bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
Condition: Hypercholesterolemia; Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose
      crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and
      Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment
      spans 7 days
    


Intervention name(s): Vytorin + Niaspan; Vytorin; Niaspan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7; Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days; Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7
Other intervention name(s): SCH 465981; ezetimibe; simvastatin; niacin; nicotinic acid; SCH 465981; ezetimibe; simvastatin; niacin; nicotinic acid
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach
Condition: Arthropathy of Hip
MeSH terms: Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain
      management after total hip arthroplasty by posterior surgical approach
    

Detailed description: 
      ASA physical status 1, 2 and 3 patients scheduled to undergo elective surgery of total hip
      arthroplasty under spinal anesthesia.

      The investigators would like to study the impact of supra-inguinal fascia iliaca block on
      postoperative pain management after total hip arthroplasty by posterior surgical approach.
      The principal investigator perform this block with ultrasound technique. The investigators
      also want to observe if this loco-regional new approach to fascia iliaca block could have
      influence on opioid side effects, postoperative nausea and vomiting, length of
      hospitalisation and first mobilisation side effects.
    

Intervention name(s): Supra-inguinal fascia iliaca compartment block; Multimodal analgesia and PCA morphine pump
Intervention type(s): Procedure; Drug
Intervention description(s): Ultrasound guided loco-regional technique as described by Desmet et al. Fascia iliaca compartment block with in-plane 40 ml ropivacaine 0,375% injection between the ilio-psoas muscle and the internal oblique muscle.
Patients in SFICB group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump; Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Bioequivalence Study of Levocetirizine DiHCl Tablets 5mg of Dr. Reddy's Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the Bioequivalence of Levocetirizine DiHCl Tablets 5mg
      with XYZAL tablets 5 mg and to monitor clinical status, adverse events and laboratory
      investigations and assess relative safety and tolerance, under fasting conditions.
    

Detailed description: 
      A pivotal study to compare the Bioequivalence of Levocetirizine DiHCl Tablets 5 mg of
      Dr.Reddy's Laboratories Limited with XYZAL® Tablets 5 mg of UCB Farchim S.A. in healthy,
      human subjects under fasting conditions.
    

Intervention name(s): Levocetirizine DiHCl
Intervention type(s): Drug
Intervention description(s): Levocetirizine DiHCl Tablets 5 mg
Other intervention name(s): XYZAL
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aromatherapy for Upper Respiratory Health
Condition: Immune System
Study type: Interventional

Summary: 
      The purpose of this study is to confirm and quantify the effects of aromatherapy on
      respiratory health.
    

Detailed description: 
      Participants will inhale the scent from an aroma stick every waking hour for the entire
      duration of a period of respiratory symptoms or 14 days, whichever is shorter. As it is a
      randomized, placebo-controlled study, some participants will inhale the scent from an aroma
      stick containing active essential oils while other participants will inhale from an aroma
      stick containing no essential oils.
    

Intervention name(s): Essential oil blend; Placebo
Intervention type(s): Other; Other
Intervention description(s): an aroma stick containing a blend of essential oils; an aroma stick containing an inert blend of oils
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Mood Effects of Serotonin Agonists
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of very low doses of serotonergic
      agonists on depressed mood in human volunteers.
    


Intervention name(s): Lysergic Acid Diethylamide
Intervention type(s): Drug
Intervention description(s): Drug will be administered in solution form.
Intervention MeSH terms: Lysergic Acid Diethylamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction
Condition: Bilateral Vestibular Loss; Vestibular Rehabilitation
MeSH terms: Bilateral Vestibulopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the etiological factors that constitute bilateral
      vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these
      patients.

      The Caloric test and Video Head Impulse test were applied to evaluate the vestibular
      hypofunction picture of the patients who applied to Clinic with complaints of vertigo,
      dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms,
      imbalance complaints and limited daily living activities were included in rehabilitation. In
      order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated
      using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was
      done with timed balance tests and quality of life assessment was performed with Dizziness
      Handicap Inventory.
    


Intervention name(s): Vestibular Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Haemodynamic Feasibility Study of Sensors Within a Tilting Table Examination
Condition: Syncope
MeSH terms: Syncope
Study type: Observational

Summary: 
      This study´s aim is to explore physiological associations concerning pulse wave velocity,
      heart rate and blood pressure in order to make taking the blood pressure more comfortable.
    


Intervention name(s): measurement of blood pressure
Intervention type(s): Device
Intervention description(s): measurement of pulse wave velocity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with syncope
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
Condition: Severe Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
      the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants
      diagnosed with severe postpartum depression.
    


Intervention name(s): SAGE-547; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as intravenous infusion.; Administered as intravenous infusion.
Intervention MeSH terms: Brexanolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial
Condition: Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography
Study type: Interventional

Summary: 
      Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic
      ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline
      solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome
      was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance
      of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to
      achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct
      cannulation in the acetic acid group versus saline group.
    


Intervention name(s): acetic acid; saline
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Acetic Acid; Retinol acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pancreatic duct; ERCP; acetic acid
Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
Condition: Obesity
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Opioid sparing analgesia is extremely important in the post-operative obese population. With
      more and more obese patients entering the operating room a multi-modal approach to analgesia
      is crucial. Finding effective alternatives to opioid therapy is the rationale of this
      proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very
      sparse.
    

Detailed description: 
      1. Patient will be identified by surgeon and consented by member of the research team

        2. Patient will be randomized to one of three groups on the day of surgery

        3. Following securement of the endotracheal tube, the study medication will be administered
           over 10 minutes via an IV infusion pump.

        4. The subject will receive ketamine, ketamine plus magnesium or a placebo.

        5. Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and
           set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A
           hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and
           given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2
           mg will be the starting dose as is standard for these patients post-operatively.

        6. Primary outcome will be the total amount of hydromorphone used in the first 24 hours
           post-operatively.

           .
    

Intervention name(s): Ketamine; Ketamine plus magnesium; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Ketamine infusion plus placebo infusion of normal saline; Ketamine plus magnesium infusion; 2 placebo infusions
Other intervention name(s): Normal Saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: opioid sparing; ketamine; obese; magnesium
Investigation of Pharmacokinetics of BIBX 245 CL and Safety in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of this trial is to investigate the single dose pharmacokinetics and the effect of food
      on single dose of 160 mg 245 CL (two 80 mg tablets) as well as its safety
    


Intervention name(s): BIBX 245 CL - fed; BIBX 245 CL- fasted
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Benralizumab in Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, single-blind study in healthy Chinese subjects at single dose
      administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3. The study design
      allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the
      safety, tolerability and PK profile of benralizumab.
    

Detailed description: 
      This study will be conducted at 1 study center in Hong Kong. Approximately 36 healthy Chinese
      male and female subjects, aged 18 to 45 inclusive, will be randomized in a 1:1:1 ratio to
      receive a single SC administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3
      (12 subjects per group). Each subject will participate in only 1 treatment group.
      Approximately 8-12 evaluable subjects in each group that met specific non-compartmental
      analysis (NCA) criteria are required to ensure eligible AUC0-∞ calculation. The total length
      of the study for each subject is up to 117 days (28 days of screening and 85+/- 4 days of
      further study visits).
    

Intervention name(s): Benralizumab
Intervention type(s): Biological
Intervention description(s): Treatment 1: Benralizumab single dose, Treatment 2: Benralizumab single dose and Treatment 3: Benralizumab single dose subcutaneously administration on 36 healthy Chinese male and female subjects in 1:1:1 ratio.
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 36 healthy Chinese male and female subjects randomized in a 1:1:1 ratio to receive a single SC administration of benralizumab, Treatment 1, Treatment 2 and Treatment 3 (12 subjects per group). Each subject will participate in only 1 treatment group.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Tolerability; Benralizumab; Healthy Chinese subjects
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      A great many soldiers are returning from Iraq and Afghanistan with symptoms of Post Traumatic
      Stress Disorder (PTSD). Clinical experience with many people has shown the effectiveness of
      the techniques of Energy Psychology for rapidly alleviating PTSD symptoms. The study proposes
      to determine whether a very brief course of treatment (3 sessions) with a common form of
      Energy Psychology called Emotional Freedom Techniques (EFT) has an effect on the stress
      biochemistry of subjects, by measuring their levels of stress hormones (cortisol, DHEA)
      before and after treatment.
    

Detailed description: 
      The Purpose of the Research: The purpose of this study is to test the effectiveness of
      Emotional Freedom Technique (EFT) versus Diaphragmatic Breathing in Reducing Post Traumatic
      Stress Disorders.

      The Scientific or Scholarly Rationale: Clinical experience and anecdotal reports have
      demonstrated EFT to be effective for a wide range of behavioral disorders, including PTSD.
      However with the exception of several studies demonstrating the efficacy of EFT for the
      treatment of simple phobias, there have been no formal research studies in this area. It is
      the intention of this study to extend the phobia studies to the area of PTSD, and to
      determine what other conditions EFT might be effective in treating. Another intention of this
      study is to see whether, and to what degree, changes in psychological functioning (as measure
      by the PAI and TSI) are reflected in physiological markers such as HRV (Heart Rate
      Variability) and levels of cortisol and DHEA.

      The Procedures to be Performed: Approximately 8 to 10 subjects would be randomly designated
      to either the experimental or Diaphragmatic Breathing control groups. There will be 4-5
      subjects in the EFT experimental group and 4-5 subjects in the control Diaphragmatic
      Breathing group.
    

Intervention name(s): Emotional Freedom Techniques (EFT)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-Traumatic Stress Syndrome (PTSD)
Delayed Positioning in Cesarean Section
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Maternal hypotension is a common problem during cesarian section under spinal anesthesia. The
      possible explanation for this is combined aortocaval compression by gravid uterus in
      parturient in addition to reduced systemic vascular resistance by spinal anesthesia. The
      investigators evaluated if the incidence of hypotension would be decreased by delayed supine
      positioning, by maintaining lateral position for 6 min after spinal injection, in patients
      undergoing elective cesarean section.
    


Intervention name(s): lateral positioning
Intervention type(s): Other
Intervention description(s): the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Immediate Versus Delayed FET Following a Stimulated IVF Cycle
Condition: Fertilization in Vitro; Embryo Transfer
Study type: Interventional

Summary: 
      Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a
      stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first
      cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to
      postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study
      aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a
      stimulated IVF cycle.
    


Intervention name(s): immediate frozen-thawed embryo transfer; delayed frozen-thawed embryo transfer
Intervention type(s): Other; Other
Intervention description(s): Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle; Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: frozen-thawed embryo transfer; time interval
IV Dexketoprofen vs Placebo in Migranie Attack
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in
      emergency department.

      H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine
      attack in emergency department.
    

Detailed description: 
      Migraine attack is one of the most leading causes presentations to emergency department.
      Patients with migraine attack seek urgent care to cease their pain. There are so many
      interventions defined in the medical literature that can be used in migraine attacks.
      However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to
      placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in
      migraine attack in emergency department.
    

Intervention name(s): Dexketoprofen; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): 50 mg intravenous arveles in 50 ml saline in 5 minutes; 50 ml normal saline
Other intervention name(s): Arveles
Intervention MeSH terms: Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: migraine, emergency department, dexketoprofen, placebo