bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of FP-025, a MMP-12 Inhibitor, on Allergen-induced Airway Responses and Airway Inflammation in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma
Condition: Asthma, COPD
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover,
      2-center (conducted in EU; The Netherlands) study in male and female subjects with stable,
      mild HDM-allergic asthma. The study will consist of two identical study periods of 12
      treatment days each, separated by a washout period of at least 3 weeks (and no more than 7
      weeks). Approximately 36 eligible subjects will be enrolled, to yield 32 evaluable subjects
      who will be treated with both FP-025 (400 mg BID) or matching placebo in a cross-over design
      from the evening of Day 1 till the morning of Day 12 (22 doses per study period in total).
    


Intervention name(s): FP-025 capsules; Placebo FP-025 capsules
Intervention type(s): Drug; Drug
Intervention description(s): FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.; Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia
Condition: Mercaptopurine Adverse Reaction; Leukemia, Lymphoblastic
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational [Patient Registry]

Summary: 
      Subjects who are recruited in this study are LLA patient, who are treated for routine control
      to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion
      criteria.
    

Detailed description: 
      On the day of the control patient, (usually the patient is asked for routine control at week
      3 on mercaptopurin) routine blood tests are performed. Patients and parents were given an
      explanation of this study. If patients and parents are willing to take part in the study,
      they are asked to sign informed consent. Patients who meet the inclusion criteria and do not
      meet the exclusion criteria, are recorded for demographic data and 5 ml of blood taking. The
      blood is directly divided into three, 2 mL for hematologic examination and albumin level, 1
      mL for genotyping, and 2 mL for examination of drug levels. Routine hematologic examination
      and albumin levels were performed in the Cipto Mangunkusumo hospital laboratory. For
      genotypic examination, blood samples were stored at -80C, until they were used for analysis.
      For examination of the drug levels the blood sample is centrifuged and the erythrocyte
      preparation is then stored at -80C, until it is used for analysis.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with LLA who received 6-MP chemotherapy in the maintenance phase, who
        come to RSCM, and who meets the inclusion criteria and does not meet the exclusion
        criteria.
      
Keywords: Mercaptopurine, acute lymphoblastic leukemia, hematotoxicity
Metabolic Activation With Almased for Type 2 Diabetes Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Overweight patients with type 2 diabetes are often being treated with an intensified insulin
      therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not
      achieve satisfying metabolic control. A new therapy option is necessary that makes it
      possible to lower the daily insulin requirement and to improve metabolic control. The aim of
      this study was to investigate whether a protein-rich meal replacement is suitable to lower
      the daily insulin requirement and to reduce HbA1c and body weight.
    

Detailed description: 
      The pilot study included patients with type 2 diabetes (n=22), that injected >100 U insulin
      daily. During the first week, all three main meals were replaced with 50 g of a protein-rich
      meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were
      replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
      Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as
      well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the
      intention-to-treat analysis and Mann-Whitney test for subgroup analyses.
    

Intervention name(s): Almased
Intervention type(s): Dietary Supplement
Intervention description(s): During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
Other intervention name(s): Almased-Vitalkost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: type 2 diabetes mellitus; insulin; hbA1c; body weight
Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection
Condition: Pain; Infant, Newborn, Disease
MeSH terms: Infant, Newborn, Diseases
Study type: Interventional

Summary: 
      This study was carried out to determine the effect of maternal heart sound listened to by
      newborns during heel blood collection on pain level and crying time.
    

Detailed description: 
      The randomized controlled and experimental study was conducted with 60 newborns applied to a
      public family health center for heel blood collection. The infants in the experimental group
      (n=30) were listened to the maternal heart sound before, during, and after the heel blood
      collection procedure, and routine blood collection was applied to the control group (n=30).
      Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.
    

Intervention name(s): Listening the maternal heart sound during the invasive interventions
Intervention type(s): Other
Intervention description(s): Heart sounds of the newborns' own mothers were recorded on the voice recorder with the help of a hand doppler device. This sound was listened by the newborns in the experimental group during the heel blood procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized controlled trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; Newborn; Non-Drug Pain Management
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the ability of montelukast to improve the signs and symptoms of
      perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an
      active control.
    


Intervention name(s): montelukast sodium; Comparator: cetirizine; Comparator: placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): montelukast 10 mg tablet orally once daily at bedtime for 6 weeks; cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks; placebo tablet orally once daily at bedtime for 6 weeks
Intervention MeSH terms: Cetirizine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Randomized Controlled Test of the Effects of CHI-554 on Fear.
Condition: Anxiety; Fear; Panic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled phase 2b clinical trial examining the
      effects of CHI-554 (CBD) on Fear (F-01)
    

Detailed description: 
      This study will examine the potential of a novel formulation of hemp-derived CBD (CHI-554) to
      reduce fear elicited via a safe, well-established, controlled, laboratory-based carbon
      dioxide (CO2)-enriched air biological challenge that causes abrupt increases in bodily
      arousal.
    

Intervention name(s): CHI-554
Intervention type(s): Drug
Intervention description(s): hemp-derived CBD in MCT oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2b, randomized, double-blind, placebo-controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effect of Obesity on Recovery Profile in Children
Condition: Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      It is planned to investigate whether obesity affects the recovery profile after anesthesia in
      pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time
      between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal
      time (the time between anesthetic discontinuation and LMA removal), open eyes (the time
      between anesthetic discontinuation and eye opening in response to verbal stimulus or painful
      pinching), and PACU discharge will be also noted.
    


Intervention name(s): Recovery profile from general anesthesia
Intervention type(s): Procedure
Intervention description(s): It includes the phases during recovery from general anesthesia: Time to spontaneous ventilation, Laryngeal Mask Airway (LMA) removal time, open eyes, and Post-Anesthesia Care Unit (PACU) discharge.
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Caloric Restriction, Exercise, and Glucoregulation in Humans
Condition: Diabetes
Study type: Interventional

Summary: 
      Weight loss induced by caloric restriction alone (CR) and by exercise alone (EX) result in
      similar effects on blood glucose and insulin. The purpose of this study is to assess the
      hypothesis that weight loss through caloric restriction plus exercise will result in greater
      improvements on glucose tolerance and insulin action than similar weight losses through CR or
      EX alone.
    

Detailed description: 
      Participants are randomized into caloric restriction, exercise, and caloric restriction plus
      exercise weight loss groups. Measurements of blood glucose and insulin, oral glucose
      tolerance, and matched glucose infusion will be done at baseline and after weight loss of 6%
      of body weight. Other tests include maximal oxygen uptake (VO2max), strength tests, blood
      pressure, blood lipids, serum inflammatory markers, dual X-ray absorptiometry (DEXA) for bone
      density and body composition, physical activity levels, dietary intakes, and measures of
      arterial stiffness.
    

Intervention name(s): Calorie Restriction; Exercise; Calorie Restriction and Exercise
Intervention type(s): Other; Other; Other
Intervention description(s): This group will undergo a 20% reduction in energy intake without any change in energy expenditure.; This group will undergo a 20% increase in energy expenditure by exercising without any change in energy intake.; This group will undergo 10% reduction in energy intake and a 10% increase in energy expenditure via exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Study of MIN-101 in Healthy Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess how MIN-101 is taken up by the body when given in different
      amounts and in different formulations. The drug will be given as a single dose in Part 1 of
      the study and during Part 2 of the study as multiple dose, once daily for 7 days. The
      ultimate aim is to find an optimal formulation which can be developed as a once daily dose
      for the treatment of schizophrenia.
    


Intervention name(s): MIN-101; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Basic Science
Keywords: modified release formulation; pharmacokinetics
Compassionate Use of Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Gastrointestinal Tract
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional

Summary: 
      RATIONALE: Beclomethasone may be effective in treating patients who have graft-versus-host
      disease of the gastrointestinal tract.

      PURPOSE: Compassionate use of beclomethasone in treating patients who have graft-versus-host
      disease of the gastrointestinal tract that has not responded to previous therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Provide beclomethasone dipropionate to patients with gastrointestinal graft-versus-host
           disease refractory to standard therapy or with a contraindication to systemic steroids.

        -  Minimize the serious side effects associated with systemic steroid use in these
           patients.

      OUTLINE: Patients receive oral beclomethasone dipropionate 4 times daily for 28 days in the
      absence of graft-versus-host disease progression or unacceptable toxicity. Patients may then
      receive a second course for 31 days if symptoms of graft-versus-host disease persist.
      Patients may receive up to 4 treatments (1 or 2 courses each) per year.

      PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 3 years.
    

Intervention name(s): beclomethasone dipropionate
Intervention type(s): Drug
Intervention MeSH terms: Beclomethasone
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: graft versus host disease
Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics, pharmacodynamics and safety/tolerability of LC51-0255
      film-coated tablet (SG85) with LC51-0255 uncoated tablet (SG82) in healthy subjects.
    


Intervention name(s): Film-coated tablet
Intervention type(s): Drug
Intervention description(s): uncoated tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A 2-Part, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CAT-2054 in Healthy Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, Phase 1, placebo-controlled, double-blind, randomized, single and multiple
      ascending dose study. CAT-2054 will be administered either as an uncoated capsule (CAT-2054)
      or a coated capsule (CAT-2054-C). In Part A, CAT-2054 or placebo is administered as a single
      dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second
      dose of the study drug after a high-fat meal. Additionally, at 1 dose level, CAT-2054-C or
      placebo will be administered as a single dose in a fasting state, and subjects will return
      for a second dose of the study drug after a high-fat meal. In Part B, CAT-2054 will be
      administered as multiple ascending doses at 4 dose levels for 14 consecutive days. In
      selected cohorts, CAT-2054, CAT-2054-C or CAT-2054 with atorvastatin will be dosed to assess
      safety in anticipation of future clinical trials.
    


Intervention name(s): CAT-2054; Placebo; CAT-2054-C; Atorvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Magnetic Resonance Imaging (MRI) of Pulp Regeneration
Condition: Pulp Necroses; Periapical Lesion; Regeneration
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study was conducted to test whether pulp-like tissue can be regenerated in mature
      teeth with closed apex? And whether the size of the apical diameter affects the success of
      REPs? And whether Magnetic resonance imaging (MRI) can be used to quantitatively assess the
      vitality of the regenerated pulp-like tissue.
    

Detailed description: 
      Regenerative endodontic procedures via blood clot were done on 18 mature anterior necrotic
      teeth with periapical lesions. The teeth were randomly assigned into two groups according to
      the size of the apical diameter of the rotary files used for instrumentation.

      In the test group, rotary instrumentation was done using Pro-taper Next till size X3, while
      in the control group, instrumentation was done till size X5.

      Calcium hydroxide was used as an intracanal medication for 1-2 weeks. Calcium hydroxide was
      then washed away using 1.5%NaOCl, followed by induction of blood using pre-curved K-fi;e #25
      2mm past the radiographic apex. Biodentine was then used as a cervical plug over the blood
      clot followed by resin-modified glass ionomer cement and composite resin as coronal
      restoration.

      MRI was used to assess the vitality of the regenerated pulp-like tissue, where the signal
      intensity of the regenerated pulp-like tissue was measured after 3,6 and 12 months follow up
      and compared to the normal contralateral teeth. In addition, sensibility tests using cold
      test and electric pulp testing were used to assess vitality of regenerated pulp-like tissue
      after 3,6,9 and 12 months. Cone beam computed tomography (CBCT) was also used to assess the
      healing of the periapical lesion after 12 months.
    

Intervention name(s): Regenerative endodontic procedures (REPs)
Intervention type(s): Procedure
Intervention description(s): Instrumentation using rotary Pro-Taper Next, disinfection using sodium hypochlorite and calcium hydroxide as intracanal medication followed by induction of blood and application of Biodentine as a cervical plug.
Other intervention name(s): Pulp Regeneration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mature teeth; Necrotic teeth; REPs; Biodentine; MRI; CBCT
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA
      INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
    


Intervention name(s): Aripiprazole Lauroxil; Paliperidone Palmitate
Intervention type(s): Combination Product; Drug
Intervention description(s): Intramuscular injection; study drug provided using a pre-filled syringe; Intramuscular injection
Other intervention name(s): ARISTADA; ARISTADA INITIO; Invega Sustenna
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate; Aripiprazole lauroxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; schizophrenia; aripiprazole lauroxil; ARISTADA; ARISTADA INITIO
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
Condition: Opioid Dependence; Opioid Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo controlled, multicenter study in male and female
      participants who are seeking treatment for opioid use disorder.
    

Detailed description: 
      After completing an up to 2-week screening period, subjects entered an open-label run-in
      induction phase with SUBOXONE (buprenorphine/naloxone) sublingual film for 3 days followed by
      a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve
      buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film
      prescribing information.

      This is a 24-week non-residential study with participants being randomized after meeting
      randomization criteria. On Day 1 and Day 29 (± 2 days) participants will receive subcutaneous
      injections of 300 mg RBP-6000 or placebo. Thereafter, participants will receive 4 injections
      (once every 28 days ± 2 days) of either 300 mg or 100 mg RBP-6000 doses or placebo.
    

Intervention name(s): SUBOXONE; RBP-6000; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.; Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.; Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
Other intervention name(s): buprenorphine; Sublingual Film; Buprenorphine; Volume-matched placebo
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy of Two Onabotulinum Toxin Doses
Condition: Neurogenic Bladder; Overactive Detrusor
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder, Overactive
Study type: Observational

Summary: 
      The changes in bladder function after the injection of Onabotulinum toxin into the detrusor
      in individuals with neurogenic bladder overactivity will be investigated retrospectively. The
      records of all patients treated with Onabotulinum toxin injections into the detrusor since
      2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units
      of Onabotulinum toxin will be compared with the changes after the injection of 200 units.
      Furthermore, the differences in urinary continence, duration between injections, side effects
      and complications between the two groups will be investigated.
    


Intervention name(s): Injection of Onabotulinum toxin
Intervention type(s): Drug
Intervention description(s): multiple injections of Onabotulinum toxin into the detrusor muscle
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients treated with Onabotulinum toxin for neurogenic detrusor overactivity as a result
        of spinal cord injury