bioihbjkbjnl/mcl2 huggingface dataset:
Single and Multiple Dose Study of VER-01 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of pharmacokinetics, tolerability and safety of VER-01 in healthy volunteers
    

Detailed description: 
      Determination of the single and multiple dose pharmacokinetic profile of VER-01 in healthy
      volunteers.

      Single dose: 6 subjects each will receive VER-01 corresponding to 2.5 mg (Group A), 5 mg
      (Group B), 10 mg (Group C) or 20 mg THC (Group D) in the morning.

      Multiple dose: 6 Subjects each receive VER-01 corresponding to 5 mg (Group E) or 10 mg (Group
      F) THC in the morning and in the evening on 4 consecutive days. A third group (Group G)
      receives VER-01 corresponding to 12.5 mg THC in the morning and 20 mg THC in the evening on 4
      consecutive days.
    

Intervention name(s): VER-01
Intervention type(s): Drug
Intervention description(s): standardised cannabis extract (containing 21 mg THC per gram drug product)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: THC; Tetrahydrocannabinol; Cannabis; Pharmacokinetics
The Acute Effects of Different Stretching Techniques
Condition: Muscle Stretching Exercises; Hamstring Muscles
Study type: Interventional

Summary: 
      The flexibility of the hamstring muscles is very important and many stretching methods are
      applied on the hamstring muscles for reducing muscle resistance on movement. The objective of
      this study was to investigate the acute effects of static stretching and the Mulligan
      traction straight leg raise (TSLR) technique administered to the hamstring muscles on
      reducing its resistance to movement by using ultrasound elastography in healthy individuals.
    

Detailed description: 
      The study will be included 22 healthy male volunteers. Static stretching will be administered
      to the hamstring muscles in the first group and the Mulligan TSLR technique will be
      administered on the same muscle in the second group. Active knee extension angles of the
      individuals will be evaluated by a digital goniometer and muscle elasticity will be assessed
      by ultrasound elastography.

      Acute effects of Mulligan TSLR on reducing muscle resistance to movement will be evaluated by
      ultrasound elastography for the first time in this study. In our study, it was planned to
      examine the acute effects of static stretching and Mulligan TSLR techniques on reducing
      muscle resistance to movement by ultrasound elastography in healthy individuals with
      hamstring shortness.
    

Intervention name(s): Static stretching; Mulligan TSLR technique
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 15 seconds of rest with 10 repetitions, and the individuals will be asked to participate in the exercise actively.; Mulligan TSLR will be applied by a physiotherapist in 3 repetitions with the patient in the supine position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hamstrings; Stretching exercises; Ultrasound elastography
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in
      bipolar 1 disorder patients.
    

Detailed description: 
      This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2
      dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study
      drug in a 24-hour period, depending on their clinical status. The primary endpoint is the
      change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component
      (also known as PEC) score, performed at 2 hours after the first dose.
    

Intervention name(s): Inhaled Placebo; Inhaled loxapine 5 mg; Inhaled loxapine 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled loxapine Placebo, may repeat after 2 hours x 2; Inhaled Staccato loxapine 5 mg, may repeat after 2 hours x 2; Inhaled Staccato loxapine 10 mg, may repeat after 2 hours x 2
Other intervention name(s): Staccato Placebo; ADASUVE 5 mg; ADASUVE 10 mg
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar 1 disorder,; agitation,; acute,; treatment
A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception
Condition: Contraceptive Usage
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a
      single 20 mg dose of levonorgestrel butanoate (LB).
    

Detailed description: 
      This is a Phase I single center, open-label, single dose pharmacokinetic and pharmacodynamic
      study of an injectable formulation of levonorgestrel butanoate (LB) jointly developed by the
      National Institute of Child Health and Human Development (NICHD) and CONRAD, and manufactured
      by Coldstream Laboratories, Inc. Healthy normal weight and obese women will be followed as
      outpatients for up to eight months. During this study, subjects will undergo a screening
      cycle to confirm normal ovulatory function, and then receive active treatment with a single
      injection of LB. They will undergo frequent evaluations to obtain serum samples to evaluate
      drug levels and ovulatory function, as well as transvaginal ultrasound and cervical mucus
      evaluation at selected visits. Follow up will continue until normal ovulatory cycles resume.
      Based upon detailed studies in non-human primates, it is expected that most subjects will
      resume menstrual cyclicity within 12- 26 weeks following the injection. Subjects will
      continue to be followed for one normal cycle after return of menses. This study will be
      conducted by the NICHD at one of the Contraceptive Clinical Trials Network (CCTN) sites
      (Oregon Health & Science University, (OHSU)) in the USA and will enroll approximately 16
      women.

      This study will enroll approximately 16 subjects that demonstrate favorable cervical mucus
      and normal ovulatory function during a baseline cycle. Enrollment will be stratified to
      ensure that 50% of the subjects have a BMI >32 kg/m2 and <40 kg/m2 and approximately 50% of
      subjects have a BMI <32 kg/m2.
    

Intervention name(s): levonorgestrel butanoate
Intervention type(s): Biological
Intervention MeSH terms: Levonorgestrel; Levonorgestrel butanoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a
      single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed
      conditions in healthy Japanese adult male participants.
    

Detailed description: 
      This is a single center, open-label (all study staff and participants will know the identity
      of the treatment assigned), single dose study in healthy Japanese adult male participants.
      The study consists of 3 phases: a screening phase up to 26 days; an inpatient phase from Day
      -2 to Day 8; and a follow-up assessment phase that occurs on Day 15 (± 2 days) or at the time
      of the participant's early withdrawal from the study. Participants who meet the selection
      criteria will be admitted to the investigational institute on two days before the dose (Day
      -2). All enrolled participants will receive orally (by mouth) a single dose of one TMC278 25
      mg tablet on Day 1 within 10 minutes after completion of the standardized breakfast. Enrolled
      participants will remain in the investigational institute for the entire duration of the
      inpatient phase. Participants will be discharged on Day 8 after the completion of all
      required assessments. Blood samples for determination of plasma concentrations of TMC278 will
      be collected over a period of 168 hours (7 days). The maximum study duration for each
      participant is 45 days, including the screening phase, in-patient period, and follow-up
      visit.
    

Intervention name(s): TMC278
Intervention type(s): Drug
Intervention description(s): 1 25-mg tablet [27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1.
Intervention MeSH terms: Rilpivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pharmacokinetics; Japanese
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and blood levels of
      AZD9742 after daily dosing for 14 days.
    


Intervention name(s): AZD9742; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion, 15 days; IV infusion, 15 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety
Morphine-Midazolam in Pre-hospital Traumatic Patients With Severe Acute Pain
Condition: Acute Traumatic Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Administration of midazolam with morphine in patients with severe acute pain is a routine
      practice in the management of pre- and post-operative patients but has not been evaluated in
      pre-hospital setting. The investigators aim to evaluate the co-analgesic effect of midazolam
      in the pre-hospital management of traumatic patients with severe acute pain.

      In a multicenter prospective randomized double-blind placebo-controlled trial, the
      investigators would like to compare the analgesic effect and safety of the intravenous
      morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and
      placebo in pre-hospital traumatic adults. Assessment will be done at the baseline using a
      validated numeric rating scale (NRS).

      The primary outcome will be the proportion of patients with a pain score less than or equal
      to 3 after 20 minutes. The secondary outcomes will be in between-group comparison of: the
      treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose
      required until obtaining a pain score less than or equal to 3.
    

Detailed description: 
      Patient will be included in pre-hospital setting. They must have an acute pain NRS greater
      than or equal to 6 from a traumatic origin. The participation of the study for each patient
      will be the time of the pre-hospital setting. The study will stop when the patient arrives at
      the hospital.

      Patient will be randomized after obtaining an informed consent. Then, the nurse will
      administered intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg or intravenous morphine
      0.10 mg/kg and placebo.

      Only the nurse will be aware of the treatment received by the patient. Every 5 minutes, life
      constants and pain score will be recorded on the case report form.

      Assessment will be done at the baseline using a validated numeric rating scale. The primary
      outcome will be the proportion of patients with a pain score less than or equal to 3 after 20
      minutes. The secondary outcomes will be in between-group comparison of: the treatment safety,
      pain score every 5 minutes during 30 minutes and the total morphine dose required until
      obtaining a pain score less than or equal to 3.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
Other intervention name(s): Midazolam (hypnovel)
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute traumatic pain, pre-hospital setting, Midazolam
Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes
Condition: Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female
      population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic
      distress. However, there is no such research for the new drug- mirabegron (a β3-agonist).
      Thus, the aim of our study is to analyze the between-group differences in heart rate
      variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic
      distress, personality trait, family support and clinical outcomes between the mirabegron and
      the solifenacin groups.

      Patients and Methods: The investigators will perform a prospective randomized controlled
      study to recruit 150 female OAB patients at the outpatient clinic of Department of Obstetrics
      and Gynecology of National Taiwan University Hospital. All OAB female patients will be asked
      to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires,
      King's Health questionnaires, UDI-6 & IIQ-7, Patient Health Questionnaire, brief symptom
      rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability, partnership,
      growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit Questionnaire,
      standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring, cardio-ankle
      vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies and
      measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron
      versus solifenacin treatment. STATA software is used for statistical analyses.

      Possible Results: The investigators can answer that the between-group differences in heart
      rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic
      distress, personality trait, family support and clinical outcomes between the mirabegron and
      the solifenacin groups. The above conclusions should be important for pre-treatment
      consultation.
    


Intervention name(s): solifenacin; mirabegron
Intervention type(s): Drug; Drug
Intervention description(s): solifenacin 5 mg per day for 12 weeks; mirabegron 25 mg per day for 12 weeks
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cortical Cerebellar Infarctions Associated With Patent Foramen Ovale in Young Stroke Patients
Condition: Brain Infarction
MeSH terms: Brain Infarction; Foramen Ovale, Patent; Infarction
Study type: Observational

Summary: 
      The investigator retrospectively analyzed consecutive young (<60 years) cryptogenic stroke
      patients with Patient Foramen Ovale (PFO) recruited between January 2016 and May 2019 in our
      center, and compared these patients with sex- and age-matched controls with cryptogenic
      stroke without PFO. Analyzed baseline characteristics: sex, age, cardiovascular risk factors,
      history of stroke, and cortical/subcortical localization, arterial territory, number of
      lesions, and lesion size of the acute symptomatic infarction, together with the ROPE score.
      The presence and the number of acute and chronic SCCI lesions were assessed.
    


Intervention name(s): MRI scanner; Contrast transoesophageal echocardiography
Intervention type(s): Other; Other
Intervention description(s): MRI was performed with a 1.5T magnet (Ingenia, Philips, The Netherlands; diffusion-weighted imaging b-values = 0 and 1,000 s/mm2, TR 4,280 ms, and TE 97 ms). In case of technical problems with the 1.5T MRI scanner, a 3T magnet (Skyra, Siemens, Erlangen, Germany) was used. MRI was analyzed by an experienced rater (DR), blinded to clinical data and MRI sequences other than diffusion-weighted imaging.; Contrast transoesophageal echocardiography (including Valsalva manoeuvre)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive young (<60 years) cryptogenic stroke patients with PFO recruited between
        January 2016 and May 2019 in our center, and compared these patients with sex- and
        age-matched controls with cryptogenic stroke without PFO.
FR01 and FR20 IUS (Intrauterine System) Wearing Study
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01
      and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and
      pain compared to a placebo T-frame intrauterine system.
    


Intervention name(s): Placebo: Flexi ring FR01; Placebo: Flexi ring FR20; Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intrauterine device, inserted once for 3 months; Intrauterine device, inserted once for 3 months; Intrauterine device, inserted once for 3 months
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
Condition: Subcutaneous Abdominal Adiposity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction
      of subcutaneous abdominal adiposity.
    


Intervention name(s): LIPO-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subcutaneous Adipose Tissue Reduction
Surgery for Intravenous Leiomyomatosis
Condition: Leiomyomatosis
MeSH terms: Leiomyomatosis
Study type: Observational

Summary: 
      Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle
      tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least
      70 cases. Most are individual case reports. Surgical experience is not much. However,
      different opinion of surgical strategies remain controversial. The purpose of this report is
      to describe our experience of surgical management for the IVL with intracardiac extension.
    

Detailed description: 
      All patients underwent surgical management. Clinical data were obtained from medical reports.
      Following-up was made through email and telephone.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From March 1997 to June 2011, 6 women patients were admitted to our hospital with
        intravenous leiomyomatosis with intracardiac extension.
      
Keywords: Intravenous leiomyomatosis; Surgery; Smooth muscle tumor
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects
      of liraglutide on energy intake in subjects with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo; placebo; glimepiride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.8 mg/day injected subcutaneously for 4 weeks; Liraglutide placebo, injected subcutaneously for 4 weeks; Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks; Dose individually adjusted, administered orally for 4 weeks
Intervention MeSH terms: Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Study type: Interventional

Summary: 
      Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.

      Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches
      to patient treatment, and biochemical, biomechanical and physiological biomarkers in other
      conditions are sensitive in distinguishing between disease state severities, type of injuries
      and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not
      widely used possibly owing to their focus postoperatively where benefits are less worthwhile.

      This study aims to investigate novel biomarkers as performance based investigations (PBIs) to
      improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The
      objectives are to identify whether biomarkers, collected before and after operations, can: 1)
      Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict
      the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further
      understand ACL injuries.
    


Intervention name(s): Surgeons knowledge of pre-operative PBIs
Intervention type(s): Procedure
Intervention description(s): Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anterior cruciate ligament; Performance based investigations
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Condition: Urinary Tract Infection; Vesicoureteral Reflux
MeSH terms: Urinary Tract Infections; Gastroesophageal Reflux; Vesico-Ureteral Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal
      ultrasound.
    


Intervention name(s): Sulfur hexafluoride type-a lipid microspheres
Intervention type(s): Drug
Intervention description(s): Used as a contrast to enhance renal ultrasound
Other intervention name(s): Lumason®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic