bioihbjkbjnl/mcl2 huggingface dataset:
A PET Study in Healthy Volunteers
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label, non-randomised [11C]PHNO PET study using healthy male volunteers.
      Each volunteer will undergo 4 [11C]PHNO PET scans to allow for further characterisation of
      this radioligand and examine the effects of [11C]PHNO mass carry-over and displaceable
      binding in the brain. This study aims to obtain data from 6 evaluable subjects.
    

Detailed description: 
      A test-retest (TRT) investigation of [11C]PHNO in human is required to further characterise
      [11C]PHNO. [11C] PHNO possesses very high affinity for the D3 receptor, and therefore most
      clinical studies are conducted at D3 occupancies >10%. As [11C]PHNO kinetics in the target
      brain regions are moderately slow, considerable mass carry over may be present on a 2nd PET
      scan conducted on the same day. In addition there appears to be a significant displaceable
      binding component in the cerebellum, which, if not accounted for, will lead to a bias in the
      quantification of specific [11C]PHNO binding. The aim of this study is therefore to examine
      the effects of [11C]PHNO mass carry-over and displaceable binding in the cerebellum, on the
      quantification of [11C]PHNO PET data.

      This will be an open label, non-randomised [11C]PHNO PET study using healthy volunteers. Each
      volunteer will undergo 4 [11C]PHNO PET scans:

      1st and 2nd scans; TRT on the same day with a minimal gap between [11C]PHNO injections to
      examine the effects of PHNO mass carry over, 3rd scan >1 week later to determine the "true"
      TRT variability and a 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound
      which allows the highest clinically acceptable blockade of central D2/D3 receptors) and will
      examine the amount of displaceable binding in the cerebellum, a proposed reference tissue for
      [11C]PHNO.

      The scan data will be quantified as regional volumes of distribution (VT).
    

Intervention name(s): [11C]PHNO; Aripiprazole
Intervention type(s): Radiation; Drug
Intervention description(s): examine the effects of [11C]PHNO mass carry-over and displaceable binding; A 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound which allows the highest clinically acceptable blockade of central D2/D3 receptors)
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Qigong and Exercise for Neck Pain in Adults (QENA)
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of qigong for the treatment of
      chronic neck pain compared to exercise therapy and waiting list group.
    


Intervention name(s): Qigong; exercise therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): 18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week; 18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: qigong; traditional chinese medicine; exercise therapy; neck pain
The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a phase II randomized multicenter study. Patients will be enrolled at time of
      diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without
      indication of intensification by allogeneic stem cell transplantation and/or without HLA
      (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of
      induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose
      Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses
      of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.

      We will compare efficacy and toxicity among the two arms.
    

Detailed description: 
      Because of the results of our former trial (ALFA-9802) [Thomas, 2005], chemotherapy will be
      combined in each arm with G-CSF (Granulocyte Colony-Stimulating Factor) given during each
      sequence of chemotherapy in order to increase the blast priming.
    

Intervention name(s): CLARA; HDAc
Intervention type(s): Drug; Drug
Intervention description(s): Clofarabine 30 mg/m2/day IV (2h) on days 2 to 6 (administered as a 2h infusion in 250 ml of 0.9% normal saline solution) Cytarabine 1 g/m2/day intravenous (2h) 4 hours later on days 1 to 5 (administered as a 2h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day intravenous from day 1 to day 6 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water); Cytarabine 3 g/m2/12h intravenous (3h) on days 1, 3, 5 (administered as a 3h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day intravenous from day 1 to day 5 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).
Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy (how well the drug works), safety, and
      side effects of paliperidone palmitate injection compared to placebo in the treatment of the
      symptoms of schizophrenia in adults. The placebo used in this study was a nutritional
      substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.
    

Detailed description: 
      Paliperidone palmitate is an aqueous suspension that releases paliperidone gradually over a
      period of about 1 month and is under development to provide a sustained and stable level of
      paliperidone. This is a randomized (patients will be assigned to different treatment groups
      based solely on chance), double-blind (neither the patient nor the physician will know if
      placebo or drug is being given and at what dose), placebo-controlled, multicenter study in
      patients with schizophrenia. The study consists of a screening period (maximum 5 days,
      including a 3-day washout of psychotropic medications other than antidepressants, if
      applicable); a 7-day, open-label, oral run-in period; and a 64-day double-blind treatment
      period. The total duration of the study is approximately 11 weeks. Efficacy will be evaluated
      during the study using the Positive and Negative Symptom Scale for Schizophrenia (PANSS) and
      the Clinical Global Impression - Severity (CGI-S) scale. Safety will be evaluated by
      monitoring adverse events and changes in clinical laboratory results, including prolactin
      levels; physical examination results; tardive dyskinesia will be rated using the Abnormal
      Involuntary Movement Scale (AIMS), akathisia will be rated according to the Barnes Akathisia
      Rating Scale (BARS), extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating
      Scale (SAS); electrocardiogram (ECG); vital sign measurements; and concomitant therapy. ER
      OROS paliperidone (6 or 12 mg) or IR paliperidone (2 or 4 mg) oral dosage administered daily
      for 7 days (Day -7 to -1), followed by i.m. injections of paliperidone palmitate (either 50
      mg eq. or 100 mg eq.), or placebo on Days 1, 8, and 36 of the study.
    

Intervention name(s): R092670
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone palmitate; R092670; antipsychotic
MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries
Condition: Transposition of Great Vessels; Surgery
MeSH terms: Transposition of Great Vessels; Situs Inversus
Study type: Observational

Summary: 
      This study involves adolescents operated with arterial switch procedure for transposition of
      the great arteries during the neonatal period. The purpose is to evaluate the coronary
      arteries and direct and indirect findings of coronary artery disease/complications with 3
      tesla magnetic resonance imaging.
    

Detailed description: 
      This study involves adolescents operated with arterial switch procedure for transposition of
      the great arteries during the neonatal period. The patients were operated with two different
      methods of re-implantation of the coronary arteries ("trap-door"/non-"trap-door", see
      description below).
    

Intervention name(s): 3 tesla magnetic resonance imaging findings; coronary artery status; 3 tesla magnetic resonance imaging findings; ventricular function and morphology
Intervention type(s): Other; Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients 10-15 years old surgically corrected in the neonatal period with arterial switch
        procedure for transposition of the great arteries at Rikshospitalet, OUS, Norway.
      
Keywords: Child, adolescent; Coronary artery disease; Magnetic resonance imaging
LAAM-HAART PET Imaging
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz
      and ritonavir on human brain LAAM disposition in vivo.
    


Intervention name(s): [11c] LAAM; Ritonavir; Efavirenz
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): intravenous administration of 15-20 mCi of [11c] LAAM.; Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.; Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
Other intervention name(s): Kaletra; Sustiva, Atripla
Intervention MeSH terms: Ritonavir; Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PET Imaging; Efavirenz; Ritonavior [11C] LAAM; Healthy volunteers
MUA to Treat Postoperative Stiffness After Total Knee Arthroplasty
Condition: Stiffness Following Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare the outcome following manipulation under anesthesia for stiffness in a randomized
      controlled fashion with one group receiving IV dexamethasone and oral celecoxib at the time
      of manipulation to a control group receiving manipulation alone.

      Outcomes will include pain, range of motion, as well as subjective outcome scores.
    

Detailed description: 
      Stiffness is a potential complication following Total Knee Arthroplasty (TKA). While a
      variety of factors have been cited as possible causes, such as component malrotation or
      improper soft-tissue balancing, however, an etiology is not always appreciated. Histologic
      and arthroscopic evidence of fibrosis suggests that an inflammatory process may contribute to
      loss of knee range of motion following surgery. Manipulation under anesthesia remains
      standard of care for stiffness following TKA. Manipulation shows improved range of motion for
      stiffness after total knee arthroplasty, however, patients do not always achieve full range
      of motion. Furthermore, repeat manipulation and manipulation greater than 8 weeks
      post-surgically have shown limited improvements. Given a possible role of the host
      inflammatory response and the importance of early gains in knee range of motion following
      total knee arthroplasty, limiting the inflammatory response at the time of manipulation may
      improve outcomes. Investigators would like to assess the role of anti-inflammatory
      medications to optimize range of motion and outcome for manipulation under anesthesia for
      stiffness following TKA.
    

Intervention name(s): Dexamethasone; Celecoxib
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg of IV dexamethasone immediately before MUA.; 2 weeks per mouth of celecoxib (200 mg daily)
Other intervention name(s): Decadron; Celebrex
Intervention MeSH terms: Dexamethasone; Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center trial in healthy participants. This is a crossover design,
      open-label treatment trial with 3 periods, 6 sequences.
    

Detailed description: 
      The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate
      the relative bioavailability and effect of food on Darigabat.
    

Intervention name(s): Darigabat
Intervention type(s): Drug
Intervention description(s): Tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, single-center trial in healthy participants. The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food of Darigabat from a single oral.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; Bioavailability; Food effect
An Open-label Pilot Study of Coenzyme Q10 in Steroid-Treated Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will help to determine the safety and efficacy of the nutritional supplement
      Coenzyme Q10 when added to steroids as a treatment for Duchenne muscular dystrophy (DMD).
      Boys with DMD who are enrolled in this study will should be on a stable dose of steroids for
      at least six months, and will remain on their usual dose throughout the study. They will
      complete two screening visits within a one-week period, and if enrolled will then have their
      strength tested monthly for three months before beginning therapy with Coenzyme Q10. Once
      Coenzyme Q10 therapy is started, participants will have their strength tested monthly for six
      months. Following the six month treatment period, participants will be given the option to
      remain on Coenzyme Q10 until the study is completed.
    


Intervention name(s): Coenzyme Q10
Intervention type(s): Drug
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: duchenne; dystrophy; DMD; clinical trial; CINRG
Distance Healing in Wound Healing
Condition: Breast Reconstruction Surgery
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial examines the impact of patients' knowledge of an experienced distant healer's
      efforts to heal them on measures of wound healing, psychosocial functioning, and
      physiological symptoms after plastic surgery.
    


Intervention name(s): Distance healing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast reconstruction surgery; prayer; distance healing; wound healing
A Study of LY3337641 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how
      long it takes the body to get rid of it. In addition, the safety and tolerability of the
      study drug will be evaluated.

      Participants will be admitted to a clinical research unit (CRU) the day before dosing.
      Participants remain confined to the CRU for at least 7 days. Participants may be discharged
      from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days
      post-dose (Day 22).

      This study will last approximately 30 days for each participant, not including screening.
      Screening is required within 28 days prior to the start of the study.
    


Intervention name(s): [¹⁴C]-LY3337641
Intervention type(s): Drug
Intervention description(s): Administered orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Longitudinal Interaction Between APOA5 -1131T>C and Overweight Accelerates Arterial Stiffness
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      The aim of this study is to evaluate whether the longitudinal interaction between APOA5
      -1131C variants and overweight could accelerate age-related increases in arterial stiffness
      and circulating triglycerides in healthy subjects.
    


Intervention name(s): rs662799 (APOA5 -1131T>C)
Intervention type(s): Genetic
Intervention description(s): Among the 349 normal-weight individuals, 168 were homozygous (TT) for the T allele, 155 were heterozygous for the C allele (TC) and 26 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. Among the 154 overweight individuals, 68 were homozygous (TT) for the T allele, 75 were heterozygous for the C allele (TC) and 11 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We performed a 3-year prospective cohort study that included 800 heathy subjects (30-65
        years old), of these, 503 nondiabetic and nonobese individuals were finally selected.
Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a
      broad spectrum of activity. In common with other fluoroquinolones, the main
      pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy
      is the area under the plasma time-concentration curve/the minimum inhibitory concentration
      ratios.

      The aims of the study were to:

        1. reveal the population pharmacokinetics, and

        2. assess the efficacy of various dosage regimens in achieving the probability of target
           attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral
           levofloxacin was prescribed as the switching therapy after intravenous levofloxacin
           treatment.

      The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of
      levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to
      determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens
      were predicted to achieve CFR greater than or equal to 90%.
    


Intervention name(s): Levofloxacin
Intervention type(s): Drug
Intervention MeSH terms: Levofloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: levofloxacin; population pharmacokinetics; pharmacodynamics
A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open lebal, single-dose, three-period, crossover
      clinical study in healthy Chinese male subjects to assess the pharmacokinetics and
      bioequivalence/bioavailability of two formulation savolitinib tablets.
    

Detailed description: 
      Thirty six Chinese male subjects who met the inclusion criteria but not met the exclusion
      criteria, will be hospitalized in Phase I Ward one day before first dosing and randomized
      into three groups, 12 subjects each, at a ratio of 1:1:1. The subjects in the different group
      will follow the fixed dosing regimen with 600 mg savolitinib tablets (200 mg/tablet x 3
      tablets) after the standard meal on day 1 in cycle 1, 2 and 3 respectively: TRR, RTR or RRT,
      where "T" indicates dry granulation savolitinib tablet and "R" indicates wet granulation
      savolitinib tablet. PK blood samples, 2 mL each time, will be collected at the following time
      points in each dosing cycle: within 0.5 hours before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4,
      5, 6, 7, 8, 12, 24, 36, 48 hours after dosing(16 time-points).
    

Intervention name(s): Savolitinib Test Preparation; Savolitinib Reference Preparation
Intervention type(s): Drug; Drug
Intervention description(s): Test preparation (T): dry granulation savolitinib tablets.; Reference preparation (R): wet granulation savolitinib tablets.
Other intervention name(s): HMPL-504, volitinib, AZD6094; HMPL-504, volitinib, AZD6094
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Study: ASP2151 and Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      CYP3A4 is involved in the metabolism of many drugs. So, it is important to assess in vivo the
      induction effect of ASP2151 on that enzyme to determine the extent of any possible drug
      interactions. The aim of this trial is to investigate the potential for interaction of
      ASP2151 with the CYP3A4 probe substrate midazolam.
    


Intervention name(s): Midazolam; ASP2151
Intervention type(s): Drug; Drug
Other intervention name(s): Midazolam-ratiopharm
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HSV; Herpes; volunteers; drug-drug interaction