bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant
      test formulation compared to a single dose of fezolinetant reference formulation under
      fasting conditions. This study will also evaluate the safety and tolerability of a single
      dose of fezolinetant test formulation and a single dose of fezolinetant reference
      formulation.
    

Detailed description: 
      Each participant will participate in 2 study periods separated by a washout of at least 5
      days between investigational product (IP) administrations. Participants will be randomized to
      1 of 2 sequences: either fezolinetant test formulation followed by fezolinetant reference
      formulation or fezolinetant reference formulation followed by fezolinetant test formulation.
      Participants will be admitted to the clinical unit on day -1 and will be residential for 2
      study periods for a total of 10 days/9 nights. Premenopausal female participants will be
      admitted to the clinical unit during days 1 to 3 of their menstrual cycle. Participants will
      receive a single dose of test formulation or reference formulation under fasting conditions
      on day 1 of each period i.e., days 2 to 4 (period 1) and days 7 to 9 (period 2) of their
      menstrual cycle for premenopausal female participants. Participants are to remain
      semirecumbent and avoid lying on either the left or right side for 4 hours postdose.
      Pharmacokinetic samples will be collected predose on day 1 of each period and at multiple
      time points postdose. Standard safety and tolerability assessments will be conducted.
      Participants will be discharged from the clinical unit on day 4 of period 2 on the condition
      that all required assessments have been performed and that there are no medical reasons for a
      longer stay in the clinical unit.

      The study will be completed with an end-of-study visit (ESV). The ESV will take place 5 to 9
      days after discharge from period 2 or at early discontinuation from the study.
    

Intervention name(s): fezolinetant - test formulation; fezolinetant - reference formulation
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): ESN364; ESN364
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fezolinetant; ESN364; menopause
Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.
Condition: Post Operative Local Anaesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site
      Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.
    

Detailed description: 
      two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either
      Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end
      of the operation.
    

Intervention name(s): Laparoscopic Guided Bupivacaine; local Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block; Bupivacaine Trocar Site Infiltration
Other intervention name(s): marcaine; marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Efficacy of Gabapentin in Therapy of Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether antiepileptic drug gabapentin is effective
      in the treatment of chronic asthma.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According GINA definition,
      asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides
      wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many
      specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides
      this, according to some authors, neurogenic inflammation may play important role in asthma
      mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are
      migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and
      valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in
      80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and
      trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in
      asthma therapy.

      We performed a double-blind, placebo-controlled 3-month trial for evaluation of gabapentin
      efficacy in therapy of bronchial asthma. Gabapentin is antiepileptic drug of new generation,
      produced by Pfizer.

      Comparison: Patients received investigational drug in addition to their usual routine
      antiasthmatic treatment, compared to patients received placebo in addition to their usual
      routine antiasthmatic treatment.
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Gabapentin; Antiepileptic drug; Efficacy
Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      This is a multi-center, prospective registry of patients with intermediate coronary lesions
      defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled
      into the study at sites in the United States and Europe. There will be no follow up beyond
      hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The
      investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical
      criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can
      predict physiological ischemia by Fractional Flow Reserve (FFR).
    

Detailed description: 
      Patients undergoing cardiac catheterization must meet clinical inclusion and exclusion
      criteria and sign an informed consent. At the time of catheterization the patients will be
      further analyzed for eligibility using angiographic inclusion and exclusion criteria.
      Patients who fulfilled the clinical and angiographic criteria will undergo further imaging
      evaluation using an IVUS RF catheter (Volcano Therapeutics) and FFR wire (Radi or Volcano).
      The decision for treatment of any lesion will be at the operator's discretion. For patients
      enrolled at Washington Hospital Center and do not undergo percutaneous coronary intervention,
      an assessment with non invasive perfusion adenosine MRI also be performed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients required to have an intermediate coronary lesion (stenosis 40-80% by visual
        estimate) in one or more native, major epicardial coronary artery with reference diameter
        ≥2.5mm (visual estimate)
The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients
Condition: Asthma; Yoga
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study was conducted to find out the effect of yoga applied to asthma patients on the
      patients' respiratory functions, symptom control and quality of life.
    

Detailed description: 
      While there are studies conducted with yoga on different patient groups in Turkey, no studies
      have been found on asthma patients specifically. For this reason, it was thought that studies
      are needed which will prove the effect of yoga practices in preventing and controlling
      symptoms of asthma patients and which will contribute to nursing literature.
    

Intervention name(s): yoga
Intervention type(s): Other
Intervention description(s): A total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Asthma; nursing; patient; yoga
High Intensity Interval Training on Cardiopulmonary Parameters With or Without Facemask in Healthy Participants
Condition: Healthy
Study type: Interventional

Summary: 
      To determine the effects of high intensity interval training on cardiovascular function,
      cardio metabolic markers and cardiorespiratory fitness in healthy individuals with or without
      facemask
    


Intervention name(s): High Intensity Interval Training (With Face Mask); High Intensity Interval Training (Without Face Mask)
Intervention type(s): Other; Other
Intervention description(s): High Intensity Interval Training on Treadmill for 4 weeks with Face mask; High Intensity Interval Training on Treadmill for 4 weeks with out Face mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
Condition: Cannabis Use
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, the investigators are interested in testing how lorcaserin influences the
      effects of cannabis in a human laboratory model of cannabis use.
    

Detailed description: 
      In order to improve treatment outcome for cannabis use disorder (CUD), the investigators have
      developed a laboratory model to investigate the effects of potential treatment medications on
      cannabis withdrawal and on the subjective and reinforcing effects of cannabis in non
      treatment-seeking cannabis smokers. In this study, the investigators are interested in
      testing how lorcaserin influences the effects of cannabis in a human laboratory model of
      cannabis use.
    

Intervention name(s): Lorcaserin; Placebo; Marijuana
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lorcaserin 10mg BID; Placebo capsule BID; Smoked marijuana cigarette
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery
Condition: Spinal Anesthesia; Hyperbaric Bupivacaine; Isobaric Bupivacaine; Lower Abdominal Surgery
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of intrathecal injection of hyperbaric
      bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing
      lower abdominal surgery.
    

Detailed description: 
      Spinal anesthesia is one of the most commonly used nerve block procedures for surgical
      operations involving the lower abdomen, the perineum, and the lower limbs, owing to its quick
      effect and cost-effectiveness. Spinal anesthesia is advantageous in that it uses a small dose
      of anesthesia, is simple to perform, and offers a rapid onset of action, reliable surgical
      analgesia, and good muscle relaxation.

      The Baricity of a solution is defined as the ratio of the density of the solution to that of
      the cerebrospinal fluid (CSF). The most common anesthetic used for SA in obstetric and
      non-obstetric surgery is bupivacaine, which can be formulated as an isobaric or hyperbaric
      solution. Baricity differences between spinal anesthetic solutions are thought to affect
      hemodynamic parameters and distribution within the subarachnoid space, which may, in turn,
      affect the onset, extent, and duration of sensory block as well as side effects.

      Spinal anesthesia has been linked to different adverse effects, out of which hypotension is
      most common complication. The incidence of hypotension is 25-75% in general population.
      Factors that increase the risk of hypotension include patient factors (advanced age,
      pregnancy, obesity, diabetes mellitus, hypertension, and anemia) and technical factors such
      as a block level at or above T5, use of opioids during premedication, and high local
      anesthetic dosages.
    

Intervention name(s): Group A (hyperbaric bupivacaine); Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)
Intervention type(s): Drug; Drug
Intervention description(s): Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution; Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Bright Light: A Novel Treatment for Anxiety
Condition: Anxiety; Depression; Sleep
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this research was to examine the influence of bright light on anxiety in
      high-anxious young adults. In an acute exposure study, participants were randomly assigned to
      45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion
      generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after
      the treatments, state anxiety, mood, and blood pressure were assessed.

      Following the acute exposure study, participants performed a 5-week study. Following a a
      1-week baseline, participants were randomly assigned to four weeks of daily exposure to
      either (1) bright light (45 min/day; 3,000 lux) or (2) placebo inactivated negative ion
      generator, which were initiated ≤1 hr after awakening. Before and after the experiment,
      clinical ratings were conducted with the Hamilton Anxiety Scale, the Hamilton Depression
      Scale, and the Clinical Global Impressions scale (CGI). Following baseline, and following
      each week of treatment, blood pressure, as well as questionnaires for state anxiety,
      depression, mood, sleep, and side effects were assessed.
    


Intervention name(s): Litebook Bright Light Box; Litebook inactivated negation ion generator (the placebo)
Intervention type(s): Device; Device
Intervention description(s): Four weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.; Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising
Other intervention name(s): Phototherapy; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Phototherapy; Psychic Anxiety
Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Pilot Interventional study with minimal risks and constraints, prospective, monocentric.
      Safety and Efficacity evaluation of a Novel Medical Device.
    

Detailed description: 
      Upper limb's phantom pain, due to amputation or to injury of the brachial plexus are possibly
      due to maladaptive CNS (central nervous system facility) plasticity and thus could be
      decreased by retraining the sensorimotor cortex using Mental Motor Imaging guided through a
      novel BCI-RV feedback system : "Ghost". The aim of this study is to evaluate safety and
      efficacy of this BCI pain treatment developed by our team.
    

Intervention name(s): BCI sessions
Intervention type(s): Device
Intervention description(s): up to 3 test sessions (D-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (D1-D5 and D8-D12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer
Condition: Moderately Overweight Individuals
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to examine and compare the effects of alternate-day reductions
      in calorie intake or daily calorie restriction on the risk for cardiovascular disease and
      cancer.
    

Detailed description: 
      Overweight individuals are at greater risk for certain chronic diseases such as
      cardiovascular disease and cancer when compared to those who are normal weight. Dietary
      restriction has been shown to lower the risk of these chronic diseases in overweight human
      subjects as well as in normal weight rodents. The majority of studies examining dietary
      restriction protocols in rodents or humans implement daily calorie restriction (CR), i.e.
      where the amount of energy consumed is decreased by a certain percentage every day. Another
      dietary restriction regimen employed, although less commonly, is intermittent caloric
      restriction, or alternate-day fasting (ADF), i.e. where food is available ad-librium every
      other day, alternating with a partial or complete caloric restriction day. Recent findings
      suggest that ADF may modulate certain indices of disease risk to a similar extent as daily CR
      in animal models. The effect of ADF regimens in comparison with CR regimens on disease risk
      has yet to be performed in human subjects, however. ADF protocols need not result in weight
      loss, and would therefore be appropriate for non-obese individuals. Accumulating evidence
      suggest that adipose tissue may play a role in modulating chronic disease risk by releasing
      substrates, such as fatty acids, or a variety of hormones, including adiponectin and leptin.
      The effect of ADF and CR on adipose tissue metabolism and hormone release remains unclear.
      Accordingly, the aim of the present study is to compare ADF regimes to CR for their effects
      on risk factors for cardiovascular disease and cancer and their effects on adipose tissue
      metabolism and hormone secretion, in normal weight to modestly overweight (BMI 22-27 kg/m2)
      human subjects.
    

Intervention name(s): calorie restriction
Intervention type(s): Behavioral
Intervention description(s): Subjects in the "calorie restriction" arm and the "alternate day fasting" arm will be asked to follow a menu plan, for three months, that includes some level of calorie restriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Calorie restriction; alternate day fasting; calorie intake
Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients
Condition: Core Temperature; Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The goal of this retrospective data-based study is to investigate the correlation between
      esophageal temperature and skin core temperature in trauma patients who underwent emergency
      surgery.

      Based on the medical records of patients who applied both temperature measurements
      simultaneously, the correlation between the skin core temperature and the esophageal
      temperature was investigated
    

Detailed description: 
      Hypothermia is known to be one of the factors that increase mortality rate in trauma
      patients. Therefore it is important to measure and manage the core temperature in trauma
      patients.

      Esophageal temperature is common method to measure core temperature in patients undergoing
      surgery under general anesthesia. However, it is not applicable in patients who have not been
      intubated or in patients with suspected esophageal damage. In addition, esophageal
      temperature probe is twisted in the mouth and does not reflect core temperature properly.

      3M™ Bair Hugger™ temperature monitoring system was developed to measure the core temperature
      by attaching to the skin using zero heat flow mechanism. It is simple to apply, and available
      at the trauma scene.

      Previous studies have reported that skin core temperature reflects core temperature well, but
      no studies have been conducted on trauma patients with rapid changes in the core temperature
      and poor perfusion state.

      This retrospective data-based study investigate the medical records of trauma patients who
      underwent emergency surgery. Patients who applied two temperature measurements at the same
      time were targeted. Since this center has the system that automatically transfer the
      hemodynamic data of the monitor to the anesthesia record, the investigators use the
      anesthesia records.
    

Intervention name(s): Esophageal temperature; Skin core temperature
Intervention type(s): Device; Device
Intervention description(s): Temperature data measured by esophageal temperature probe (disposable probe, Ace-medical, Seoul, Korea); Temperature data measured by skin core temperature device measured by 3M™ Bair Hugger™
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021
A Drug Drug Interaction Study Between PF-06826647 And Oral Contraceptive Steroids In Healthy Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, fixed sequence, multiple dose, open label study of the effect of
      PF-06826647 on oral contraceptive (OC) pharmacokinetics (PK) and vice versa in healthy female
      participants. A total of approximately 15 healthy female participants will be enrolled and
      dosed to achieve at least 12 participants completing the study.
    


Intervention name(s): PF-06826647; Oral Contraceptive (OC)
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg tablet; OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oral contraceptive; Drug-Drug Interaction (DDI); PF-06826647