bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus
      placebo in adult subjects with systemic lupus erythematosus (SLE).
    

Detailed description: 
      This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled
      study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult
      subjects with moderately to severely active, autoantibody-positive systemic lupus
      erythematosus (SLE).
    

Intervention name(s): Cenerimod 0.5 mg; Cenerimod 1 mg; Cenerimod 2 mg; Cenerimod 4 mg; Placebo; cenerimod 2 mg (ex-4 mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg; Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg; Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg; Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg; Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod; Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized to the 4 mg arm who are still on treatment at month 6 will be re-randomized in a 1:1 ratio to placebo or cenerimod 2 mg to enter Treatment Period 2 and will continue study treatment for a total maximum of 12 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal and connective tissue disorders
Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia
Condition: Ketosis; Hypoxia; Sleep
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This study specifically aims to elucidate the effects of IEK on sleep and recuperation in
      hypoxia, after training in normoxia. These conditions are in line with the widely applied
      live-high train-low strategy. Moreover, blood and tissue oxygenation status, as well as
      cerebral blood flow and cognitive function will be assessed.
    

Detailed description: 
      During training stages in order to prepare for an important event, sleep and recuperation are
      almost equally important as the appropriate training strategy. This training strategy often
      consists of living-high (sleeping at -stimulated- altitude) and training low (training at sea
      level). A decreased oxygen availability, also known as hypoxia, however often disrupts sleep
      quality and thus compromises the overall training efficiency. Ketones are recently found to
      improve sleep quality, thus potentially playing a pivotal role in altitude training.
      Therefore, the investigators want to evaluate the effects of ketones on sleep in hypoxia,
      after training in normoxia. Moreover, the effect on a performance test, during a simulated 30
      min time trial on the next morning, will be investigated. During this protocol, cerebral
      blood flow will be assessed, as well as ventilation, blood and tissue oxygen status, heart
      rate variability, and cognitive function.
    

Intervention name(s): Placebo; Ketone ester
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Water, 5% collagen(w/w), octoacetate (1 mM); A total of 75g ketone ester supplementation will be administered in 3 bouts of 25g in order to establish intermittent exogenous ketosis: twice immediately after training, and one 30 minutes before sleep. The ketone ester used is (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 1 session with both training and sleep in normoxia, supplemented with placebo (NPL)
1 session with training in normoxia, sleep in hypoxia, supplemented with placebo (HPL)
1 session with training in normoxia, sleep in hypoxia, supplemented with ketones (HKE)
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Exercise; Ketones; Living-high Training-low
Phielix et al.: Hepatic Fat Content and Adipokines
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the
      investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently
      of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as
      mediators.
    


Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention description(s): 12 weeks of pioglitazone treatment
Intervention MeSH terms: Pioglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26
Condition: Prostate Cancer; Breast Cancer Female
MeSH terms: Breast Neoplasms; Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study should evaluate the biological distribution of 99mTc-RM26 in patients with prostate
      cancer and breast cancer.

      The primary objective are:

        1. To assess the distribution of 99mTc- RM26 in normal tissues and tumors at different time
           intervals.

        2. To evaluate dosimetry of 99mTc- RM26.

        3. To study the safety and tolerability of the drug 99mTc- RM26 after a single injection in
           a diagnostic dosage.

      The secondary objective are:

      1. To compare the obtained 99mTc- RM26 SPECT imaging results with the data of CT and/or MRI
      and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer and
      breast cancer patients.
    

Detailed description: 
      The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast
      cancer patients Using technetium-99m labeled RM26.

      Phase I of the study:

      Biodistribution of 99mTc-RM26 in patients with prostate cancer and breast cancer.

      The main objectives of the study:

        1. To evaluate the distribution of 99mTc-RM26 in normal tissues and tumors in patients with
           prostate cancer and breast cancer at different time intervals.

        2. To evaluate dosimetry of 99mTc-RM26 based on the pharmacokinetic parameters of the drug
           after a single intravenous administration.

        3. To study the safety of use and tolerability of the drug 99mTc-RM26 after a single
           intravenous administration in a diagnostic dosage.

      Additional research tasks:

      1. To conduct a comparative analysis of the diagnostic information obtained in the
      visualization of prostate cancer and breast cancer by SPECT using 99mTc-RM26 with data
      obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC)
      research of postoperative material.

      Methodology:

      Open-label, exploratory, single centre study. The subjects will receive a single injection of
      the labeled tracer.
    

Intervention name(s): whole body study and SPECT with 99mTc-RM26
Intervention type(s): Diagnostic Test
Intervention description(s): One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Gastrin releasing peptide receptors; Prostate cancer; Breast cancer; 99mTc-RM26; SPECT
Full Thickness Mucoperiosteal Flap Versus Low Level Laser in Orthodontic Tooth Movement Acceleration
Condition: Mesial Movement of Teeth
MeSH terms: Mesial Movement of Teeth
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of using full thickness mucoperiosteal flap (FTMPF)
      elevation only versus low level laser therapy (LLLT) on acceleration of orthodontic tooth
      movement.
    

Detailed description: 
      This study was a split mouth design study included 32 side according to sample size
      calculation. Those sides were divided into 2 groups. Group 1divided into (group 1a: 8 sides
      with FTMPF, group 1b:8 sides control). Group 2(group 2 a: 8 sides with LLLT, group 2b: 8
      sides control). Extraction of the first maxillary premolars followed by canine retraction in
      the extraction space with maximum anchorage were indicated. FTMPF was elevated from the
      mesial interdental papilla of maxillary canine to the mesial interdental papilla of second
      maxillary premolar. LLLT was applied at 3,7,14,28.56 days of retraction. During retraction
      study model for all patients were taken at 2ed, 6th, 14th,16th weeks and at the end of
      retraction (I1,I2,I3,I4,I5 or overall interval). 3D laser scanning and digital
      superimposition was done to measure the rate of canine retraction and anchorage loss.
    

Intervention name(s): elevation of full thickness mucoperiosteal flap; low level laser therapy
Intervention type(s): Procedure; Device
Intervention description(s): A free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine.; LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip)
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: split mouth study design, side intervention and other side for control
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Acetaminophen is one of the most widely used analgesic in the world, recommended for the
      symptomatic treatment of fever and pain.

      The purpose of this study is to assess the effectiveness of acetaminophen in association with
      N-acetylcysteine.

      The objective of this study is to evaluate if the association in healthy volunteers of
      acetaminophen and N-acétylcystéine

        1. - decrease the antinociceptive effect of acetaminophen in comparison to a group control

        2. - and if this antinociceptive effect may depend of the genetic polymorphism of GSH
           enzyme.
    

Detailed description: 
      Period 1 : To Day -4 to Day 0

      Day -4 at 8:00 am at Clinical Pharmacology Center

        -  Inclusion Visit, signature of Informed consent form, clinical exam.

        -  Training test

        -  Blood sample (GSH, pharmacogenetic, Biochemistry assay)

        -  Randomization and attribution of treatment for the fisrt study period at home: (day -4,
           -3, -2, -1) 4 days of oral acetaminophen and [N-acetylcysteine or placebo] according to
           the randomization plan.

      At day -3, -2 and -1 a salivary sample will be done to control the treatment compliance.

      Day 0 at Clinical Pharmacology Center Clinical examination Measurement of the basal pain
      thresholds and pain evaluation (Visual Analog Scales) Blood and urinary sample (acetaminophen
      and GSH assay)

      T0 : Administration of product: acetaminophen and [N-acetylcysteine or placebo]

      T0+1H: Thermal stimulation according to the established paradigm (threshold temperature +3°C
      ) and pain evaluation (Visual Analog Scales)

      T0+2H: Thermal stimulation according to the established paradigm (threshold temperature +3°C
      ) and pain evaluation (Visual Analog Scales) and Blood sample (acetaminophen assay)

      T0+3H: Thermal stimulation according to the established paradigm (threshold temperature +3°C
      ) and pain evaluation (Visual Analog Scales)

      T0+4H: Thermal stimulation according to the established paradigm (threshold temperature +3°C
      ) and pain evaluation (Visual Analog Scales) and Blood and urinary sample (acetaminophen,
      GSH, biochemistry assay)

      - Lunch before departure

      2 weeks of wash-out

      Period 2 : To Day 17 to Day 21

      Same of period 1. Subject who receives N-acétylcystéine in period 1 will receive placebo in
      second period and vice versa.
    

Intervention name(s): N-acetylcysteine combination with acetaminophen; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and
      Pavlovian-to-instrumental transfer (PIT), part II Saracatinib
    

Detailed description: 
      To assess the effect of oral AZ D0530 at various doses on neuroimaging parameters associated
      with various forms of impulsivity mediated through glutamate-dopamine interactions, as
      ascertained through functional magnetic resonance imaging. -- --NOTE-- AZD0530 dosage of 50mg
      was discontinued by manufacturer. Adjustments were made to account for the removal of the
      50mg dosage in all arms of the study.
    

Intervention name(s): 125 mg AZD0530; 50 mg AZD0530; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Randomized to receive 125 mg of AZD0530; Randomized to receive 50 mg of AZD0530; Placebo
Other intervention name(s): saracatinib; AZD0530; saracatinib; AZD0530
Intervention MeSH terms: Saracatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
Condition: Insomnia; Generalized Anxiety Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of
      insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will
      receive an approved anxiolytic agent and will be randomized to nightly therapy with either
      eszopiclone or placebo.
    

Detailed description: 
      An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy
      trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder
      who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime,
      and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks.
      This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired
      by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to
      Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone (Lunesta)
Intervention type(s): Drug
Intervention description(s): Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Insomnia; Anxiety; Generalized Anxiety Disorder
Wellness Intervention for Menstrual Mood Disorders
Condition: Menstrual Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      This study has been funded by National Institute of Mental Health (NIMH) to compare two
      behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric
      disorder (PMDD). Both of these interventions will be run in a group format, meaning that you
      will be part of a group of other women who have a menstrual mood disorder. Both of these
      interventions will be run by experienced mental health professionals and both interventions
      have been shown to be effective in reducing mood symptoms, increasing a sense of well-being,
      and helping individuals cope with stress. While it is expected that both interventions to be
      associated with some benefit, this study is designed to see which is better for women with a
      menstrual mood disorder.
    


Intervention name(s): Mindfulness Intervention; Social Support Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.; The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Condition: Neutropenia; Breast Cancer
MeSH terms: Breast Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase I, dose escalation study to evaluation the safety and
      pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up
      to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were
      assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.
    

Detailed description: 
      A Phase I, dose escalation study to evaluation the safety and
      pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients receiving 4
      cycles of EC chemotherapy (Epirubicin plus Cyclophosphamide).

      18 patients (6 patients each cohort) were assigned to three sequential doses cohort of F-627
      at the dose of 80, 240 and 320 µg/kg. The patients received chemotherapy (100 mg/m2
      epirubicin and 600 mg/m2 cyclophosphamide) administrated by i.v. injection on Day 1 and F-627
      by s.c. injection on Day 3 of each cycle for 4 cycles. If no dose-limiting toxicity (DLT) was
      observed in 6 patients during first cycle, the next cohort was escalated.

      Blood samples were collected for completed blood counts with differential, serum F-627
      concentration and safety evaluation at different point following F-672 injection.

      The decision to proceed to the next higher dose was be made jointly by the sponsor's medical
      expert and the investigator based upon the review of safety data in the first cycle
      treatment.
    

Intervention name(s): F-627; EC regimen
Intervention type(s): Biological; Drug
Intervention description(s): F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.; Epirubicin 100 mg/m2 (in vein) and Cyclophosphamide 600 mg/m2 (in vein) on Day 1 of each cycle for 4 cycles.
Other intervention name(s): rh G-CSF Fc fusion protein; Epirubicin + Cyclophosphamide
Intervention MeSH terms: Cyclophosphamide; Epirubicin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-invasive BCI for Cognitive Enhancement
Condition: Healthy Subjects; Neuropsychiatric Disorders
Study type: Interventional

Summary: 
      People's perceptual skills can significantly affect their abilities to make optimal
      decisions, judgments, and actions in real-world dynamic environments. Perceptual learning
      refers to training and experiences to induce improvements in the ability to make sense of
      what people see, hear, feel, taste or smell based on ambiguous sensory information. In this
      study, investigators hypothesise that there exist neural signatures that robustly encode the
      conscious visual perception of rotations of a cursor and the magnitudes of these rotations in
      a novel, rotation-based perceptual learning task. Investigators also hypothesise that online,
      instantaneous EEG-based feedback on subjects' visual perceptions of rotations with an
      EEG-based Brain Computer Interface (BCI) can foster perceptual learning much more effectively
      than behaviour perceptual training, especially in very small rotation magnitudes that
      represent extremely difficult perceptual tasks.
    


Intervention name(s): EEG-based perceptual training; Behavior based perceptual training
Intervention type(s): Device; Device
Intervention description(s): Electroencephalography (EEG) signals will be recorded from subjects as they perform rotation-based perceptual tasks. The neural correlates of conscious perception of rotations will be processed and decoded in real-time using machine learning algorithms to provide feedback. Subjects are instructed to assume a mental state/find a strategy to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of perceptual training with this intervention.; Subjects complete the rotation-based perceptual tasks, and ground truth visual feedback is provided indicating whether subjects have spotted the rotations correctly. Subjects are instructed to spot as many rotation as possible to maximise the accuracy of feedback. In total, each subject will complete 5 sessions of perceptual training with this intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two
      dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial
      hypertension (PAH) <12 years of age.
    


Intervention name(s): bosentan
Intervention type(s): Drug
Intervention description(s): 32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.
Other intervention name(s): Tracleer; ACT-050088
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary arterial hypertension; children; pediatric; bosentan