bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to assess the effects of co-administration of itraconazole or
      diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T)
      of BMS-986177
    


Intervention name(s): BMS-986177; Itraconazole; Diltiazem ER
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Itraconazole; Diltiazem
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy
Condition: Malignant Breast Tumours
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast Ultrasound Elastography is a complementary technique permitting a better
      characterization of breast lesions. 3D breast ultrasound elastography is a novel technique
      permitting a volumetric calculation of lesion stiffness. This could be particularly useful in
      patients with large breast tumors under pre-operative chemotherapy
    

Detailed description: 
      3D breast ultrasound elastography provides volumetric lesion stiffness details in real time.
      3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated
      in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The
      purpose of this prospective study is to evaluate the feasibility of this technique and
      compare the results to those of Breast MRI. For women receiving preoperative chemotherapy,
      this technique will be evaluated with regard to tumour shrinkage and lesion elasticity
      modifications under treatment.
    

Intervention name(s): 3D Ultrasound elastography by means of shear wave propagation into breast tissue
Intervention type(s): Device
Intervention description(s): Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography
Other intervention name(s): Aixplorer Supersonic Imagine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Global Behavior and Periodontal Disease in Down's Syndrome Patients
Condition: Behavior; Periodontal Diseases
MeSH terms: Periodontal Diseases; Down Syndrome
Study type: Observational

Summary: 
      This study aimed at correlating global behavior of Down's Syndrome patients to periodontal
      disease status.
    

Detailed description: 
      There is a higher prevalence and severity of periodontal disease in Down's Syndrome patients.
      Plaque levels in these patients are high due to poor hygiene habits. Behavior also may
      contribute to the overall periodontal condition.
    

Intervention name(s): Behavior Analysis
Intervention type(s): Behavioral
Intervention description(s): One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with a medical diagnose of Down's Syndrome
      
Keywords: Social behavior; Gingivitis; Periodontitis; Down's Syndrome
Transversus Thoracic Muscle Plane Combined With Pectoral Nerves Block for Breast Cancer Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is a prospective, randomized, controlled trial for evaluating the efficacy of addition
      of transversus thoracic muscle plane block to pectoral nerves block versus pectoral nerves
      block for quality of recovery scores in breast cancer surgery.
    

Detailed description: 
      The pectoral nerves (PECS) block cannot block the most internal mammary region, whereas a
      transversus thoracic muscle plane (TTP) block can. The combination of PECS and TTP blocks may
      be suitable for breast cancer surgery. We studied patients undergoing breast cancer surgery
      to assess whether the combination of PECS and TTP blocks provides better postoperative
      recovery than PECS block alone.
    

Intervention name(s): the combination of transversus thoracic muscle plane and pectoral nerves blocks; the pectoral nerves block only
Intervention type(s): Procedure; Procedure
Intervention description(s): For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle. For the transversus thoracic muscle plane block, ropivacaine 0.375%,15ml was injected between the transversus thoracic muscle and the internal intercostal muscle.; For the pectoral nerves block, 0.375% ropivacaine , 10ml was injected between the pectoralis major and pectoralis minor and 20 ml above the serratus anterior muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heart and Kidney Ketones Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      Participants will undergo 3 Positron Emission Tomography (PET) scans in 3 different
      conditions :

        1. Fasting without exogenous ketone salt

        2. Fasting with exogenous ketone salt supplement

        3. Post-Prandial with exogenous ketone salt supplement.
    

Detailed description: 
      This study will help to quantify heart and kidney ketone uptake with or without an exogenous
      ketone salt with or without food intake in middle-aged adults. Participants will have 3
      different PET scan to perform :

        1. Fasting without exogenous ketone salt

        2. Fasting with exogenous ketone salt supplement

        3. Post-Prandial with exogenous ketone salt supplement.
    

Intervention name(s): Fasting with exogenous ketone salt supplement; Post-Prandial with exogenous ketone salt supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan.; Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan and they will have a liquid meal 20 minutes before the scan.
Other intervention name(s): Post-Prandial with exogenous ketone salt supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will have to do the 3 acute interventions
Masking: None (Open Label)
Primary purpose: Basic Science
Cardiac Rehabilitation in Cardiomyopathies
Condition: Cardiomyopathies
MeSH terms: Cardiomyopathies
Study type: Interventional

Summary: 
      This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary
      function, cardiovascular function, and impact on quality of life in patients after cardiac
      rehabilitation associated with the diaphragmatic muscle training.
    


Intervention name(s): Cardiac Rehabilitation with diaphragmatic muscle training
Intervention type(s): Other
Intervention description(s): Stretching and aerobic exercises and respiratory muscle training with a Threshold ® device, with load of 40% of the maximal inspiratory pressure (MIP), two times a week during one hour.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rehabilitation; dyspnea; strength
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Fluid responsiveness is difficult to assess at the bedside. The accuracy of published
      techniques to detect preload-dependent patients have many pitfalls and limitations. The
      present study test the role of noninvasive effective pulmonary blood flow measured by expired
      carbon dioxide to detect fluid responsivess in mechanically ventilated patients.
    

Detailed description: 
      This is a prospective and observational study designed to test the accuracy of the
      non-invasive effective pulmonary blood flow measured by the capnodynamic methodology for
      detect preload-dependent patients.

      Fourty patients undergoing mechanical ventilation during surgery will be studied.
      Preload-depency (fluid responsiveness) will be tested during an increase in end-expiratory
      pressure (PEEP) from 5 to 10 cmH2O during one minute. Pulse pressure variation will be use as
      the reference method to detect preload-dependency. The effective pulmonary blood flow will be
      continuously recorded during the PEEP maneuver. Receiver Operator Curves will be used to
      detect fluid responsiveness taking a pulse pressure variation higher than 13%.The
      corresponding cut off value for the effective pulmonary blood flow signal will be
      determined..
    

Intervention name(s): PEEP trial
Intervention type(s): Procedure
Intervention description(s): Positive end-expiratory pressure (PEEP) is increased from 5 to 10 cmH2O during one minute.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac and noncardiac surgery patients ASA 2-4
      
Keywords: Carbon dioxide; Pulmonary blood flow; Ventilation
Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as
      compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric
      population (10-17 years old) and adults as controls

      Secondary Objectives:

      - To evaluate in both paediatric and adult populations:

        -  the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single
           subcutaneous ascending doses

        -  the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide
           and glucagon plasma concentrations following a standardized breakfast

        -  safety and tolerability.
    

Detailed description: 
      The duration of the study for each patient is planned between 4 and 7 weeks including a
      screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting
      only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose
      administration.
    

Intervention name(s): Lixisenatide (AVE0010); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution for injection
Route of administration: subcutaneous; Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
Intervention MeSH terms: Lixisenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns
Condition: Сhanges in the Cardiovascular System in Healthcare Workers During Work Shift
Study type: Observational

Summary: 
      The purpose of this work is to assess the functional state of the body of medical workers in
      the neonatal resuscitation and intensive care unit in the conditions of work.
    


Intervention name(s): work conditions
Intervention type(s): Other
Intervention description(s): an increased degree of responsibility for the life of newborns, high psycho-emotional stress, intellectual stress, an irrational work and rest regime, in connection with the COVID-19 pandemic, also using personal protective equipment against biological factors
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy medical workers in neonatal intensive care unit
      
Keywords: functional state of the body; medical personnel; heart rate variability; cognitive functions; cardiovascular system
Effects of Probiotics on Neonatal Hyperbilirubinemia
Condition: Neonatal Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Interventional

Summary: 
      This study was designed as a prospective controlled study to investigate the effects of
      probiotic support started immediately after birth on newborn jaundice in breastfed babies
      born by normal spontaneous vaginal delivery.
    

Detailed description: 
      Objectives: Enterohepatic circulation of bilirubin imposes an extra burden of approximately
      30% on total serum bilirubin levels. Intestinal microflora is the main factor affecting
      enterohepatic circulation. This study investigated the effects of probiotic support started
      immediately after birth on neonatal hyperbilirubinemia in babies born by normal spontaneous
      vaginal delivery and breastfed only.

      Methods: A total of 150 healthy term newborns were included in the study and allocated in the
      study and control groups. Immediately after birth, newborns in the study group received
      probiotic in liquid drop form (Maflor® drops containing Lactobacillus Rhamnosus GG 109 Colony
      Forming Units(CFU), Mamsel Pharmaceuticals, Turkey), at a dose of 5 drops a day orally for 10
      days. Newborns in the control group received 5 drops of saline solution per day orally,
      instead. In addition to routine biochemical examinations;serum bilirubin levels in the cord
      blood, and blood samples of the newborns on the 3rd, 5th and 10th days of birth were measured
      in all subjects in both groups. Defecation frequency was recorded for all subjects.
    

Intervention name(s): Maflor®, Mamsel Pharmaceuticals, Turkey; drops of saline
Intervention type(s): Biological; Other
Intervention description(s): Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey)
Other Name: Maflor®; Dietary Supplement: Breast milk +drops of saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Probiotic; Neonatal Hyperbilirubinemia
Liposome Bupivacaine for WRIST Blocks
Condition: Dupuytren's Contracture of the Hand (Viking's Disease)
MeSH terms: Dupuytren Contracture; Contracture
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of Dupuytren's contracture requires multiple injections into the palm of the hand
      to weaken the cords, followed by rupture of the strands 2 days later. Anesthesia is required
      for both phases of treatment. It is hypothesized that extended-release liposome bupivacaine
      prolongs nerve blockade of the wrist allowing patients to undergo this 2-part regimen with
      less pain.
    


Intervention name(s): Liposome bupivacaine + bupivacaine
Intervention type(s): Drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Postprandial Effects of a High Potassium Meal
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The investigators aim to evaluate the acute effects of potassium supplementation achieved by
      ingestion of potassium rich food, on vascular health.
    

Detailed description: 
      Many studies have shown that an increase in potassium through the diet or through potassium
      pills helps to lower blood pressure. Also, the amount of oral potassium taken can improve how
      well the participants blood vessels work. These studies have focused on potassium given in
      the form of a pill. The investigators are interested in the effect of potassium consumed
      through food sources and how it will effect arterial health and blood pressure. The world
      health organization (WHO) recommends a K⁺ intake of at least 3510 mg/day from food for
      adults, excluding those with impaired K⁺ excretion. In this study the investigators aim to
      provide approximately 75% (approximately 2000 mg) of the total daily recommended intake for
      potassium in one meal. The investigators do not know whether dietary potassium (not pill
      form) will acutely improve the arterial health and if it will cause a decrease in blood
      pressure. The investigators hypothesis to see an improvement in vascular function following a
      high potassium meal compared to a low potassium meal.
    

Intervention name(s): High Potassium Meal; Low Potassium Meal
Intervention type(s): Other; Other
Intervention description(s): Breakfast meal that provides ~2400 mg of dietary potassium. Meals are isocaloric.; Breakfast meal that provides ~540 mg of potassium. Meals are isocaloric.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Dietary Potassium
The Effect of Exercise on Individuals With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The goal of this trial is to compare the effect of two different exercise programs on
      neuro-physiological, motor, functional, and quality-of-life issues in individuals with
      Parkinson's disease to determine which program is most beneficial.
    

Detailed description: 
      Parkinson's disease (PD) negatively affects the quality of life for a million individuals in
      the United States. While medication and surgery are the most effective treatments for PD,
      physicians and people with PD often delay using these treatments because of their
      considerable adverse side effects. Until a cure for PD is discovered, there is a compelling
      need to develop interventions that provide relief of symptoms without causing negative side
      effects.

      Recent research suggests that exercise may provide symptom relief in some characteristics of
      PD. While various exercise interventions appear to effectively improve motor, functional, and
      quality-of-life issues, the research is mixed regarding the nature, extent and duration of
      these improvements. Understanding how multiple characteristics of PD change and whether they
      can be modified by different exercise programs is essential to determining if an exercise
      program is clinically effective for PD.

      This study is designed to compare the initial (six months), and then long-term (2 years)
      effect that 2 different exercise programs (progressive resistance program or flexibility
      program) have on neuro-physiological, motor, functional, and quality-of-life issues in
      individuals with Parkinson's disease. The goal is to determine which program is most
      beneficial. Results from this study will be used to determine which exercise program produces
      the most beneficial effects on neuro-physiological, motor, functional and quality-of-life
      measures.

      NOTE: Recruitment for Parkinson's disease participants is now closed.
    

Intervention name(s): Progressive resistance training; Modified Fitness Counts
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise twice a week for 2 years doing either progressive resistance training. The The PRE program consisted of 11 strengthening exercises: chest press, latissimus pull downs, reverse flys, double leg press, hip extension, shoulder press, biceps curl, rotary calf (ankle plantar flexion), triceps extension, seated quadriceps extension and back extension.; The modified Fitness Counts program was taken from Chapters 2 and 3 of the Parkinson's disease: Fitness Counts booklet and focused on non-progressive stretching, strengthening and balance exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; exercise
Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
Condition: Pulmonary Fibrosis; Lung Disease
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Despite the implementation of modern public health interventions, 1 in 5 adults in the United
      States are either current or former smokers and remain at risk for the development of chronic
      lung diseases. It is unknown how or why any one individual smoker can develop a wide range of
      lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The
      purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar
      samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles
      that correspond to divergent pathways in the expression of such proteins as the transforming
      growth factor-beta1 (TGF-beta <=1). The information generated from this study will provide
      insight into the pathogenesis of smoking-related lung injury and potentially allow for the
      development of early therapeutic interventions.
    

Detailed description: 
      Despite the implementation of modern public health interventions, 1 in 5 adults in the United
      States are either current or former smokers and remain at risk for the development of chronic
      lung diseases. It is unknown how or why any one individual smoker can develop a wide range of
      lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The
      purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar
      samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles
      that correspond to divergent pathways in the expression of such proteins as the transforming
      growth factor-beta1 (TGF-beta1). The information generated from this study will provide
      insight into the pathogenesis of smoking-related lung injury and potentially allow for the
      development of early therapeutic interventions.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        One hundred thirty-eight study subjects with chronic obstructive pulmonary diseases (COPD)
        and interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF) along with 85
        control subjects will be enrolled in this study.
      
Keywords: COPD; Smoking; Idiopathic Pulmonary Fibrosis; Natural History