bioihbjkbjnl/mcl2 huggingface dataset:
Priming rTMS In Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to assist in understanding the most effective parameters for TMS
      in Depressive Disorders. Most research conducted has used high frequency stimulation on the
      left hemisphere.However, low frequency on the right hemisphere has also been shown to have
      antidepressant properties and appears to be better tolerated. A promising approach to improve
      responses to rTMS may be to combine high and low frequency stimulation where they are both
      applied to the right side of the brain. In this approach, high frequency stimulation is
      provided first which may 'prime' or pre-prepare the brain for low frequency stimulation in a
      way that enhances its response. Participants are randomised to receive active or placebo
      priming stimulation.If participants do not respond to this treatment condition after 10
      sessions applied over a two week period they will be offered 10 session of high frequency
      left sided TMS treatment. Alternatively, if participants respond favorably they may continue
      with that treatment condition for another 10 sessions.
    

Detailed description: 
      The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale).
      This is administered at baseline and on a fortnightly basis. At study end response criteria
      is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of
      less than or equal to 10.

      Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale),
      CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global
      Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also
      administered.

      Inclusion Criteria:

        -  Moderate to severe depressive symptoms as indicated as MADRS >20

        -  Failure to respond to a minimum of two antidepressant medications

        -  No increase or initiation of new antidepressant therapy in the four weeks prior to
           entering the trial Exclusion Criteria

        -  Have an unstable medical condition, neurological disorder or any history of seizure
           disorder or are currently pregnant or lactating

        -  Previous brain injury or surgery, any metal clips, plates or other metal items in the
           head, cardiac pacemaker

        -  In the opinion of the investigator, are a sufficient suicide risk to require immediate
           electro-convulsive therapy

        -  Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of
           a personality disorder or another axis 1 disorder
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; Depression
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho
      Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years
      of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG),
      norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a
      21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or
      headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho
      Tri-Cyclen Lo.
    

Detailed description: 
      Safety issues are addressed in the Adverse Events section.
    

Intervention name(s): Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Ortho Tri Cyclen Lo
Intervention type(s): Drug; Drug
Intervention description(s): Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo; Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo
Intervention MeSH terms: Moxifloxacin; Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oral contraceptive; Estradiol valerate and dienogest; EV/DNG; comparative tolerability
Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics
Condition: Alzheimer Disease; Cognition Disorder
MeSH terms: Alzheimer Disease; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The SAD design of the study is based on the aim to study safety, tolerability and PK of
      selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be
      administered orally.
    


Intervention name(s): ACD856; Placebo; ACD856 (fed cohort)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral doses of ACD856 administered in a fasted state in escalation schedule of dose 1, dose 2, dose 3, dose 4, dose 5, dose 6 and dose 7. The escalation schedule may be adapted based on evaluation by internal Safety Review Committee.; Placebo oral solution; Single oral dose of ACD856 in fed state of either dose 4 or dose 5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cognition Disorder; Alzheimer's Disease
An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
Condition: Healthy Subjects; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will explore potential next-day residual effects of a single evening dose of 3mg
      of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.
    


Intervention name(s): GSK1755165; placebo; zopiclone
Intervention type(s): Drug
Intervention description(s): Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone
Intervention MeSH terms: Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Zopiclone; Hypnotic; Residual effects; Eszopiclone
Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of this trial is:

        -  to determine complete response rate (CRR) after six cycles of chemotherapy

        -  to determine complete remission rate (CR/CRr) as final treatment outcome after
           completion of treatment
    


Intervention name(s): Etoposide; Cyclophosphamide; Doxorubicin; Prednisone; Procarbazine; Dexamethasone; Dacarbazine; Brentuximab Vedotin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Prednisone; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Brentuximab Vedotin; Procarbazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men
Condition: Glycemic Control; Gastrointestinal Hormone Response; Healthy Young Men
Study type: Interventional

Summary: 
      The investigators hypothesize that the physiological effects of milk on satiety and glycemic
      control are mediated by the interaction between its macronutrient components by both
      insulin-dependent and independent mechanisms.
    


Intervention name(s): Milk Fat; Milk Protein; Lactose; Whole milk (3.25% M.F.(; Simulated Milk Beverage
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Commercially available milk from the grocery store; Added lactose + fat + protein together to form a mixture
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Prevention
Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone
      compared to an intramuscular dose of naltrexone.
    


Intervention name(s): Naltrexone; Intravail
Intervention type(s): Drug; Other
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bronx MBCT-Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This randomized clinical trial aims to examine the effect of a standardized 8-week course of
      Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people
      with migraine.
    


Intervention name(s): MBCT for Migraine
Intervention type(s): Behavioral
Intervention description(s): 8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; MBCT; Cognitive Therapy; Disability
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to establish bioequivalence of two FDC tablets and the
      single tablets when administered together after a high fat high caloric meal.
    


Intervention name(s): Empagliflozin; Empagliflozin + Metformin; Metformin; Metformin; Empagliflozin + Metformin; Empagliflozin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): empagliflozin tablets and metformin tablet; fixed dose combination tablet (low); empagliflozin tablets and metformin tablet; empagliflozin tablet and metformin tablet; fixed dose combination tablet (low); empagliflozin tablet and metformin tablet
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Carotenoid Response to the Intake of Vegetables and Fruits
Condition: Resonance Raman Spectroscopy for Dietary Carotenoid Intake
Study type: Interventional

Summary: 
      The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy
      for assessing vegetable and fruit consumption.
    

Detailed description: 
      This study will validate the use of resonance Raman spectroscopy to assess vegetable and
      fruit intake by performing a controlled feeding study during which volunteers will consume a
      provided diet with known amounts of carotenoids in the form of fruits and vegetables.
    

Intervention name(s): Carotenoid Depletion; Carotenoid Repletion; Carotenoid Depletion; Natural Repletion
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Depletion of carotenoids using a restricted food list; Carotenoid repletion with provided diet based on dietary guidelines.; Carotenoid depletion using a restricted food list.; Resumption of usual personal diet regimen. No restrictions.
Intervention MeSH terms: Carotenoids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: resonance Raman spectroscopy; Dietary Guidelines; fruits; biomarkers; carotenoids; MyPlate; vegetables
Environments as Smoking Cues: Imaging Brain Substrates, Developing New Treatments (CameraCue)
Condition: Smoking; Healthy
Study type: Interventional

Summary: 
      The overarching goals of this proposal are to 1) identify the network of brain regions
      specifically activated by personal smoking environment cues and 2) to evaluate the effects of
      exposure to these cues on smoke self-administration and subjective reactivity. The results of
      this study will inform the development of novel and more efficacious cue-exposures therapies
      targeted at helping smokers quit smoking and will provide novel mechanism information
      regarding the influence of environmental context on drug taking.

      The investigator hypothesizes that cue-exposure treatments (CETs), in which drug use is
      prevented during exposure to drug cues (e.g. lit cigarette) have been of limited efficacy in
      part because they have not included cues representative of the contexts in which drug use
      occurs. By demonstrating that context cues have a differential and robust influence on brain
      and behavioral responses, we will have provided a substantial basis for including such
      stimuli in the context of treatment. At the same time, we will have identified novel
      mechanisms by which such stimuli promote continued drug use and relapse.
    


Intervention name(s): Quit Smoking 6 hours; Quit Smoking 24 hours
Intervention type(s): Behavioral; Behavioral
Intervention description(s): participants will quit smoking 6 hours prior to the cue-exposure sessions; participants will quit smoking 24 hours prior to the fMRI scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: smoking environment; cue-exposure; cigarettes; nicotine; fMRI
A Pilot Study Using Photo-plethysmographic (PPG) Camera
Condition: Infant Development
Study type: Observational

Summary: 
      The researcher want to use video signals to monitor heart rate, respiration rate and oxygen
      saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method:
      periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using
      light.
    

Detailed description: 
      The Researcher want to use ambient light to monitor heart rate, respiration rate and oxygen
      saturation (SpO2) in infant patients in a hospital setting. The plethysmographic signal is
      typically strong on children. This provides a reliable heart rate monitor. However, to
      measure oxygen saturation, a quantitative value of the strength at two wavelength regions
      (green and red) is required. It is also not known if the normal ambient light is spectrally
      appropriate to analyze the video signals for oxygenation. With the current prototype of our
      system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using
      normal artificial light or daylight, entering through a window.
    

Intervention name(s): Photo-plethysmography monitoring
Intervention type(s): Device
Intervention description(s): monitoring vital sign in infant
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infant
      
Keywords: assessment
Correlation Between Body Mass Index, Selective Motor Control and Functional Ability in Children With CP
Condition: Diplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      PURPOSE:

      To investigate the correlations between body mass index, spasticity, functional ability and
      isolated motor control in children with spastic diplegia.

      BACKGROUND:

      Cerebral palsy is primarily a disorder of movement and posture

      HYPOTHESES:

      There is no correlation between body mass index, spasticity, functional ability and isolated
      motor control in children with spastic diplegia.

      RESEARCH QUESTION:

      Is there a correlation between body mass index, spasticity, functional ability and isolated
      motor control in children with spastic diplegia?
    

Detailed description: 
      This is an observational correlational study. SCALE will be used to assess selective motor
      control of lower extremity. GMFM-88 and WEE FIM will be used to assess functional ability.
      MAS will be used to assess degree of spasticity
    

Intervention name(s): correlation study
Intervention type(s): Other
Intervention description(s): investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        spastic diplegic cerebral palsy children
      
Keywords: isolated motor control; functional ability; body mass index; cerebral palsy
Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section
Condition: Superior Hypogastric Plexus Block
Study type: Observational

Summary: 
      PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after
      cesarean section
    

Detailed description: 
      Superior hypogastric plexus block(SHPB) for pain relief is routinely implemented in cesarean
      section operations at H.S.U Kocaeli Derince Education and Research Hospital. The
      implementation of this procedure depends on the clinical situation of the patient, the
      preference of the surgeon and the anesthesiologist, the course of the operation, and whether
      the patient wishes or not. Superior hypogastric plexus block is performed with 0.25 %
      bupivacaine 30 ml injected under peritoneum above promontorium.

      This is a prospective case-control study. The sample consisted of 60 women having
      cesarean-section with general anesthesia at H.S.U Kocaeli Derince Education and Research
      Hospital divided into two groups: the first group having superior hypogastric plexus block
      for pain relief and the control group not having superior hypogastric plexus block. All
      participants signed an informed consent and the study was approved by the Ethics Committee of
      Kocaeli University ( KUGOKAEK 2017/270). The sample size was calculated with G Power 3.1
      program. With ki-square Goodness-of-fit test α:0.05 ,power 95% ,effect size 0.5 total sample
      size was calculated 52, including 26 in case group and 26 in control group. Women having
      cesarean-section with spinal anesthesia, women with known bupivacaine allergy, women with
      anxiety-depression disorder, women with known fibromyalgia were not enrolled to the study.
      Age, BMI(body mass index), education status, VAS (visual analog scale) scores ,the amount of
      analgesic used and the hour of gas extraction and bowel movement will be recorded.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, pregnant, literate women having cesarean-section operation with general anesthesia
        at H.S.U Kocaeli Derince Education and Research Hospital Obstetrics and Gynecology Clinics
      
Keywords: nerve blockade; hypogastric plexus; cesarean section
PK Study of PT003 and PT001 in Japanese Healthy Subjects
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,
      Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the
      Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
    


Intervention name(s): Glycopyrronium and Formoterol Fumarate (GFF) Dose 1; Glycopyrronium and Formoterol Fumarate (GFF) Dose 2; Glycopyrronium (GP) Dose 1; Glycopyrronium (GP) Dose 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID); Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID); Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID); Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Japanese Healthy Volunteers
Growth and Tolerance of Infants Fed Formula for 16 Weeks
Condition: Child Development
Study type: Interventional

Summary: 
      Growth and Tolerance Trial of Iron-fortified infant formulas
    

Detailed description: 
      16 WEEK GROWTH AND TOLERANCE
    

Intervention name(s): Infant formula
Intervention type(s): Other
Intervention description(s): Multi-centered, prospective, randomized clinical trial
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-Investigator, Prospective, Randomized Clinical Trial
Masking: None (Open Label)
Primary purpose: Other