bioihbjkbjnl/mcl2 huggingface dataset:
Riluzole in Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

        -  The primary objective of the study is to establish that riluzole slows down (1) the
           decrease in total functional capacity (TFC), (2) the increase of the motor score of the
           Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a
           combined score of these.

      Secondary objectives:

      Secondary objectives are to assess

        -  changes in the other UHDRS subscales

        -  the number of patients who need antichoreic treatment and the time until this treatment
           has to be initiated

        -  the safety/tolerability of riluzole in Huntington patients
    


Intervention name(s): Riluzole
Intervention type(s): Drug
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Dose Study of BMS-820836
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of BMS-820836 after
      single doses
    


Intervention name(s): BMS-820836; BMS-820836; BMS-820836; BMS-820836; BMS-820836; BMS-820836; BMS-820836; BMS-820836; BMS-820836; Placebo; BMS-820836; BMS-820836
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral Solution, Oral, 0.025 mg, single dose, one dose; Oral Solution, Oral, 0.1 mg, single dose, one dose; Oral Solution, Oral, 0.25 mg, single dose, one dose; Oral Solution, Oral, 0.5 mg, single dose, one dose; Oral Solution, Oral, 1 mg, single dose, one dose; Oral Solution, Oral, 2 mg, single dose, one dose; Oral Solution, Oral, 3 mg, single dose, one dose; Oral Solution, Oral, 5 mg, single dose, one dose; Oral Solution, Oral, 8 mg, single dose, one dose; Oral Solution, Oral, 0 mg, single dose, one dose; Oral Solution, Oral, 3 mg, single dose, one dose; Oral Solution, Oral, 0.5 mg, single dose, one dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Two Way Crossover Closed Loop Study R-AP vs MPC
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      An artificial pancreas (AP) is a control system for automatic insulin delivery. The
      investigators have implemented a missed meal bolus detection algorithm for use within an AP
      control system. The robust R-AP system used in this protocol has been designed to handle a
      variety of real-world scenarios that are critical to a high-risk patient population. The
      investigators will test how well the new algorithm handles missed or inaccurate meal
      announcements. This type of algorithm may significantly improve glucose control over the
      standard model predictive control (MPC) closed-loop algorithm without these new algorithm
      features for patients with type 1 diabetes.
    

Detailed description: 
      Participants will undergo two visits at Oregon Health and Science University (OHSU) that will
      evaluate missed meal bolus detection. Participants will arrive at approximately 7am for all
      visits, be monitored through the afternoon and discharged before dinner. During each of these
      intervention visits, participants will wear an Omnipod to deliver insulin and a Dexcom G6
      Continuous Glucose Monitoring System (CGM) to measure glucose. The closed loop system will
      receive activity data through a Polar M600 watch worn by the participant. The studies will
      test the ability of the system to adapt to a missed meal bolus. Participants will eat self
      selected meals at 10 am and 2pm, both meals with a missed bolus, and these meals will be
      repeated across both study arms. For one missed meal bolus study, glucose will be controlled
      using the Robust R-AP closed-loop mode. During the other missed meal bolus study, glucose
      will be controlled using the MPC closed-loop mode. Participants will complete frequent
      glucose and ketone checks for safety.
    

Intervention name(s): MPC AP algorithm; Robust R-AP algorithm
Intervention type(s): Device; Device
Intervention description(s): The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal inputs. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure. The metabolic expenditure then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM.; The R-AP is a modified MPC algorithm. A new feature in the algorithm includes a model for missed meal insulin detection. The model includes estimations for carbohydrate consumption based glucose patterns to determine if that person has consumed a meal without announcing it to the system.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucose sensor; automated insulin delivery systems
Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber
      laminectomy under general anesthesia were included in this randomized controlled double-blind
      study. Patients were randomly divided into 3 groups 25 each, C group patients received
      transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of
      postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative
      monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory
      depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours
      postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding
      and plasma cortisol (µg / dl) postoperatively were also assessed.
    


Intervention name(s): Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl; Melatonin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was designed to be a randomized, placebo-controlled, double-blind parallel study
        in which the patients, investigators, anesthesiologists and the surgeons were blinded to
        the given treatment. This study was conducted in Ain-Shams university hospitals, from March
        2013 to April 2015 on 75 patients aged between 18 and 50 years old of both sex of ASA
        physical status I and II of 70-90 kg body weight and height 160-180 cm undergoing elective
        single level lumber laminectomy under general anesthesia. The study protocol was approved
        from the institutional ethical committee and written informed consent was obtained from all
        the patients.
      
Keywords: Transdermal fentanyl; Transdermal melatonin; Postoperative pain; lumber laminectomy; Relief
Dose Response to Recombinant Factor VIIa When Administered for Bleed
Condition: Congenital Bleeding Disorder; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The purpose of this trial is
      to investigate the dose response to recombinant factor VIIa in healthy volunteers when
      administered for bleed.
    


Intervention name(s): activated recombinant human factor VII
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rFVIIa; Punch Biopsy; Dose Response; Healthy People Programs
A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )
Condition: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      This is a five year, post-marketing observational study to follow-up patients with rheumatoid
      arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA
      (adalimumab).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Rheumatologists
      
Keywords: Multicenter study
Pea Protein and Postprandial Response (PEA)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The main objective is to investigate the postprandial effect of arginine-rich protein (i.e.
      pea-protein) on metabolic control, inflammation and endothelial function after a high-fat
      meal in subjects with characteristics of the metabolic syndrome.
    

Detailed description: 
      Arginine is potential interesting considering the metabolic syndrome. Studies so far
      indicated both long-term effects, as well as acute - postprandial - actions; especially when
      metabolism is already challenged, e.g. in diabetic patients or after a high-fat meal. If
      arginine-rich proteins are equally effective is not known. Therefore we are interested in the
      effect of (arginine rich) protein on postprandial (dys)metabolism, inflammation and
      endothelial function, within 6 hours after a meal.
    

Intervention name(s): High-fat shake with Pea protein; High-fat shake with Pea protein hydrolysate; High-fat shake - Control; High-fat shake with Gluten protein; High-fat shake with Gluten protein hydrolysate
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Shake containing 95 gram of fat, additive 30 gram pea protein; Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate; Shake containing 95 gram of fat, no protein additive; Shake containing 95 gram of fat, additive 30 gram gluten protein.; Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate
Other intervention name(s): Experimental; Experimental; Control; Experimental; Experimental
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Ultrasound Guided Bilateral Erector Spinae Plane Block in Caesarean Delivery
Condition: Pain
Study type: Interventional

Summary: 
      Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years
      ago. Its use for many indications has been identified by case reports in the literature. As
      the investigators have considered that ESPB could be efficacious for providing postoperative
      analgesia in the cesarean section, the investigators have implemented the application of this
      blockade into practice at the clinic. The main purpose of this study is to evaluate the
      analgesic effect of ultrasound-guided bilateral low thoracic ESPB in cesarean section.
    


Intervention name(s): erector spinae plane block
Intervention type(s): Other
Intervention description(s): Erector espine plane block will be administrated bilaterally to this group at low thoracic level (Th11).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Virtual Reality Glasses on Pain and Anxiety
Condition: Pain and Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In recent studies using virtual reality has been proposed as a non pharmacological methods
      for pain relief but until this time , its effects has not been assessed on pain and anxiety
      during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain
      and anxiety in Primiparity women during episiotomy repair.
    


Intervention name(s): Virtual reality glasses and Lidocaine; Lidocaine
Intervention type(s): Device; Drug
Intervention description(s): The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.; The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
Condition: Drug Safety; Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the range of single inhaled doses of a new dry
      powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects
      on pulmonary function and determination of blood levels of MDT-637 following inhalation.
    


Intervention name(s): MDT-637
Intervention type(s): Drug
Intervention description(s): Inhaled doses of MDT-637 over a 24 hour period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSV
Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a randomised, controlled, double blinded study comparing in the postoperative setting
      the analgesic efficacy, the safety and the cost in two groups of patients receiving in the
      postanesthesia care unit either intravenous morphine titration alone or intravenous morphine
      titration combined to ketamine.
    

Detailed description: 
      Randomised, controlled, double blinded study comparing in the postoperative setting the
      analgesic efficacy, the safety and the cost in two groups of patients receiving in the
      postanesthesia care unit either intravenous morphine titration alone or intravenous morphine
      titration combined to ketamine
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): intravenous morphine titration combined to ketamine
Other intervention name(s): two groups of patients recevieving; in the postanesthesia care unit either; intravenous morphine titration alone; or intravenous morphine titration combined to ketamine
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postoperative; pain; analgesia; morphine; titration; ketamine
Inhibition Metamizole 2020
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical phase I trial had 3 arms: inhibition by fluconazole, inhibition by
      ciprofloxacin and placebo. Subjects were treated for 3 days prior to the study day. The
      intervention was a single dose of 1 gram metamizole. We took blood samples at set time points
      and analysed the concentration of the main metabolites of metamizole at each time point in
      plasma.
    

Detailed description: 
      While the clinical pharmacokinetics of metamizole have been described in detail before, the
      enzymes responsible for the metabolism have not been identified yet (except for the
      acetylation of 4-aminoantipyrine). Former investigations delivered mixed results and the
      question of the participation of the hepatic cytochrome p450 enzymes could not been answered.

      Thus, a double-blind randomized cross over clinical phase I study with healthy, male,
      caucasian volunteers was conducted. After giving consent for participation and enrolment, the
      subjects were treated for 3 days with either one inhibitor (either ciprofloxacin, CYP1A2
      inhibitor, or fluconazole, strong CYP2C9 and moderate CYP2C19 and CYP3A4 inhibitor) or
      placebo. The doses were 750 mg ciprofloxacin twice daily for 3 days and in the morning of the
      study day or 400 mg fluconazole loading dose with consecutive 200 mg fluconazole once daily.
      For the study day, the subject were invited to the study center and a venous access was
      placed on the non-dominant arm. The last dose of either inhibitor or placebo was taken 1h
      prior to a single dose of 1000 mg metamizole. Blood samples were drawn at t: 0h, 0.25h, 0.5h,
      0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h. The blood samples were centrifuged, the plasma
      was isolated and frozen at -20°C. All subjects received both inhibitors and placebo
      treatment, attending to a total of 3 study days. Furthermore, the genotype for CYP1A2,
      CYP2B6, CYP2C9, CYP2C19 and CYP2D6 was assessed.

      Plasma samples will be analyzed and the concentrations of the main metabolites of metamizole
      and the inhibitors will be measured. Pharmacokinetic parameters such as maximal
      concentration, half life, time to reach maximal concentration and the area under the curve
      will be assessed and compared.
    

Intervention name(s): Novalgin
Intervention type(s): Drug
Intervention description(s): Single dose of 1000 mg metamizole, 1h after the last inhibitor or placebo intake
Intervention MeSH terms: Dipyrone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over treatment with 3 different sequences
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Metamizole; Inhibition; Cytochrome P450
Procedure Sedation With Dexmedetomidine in Children With Autism Spectrum Disorders During Magnetic Resonance Imaging
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      Autism spectrum disorders (ASD) is a neurodevelopmental disorder and is characterized by
      functional impairment in social communication, restricted interests, and repetitive
      behaviors.The children with ASD has been shown different drug responses from the normal
      population of children. The children with ASD maybe more prone to elevate anxiety and the
      difficult of sedation during MRI scanning.The purpose of this investigation was to compare
      the effectiveness of dexmedetomidine sedation in children with and without ASD undergoing MRI
      scanning.
    

Detailed description: 
      The use of medications in adolescents and young adults with ASD is extremely common. However,
      few data address the effectiveness and harms of medications for procedural sedation in this
      population. It's advisable to be used as a first line medication with alpha-2 agonists for
      procedure sedation. The primary goal of this study was to compare the effectiveness of
      dexmedetomidine sedation, also determine the 50% and 95% effective doses in children with and
      without ASD undergoing MRI scanning.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): participants were randomly allocated to receive sedation with oral midazolam(0.3 mg/kg) combined with 4 doses of intranasal dexmedetomidine(1.0, 1.5, 2.0, 2.5)
Other intervention name(s): intranasal dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing MR scanning at Guangzhou Women and Children Medical Center
      
Keywords: Autism Spectrum Disorder; Dexmedetomidine
A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential effect of Dantonic on the steady-state
      pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety of the
      co-administration of Dantonic and warfarin.
    

Detailed description: 
      Due to a large proportion of patients that could benefit from Dantonic treatment is likely to
      take warfarin concomitantly. And there is no systematic experience of warfarin drug-drug
      interaction between Dantonic and warfarin on humans. It is highly relevant to investigate the
      potential interaction of theses two drugs.

      Primary endpoint:

      •The change in INR with T89 (Day 25) compared with that without T89 (Day 18)

      Secondary endpoints:

        -  The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those
           on Day 24

        -  Safety assessments across all time points
    

Intervention name(s): Warfarin; Dantonic
Intervention type(s): Drug
Intervention description(s): Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week
Other intervention name(s): coumadin
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Warfarin; Dantonic; Pharmacodynamics; Pharmacokinetics; Interaction
Short-term Intervention and Health Trajectories After Mass Trauma
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study has two aims. The first is to understand more of what may be typical health
      trajectories after mass trauma for children and adults and what predicts these trajectories.
      The second is to understand what may be effective early interventions to prevent long-term
      health and psychosocial problems for youth (6-19). Participants are recruited from an
      outreach program implemented after a landslide killed 11 persons and destroyed 33 houses in
      Gjerdrum in Norway. One third of the inhabitants were evacuated. All evacuated are contacted
      and screened for trauma related difficulties. Those who have significant post-trauma
      reactions are offered trauma focused interventions.
    

Detailed description: 
      Two short step-wise interventions are developed for this study as an early intervention after
      mass trauma based on components from TF-CBT to test the relative importance of dosage and the
      sequencing of components.
    

Intervention name(s): TF-CBT-Short
Intervention type(s): Behavioral
Intervention description(s): Participants receive either 4-5 sessions of TF-CBT-Skills or TF-CBT-Narr. If the participant still has significant PTSS they are provided with step two which is the components provided in the arm they did not receive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment