bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in
      the strengths of 1000 mg (part I) and 500 mg (part II)
    


Intervention name(s): Merck Glucophage® high dose; BMS Glucophage® high dose; Merck Glucophage® low dose; BMS Glucophage® low dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Part I: Treatment A; Part I: Treatment B; Part II: Treatment C; Part II: Treatment D
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine
Condition: Cesarean Delivery
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized controlled trial, compared postoperative pain score in patient undergoing
      cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac
      intramuscular injection
    

Detailed description: 
      Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor
      quality of life and required morphine injection to relief pain which had both maternal and
      breastfeeding infancy side effect. So this study compare efficacy of diclofenac and
      bupivacaine by measured the pain score and requirement of morphine injection.
    

Intervention name(s): Bupivacaine; Diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): 0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration; diclofenac 75 mg intramuscular, 2 hours postoperation
Intervention MeSH terms: Diclofenac; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to investigate, whether Sugammadex improves muscle function after
      standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.
    

Detailed description: 
      Muscle relaxants are an integral part of today's anesthesia. They improve intubating
      conditions and reduce doses of other substances needed for general anesthesia. For ensuring
      patient safety, neuromuscular function is monitored during general anesthesia. The latter one
      is only terminated, when neuromuscular monitoring shows an objective normal value. Despite
      this accurate surveillance, a lot of patients complain about subjectively uncomfortable
      muscle weakness in the recovery room. A possible explanation for this ostensive contradiction
      can be the variable "margin of safety" of neuromuscluar transmission in different muscle
      groups. Waud et al describe this phenomenon, as the fact, that neuromuscular transmission is
      only clinically detectable, when a certain number of post-synaptic receptors is not blocked.
      The necessary fraction of free receptors differs a lot between the muscle groups (15-50%). As
      neuromuscular monitoring only measures one muscle group exemplarily, and a clinically
      non-detectable number of post-synaptic receptors can be blocked shortly after anesthesia, the
      subjective muscle weakness of patients could need treatment.

      Sugammadex can encapsulate steroid-typ muscle relaxants within 2 to 5 minutes. After applying
      a sufficiently high dose, also those receptors will be free that elude neuromuscular
      monitoring. This constellation brings up the interesting problem to quantify the possible
      effect on patients' subjective muscle weakness.

      This study is designed to investigate, if the application of sugammadex improves muscle
      function and consequently well-being of patients, that have been extubated according to
      clinical standard.
    

Intervention name(s): Sugammadex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex (single intravenous injection 0.25 mg/kg); Placebo: single intravenous injection Saline 0.9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Condition: Hypogonadotropic Hypogonadism; Prolactinoma
MeSH terms: Prolactinoma; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes.
      Clomiphene citrate is a well known selective estrogen receptor modulator that increases
      gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open
      label clinical trial of CC to evaluate its effects in reverting persistent HH in male
      patients with prolactinomas under dopaminergic agonist treatment.
    


Intervention name(s): Clomiphene citrate
Intervention type(s): Drug
Intervention description(s): Clomiphene 50 mg/day for 12 weeks
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Hypogonadotropic hypogonadism; Prolactinoma
Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional

Summary: 
      A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive
      mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease
      the number of days they require invasive mechanical ventilation.
    

Detailed description: 
      Patients in intensive care units (ICUs) as a result of injuries resulting from penetrating or
      non-penetrating trauma who are intubated and receiving invasive mechanical ventilation will
      be randomized to either usual care or usual care with the addition of sigh breaths given once
      every 6 minutes. Patients will be randomized to one of the two study arms as soon as
      possible, but not longer than 24 hours after initiation of invasive mechanical ventilation.
      Patients will be followed for 28 days to assess ventilator-free days (VFDs), mortality,
      ICU-free days, and the occurrence of complications.
    

Intervention name(s): Sigh breaths
Intervention type(s): Other
Intervention description(s): Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ARDS; Shock Lung; Acute Chest Syndrome; Respiratory Distress Syndrome, Adult; Respiratory insufficiency; Trauma
A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of trametinib once daily on the
      pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone
      (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib
      and its metabolite M5 will also be assessed.
    


Intervention name(s): Trametinib; Trametinib; Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each tablet is 2mg trametinib to be taken orally once daily.; Each tablet is 0.5mg trametinib to be taken orally once daily. 0.5mg tablets may be used if a dose reduction is required.; Combined oral contraceptive to be taken orally once daily.
Intervention MeSH terms: Trametinib; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Contraceptive Agents; Contraceptives, Oral; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intra-articular Pulsed Radiofrequency in Chronic Knee Pain
Condition: Osteoarthritis, Knee; Osteoarthritis; Pain, Chronic
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate the additional effect of Intra-articular Pulsed
      Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular
      steroids in patients with grade II and III knee osteoarthritis.
    

Detailed description: 
      This randomized controlled trial included patients over 18 years of age with knee pain
      persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence
      scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group
      1) and only steroid injection (Group 2) groups. The injections were administered under
      fluoroscopic guidance in both groups, and the needle was advanced to the midline of the
      tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of
      intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the
      temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only.
      Pain intensity and participation in daily activities were evaluated using the numerical
      rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC),
      respectively, before the procedure and 1, 4, and 12 weeks after the procedure.
    

Intervention name(s): Intra-articular Pulsed Radiofrequency; Steroid Injection
Intervention type(s): Procedure; Drug
Intervention description(s): A 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C.; 8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, single-blinded, randomized prospective trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: intra-articular pulsed radiofrequency; knee osteoarthritis; intra-articular steroid injection
Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional

Summary: 
      Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of
      non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of
      cluster headache. The study compares the safety and effectiveness of an active treatment
      (GammaCore) against a sham treatment.
    

Detailed description: 
      Phase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double
      blinded, sham controlled treatment (active or sham) phase

      Phase 2: Prospective, non-randomized, active treatment phase.

      Phase 1 - Two Arms:

        1. Active Treatment with the GammaCore Device

        2. Sham Treatment with a placebo device

      Phase 2 - One Arm:

      Active Treatment with the GammaCore Device
    

Intervention name(s): GammaCore; Sham GammaCore device
Intervention type(s): Device; Device
Intervention description(s): Treatment with active gammacore vagus nerve stimulator; Treatment with sham stimulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cluster Headache; GammaCore; vagal nerve stimulation; nVNS; VNS; non invasive; vagus nerve stimulation
e-Nose and Colorectal Cancer
Condition: Colorectal Cancer; Polyps
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is the third most common new cancer diagnosis and a major cause of
      morbidity and mortality throughout the world. Early detection and treatment are critical
      factors in the course and prognosis of CRC, and screening programs have proven to be an
      important means to reduce both CRC related mortality and secondary economic burden.

      The diagnostic accuracy of non-invasive screening tests is still limited and a follow-up
      colonoscopy is required for confirmation of the diagnosis. The faecal occult blood test (FIT)
      is the most commonly used fecal screening test worldwide, but sensitivity for CRC ranges
      between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced
      adenomas is disturbingly low (39%-57%).

      The aim of this study is to evaluate the diagnostic accuracy of the AeonoseTM to distuinguish
      people with CRC from healthy controls.
    

Detailed description: 
      Rationale: An electronic nose (eNose) is an artificial olfactory system that analyses volate
      organic compounds (VOCs) in exhaled breath. Exhaled human breath is mainly composed of
      inorganic compounds, inert gases and VOCs. VOCs are exhaled in very low concentrations and
      reflect pathological processes such as inflammation, oxidation, infection and neoplasms. The
      perspective is that metabolic and biochemical processes in several pathological situations
      cause different endogenous VOCs to arise, were they can serve as non-invasive biomarkers for
      certain diseases.

      Primary objective: To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the
      breathing pattern from patients with colorectal cancer from healthy controls using the
      previously established breathing pattern.

      Secondary objecitves:

        -  To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing
           pattern from patients with polyps (e.g. advanced adenomas, sessile serrated lesions).

        -  To determine the influence of colonic cleansing (laxative use) on breathing patterns.

      Study population: Adult patients referred for colonoscopy.

      Estimated sample size: 66 patients with CRC.

      Intervention: Participants will be asked to breath through the AeonoseTM for 5 minutes. There
      are no risks, nor benefits for the participants.
    

Intervention name(s): AeonoseTM
Intervention type(s): Device
Intervention description(s): Breath test
Intervention model: Single Group Assignment
Intervention model description: This is a Multi center prospective cohort study in subjects eligible for colonoscopy with suspicion for malignant or premalignant lesions of the colon.
Masking: None (Open Label)
Primary purpose: Diagnostic
The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects
Condition: Health
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label study evaluating the pharmacokinetics, tolerability
      and safety of single dose oral brexpiprazole tablets in healthy Chinese subjects. A total of
      30 healthy adult subjects are to be enrolled into the study. Three dose groups will be set
      up, with about 10 subjects in each dose group. Subjects will enter 1 mg, 2 mg and 4 mg dose
      groups in sequence.
    

Detailed description: 
      A total of 30 healthy adult subjects are to be enrolled into the study. Three dose groups
      will be set up, with about 10 subjects in each dose group. Subjects will enter 1 mg, 2 mg and
      4 mg dose groups in sequence.

      After the clinical trial responsible physicians obtain the informed consent forms from
      subjects, the subjects will be screened 14 days to 1 days prior to taking the study drug
      (D-14~D-1).

      One day prior to dosing in each group (D-1), the included subjects are hospitalized On the
      next day (D1), after completed the hospitalization inspection, eligible subjects will be
      assigned subject numbers to start with the first dose, complete corresponding examination,
      stay in hospital for observation and be discharged on Day 4 of medication. On days 6, 8, 10,
      12 blood samples are collected and safety evaluation will be performed. Telephone follow-up
      will be performed on day Day31.

      Blood samples are collected to determine and evaluate blood concentrations of Brexpiprazole
      and its main metabolite DM-3411 before dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,
      96, 120, 168, 216, 264 hours after dosing, with 18 sampling points in total.
    

Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Brexpiprazole , single/oral/with fasting
Other intervention name(s): Brex
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder
Condition: Bulimia Nervosa; Body Dysmorphic Disorder
MeSH terms: Bulimia; Bulimia Nervosa; Body Dysmorphic Disorders
Study type: Interventional

Summary: 
      The primary objective of this 13-week clinical trial is to test the hypothesis that treatment
      with Memantine will significantly improve the symptoms of those suffering from either bulimia
      nervosa, purging type or suffering from body dysmorphic disorder.
    

Detailed description: 
      The primary objective of this clinical trial is to test the hypothesis that treatment with
      Memantine, an anti-glutamatergic drug, will significantly improve the core symptoms of those
      suffering from either bulimia nervosa, purging type or suffering from body dysmorphic
      disorder.

      We will test this hypothesis by performing a 13-week open label study investigating the use
      of memantine, at a dose of 10-40mg daily, as a treatment for patients with either bulimia
      nervosa or body dysmorphic disorder. Improvement for patients with bulimia nervosa will be
      assessed using the Frequency of binge eating and vomiting as recorded in diary card, Eating
      Disorder Evaluation (EDE), and the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS).
      Improvement for patients with body dysmorphic disorder will be assessed using the the
      Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS) and Brown Assessments of Beliefs Scale.
      In addition both groups will also receive the Clinical Global Impression (CGI) Severity and
      Improvement Scales (clinician rated), Patient Global Impression of Improvement
      (PGI-Improvement), Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating
      Scale (HAM-A), Barratt Impulsiveness Scale (BIS), Version 11, Sheehan Disability Scale (SDS),
      and Columbia Suicide Severity Rating Scale (C-SSRS).
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): Drug: Memantine, 10-40 mg daily
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bulimia nervosa; Bulimia; Body dysmorphic disorder; Eating disorders; Body image; Binge eating; purging
A Food Effect Study of JAB-21822 in Healthy Subjects
Condition: Food Effect in Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effect of food in healthy
      participants on the bioavailability of JAB-21822 following single dose administration with
      and without a meal
    

Detailed description: 
      This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of
      each period, subjects will receive a single oral dose of JAB-21822 administered either under
      fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for
      JAB-21822 will be collected predose and postdose. There will be a washout period between
      doses.
    

Intervention name(s): JAB-21822; JAB-21822
Intervention type(s): Drug; Drug
Intervention description(s): 2 discrete single doses; 2 discrete single doses
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
Masking: None (Open Label)
Primary purpose: Treatment
Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a phase I, single centre, randomised, double blind, double-dummy, placebo
      controlled, parallel group single-dose study in healthy volunteers. The purpose of this study
      is to assess the effect of a single-dose administration of GSK424887, a potent, selective
      competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the
      human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus
      citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and
      safety following oral administration of GSK424887 will be also evaluated. An Emotional Test
      Battery (ETB) previously used to characterise the effects of antidepressants on positive and
      negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise
      that GSK424887 will modulate emotional information processing acutely. We anticipate that
      these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy,
      thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms
      in humans.
    


Intervention name(s): Citalopram; GSK424887; Plactebo To Match
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Neurophysiological testing.; Neurophysiological testing; Neurophysiological testing
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers; Anxiety Disorder; neuropsychological tests