bioihbjkbjnl/mcl2 huggingface dataset:
Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.
    

Detailed description: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.
    

Intervention name(s): HCP1104 / Mulex Tab. and Airtal Tab.
Intervention type(s): Drug
Intervention description(s): HCP1104 / Eperisone plus Aceclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCP1104; Eperisone Hydrochloride; Aceclofenac
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
Condition: Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the pharmacokinetic (PK) and
      pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg
      natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis
      (MS) participants. The secondary objectives are to investigate the safety, tolerability and
      PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of
      repeated natalizumab doses administered SC and IM, to explore proof of concept within the
      secondary progressive multiple sclerosis (SPMS) population using change from baseline in
      clinical measures including: expanded disability status scale (EDSS), multiple sclerosis
      functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale
      (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures
      including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1
      hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy,
      magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the
      effect of natalizumab administered IV and SC on brain MRI measures in participants with
      relapsing forms of MS.
    


Intervention name(s): natalizumab; standard of care
Intervention type(s): Drug; Other
Intervention description(s): natalizumab; standard of care as determined by the Investigator and Treating Neurologist
Other intervention name(s): Tysabri ®; BG00002
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: natalizumab; multiple sclerosis; Tysabri ®
MiCo - Mirena or Conventional Medical Treatment for Menorrhagia
Condition: Idiopathic Menorrhagia
MeSH terms: Menorrhagia
Study type: Observational

Summary: 
      The aim of this prospective, non-interventional post-marketing surveillance study is to
      obtain data on safety and efficacy of Mirena in treatment of heavy menstrual bleeding
      (Menorrhagia) under daily-life treatment conditions.For each patient, an initial visit and
      one to three follow-up visits after about 3, 6 and 12 months will be documented by the
      treating physician on the case report form. Observations include the patient's demographic
      parameters (date of birth, height, weight, race and smoking habits), previous contraceptives
      and menorrhagia treatment, gynaecological history, baseline menstruation, result of
      insertion, concomitant medications and diseases as well as menorrhagia symptoms. Overall
      treatment success will be evaluated at the end of treatment including number of weeks until
      improvement and reduction of menstrual bleeding with respect to duration and severity, and
      patient's satisfaction.
    

Detailed description: 
      The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two
      parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).

      Data from both parts will be analysed in separate pools as well as in a global pool. The
      trial alias are IMPACT Nos. 14697 (NCT00864136), 14536.
    

Intervention name(s): Levonorgestrel (Mirena, BAY86-5028); Hormonal treatment; Antifibrinolytic treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Women using Mirena for treatment of menorrhagia; Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens); Antifibrinolytic treatment (such as tranexamic acid)
Intervention MeSH terms: Antifibrinolytic Agents; Levonorgestrel
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care
      
Keywords: Menorrhagia
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient
      study,looking at the clinical treatment of cannabis use disorder.

      The treatment study is a total of 12 weeks. There will be two options offered to participants
      for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after
      discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2)
      patients who cannot complete the inpatient phase due to work or other obligations will
      complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis
      use disorder will be enrolled into either the inpatient/outpatient or only outpatient study.
      This combined design will provide a comprehensive understanding of clonazepam's effects on
      individuals with cannabis use disorder across a range of outcome measures while also testing
      the medication's ability to prevent relapse in cannabis-abstinent patients.
    

Detailed description: 
      Patients seeking treatment for Cannabis Use Disorder (CUD) will be enrolled into an inpatient
      laboratory for 5 nights, where they will be initiated on medication and be assessed for the
      influence of clonazepam (or placebo) on (1) cannabis withdrawal (mood, sleep, cannabis
      craving, food intake), ratings associated with medication abuse liability, cognitive
      performance, and (2) relapse to cannabis use after patients (now abstinent from cannabis)
      leave the inpatient setting maintained on clonazepam (or placebo) for 8 weeks (with a 4-week,
      medication-free follow up). This combined design will provide a comprehensive understanding
      of clonazepam's effects on individuals with cannabis use disorder across a range of outcome
      measures (safety, abuse liability, withdrawal symptoms) while also testing the medication's
      ability to prevent relapse in cannabis-abstinent patients. Patient's who are unable to
      complete the inpatient approach will complete the 12 week trial as an outpatient only.
    

Intervention name(s): Clonazepam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
Other intervention name(s): Klonopin; Matched Placebo
Intervention MeSH terms: Clonazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Marijuana; Treatment
Bioequivalence Study of Klaribact 125mg/5ml, Suspension
Condition: Healthy
Study type: Interventional

Summary: 
      A two way crossover BE study will be performed to evaluate the comparative bioavailability of
      Klaribact (Clarithromycin 125 mg/5ml) suspension (Merck Pvt. Ltd, Pakistan) with Klaricid
      (Clarithromycin 125mg/5ml) suspension (Abbot Laboratories Pakistan Limited) at the clinical
      site (CBSCR), Karachi Pakistan.
    

Detailed description: 
      The Bioequivalence study of Klaribact Suspension will be conducted on 24 healthy
      participants. Finally selected subjects will be divided into two groups, Group A and Group B,
      with 12 subjects in each group. The study will be consisted of two periods, Period I and
      Period II, each comprising of 35 hours, 11 hours before and 24 hours after the drug
      administration. A washout period of 6 days will be provided between the two periods to ensure
      the absence of carry over effect. Each group (A & B) will be treated with either of the two
      sequences, TR or RT, in Period I and the sequence will be inter-changed in Period II. blood
      samples from each volunteer will be collected at specific time points to analyze plasma
      concentration of Clarithromycin.
    

Intervention name(s): Klaribact 125mg/5ml Suspension; Klaricid 125mg/5ml Suspension
Intervention type(s): Drug; Drug
Intervention description(s): one single 20 mL dose (500mg) of the test drug will be administered to the volunteers; one single 20 mL dose (500mg) of the Reference drug will be administered to the volunteers
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An Open Label, Randomized, Two Way Cross Over, Two Period, Two Treatment, Two Sequence Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study; macrolide antibiotic; Bioavailability comparison
Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty
Condition: Anesthesia Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      Mask ventilation has great importance during anesthesia induction because it is the only way
      to oxygenate patients who have lost consciousness and spontaneous breathing. Opioid-derived
      drugs used in anesthesia induction may cause difficulty in mask ventilation due to their
      chest wall rigidity and respiratory depressant effects. Adequate muscle relaxation and depth
      of anesthesia may assist with mask ventilation. It is known that premedication reduces
      anxiety and has a relaxing effect on airway muscles. Midazolam is frequently used in
      premedication because it has a rapid onset of action and does not cause hemodynamic changes.
      In addition, midazolam may relax the airway by acting directly on the airway smooth muscle
      and thus facilitate mask ventilation during anesthesia induction. In this study, the
      investigators will evaluate the effect of midazolam premedication on the mask ventilation
      after induction with remifentanil.
    

Detailed description: 
      American Society of Anesthesiologists (ASA) class I and II patients who are admitted to
      undergoing elective surgery under general anesthesia will be enrolled. Patients in midazolam
      group (Group M) will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg
      midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously in a waiting area 3
      minutes before transportation to an operating room, while 3 cc normal saline will be
      administered to control group (Group S) patients. The difficulty of mask ventilation will be
      evaluated before the injection of neuromuscular blocking during general anesthetic induction.
      The anxiety and sedation levels of patients will be estimated before the intervention and
      before anesthetic induction in an operating room. Remifentanil will be used as an opioid in
      the induction of the patients. In anesthesia induction, propofol 1.5 mg/kg will be given
      after remifentanil is infused at a dose of 0.30 µg/kg/min for three minutes. Before the
      patients were given muscle relaxants, the patients were evaluated with the Warter scale
    

Intervention name(s): Midazolam; Saline
Intervention type(s): Drug; Drug
Intervention description(s): . Patients of the midazolam group will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously a waiting area 3 minutes before transportation to an operating room; Control group patients are treated with 3 cc normal saline in a waiting area 3 minutes before transportation to an operating room
Other intervention name(s): Group M; Group S
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premedication; midazolam; opioids; remifentanil; Anesthesia, General
Brain Imaging Study of F17464
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.
    


Intervention name(s): F17464
Intervention type(s): Drug
Intervention description(s): Single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope
Condition: Hemodynamic Instability; Intubation Complication
Study type: Interventional

Summary: 
      The 50% effective concentration of remifentanil by target controlled infusion was not
      determined for inhibiting the haemodynamic response during double-lumen tube (DLT)
      intubation. Previous study showed that Airtraq videolaryngoscope provided more stable
      haemodynamics than Macintosh for double-lumen tube intubation. In this study, the
      investigators will compare the 50% effective concentration of remifentanil between Airtraq
      videolaryngoscope and Macintosh laryngoscope for inhibiting haemodynamic responses during DLT
      intubation.
    

Detailed description: 
      Dixon "up-and-down" method was used to determine 50% effective concentration of remifentanil
      by target controlled infusion for inhibiting the haemodynamic responses during DLT intubation
      with Airtraq videolaryngoscope or Macintosh laryngoscope.
    

Intervention name(s): Airtraq; Macintosh
Intervention type(s): Device; Device
Intervention description(s): Airtraq is a kind of videolaryngoscope for intubation; Macintosh is a traditional laryngoscope for intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: double-lumen tube intubation; remifentanil; target controlled infusion
Effectiveness of Augmented Reality in the Teaching of Health University Students.
Condition: Education
Study type: Interventional

Summary: 
      The exponential growth of new technologies has meant that the educational field has had to
      update itself. From the educational point of view, there are some studies that have promoted
      the implementation of new technologies. These facts have raised the need to implement
      augmented reality in the university environment, especially among students of health
      sciences. The use of augmented reality can mean a new approach to teaching by teachers and
      better learning by students. Objetive: To compare the degree of usability of the two
      augmented reality applications and to analyse the academic performance of the control group
      and the experimental group at the Universities of Cadiz and Malaga. The existence of
      significant differences and relationships between the two variables will be observed.
    

Detailed description: 
      This research has followed the SPIRIT statement and the ethical and legal aspects of the
      Principles of the Declaration of Helsinki. An intervention was carried out using two
      augmented reality applications in the subject of General Procedures in Physiotherapy II at
      the Universities of Malaga and Cadiz.
    

Intervention name(s): Augmented reality; Control group
Intervention type(s): Other; Other
Intervention description(s): The intervention will be carried out in the Physiotherapy Degree of the Universities of Malaga and Cadiz. It will consist of the use of software and a platform that works with augmented reality. Previously a study of the demographic variable of the population that conforms the study will be carried out. During the intervention, teaching will be carried out with the support and enhancement of the use of augmented reality through Zapworks and Aumentaty. A study and analysis of the variables of the qualifications and usability of the study population will be carried out. For the qualification variable, the academic performance of the students will be taken into account and for the usability variable, the System Usability Scale will be used. Subsequently, an analysis and interpretation will be carried out to assess the correlation between both variables.; Traditional education will be carried out
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Augmented reality; Usability; Competencies
Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal
Condition: Intrauterine Device
Study type: Interventional

Summary: 
      Intrauterine devices are the most common used method of contraception in the world, mostly in
      developing countries, because they offer long-term, reversible and relatively safe
      contraception. At present, 50% of intrauterine devices users are women of reproductive age
      and most of them are requesting Intrauterine device removal to regain their fertility. In
      general, an intrauterine device should be removed during menses or preferably immediate after
      menses because intrauterine device removal is usually easy because the cervix is still soft.

      The intrauterine device is usually removed by firmly grasping the threads at the external os;
      traction should be applied away from the cervix. If resistance is present, the removal should
      be stopped until it is determined why the intrauterine device is not moving. Some deeply
      embedded intrauterine device may need to be removed by hysteroscope [4].

      In practice, many women, however, have an intolerable pain during intrauterine device removal
      and some of them requesting painkiller or even anesthesia to allow the physician to remove
      it. Cervical hardening and adhesions are the major factors making IUD removal difficult
      especially in post-menopausal women.

      Insertion and removal of IUD in nulliparous women is possible but it may carry more pain,
      more difficulty than in parous women. We think that this problem is also present in women has
      no vagina delivery before. So, the intrauterine device removal actually has some difficulty
      or pain in the nulliparous women, women delivered by elective caesarian section or
      postmenopausal women.

      Many medical agents for cervical ripening prior to the removal have been emerged like
      misoprostol. Misoprostol is commonly used for cervical ripening in the first and second
      trimester miscarriage and prior intrauterine devices insertion. The use of vaginal
      misoprostol before intrauterine device insertion in women who had never delivered vaginally
      before may increase the ease and success of insertion with pain felt during the procedure .

      However and up to our knowledge; no studies had been reported the effect of misoprostol on
      removal pain in women delivered only by elective cesarean section.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): the women will be received two tablets of misoprostol 400 mcg vaginally before IUD removal (Misotac®; Sigma Pharma, SAE, Egypt).
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
Condition: Pain
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in
      subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The
      hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381.
      Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing.
      Subjects will be housed from the evening before dosing until 24 hours after dosing. A
      follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.
    


Intervention name(s): GW406381
Intervention type(s): Drug
Intervention description(s): GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic impairment pharmacokinetics
Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
Condition: Stroke; Foot Drop (Acquired)
MeSH terms: Peroneal Neuropathies
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the effectiveness of adopting a home-use Wearable
      Technical Aids (WTA) with the structured Active Living Program (ALP) to promote community
      participation in young stroke patients.
    

Detailed description: 
      Two groups of patients would receive Wearable Technical Aids Training or Wearable Technical
      Aids Training and structured Active Living Program (ALP) for 8 sessions.
    

Intervention name(s): Active Living programme and wearable technical aids; Wearable technical aids
Intervention type(s): Device; Device
Intervention description(s): attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.; apply wearable technical aids for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wearable