bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Effects of a Hallucinatory Meal on Appetite Regulation
Condition: Change in Subjective Appetite Score (VAS)
Study type: Interventional

Summary: 
      Several and complex mechanisms are involved in the regulation of appetite and food intake in
      humans. By means of rapid hypnosis techniques, it is possible to induce some individuals to
      hallucinate a meal.

      The same meal (breakfast) is administered as i) a real meal and ii) is evoked as a
      hallucination under hypnosis in healthy postmenopausal women. The aim of this pilot
      randomized-controlled cross-over trial is to assess appetite sensation and the blood levels
      of the appetite-related hormones in the participants.
    

Detailed description: 
      The regulation of appetite is crucial to control food intake and consequently body weight.
      Hypnosis has been successfully used to modulate gastrointestinal functions, by imagining
      eating food.

      In the present pilot trial, the investigators search to investigate the effects a
      hallucinatory meal by hypnosis on subjective appetite and appetite hormone blood levels.
      Hence, two different breakfast meals are randomly administered to eight healthy
      postmenopausal women, in a crossover design, consisting of i) a hallucinatory breakfast meal
      (HB) and ii) a real breakfast meal (RB). On each test day, participants undergo baseline
      measurements, including appetite sensation and blood sample, then the test meal is
      hallucinated or served. Subjective appetite is assessed each 30 minutes for 4 hours and half,
      while blood samples are taken at 20', 60', 90' and 180 minutes. At the end of each session,
      participants are instructed to fill in a food record for the following 3-days.
    

Intervention name(s): hallucinated meal; Real meal
Intervention type(s): Other; Other
Intervention description(s): a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis; A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Bioequivalence Study of Pseudoephedrine HCl 120 mg ER Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of the study was to compare the single dose oral bioavailability of
      Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of
      Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.
    

Detailed description: 
      This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence,
      single dose crossover bioavailability study planned on 40 healthy, adult, human subjects
      under fed conditions.

      A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the
      dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects
      completed both the periods of the study.
    

Intervention name(s): Pseudoephedrine hydrochloride 120 mg ER tablets
Intervention type(s): Drug
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Pseudoephedrine hydrochloride 120 mg ER tablets
Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With ADHD
Condition: ADHD; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study proposes to evaluate the effects of guanfacine extended release on brain
      activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD
      subjects randomized to placebo treatment.

      This study also proposes to collect DNA on study participants, to examine the genetic
      underpinning of the observed fMRI activation profiles at baseline and in response to
      treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other
      related targets) for genetic biomarkers in association with the fMRI findings of this study.
    

Detailed description: 
      This study proposes to evaluate the effects of guanfacine on brain activation during fMRI in
      12 children and adolescents ages 8 - 15 with ADHD treated with once-daily INTUNIV(TM)
      (guanfacine; GXR) extended release tablets and 12 ADHD subjects randomized to placebo
      treatment. Children will be comprehensively assessed using a variety of clinical and
      neuropsychological measures. They will be scanned at baseline while performing both the
      go/no-go task (a well validated task for measuring inhibitory control (Durston et al., 2002,
      2003)) and the Stay Alert task - a new task designed to measure the arousal component of
      attention, which was used successfully in a recent fMRI study of guanfacine in healthy adults
      (Clerkin et al., 2009). They will then be treated with GXR or placebo for 6 - 8 weeks in
      accordance with titration and dosing strategies used in recent Phase III dose optimization
      trials (e.g., up to 4 mg/day), and re-scanned while performing the same two tasks. The fMRI
      scans will be conducted using a dedicated research 3.0 T Siemens scanner.
    

Intervention name(s): Guanfacine Hydrochloride XR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose; Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose
Other intervention name(s): INTUNIV non-stimulant medication; GXR
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intuniv; Attention Deficit Hyperactivity Disorder; fMRI
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery
      Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
    

Detailed description: 
      Study Procedures:

      Visit 1: Screening - Eligibility determination

      Visit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging

      Visit 3 (within 24-48 hours post dose): Follow-up Visit
    

Intervention name(s): BFPET
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: BFPET; Coronary Artery Disease; Myocardial Perfusion Imaging; Radiation Dosimetry
Time Dependent Professional Toothbrushing Study
Condition: Toothbrushing
Study type: Interventional

Summary: 
      Aim:

      The study was designed to test the time dependent efficacy in plaque removal of four
      toothbrushes: one electric toothbrush, the Philips Sonicare Elite with long (A) and short (B)
      brushing head and two manual brushes, the Gaba Sensitve (C), and the ADA reference brush (D)
      and.

      Materials and Methods:

      The study was a single-blind, randomized clinical timer study consisting of four identical
      experiments testing each brush in one quadrant. The distribution of the quadrants and brushes
      was randomized so that always all brushes were used within one participant. The teeth were
      brushed by a dental hygienist for 10, 20, 30, 45, 60 und 90 seconds per quadrant. No
      toothpaste was used throughout this study. The plaque assessment (Tureskey modified QHI) was
      done after each time interval blinded on six sites per tooth by a separate investigator.
      Ninety subjects participated in the study and received a professional prophylaxis prior to
      the experiment. They were requested to refrain from brushing their teeth for 48 hours prior
      to the experiment.
    


Intervention name(s): Sonicare elite medium brush head; Sonicare elite mini brushhead; GABA Elmex sensitive extra soft toothbrush; ADA reference toothbrush
Intervention type(s): Device; Device; Device; Device
Allocation: Randomized
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: sonic brushes; time effectiveness; brush head design; ADA-toothbrush; professional brushing; time dependence; efficacy; toothbrush
Testing Delivery Channels of Brief Motivational Alcohol Intervention
Condition: Hazardous Drinking
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to investigate whether motivation-tailored alcohol interventions are
      more effective when delivered by person or by computer-generated feedback letters. A sample
      of 920 general hospital inpatients with risky drinking will be recruited through a
      computerized screening procedure. Patients with more severe alcohol problems will be excluded
      from the study. Participants will be allocated by time frame randomization to one of three
      study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert
      system intervention that generates individualized feedback-letters, and (3) control group
      (treatment-as-usual). The interventions differ in their channel of delivery, but not
      regarding their content. Both intervention groups receive interventions at three time points:
      directly after the baseline-assessment at the general hospital, and 1 and 3 months later by
      mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after
      baseline.
    


Intervention name(s): Personal Counseling; Computer-generated feedback letters
Intervention type(s): Behavioral; Behavioral
Intervention description(s): At three time-points, participants receive counseling by health professionals trained in Motivational Interviewing based counseling. To assure that both interventions do not differ in their content, individual manuals generated by a software program are used. Counseling will be face-to-face during the hospital stay, and by phone one and three months later.; At three time points, participants receive feedback letters, tailored to the stages of change according to the TTM, and generated by a computer software program. The first letter is handed out during their hospital stay and includes normative feedback. One and three months later, participants receive ipsative feedback letters by mail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hazardous drinking; general hospital; brief intervention; Motivational Interviewing; computer-generated feedback; stage-tailored; delivery channel
Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging.
Condition: Pediatric Solid Tumor; Pediatric Brain Tumor; Pediatric Cancer
Study type: Interventional

Summary: 
      To evaluate the effects of music and maternal voice in children on sedation depth and
      sedative use during pediatric magnetic resonance imaging.
    

Detailed description: 
      When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes
      before the procedure, the anesthetist is obtained a medical history and carried out a
      physical examination and clinical assesment.

      Patients were categorized into 3 groups: music, maternal voice and isolation. During the
      procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin
      concertos by sound isolating headphones, whereas the patients in the isolation group wore the
      headphones but did not listen to music.

      All patients were sedated by midazolam and propofol. During the procedure, an additional
      propofol was administered as required
    

Intervention name(s): Group headphone; Group music; Group maternal voice
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients.; The patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.; The patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Magnetic Resonance; sedation; maternal voice; sedative effects
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Condition: Smoking Lapse Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine how smoking cessation medications (varenicline,
      bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in
      non-treatment seeking daily smokers.
    


Intervention name(s): varenicline; bupropion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).; 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).; Placebo
Other intervention name(s): Chantix; Zyban
Intervention MeSH terms: Bupropion; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking lapse behavior; smoking cessation; varenicline; bupropion; medication effect on smoking lapse behavior
The Effect of Injection Rate of Local Anesthetic in Caesarean Section
Condition: Anesthesia, Spinal; Anesthesia, Obstetrical
Study type: Interventional

Summary: 
      This randomized double-blind study aimed to compare the effects of two different subaracnoid
      lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. The
      groups were compared in terms of maximum sensory and motor block level, time to reach T6
      level, hemodynamic changes and nausea- vomiting saved.
    

Detailed description: 
      A total of 67 patients 18-40 years undergoing cesarean, who were graded as American Society
      of Anesthesiologists physical status were randomly allocated into two groups, 120-sn
      injection time (n=34, Group F), 15-sn injection time (n=33, Group S). When the level of the
      sensory block achieve the T6 level the surgery was let to begin. The groups were compared in
      terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the T6
      level, maximum sensory block level and motor block level.
    

Intervention name(s): Local anesthetic injection rate in spinal anesthesia
Intervention type(s): Other
Intervention description(s): Administering intrathecal local anesthetics for all patients according to height and weight.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Laparoscopic Adnexal Mass Extraction Via the Transumbilical and Transvaginal Routes
Condition: Surgical Procedure, Unspecified
Study type: Observational

Summary: 
      Adnexal masses are a common clinical problem encountered in gynecological practice. Minimally
      invasive surgery (MIS) for ovarian pathologies has been adopted widely. Its goals are to
      minimize abdominal incisions and postoperative pain and to prevent incisional complications,
      such as incisional hernias and adhesions. Compared with open procedures, MIS is associated
      with faster recovery times, better patient quality of life, and lower postoperative
      complication rates. The removal of an adnexal mass from the abdominal cavity is performed
      most commonly using the suprapubic, umbilical, or vaginal route. Apart from these, mini
      laparoscopy can provide a better cosmetic result without additional operative time or
      complications. Despite the limited use of mini laparoscopy for gynecological procedures, its
      use has increased recently.

      After excision, an adnexal mass can be removed through a laparoscopic (LS) port using a
      variety of endoscopic or containment bags. After the mass has been placed in it, the bag is
      withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal.
      When a mass is large or cannot be removed through the port, the incision may be enlarged
      slightly. This situation may yield a cosmetically worse outcome and increases the risk of
      postoperative complications, such as adhesion, hernia, and increased postoperative pain.
      Thus, natural orifice surgery (NOS) has emerged for tissue removal in such cases.

      This study was performed to compare the transumbilical (TU) and transvaginal (TV) routes for
      adnexal mass removal from the abdominal cavity
    


Intervention name(s): Laparoscopic adnexal mass extraction
Intervention type(s): Procedure
Intervention description(s): Compared with open procedures, Minimally invasive surgery (MIS) is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, trans umbilical (TU), or trans vaginal (TV) route.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who underwent laparoscopic surgery for the removal of benign adnexal masses at three
        centers between January 2016 and December 2020 were examined retrospectively.
Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK
Condition: Healthy Volunteers Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability and PK of selumetinib
      (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian
      volunteers following administration of a single dose. Standard safety assessments including
      ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and
      an optional exploratory pharmacogenetics will be performed.
    

Detailed description: 
      A Phase I, Single-centre, Open-label, Dose-escalation Study to Assess the Safety,
      Tolerability and Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) Given
      Orally in Japanese and Non-Japanese Asian Healthy Male Volunteers
    

Intervention name(s): Selumetinib
Intervention type(s): Drug
Intervention description(s): 1, 2 or 3 x 25 mg selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) capsule administered orally as a single dose on Day 1 of the study (total dose 25 mg, 50 mg and 75 mg respectively) with 240 ml of water at room temperature.
Other intervention name(s): (AZD6244; ARRY-142886) (Hyd-Sulfate)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: RAS or RAF oncogenes, Inhibition of MEK pathway, inhibition cancer cell proliferation promising anti-cancer therapeutic strategy.
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study is a feasibility study of the HeartPOD™ Heart Failure Management System with
      DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The
      device being studied in this trial monitors heart function and alerts the patient and
      physician of necessary changes to medication. The study will assess the safety, reliability,
      and preliminary efficacy of the HeartPOD™ system.
    

Detailed description: 
      Direct cardiac measurements may provide an accurate, reliable and medically acceptable way of
      informing patients and physicians of worsening CHF prior to the development of symptoms. This
      may enable physicians to take preventative measures and avoid hospitalization.

      This is a feasibility study to assess the safety, reliability, and preliminary efficacy of
      the HeartPOD™ Heart Failure Management System with DynamicRx®. This feasibility study will be
      performed in two phases. The first phase will enroll 20 patients at sites in Australia and
      New Zealand and the second phase will enroll 20 patients at sites in the U.S.
    

Intervention name(s): HeartPOD™ System
Intervention type(s): Device
Intervention description(s): HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Heart Failure; Left Atrial Pressure Monitoring
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified
      artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by
      intramuscular immunization.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a
      total of 60 volunteers will receive one of three doses of Invaplex[AR-DETOX] or placebo
      (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1,
      22, and 43. Each participant will receive the same formulation at each vaccination dependent
      upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and
      will proceed to the next highest dose in an escalating fashion. All safety data will be
      summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation.

      Specimens will be collected at prescribed intervals to examine systemic and mucosal immune
      responses. Vaccine safety will be actively monitored during vaccination and for 28 days
      following the third vaccine dose.
    

Intervention name(s): Invaplex[AR-DETOX]; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex[AR-Detox]) Vaccine; Saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Shigella flexneri 2a; Enteric; Shigella