpel® (TIE) to detect the beginning of the formation of areas of
      atelectasis after pulmonary recruitment, with decreasing PEEP values. In addition, the lung
      ultrasound will be validated for intraoperative use for both adequacy of PEEP, as well as
      quantitative analyzes of ultrasound images to assess atelectasis.

      18 patients (> 18 years) of both sexes, submitted to general anesthesia, will be
      prospectively studied. All patients will receive, in addition to the usual monitoring, the
      monitoring with the electrical impedance tomography and chest ultrasonography, after being
      anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50%
      oxygen (or greater to maintain oxygen saturation > 96% ), Tidal volume of 6 mL / kg and
      respiratory rate to maintain expiratory tidal CO2 between 35-45 cmH2O.
    


Intervention name(s): PEEP TITRATED; Use ultrasound; Impedance tomography; Best PEEP for less collapse; PEEP 4
Intervention type(s): Procedure; Device; Device; Other; Other
Intervention description(s): After titrated peep levels, we choice this level of peep for de group (peep titrated); We make a lung ultrasound after we setup a different level of PEEP; We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.; After titrated PEEP levels we setup the best PEEP the according of tomography impedance; We set the peep level after titrated peep = 4 cmH20.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
The Efficacy and Safety of Prophylactic Central Lymph Node Dissection in Papillary Thyroid Carcinoma
Condition: Thyroid Cancer, Papillary
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy and safety of prophylactic central lymph
      node dissection in papillary thyroid carcinoma.
    

Detailed description: 
      The aim of this study is to investigate the efficacy and safety of prophylactic central lymph
      node dissection in papillary thyroid carcinoma. Primary outcome is the surgical completeness,
      recurrence rate, and successful ablation rate. Secondary outcomes are the incidence of
      postoperative complications and PTC stage. The enrolled patients were randomly assigned to
      control group and intervention group (1:1 allocation).
    

Intervention name(s): prophylactic central lymph node dissection
Intervention type(s): Procedure
Intervention description(s): dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain
Condition: Chronic Pain; Anaesthesia; Genetics Predisposition
MeSH terms: Chronic Pain; Pain, Postoperative; Genetic Predisposition to Disease
Study type: Interventional

Summary: 
      To determine whether central sensitization is a mechanism of CPSP (chronic postsurgical pain)
      in women who will develop CPSP compared to women with no CPSP after hysterectomy. This
      mechanism is illustrated by a higher pain score in experimental pain models such as tonic
      heat stimulation, increased evoked mechanical temporal summation and increased wound
      hyperalgesia.
    

Detailed description: 
      Chronic pain affects 9% of Singapore population resulting in major socioeconomic burden.
      Chronic postsurgical pain (CPSP) that persists for over 3 months could be related to nerve
      injury making this a strategic model to study the transition of acute to chronic pain. CPSP
      occurs in up to 50% after surgery and up to 32% after hysterectomy. Over 600000
      hysterectomies were performed in the US in 2003 making CPSP a significant problem.

      Investigators will perform this prospective cohort study to determine whether increased
      central sensitization and negative psychological experience are involved in the transition of
      acute to chronic pain after hysterectomy. Investigators will recruit 444 women undergoing
      hysterectomy and employ validated physical pain testing including tonic heat stimulation,
      mechanical temporal summation and wound hyperalgesia which had been shown to be related to
      central sensitization. Pain catastrophizing (negative thoughts of pain) and state trait
      anxiety scoring will be assessed for the impact of negative cognitive-affective experience on
      CPSP. A phone survey will be performed at 4 months to determine the primary outcome of CPSP.
      Arterial spin labeling will be used to delineate cerebral blood flow using arterial spin
      labeling, functional connectivity and structural connectivity to evaluate insula-anterior
      cingulate cortex differences in 30 women with CPSP compared to 30 women without CPSP.

      In addition to evaluating whether central sensitization, negative psychological experience
      and activation of brain regions are different in women with CPSP after hysterectomy, the
      results of this study will elucidate potential mechanisms of CPSP development that will guide
      in future studies on potential novel therapeutic targets.
    

Intervention name(s): pain testing
Intervention type(s): Other
Intervention description(s): physical testing, psychological testing, genetics testing and functional brain imaging
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Physical Activity Counseling After an Exacerbation in COPD
Condition: COPD Exacerbation
Study type: Interventional

Summary: 
      Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant
      a hospitalization. During the hospitalization, patients are extremely physically inactive
      with only a limited recovery one month after discharge. Physical inactivity is associated
      with negative health benefits. Therefore intervening in the period after and exacerbation
      seems useful to improve the levels of physical activity. Physical activity counseling and
      real-time feedback have already been applied in stable patients with COPD, with beneficial
      effects.The present study will investigate whether this specific intervention will help to
      improve the activity level in patients after an acute exacerbation. Further we investigated
      the effects of the intervention on improvements in functional exercise capacity.
    

Detailed description: 
      After signing the informed consent, the patients will be randomized into a control group,
      receiving usual care, or the intervention group receiving real-time feedback and physical
      activity counseling.

      Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts
      based on the step count from the Fitbit Ultra. In agreement with the patient and based on the
      step counts a patients provided, a new goal for the next week was set. The goal was to strive
      for the highest possible level of physical activity during one month.
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: physical activity; COPD; activity monitors