bioihbjkbjnl/mcl2 huggingface dataset:
Associations Between Air Pollutants Exposures and Respiratory System Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Epidemiological investigations has suggested exposure to air pollution linked with
      respiratory disease, especially chronic obstructive pulmonary disease. However, the potential
      mechanisms of adverse effects remains scare. The present study will assess the association
      between air pollutants and respiratory related parameters to elucidate possible mechanisms.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects including health volunteers and COPD patients,both of them without severe
        cardiopulmonary diseases and long-term residents in Beijing
      
Biospecimen description: 
      Urine,Blood,Sputum and Exhaled breath condensate
    
Keywords: Chronic Obstructive Pulmonary Disease
Effect of Propranolol on Preventing Posttraumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the effectiveness of taking propranolol soon after a traumatizing
      incident in reducing the incidence and severity of posttraumatic stress disorder in acutely
      traumatized individuals.
    

Detailed description: 
      Posttraumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following
      exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD
      is marked by clear biological changes as well as psychological symptoms. Many people with
      PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or
      frightening thoughts. This study will assess the effect of post-trauma propranolol on
      reducing the incidence and severity of PTSD. The study will also evaluate propranolol's
      effectiveness as a preventive measure against subsequent PTSD symptoms.

      Participants in this double-blind study will be recruited upon admission to the Massachusetts
      General Hospital Emergency Department after exposure to a psychologically traumatic event.
      Baseline psychometric and psychobiologic measurements will be collected. Within 6 hours
      following the traumatic event, participants will be randomly assigned to receive either 40 mg
      of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or
      placebo. For the next 10 days, participants will receive 120 mg of either long-acting
      propranolol or placebo twice daily. A 9-day medication tapering will follow. Participants
      will undergo psychophysiologic, psychodiagnostic, and psychometric testing for PTSD 1 and 3
      months following the traumatic event.
    

Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Propranolol short-acting or long-acting capsule; Placebo-matching propranolol short-acting or long-acting capsule
Other intervention name(s): Inderal
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Post-Traumatic Stress Disorder; Prevention; Propranolol; Psychophysiology
Characterization of Fingertips Using MRI Images (FINGERS-COMPRESSION)
Condition: Healthy
Study type: Interventional

Summary: 
      The objectives was to obtain MRI images of the index finger of the subjects without loading
      and with loadings (normal and shear forces from 1 to 4N).
    


Intervention name(s): Compression of the fingertip under MRI.
Intervention type(s): Other
Intervention description(s): Compression of the fingertip by a static loading on the phalanx distal of the index of the subjects; Then also a shear stress in the transverse direction of the finger. The data provided by the MRI images will be geometric information such as the thickness of the skin and its possible variation as a function of the area of the finger, the total thickness of soft tissues in compression as a function of the variation in l The angle between the axis of the phalanx and the plane of contact; Mechanical type information relating to the displacements and reaction forces, to the internal deformations of the different areas of the finger.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: MRI, fingers compression
Effects of KDT501 on Metabolic Features in Insulin Resistant Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      KDT501 is an orally administered product designed to help control impaired glucose and
      insulin regulation in patients with insulin resistance. Nonclinical studies demonstrate
      agonist activity of KDT501 at the G-protein coupled receptor 120 as well as other G-protein
      receptors. Nonclinical studies have also documented the ability of KDT501 to improve insulin
      sensitivity and glucose regulation as well as reduce proinflammatory signals. These
      properties combined with antihyperglycemic activity and modest, partial agonist effect of
      KDT501 at the peroxisome proliferator-activated receptor-gamma (PPARγ) receptor suggests an
      atypical and pleiotropic mechanism of action for KDT501.

      Following providing informed consent, potential subjects will undergo screening procedures to
      ensure that they meet all inclusion and exclusion criteria. Following registration on study,
      subjects will undergo baseline pretreatment studies, including two abdominal fat biopsies,
      one taken after cold challenge, as well as determination of resting metabolic rate, a 4 hour
      lipid tolerance test, and a 2 hour euglycemic clamp study. All pretreatment studies in
      registered subjects will be performed within 7 days prior to initiating therapy. On the first
      day of treatment (Day 0), subjects will take the first 600 mg dose of KDT501 in the clinic,
      followed by serum pharmacokinetic (PK) samples being obtained every hour for 6 hours after
      dosing. Subjects will then continue dosing as an outpatient, 600 mg po twice daily. All doses
      will be taken with meals (breakfast and dinner). On Day 7, subjects will return to the clinic
      to undergo safety and laboratory assessments, including PK. On Days 14 and 21, subjects will
      again return to the clinic to undergo safety and laboratory assessments. On Day 17 subjects
      will return to the clinic for PK studies, as noted below. Treatment in all subjects will end
      on Day 28. Rapid PK assessment of drug exposure, defined as AUC0-12h, will be performed
      following PK samples drawn at Time 0, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, and 12h on both Days 7
      and 17. On Days 11 and 21 (±1day), based on the KDT501 drug exposure level, the subject will
      be provided instructions on dose adjustments of KDT501. The maximum allowed KDT501 exposure
      ceiling for all subjects enrolled is AUC0-12h = 22,500ng-hr/mL.
    


Intervention name(s): KDT501
Intervention type(s): Drug
Intervention description(s): 600mg twice daily, Oral, for 10days; then 800mg twice daily, Oral, for 10 days; then 1,000mg twice daily, Oral, for 8 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KDT501; Diabetes; Diabetes Mellitus; Type 2; KinDex
Postbiotic MBS and Metformin Combination in Patients With T2DM
Condition: Type-II Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary objective is to evaluate the effect of MBS treatment in human subjects, and to
      validate its impact on intestinal flora and diabetes symptoms on diabetic patients
      undertaking metformin. The scientific data collected will be referenced for future product
      development.
    


Intervention name(s): MBS oral solution
Intervention type(s): Dietary Supplement
Intervention description(s): Oral BIDAC, twice a day before breakfast and dinner times
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus (DM); diabetes; T2DM; MBS; microbial
Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery
Condition: Quality of Life; Pelvic Floor Distress and Impact Scores; Sexual Function Scores
Study type: Interventional

Summary: 
      i) The primary objective of this study is to determine if physical therapy improves
      postoperative quality of life in participants following vaginal reconstructive surgery for
      pelvic organ prolapse and urinary incontinence.

      ii) Secondary objectives include:

        1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse
           symptoms) in participants undergoing physical therapy compared to standard postoperative
           care

        2. Comparing sexual function in participants undergoing physical therapy compared to
           standard postoperative care;

        3. Comparing postoperative pain scales, and activity assessment in participants undergoing
           physical therapy compared to standard postoperative care;

        4. Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in
           participants undergoing physical therapy compared to standard postoperative care.
    

Detailed description: 
      This is a single center randomized controlled trial assessing quality of life in participants
      following vaginal surgery receiving physical therapy compared to standard postoperative care.
      Patients will be under care of the physicians of the Division of Urogynecology and
      Reconstructive Pelvic Surgery. All physicians are board certified, fellowship trained
      urogynecologists.
    

Intervention name(s): Physical therapy
Intervention type(s): Behavioral
Intervention description(s): pelvic floor physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical therapy; pelvic prolapse; incontinence; quality of life
Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults.
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The hypothesis is that seafood proteins given in combination with carbohydrates with low GI
      are superior to seafood proteins in combination with carbohydrates with high GI and meat in
      combination with both carbohydrates with low and high GI in promoting energy expenditure and
      satiety. The overall objective of this study is to investigate the acute effects of meals
      containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating
      hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.
    


Intervention name(s): Fish and carbohydrats with low or high GI; Veal and carbohydrats with low or high GI
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Proteins (seafood and meat); GI; Energy expenditure; Energy balance; Thermogenesis (DIT); Appetite regulating hormones; Appetite sensations; Glucose allostatis; Amino acid metabolism; Satiety; Food preferences
Mechanical Insufflation -Exsufflation in Children With NMD and Weak Cough
Condition: Neuromuscular Diseases in Children
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan
      conditions. The children are vulnerable and often subject to rapid deterioration of pulmonary
      function due to impaired ability to clear airway secretions. The use of mechanical cough
      augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent.
      Possible major benefits are described, but optimal settings for best efficacy and comfort in
      children are not established. The project aim to improve the quality of the treatment with
      MIE in children with NMD and weak cough. On the basis of a bench study a clinical trial aims
      to examine the most effective MIE settings when used in stable state and when respiratory
      tract infections are present.
    

Detailed description: 
      On the basis of a prevalence study and a bench study different settings will be studied in
      children with NMD and weak cough to examine if settings derived from the lung model, are
      optimal to increase the peak cough flow (PCF) and comfort measured by visual analogue scale
      (VAS) in children with NMD and weak cough.
    

Intervention name(s): Symmetric settings (high pressures/fast rate); Asymmetric settings (Pi<Pe/Ti>Te); Preinclusion settings
Intervention type(s): Other; Other; Other
Intervention description(s): Describes settings on the MI-E device; Lower insufflation pressures at longer times; Settings in use at start of study
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Three different settings are tested on the same patients but in randomized order.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Felodipine Event Reduction Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      FEVER is an investigator-designed, prospective, multicentre,double-bind, randomized,
      placebo-controlled,parallel-group trial. The primary objective is to compare the long-term
      effects on the incidence of fatal and non-fatal stroke (and secondarily of other
      cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5
      mg once a day) or of a placebo, in hypertensive patients whose blood pressure had
      preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg
      once a day) to be continued in association with felodipine or placebo, throughout the trial.
    


Intervention name(s): Felodipine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Felodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertension; felodipine; moderate to high risk patients
Effect of Ketamine Addition to Lidocaine in Rhinoplasty
Condition: Nose Deformities, Acquired
MeSH terms: Nose Deformities, Acquired
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether subanesthetic ketamine addition to
      lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.
    

Detailed description: 
      In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient
      comfort. The investigators designed this study to prolonged the time of infiltration block
      and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa
      of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand,
      postoperative pain scores and side effects will determine.
    

Intervention name(s): Lidocaine 2 %; Ketamine plus Lidocaine; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12 mL lidocaine 2% 1mg/kg; ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL; 12 mL saline (0.9% isotonic solution)
Other intervention name(s): preincisional infiltration of lidocaine; preincisional infiltration of ketamine plus lidocaine; preincisional infiltration of saline
Intervention MeSH terms: Lidocaine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Condition: Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese
      individuals planning to undergo weight loss surgery. Individuals taking the medication before
      and after surgery will be compared to historical controls who had surgery without taking the
      medication.
    

Detailed description: 
      While there is obvious focus on the obesity epidemic that affects approximately one-third of
      the U.S. population, one subgroup within the epidemic remains on the fringe of scientific
      study and effective treatment options. The super obese patient, in this instance defined as
      those with a BMI ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level
      of obesity. While bariatric surgery, including Roux-en-Y gastric bypass and biliopancreatic
      diversion with duodenal switch, have been shown to be effective in severe obesity (BMI ≥ 40
      kg/m2), the risks involved with surgical intervention in the super obese patient are high.

      Qsymia provides a potential opportunity to develop an effective treatment plan that would be
      an adjunct to surgical intervention in the super obese patient. Use of Qsymia in addition to
      a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to
      surgical intervention, lowering surgical risk to some extent. Additionally, if continued
      post-operatively, Qsymia as an adjunct to the post-surgical dietary plan would potentially
      extend the weight loss horizon so that the probability of the typical weight loss plateau at
      12-18 months is decreased.
    

Intervention name(s): Phentermine/topiramate; low calorie diet
Intervention type(s): Drug; Other
Intervention description(s): Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery.; The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
Other intervention name(s): Qsymia
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with
      entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa
      Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose
      motor fluctuations.
    

Detailed description: 
      Efficacy and safety of BIA 9-1067 in idiopathic Parkinson's disease patients with
      "wearing-off" phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a
      double-blind, randomised, placebo- and active-controlled, parallel-group, multicentre
      clinical study.
    

Intervention name(s): BIA 9-1067; Entacapone; Placebo; Levodopa; Carbidopa; Benserazide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5, 25 and 50 mg of BIA 9-1067 (once-daily); 200 mg entacapone (concomitantly with each L-dopa/DDCI dose); 200 mg; DOPA decarboxylase inhibitor; DOPA decarboxylase inhibitor
Other intervention name(s): OPC, Opicapone; Comtan®; PLC; L-Dopa
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Entacapone; Benserazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson; PD; Wearing-off; Levodopa/DDCI
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo
      controlled, pediatric study conducted in three phases.
    


Intervention name(s): rilonacept (IL-1 Trap); Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Rilonacept
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SJIA
Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block
Condition: Pericapsular Nerve Group Block (PENG Block); Lumbar Erector Spinae Plane Block
Study type: Interventional
Phase: Phase 2

Summary: 
      assess and compare the efficacy of pericapsular nerve group block wersus lumber erector
      spinae plane block in reducing postoperative pain within the first 24 hours after hip
      surgeries.
    

Detailed description: 
      after being informed about the study and potential risks. All patients giving written consent
      will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG
      group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before
      positioning for spinal anesthesia.

      ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before
      positioning for spinal anesthesia.

      Control group C(n =23 ): patients received spinal anesthesia without any block.
    

Intervention name(s): Pericapsular Nerve Block; Lumbar Erector Spinae Plane Block; Fentanyl
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): regional anaesthia; regional anaesthia; intavenous
Other intervention name(s): PENG; LESB
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Lumbar Erector Spinae Plane Block, Pericapsular Nerve Group Block (PENG Block)