bioihbjkbjnl/mcl2 huggingface dataset:
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study in patients with chronic obstructive pulmonary disease (COPD) to
      assess the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and safety of two dose
      levels of CSJ117 in comparison to placebo. For this, the impact of CSJ117 on disease symptom
      burden and lung function will be explored.
    

Detailed description: 
      This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel
      group, multicenter study with two fixed-dose levels of CSJ117 (4 mg, 8 mg) administered
      once-daily via oral inhalation over 12 weeks in participants with COPD, prone for
      exacerbations and symptomatic at baseline despite background maintenance triple therapy
      (inhaled corticosteroids/long acting beta-2 agonist/long acting muscarinic antagonist
      (ICS/LABA/LAMA) combination, standard of care in this population) for at least three months
      prior to screening.

      The study will include:

        -  Screening period of up to 2 weeks to assess eligibility.

        -  Run-in period of 4 weeks where participants will be placed on fixed-dose triple
           background therapy (ICS/LABA/LAMA) that will be used until the patient's last study
           treatment.

        -  Treatment period of 12 weeks. Participants will be stratified by eosinophil levels and
           then randomized 1:1:1 to either 4 mg CSJ117, 8 mg CSJ117, or placebo.

        -  Follow-up period of 55 days following the last dose of study drug. The primary objective
           of the study is to assess the effect of CSJ117 on disease/symptom burden after 12 weeks
           of treatment.
    

Intervention name(s): CSJ117; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device.; Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; COPD; CSJ117
Alternate Day Fasting Combined With a High Protein Background Diet
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aims of this study are as follows: AIM 1: To examine the weight loss and weight
      maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To
      examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids,
      fasting glucose, fasting insulin, insulin resistance).
    

Detailed description: 
      Background: Accumulating evidence suggests that alternate day fasting (ADF) is an effective
      diet strategy to help individuals with obesity lose weight and lower metabolic disease risk.
      ADF regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated
      with a "fast day" where intake is limited to ~600 kcal over 24 h. What has yet to be
      elucidated is whether consuming a high protein diet (as meal replacements) during ADF is
      effective for weight loss, weight maintenance, and metabolic disease risk reduction in
      individuals with obesity.

      Objective: The aims of this study are as follows: AIM 1: To examine the weight loss and
      weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To
      examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids,
      fasting glucose, fasting insulin, insulin resistance).

      Methods: A 24-week, single-center, longitudinal pilot study will be conducted to test the
      study objectives. The trial will be divided into 2 consecutive intervention periods: (1)
      12-week weight loss period, and (2) 12-week weight maintenance period. Subjects with obesity
      will participate in an ADF-HP: alternate day fasting-high protein diet: 600 kcal "fast day"
      alternated with ad libitum "feast day", 35% kcal as protein. ADF-HP subjects will consume the
      Optifast HP Shake Mix (Nestle) on each day of the trial. Body weight, insulin, glucose, and
      insulin resistance, will be measured at baseline, week 12, and week 24.

      Significance: These findings may show that alternate day fasting combined with high protein
      meal replacements may be implemented as an effective diet therapy to help individuals with
      obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.
    

Intervention name(s): Alternate day fasting
Intervention type(s): Other
Intervention description(s): Alternate day fasting with a high protein diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Steroids on Post-tonsillectomy Morbidities
Condition: Postoperative Pain; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the effect of postoperative systemic rapid onset and short acting
      dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy
      morbidities. Half of the patients who comply with the inclusion criteria were selected to
      receive a single postoperative dose of intravenous dexamethasone followed by oral steroids;
      the second group received placebo.
    

Detailed description: 
      The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain,
      nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the
      effect of postoperative systemic rapid onset and short acting dexamethasone followed by a
      tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the
      duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy
      procedure were screened for medical history and those who comply with the inclusion criteria
      were randomly assigned into two equal groups of 50 patients each. One group was selected to
      receive a single postoperative dose of intravenous dexamethasone followed by oral steroids;
      the second group received placebo. Questionnaires investigating postoperative pain, nausea,
      vomiting, and oral intake were answered by patients, parents or guardians where applicable.
    

Intervention name(s): IV dexamethasone; Oral prednisolone; Paracetamol; IV saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.15 mg/kg; 0.25mg/kg/day for 7 days then tapering for next 7 days; acetaminophen 15 mg/kg/dose every 6 hours; IV saline
Other intervention name(s): Decadron; Predosone; Adol; Saline
Intervention MeSH terms: Acetaminophen; Dexamethasone; Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexamethasone; Prednisolone; Tonsillectomy Nausea; Pain, Postoperative; Postoperative Nausea and Vomiting; Randomized controlled trial; Post-tonsillectomy pain; delayed feeding
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of renal impairment on the
      pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and
      will evaluate the effect of renal function on the safety of the drug. Patients will be
      assigned to treatment groups according to their renal function (normal, moderate renal
      impairment, or severe renal impairment). After a 1 week washout period from current oral
      anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator
      (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on
      study treatment is <3 months, and the target sample size is <100 individuals.
    


Intervention name(s): GK Activator (2)
Intervention type(s): Drug
Intervention description(s): 100mg po
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess in healthy subjects the safety, tolerability,
      pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal
      antibody against influenza A viruses.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled dose escalation study will enroll up to 6
      cohorts of healthy subjects. Eight subjects will be enrolled in each cohort (1 to 5) and will
      receive a single 2-hour intravenous infusion of CR6261 (6 subjects) or placebo (2 subjects)
      on Day 1. Subjects will be dosed in pairs of two. Once all subjects in a cohort have
      completed Study Day 8, the preliminary safety data will be reviewed. Provided that no safety
      issues are identified, dose escalation to the subsequent cohort may be permitted.

      To obtain additional data at the 30 mg/kg dose level, a sixth cohort will be enrolled after
      the preliminary safety and tolerability of the 30 mg/kg dose in Cohort 4 is demonstrated.
      Cohort 6 will be comprised of 24 subjects (randomized 5 : 1 to CR6261 or placebo) following
      the same visit schedule as subjects in Cohorts 1-5.
    

Intervention name(s): CR6261 2 mg/kg; CR6261 5 mg/kg; CR6261 15 mg/kg; CR6261 30 mg/kg; CR6261 50 mg/kg; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Administered as a single 2-hour intravenous infusion; Administered as a single 2-hour intravenous infusion; Administered as a single 2-hour intravenous infusion; Administered as a single 2-hour intravenous infusion; Administered as a single 2-hour intravenous infusion; Administered as a single 2-hour intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza; Virus; Monoclonal; Antibody; Immunization; Treatment
Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg
      Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic
      Idiopathic Urticaria.
    

Detailed description: 
      A total of 540 patients with CIU will be enrolled in this pivotal, randomised, multicentre,
      international, double-blind, placebo and active-comparator controlled, parallel study .
      Patients will be selected from both public and private clinical practices. The study
      population includes males and females between 18 and 70 years of age, suffering from CIU for
      at least 6 weeks prior to entry in the study with no identifiable cause.
    

Intervention name(s): Bilastine; Levocetirizine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Encapsulated 20 mg Tablet. Once daily for 28 days; Encapsulated 5 mg tablet. Once daily for 28 days; Encapsulated tablet. Once daily for 28 days
Other intervention name(s): Xyzall
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Urticaria; Hives; Wheals; Flare; Chronic; Idiopathic; Erythema; Skin diseases, vascular; Hypersensitivity, Immediate; Allergic; Cutaneous
The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars
Condition: Edema; Pain; Trismus
MeSH terms: Trismus
Study type: Interventional

Summary: 
      Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana
      on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.

      Materials and Methods: The study is a double-blinded clinical trial recruiting patients
      undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars
      (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12
      CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7
      days postoperatively. Clinical parameters are collected and include: pain score, maximum
      mouth opening and facial measurements to assess edema's intensity.
    


Intervention name(s): Arnica montana; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Assess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery; Patients will take placebo drug after surgeries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population
Condition: FRENCH STUDY
MeSH terms: Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Observational

Summary: 
      Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal
      squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert
      centres but its specificity in current practice is not known. This study aimed to prove the
      superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and
      high-grade dysplasia (HGD) in current practice (including tertiary care centres, local
      hospitals and private clinics).
    


Intervention name(s): UPPER ENDOSCOPY
Intervention type(s): Diagnostic Test
Intervention description(s): UPPER ENDOSCOPY
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIGH RISK OF OESOPHAGEAL SQUAMOUS CELL CARCINOMA
Demonstrate Bioequivalence Between 3 x 2-mg Tablets of Perampanel and a Single 6-mg Tablet of Perampanel in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine that three 2-mg tablets of perampanel are
      bioequivalent to one 6-mg tablet of perampanel.
    


Intervention name(s): perampanel; perampanel
Intervention type(s): Drug; Drug
Intervention description(s): 3 x 2 mg perampanel once per day; 6 mg perampanel once per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Central Nervous System
Using Red Djulis Products Can Improve Skin Conditions
Condition: Skin Condition
MeSH terms: Skin Diseases; Disease
Study type: Interventional

Summary: 
      Hypothesis: Using red djulis products can improve skin conditions
    


Intervention name(s): placebo group; red djulis drinks
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): subjects drank 50 ml , 1 bottle a day for 8 week; subjects drank 50 ml , 1 bottle a day for 8 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Sodium Nitrate on Blood Flow in Becker Muscular Dystrophy
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is intended to build on a growing body of literature showing a blood flow
      abnormality in patients with Becker muscular dystrophy. The investigators' laboratory
      recently showed that this blood flow abnormality could be corrected by a single oral dose of
      the drug Tadalafil (also known as Cialis). The investigators now wish to replicate these
      exciting results using a common nitric oxide donor (sodium nitrate).
    

Detailed description: 
      There are 2 phases to this research project: (1) an initial baseline study to confirm the
      blood flow abnormality in Becker muscular dystrophy, and (2) a subsequent brief treatment
      trial. There are also 3 optional study protocols: (A) dose-escalation trial, (B) placebo
      trial, and (C) increased exercise intensity trial.

      The baseline study involves an intake history, physical examination, and phlebotomy for blood
      chemistries and DNA followed by non-invasive forearm blood flow studies (Near Infrared
      Spectroscopy, Doppler Ultrasound) before and after a brief bout of handgrip exercise
      (approximately 3-5 hours to complete). Blood flow studies will be performed with the
      subject's lower body enclosed in an airtight chamber. Blood flow and oxygen delivery to the
      forearm muscles will be measured before and during application of lower body negative
      pressure at rest and during handgrip exercise. Lower body negative pressure simulates the
      blood flow changes that normally occur when a person sits up after lying down.

      The results of the baseline study will determine which patients meet preset eligibility
      criteria to participate in the medication phase of the study. These criteria include (1)
      normal kidney and liver function tests and normal BNP levels (the latter to exclude heart
      failure), and (2) abnormal blood flow responses to handgrip exercise.

      Eligible patients will be asked to repeat the above laboratory procedures on a subsequent
      study day after receiving a single dose of sodium nitrate. Eligible patients will also be
      offered the option to repeat the above laboratory procedures on three subsequent study
      visits, where upon: (A) the dose of sodium nitrate is increased, (B) a placebo is ingested,
      and/or (C) the level of exercise in increased.

      The investigators plan to enroll 20 adult men with Becker muscular dystrophy.
    

Intervention name(s): Sodium Nitrate; Sodium Nitrate - double dose; Placebo; Increased exercise intensity
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Exercises on Physical Performance
Condition: Physical Performance
Study type: Interventional

Summary: 
      Aim: The aim of the study was to investigate the effects of thrower's ten exercises on the
      upper extremity performance in healthy sedentary individuals.

      Method: 36 healthy sedentary men and women aged 18-35 years will be included in the study.
      Subjects will be divided into two groups: exercise and control. The exercise group will be
      given Thrower's Ten training sessions 3 times a week over an 8-week period. Before and after
      the study, the subjects were tested for dynamic balance on the upper extremity with the Upper
      Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the
      strength of the shoulder rotator muscles was measured with an isokinetic dynamometer at a
      speed of 60º/sec.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Thrower's ten exercises will given for 8 weeks, 3 days in a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; power; muscle strength; balance
A Study of LY3050258 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and how well the body will handle a
      single dose of increasing strength of study drug LY3050258. Each participant will receive
      LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between
      doses. This study will last approximately 45 days for each participant. Screening is required
      within 28 days before the start of the study.
    


Intervention name(s): LY3050258; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Differential Effects of Vasopressin and Oxytocin on Attention Control
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the present study is to investigate whether intranasal vasopressin (20IU) and
      oxytocin (24IU) have differential effects on attention control in a social-emotional
      saccade/antisaccade eye-tracking paradigm.
    

Detailed description: 
      Previous studies have demonstrated intranasal vasopressin and oxytocin's divergent effects on
      social behavior and emotion processing such as empathy and negative emotion processing,
      however, it remains unclear whether vasopressin and oxytocin treatment would have
      differential effects on attention processing to social stimuli. Based on the previous
      registered studies (ClinicalTrials.gov ID: NCT04493554 and NCT03486925) from our group using
      a validated emotional anti-saccade task with social stimuli (emotional faces) and non-social
      stimuli (oval shape) have separately explored intranasal vasopressin and oxytocin's
      modulatory effects on attention processing, the present study aims to conduct a secondary
      analysis of the previously acquired data to directly compare vasopressin and oxytocin's
      effects on attention control to social emotional stimuli. To this end data from subjects who
      underwent intranasal oxytocin administration (n = 33; NCT03486925) will be compared with data
      from subjects who underwent intranasal vasopressin or placebo administration (n = 39, or 45
      respectively; NCT04493554). To further control for non-treatment related factors the
      intranasal placebo groups from the previous studies (ClinicalTrials.gov ID: NCT04493554 and
      NCT03486925) will be compared with respect to primary and secondary outcome measures of the
      trial, in particular general and emotion-specific effects on attentional control.
    

Intervention name(s): Vasopressin; Oxytocin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of vasopressin (20IU) intranasally; Administration of oxytocin (24IU) intranasally; Administration of placebo intranasally
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between-subject randomized placebo-controlled double-blind pharmacological eye-tracking design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vasopressin; Oxytocin; Eye-tracking; Attention control