bioihbjkbjnl/mcl2 huggingface dataset:
Multimedia Program to Promote Positive Bus Behavior
Condition: Student Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      This project evaluated a multimedia student behavior management program for school bus
      drivers and school administrators.
    

Detailed description: 
      We developed a comprehensive multimedia training program for transportation departments. In
      the Driver's Seat: A Roadmap to Managing Student Behavior on the Bus guides transportation
      departments in creating and maintaining a safe, responsible, and positive environment on the
      bus through drivers' use of effective student behavior management techniques. The program
      teaches skills for the bus context based on the principles of positive behavior supports and
      the foundational work of Sprick and colleagues (Sprick, 1990; Sprick, Garrison, & Howard,
      2002; Sprick, Sprick, & Garrison, 1992). In the Driver's Seat was designed as a stand-alone
      DVD-based training program for school bus drivers of elementary schools, using video examples
      presenting real driver and student interactions on the bus. A computer-based program for
      transportation supervisors supplemented the driver training materials and included
      information for supervisors about developing and maintaining department-wide transportation
      policies, as well as an overview of the bus driver training materials and instructions for
      their use.

      The components of the In the Driver's Seat bus driver training program could be implemented
      by a transportation team without the need of an expert and could be used to train new
      personnel or review and refresh veteran personnel's skills. The DVD-based component was
      designed for use by a transportation supervisor or driver trainer in a group setting with
      drivers and augmented the material presented in the drivers' program.
    

Intervention name(s): In the Drivers Seat; School bus driver training videos
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Multimedia student behavior management program for school bus drivers and school administrators; Basic bus driving safety videos
Other intervention name(s): A Roadmap To Managing Student Behavior On the Bus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: school; bus; school bus; driver; training; behavior; management; interactive; computer
Study With Migraid Device in Acute, Early Treatment of Migraine With Typical Aura
Condition: Migraine With Typical Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional

Summary: 
      The purpose of the study was to assess the efficacy of Migraid in terms of preventing
      headaches in patients with migraine with typical aura. The secondary objectives were to
      assess whether Migraid is able to achieve pain relief and/or relief of migraine associated
      symptoms and to evaluate the safety and tolerability of the study treatment.
    

Detailed description: 
      Migraid is to be used only once during the aura phase of a migraine attack for a duration of
      60 minutes.

      Reference therapy: No treatment. This means that at random the patient will be allocated to
      either of the two treatment orders; the first treatment order is to use the Migraid whenever
      a migraine attack with an aura occurs. During the next migraine attack the Migraid will not
      be used and vice versa for the other group of patients.

      Patients will be asked to complete diary cards to record details for each of the two migraine
      attacks and the severity of the migraine headache at certain points in time: at t = 30
      minutes, t = 60 minutes, t= 90 minutes, t =120 minutes, t =150 minutes, t =180 minutes and t
      = 24 hours.

      Also, associated symptoms will be asked for. Rescue medication data including name, time
      taken and amount will also be registered in the diary card.

      For all primary and secondary variables of efficacy, the following definitions will be used:

      Grade or score: Pain level: Description

      0: None - No pain;

        1. Mild - A headache with no remarkable pain that does not hinder you in performing your
           usual daily activities;

        2. Moderate - A headache with pain that hinders you in performing your usual daily
           activities, but that does necessitate you to go to bed;

        3. Severe - A headache with pain that necessitates you to go to or stay in bed.

      The associated symptoms will be graded as either present or absent. These symptoms are
      defined to conform to the following table:

      Symptom: Description

      Nausea: Sick to the stomach/feel like throwing up; Vomiting: Throwing up or puking;
      Photophobia: Light bothers or hurts the eyes; Phonophobia: Noise bothers or hurts the ears.

      A migraine attack is defined as:

      New onset of migraine pain, preceded by a pain-free period of at least 24-hours duration.
    

Intervention name(s): Migraid
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Migraine; Device; Migraid; Treatment; Aura
Quadratus Lumborum Plain Block Versus Fascia Iliac Block
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      evaluation the efficacy of Quadratus Lumborum plain Block Versus Fascia Iliac Block for
      postoperative pain after hip surgery
    


Intervention name(s): Quadratus Lumborum plain Block; fascia iliaca block; control group
Intervention type(s): Procedure; Procedure; Diagnostic Test
Intervention description(s): ultrasound guided Quadratus Lumborum plain Block using 0.5 ml/kg bupivacaine 0.25% .; ultrasound guided fascia iliaca block using 0.5 ml/kg bupivacaine 0.25%; no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: QLB; Fascia Iliac Block; hip surgery
Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to establish the bioequivalence of two levothyroxine
      formulations through the estimation of T4 levels in serum samples after baseline correction,
      according to Food and Drugs Administration (FDA), World Health Organization (WHO) and
      Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
    

Detailed description: 
      Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in
      lifelong therapy. Its physiologically active metabolite is tri-iodothyronine (T3).
      Levothyroxine is also endogenously produced in the body. Since small changes in levothyroxine
      administration (e.g. change in brand or formulation) can cause significant changes in serum
      thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is
      critical to avoid potential adverse iatrogenic effects. Tecnoquimicas modified its
      Levothyroxine tablets formulation in order to comply with new pharmacopeial specifications.
      It will then evaluate the impact on drug product performance based on pharmacokinetic (PK)
      measures of total serum T4 and total serum T3 of the new formulation of levothyroxine (Test
      formulation) relative to the reference formulation from Merck (Reference formulation)

      This will be a single-center, open-label, two-period, two-treatment, two-sequence,
      randomized, single-dose, crossover study. 80 healthy adults will be randomized to receive a
      single dose (6 x 100 mcg tablets = 600 mcg) of the test formulation of levothyroxine and
      reference formulation of levothyroxine separately in each treatment period. There will be two
      treatment sequences (AB, BA) and a 42 day washout between the two treatment periods.
    

Intervention name(s): Drug Levothyroxine 100 mcg; Drug Eutirox 100 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Administration of a 600 mcg levothyroxine dose; Administration of a 600 mcg levothyroxine dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      The Novel Markers Trial will compare the safety, feasibility and effectiveness of two
      different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either
      a first or second line screen. This study is the next step in a larger research effort to
      develop a blood test that can be used as a screening method for the early detection of
      epithelial ovarian cancer.
    

Detailed description: 
      Epithelial ovarian cancer (EOC) is usually lethal unless it is diagnosed at an early stage,
      thus early detection is likely to play an important role in reducing its mortality. Within
      the Ovarian Specialized Programs of Research Excellence Pacific Ovarian Cancer Research
      Consortium (POCRC) researchers have been working for a decade to discover, develop, and
      validate biomarkers (proteins or substances found in blood) that could help save lives by
      detecting EOC early. During the last five years several biomarkers, including CA125, have
      been evaluated for their ability to detect EOC at an earlier stage. The best markers will now
      be studied in a new randomized controlled trial of ovarian cancer screening.
    

Intervention name(s): CA125 assay on Abbott Architect i1000SR platform; HE4 assay on Architect i1000SR platform; Transvaginal Ultrasound
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Bead-based sandwich ELISA style assay; Bead-based sandwich ELISA style assay; Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.
Other intervention name(s): Abbott Architect CA125 assay; Abbott Architect HE4 assay
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Ovarian Cancer; Screening; Biomarkers
Migraine and Infertility
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The purpose of this study is to determine the prevalence of migraine in infertile women and
      during in Vitro Fertilization protocol. Migraine is two to three times as common in women as
      in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has
      become a common therapeutic modality in modern fertility medicines. Treatment protocols are
      associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely
      linked to migraine and its fluctuations have been considered to trigger migrainous headaches.
    

Detailed description: 
      In Vitro Fertilization has become a common therapeutic modality in modern fertility
      medicines. Treatment protocols are associated with exaggerated hormonal fluctuations.
      Estrogen is considered to be closely linked to migraine and its fluctuations have been
      considered to trigger migrainous headaches.

      Both migraine and infertility are associated with impaired quality of life.

      Objectives: to assess the prevalence of migraine in infertile women and during in Vitro
      Fertilization protocol in order to improve the management of these patients.

      Protocol:

      Women coming to consult at the Port Royal infertility center and meeting the inclusion
      (infertile women without long-term analgesic treatment) criteria will be offered the study.
      The information note and no objection form will be given by the gynecologist receiving them
      for consultation. After collecting their non-opposition, a self-questionnaire will be given
      to them. This questionnaire is validated in the literature concerning the diagnosis of
      migraine. It includes questions about medical history and possible headaches. The patient
      fills it immediately and gives it to the investigator. As part of the usual management, and
      regardless of their answers to the questionnaire, some of the patients will be reviewed in
      consultation for the programming of an IVF. During this "incoming" consultation with one of
      the midwives of the unit, a schedule of migraine headaches will be given to the patients.
      They will keep it, will complete it in case of migraine, and will give it to the gynecologist
      during the embryo transfer or the doctor receiving the couple in consultation on day 7 in
      case of absence of embryo transfer.
    

Intervention name(s): self-questionnaires
Intervention type(s): Other
Intervention description(s): After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Unit of assisted reproductive medicine in a University hospital
      
Keywords: migraine; in vitro fertilization; infertility
Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Condition: Typhoid Fever
MeSH terms: Typhoid Fever; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine
      in healthy adult subjects.
    


Intervention name(s): Ty800 (Salmonella typhi) Oral Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prevention of Typhoid Fever in Adult Travelers
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Condition: Acute Respiratory Distress Syndrome; COVID-19
MeSH terms: COVID-19; Ganglion Cysts; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate
      Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome
      (ARDS) due to COVID-19 infection.
    

Detailed description: 
      Primary Aim:

      • To determine safety of stellate ganglion block (SGB) in ARDS

      Secondary Aim:

        -  To determine efficacy of SGB in slowing the progression of ARDS
    

Intervention name(s): Stellate Ganglion Block
Intervention type(s): Procedure
Intervention description(s): The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Respiratory Distress Syndrome; COVID-19; Autonomic Nervous System; Stellate Ganglion
E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)
Condition: Depression; Anxiety; Infertility
MeSH terms: Infertility; Depression
Study type: Interventional

Summary: 
      Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with
      a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has
      relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk
      profile has been identified and translated into a screening tool. Identification of women at
      risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT),
      which reduces more serious maladjustment and corresponding costs.

      Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in
      women ongoing IVF and having been screened at risk.

      Design: A single-centered randomised controlled trial comparing Digicoach (intervention) with
      standard care (control).

      Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following
      a woman's IVF course and covering in modules the main problems: depressed mood, anxiety,
      strong focus on child wish and acceptance.

      Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful
      IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3.
      productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical
      record audit and page view registrations.

      Process evaluation: Individual's use (e.g. module progress, completion rate), experiences,
      (e.g. satisfaction and usability) and potential barriers for implementation are evaluated.

      Economic evaluation: studied during the Digicoach exposures from a societal perspective.
      Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both
      study groups.

      Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates
      (alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.
    


Intervention name(s): Digicoach
Intervention type(s): Behavioral
Intervention description(s): Digicoach is an e-health cognitive behavioral therapy with 4-12 weekly sessions especially developed for IVF women. Digicoach is facilitated by an e-therapist. The investment for the weekly home work assignments is about one and a half hour. Digicoach consist of different modules (e.g. stress reduction, acceptance). Digicoach starts before the hormonal down regulation as the start of the IVF procedure and ends three weeks after the pregnancy test.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: in vitro fertilization; e-health; cognitive behavioral therapy; psychosocial risk profile; emotional maladjustment
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19; Pneumonia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients
      infected by 2019-nCoA.
    

Detailed description: 
      According to the results of nonclinical study of humanized Meplazumab for Injection, a single
      dose will be used for the treatment. The treatment plan is first dose on the first day (0d)
      and second dose on the second day (1D) of the treatment period by intravenous(IV) infusion,
      each dose 10mg; The third dose will be given within 3-5 days after the second dose according
      to the patient's 2019-nCoV nucleic acid load, clinical manifestations and the overall
      evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously
      30 minutes before each administration. Each subject will be evaluated the therapeutic effect
      within 28 days after the first administration, and to determine the preliminary therapeutic
      effect, safety and tolerability of humanized Meplazumab for Injection.
    

Intervention name(s): Meplazumab for Injection
Intervention type(s): Drug
Intervention description(s): humanized MAb against CD147
Intervention MeSH terms: Meplazumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19, pneumonia
Paracetamol Compared With Ketorolac for Post-operative Analgetic
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Post-operative analgetic modalities vary between center to center, especially in Indonesia.
      Considerations include potency/effectivity of the analgetics to achieve adequate pain control
      as soon as possible, reducing the total opioid dose intake and overall reducing potential
      opioid adverse effects. NSAID have been known to have more adverse effects than acetaminophen
      (paracetamol) but offers a higher potency for analgetic effects. Here the investigators
      compare whether paracetamol is adequate as a post-operative analgetics and confers fewer
      overall adverse effects when compared with ketorolac (NSAID)
    

Detailed description: 
      OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus
      Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following
      elective cardiac surgery.

      STUDY DESIGN: Randomized (single-blind) control trial.

      SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability
      of assignment into either group.

      PLACE AND STUDY DURATION: (single center) PICU and Neurosurgery HCU at the Cipto Mangunkusumo
      National Referral Center Hospital, Jakarat, Indonesia, over a period of 6 months, from March
      to August 2022.

      METHODS: Eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were
      randomly assigned to receive either Paracetamol (treatment) or Ketorolac (control), along
      with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the
      first 48 hours postoperatively. The treatment group received injection Paracetamol 15mg/kg
      six hourly, whereas control group received injection Ketorolac 0.5mg/kg eight hourly.

      PRIMARY OUTCOME: The rFLACC (pain score) was evaluated at 0, 8, 12, 24 and 48 hours
      post-operation and a score of 4 or less was taken as a cut-off for adequate pain control.

      SECONDARY OUTCOMES: The total dose of opioid administered to each patient and adverse effects
    

Intervention name(s): Paracetamol; Ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous paracetamol/acetaminophen; Intravenous ketorolac/NSAID
Other intervention name(s): Acetaminophen; NSAID
Intervention MeSH terms: Acetaminophen; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Computer generated, randomized selection of patients with 50% probability of assignment into either group Treatment group : paracetamol group Control Group: ketorolac
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acetaminophen; Ketorolac; Postoperative pain; Pediatric; NSAID; Paracetamol; Opioid; Morphine