bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is the most common chronic disease of childhood and is responsible for large portion
      of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow
      for optimal delivery of care and may result in decreased length of stay, leading to important
      economic benefits. Weaning of asthma medications prescribed for asthma exacerbation is not
      standardized in the current model of care. Currently, weaning is performed by ward
      physicians; in a teaching hospital, this most often done by residents staff. Differences in
      practice between different physicians, delays in patient assessment and adjustment of
      doctor's orders, likely prolong the hospital stay for children admitted with asthma.

      This study's main objective is to determine the effect of a nursing-driven clinical pathway
      on children's length of stay when admitted to hospital with a diagnosis of acute asthma
      exacerbation. The pathway will allow nurses to wean a specific type of
      medication(β2-agonist), as compared to the current standard of care, which dictates that a
      physician writes an order to wean the medication. Number of administered β2-agonist
      treatments will be compared between both groups, as well as asthma-related health care
      utilization within two weeks of hospital discharge. Nursing, physician, and patients'
      satisfaction with the pathway will be evaluated, and a cost minimization analysis will be
      performed.

      This study has the potential to improve resource use efficiency, increase patient safety by
      avoiding administration of unnecessary medications, and ameliorate quality of care by
      standardizing the care of children admitted to the hospital with a diagnosis of acute asthma
      exacerbation. The results of the study will be disseminated across the Canadian Health Care
      System with the goal of improving outcomes of children admitted to hospitals with acute
      asthma exacerbations.
    


Intervention name(s): Nursing-driven clinical pathway for management of inpatient asthma
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Nursing; Protocol; PRAM; Length of Stay; Weaning; Clinical pathway; Asthma exacerbation
A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, open-label, multiple doses, one-sequence design study in two parallel groups
      of healthy volunteers
    

Detailed description: 
      Single centre, open-label, multiple doses, one-sequence design study in two parallel groups
      of healthy volunteers: Group A: Pre-treatment with ESL, treatment with ESL and ascending
      doses of Topamax (TPM) in last phases; Group B: Pre-treatment with TPM, treatment with TPM
      and ascending doses of ESL in last phases
    

Intervention name(s): BIA 2-093; Topamax
Intervention type(s): Drug; Drug
Other intervention name(s): ESL, Eslicarbazepine acetate; TPM
Intervention MeSH terms: Topiramate; Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short-term Effects of the Simultaneous Use of Two Physiotherapeutic Methods in the Treatment of Adolescent Idiopathic Scoliosis - Pilot Study
Condition: The Spirometry;; The Strength of Respiratory Muscles - MIP, MEP;; Kyphosis (Plurimeter-V); The Angle of Trunk Rotation in Thoracic Part
MeSH terms: Scoliosis; Kyphosis
Study type: Interventional

Summary: 
      The assessment of influence joint physiotherapy (DoboMed and OMT Kaltenborn - Evjenth) on the
      function of the respiratory system and the morphology of the ribcage in short-term intensive
      physiotherapy.
    


Intervention name(s): Derotational manual therapy techniques in selected segments in spine; Sham therapy
Intervention type(s): Other; Behavioral
Intervention description(s): Derotational manual therapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Manual therapy; DoboMed exercise; Spirometric test
A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery
Condition: Pain; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl
      immediate release capsules for the treatment of postoperative pain over a period of 12 hours
      on the first day following a bunionectomy in men and women.
    

Detailed description: 
      Tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound. This was
      a multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled dose
      study in men and nonpregnant, nonlactating women. The patients were at least 18 and no more
      than 75 years of age and experienced moderate to severe pain within 9 hours after removal of
      postoperative analgesia. The surgery was a standardized first metatarsal bunionectomy.
      Treatment of postsurgical pain after the 9 hr period was with either placebo, tapentadol, or
      oxycodone using various dosing regimens. The primary objective of this study was to evaluate
      the efficacy and safety of these treatments on total pain relief and total change in pain
      intensity over 12 hours and reporting of adverse events, laboratory values, vital signs, and
      ECGs. Secondary objectives included evaluation of several other pain measures, and drug
      pharmacokinetics and pharmacodynamics. Six patient treatment groups received study medication
      orally at 0, 4, and 8 hours with one of the following dosing regimens: 1) placebo, placebo,
      and placebo, 2) 93 mg, 93 mg, and 93 mg tapentadol IR, 3) 140 mg, 140 mg, and 140 mg
      tapentadol IR, 4) 140 mg, 70 mg, and 70 mg tapentadol IR, 5) 186 mg, 93 mg, and 93 mg
      tapentadol IR, and 6) 10 mg, 10 mg, and 10 mg oxycodone IR.
    

Intervention name(s): tapentadol HCl
Intervention type(s): Drug
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tapentadol; Bunionectomy; Analgesia; Acute pain; Postsurgical pain
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in
      short children born SGA. Safety of the drug is a main objective as well. The growth promoting
      effect of two different dosages is compared. The effect of long-term treatment on final
      height is evaluated (according to several amendments)
    


Intervention name(s): Genotropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV
Condition: Healthy Adult Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic
      Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial
      Virus (RSV).
    

Detailed description: 
      As no data exists for Palivizumab in the RSV human challenge model, this exploratory study is
      therefore planned to establish the margins of effect and variance of prophylactically
      administered Palivizumab within the RSV-A Memphis 37b challenge model in healthy adult
      volunteers.

      The study will be performed in adults aged 18-55 years, in two parts.

      • Part 1: All participants will be administered Palivizumab (8mg/Kg, intravenously).
      Pharmacokinetic (PK), safety will be measured.

      If there are no safety concerns in Part 1, and PK analysis of Palivizumab treated
      participants confirm the modelling of 8mg/Kg to be appropriate, Part 2 will commence with the
      planned 8mg/Kg treatment dose. However, if PK analysis of Part 1 suggests that 8mg/kg may be
      insufficient dose to provide suitable efficacious coverage in Part 2, then Part 2 will
      proceed with a dose of 15mg/Kg.

      • Part 2: Participants will be either administered Palivizumab (8mg/Kg or 15mg/Kg, as
      determined in Part ) or a placebo and they will subsequently be challenged with an RSV-A
      strain (Memphis 37b). The margin of effect and variance between groups will be measured, as
      well as safety and reactogenicity.
    

Intervention name(s): Palivizumab; Placebo; RSV-A Memphis 37b virus
Intervention type(s): Drug; Drug; Other
Intervention description(s): Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg or 15mg/kg, administered at a rate of 1mL/min; Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min; Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
Other intervention name(s): Synagis™
Intervention MeSH terms: Palivizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug
      effects of BMS-986308 compared to placebo in healthy participants.
    


Intervention name(s): BMS-986308; Placebo (for BMS-986308); Furosemide
Intervention type(s): Drug; Other; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BMS-986308; Congestive heart failure (CHF); Diuretics; Diuretic resistance; Fluid overload; Furosemide; Persistent congestion
Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
Condition: Non-Vital Tooth
MeSH terms: Tooth, Nonvital
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this randomized controlled clinical trial is to use Allium sativum oil as
      non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its
      antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is
      hypothesized that there is no difference in the antibacterial effect of Allium sativum oil
      compared with Formocresol, when used as non-vital Pulpotomy medicaments.
    

Detailed description: 
      It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4
      to 8 years, each containing at-least one non-vital primary molar, will be selected and
      randomly divided into Group A (Formocresol) and Group B (Allium sativum oil). Non-vital
      Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will
      be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the
      respective medicaments will be placed over the root canal orifices and filled temporarily.
      Patients will be recalled after one week. Samples will be again taken, and tooth restored.
      Comparison between bacterial count at baseline and after one week of treatment will be made
      and expressed as Colony-Forming Units/ml (CFU/ml).
    

Intervention name(s): Formocresol; Allium Sativum Oil
Intervention type(s): Drug; Drug
Intervention description(s): Formocresol will be used as non-vital pulpotomy medicament (which is gold standard); Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)
Other intervention name(s): medicament for Non-vital pulpotomy procedure; medicament for Non-vital pulpotomy procedure
Intervention MeSH terms: Allyl sulfide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Physician Self Disclosure of IUC Use
Condition: Contraception
Study type: Interventional

Summary: 
      As many as one-third of female healthcare providers use intrauterine contraception (IUC), but
      only about 8 percent of US women overall do. This begs the question: Might physician
      self-disclosure of personal IUC use increase IUC use among patients? However, the positive or
      negative impact of physician self disclosure on IUC uptake or patient satisfaction is
      generally unknown. The purpose of this study was to evaluate if physician self-disclosure of
      personal IUC use increases patient use of IUC or impacts patients' satisfaction with their
      clinical encounter.
    

Detailed description: 
      We performed a prospective randomized block design pilot trail of usual contraceptive
      counseling versus usual counseling plus physician self-disclosure of personal intrauterine
      contraceptive use.
    

Intervention name(s): Physician self-disclosure of personal IUC use; Usual contraceptive counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling; all subjects recieved usual contraceptive counseling
Other intervention name(s): contraceptive counseling
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Contraceptive counseling; Physician self disclosure; Satisfaction; Intrauterine contraceptive use
A Study of CX157 (TriRima) for the Treatment of Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the efficacy of CX157 60 mg administered three times
      a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder
      (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state
      pharmacokinetic profile of CX157 in these subjects.
    

Detailed description: 
      This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group,
      multi-center study comparing the efficacy, safety and tolerability of CX157 60mg TID and
      placebo. This study will be conducted at approximately 12 investigative sites in the US.

      Subjects with suspected Major Depressive Disorder (MDD) and experiencing a Major Depressive
      Episode (MDE) who the investigator wishes to consider for enrollment in the study and who
      provide written informed consent will initially be evaluated by the Inventory of Depressive
      Symptomatology 30 item -Self Report (IDS-SR30) administered via Interactive Voice Response
      System (IVRS). Subjects who meet the minimum score of 40 on the IDS-SR30 will proceed with
      the remaining study related assessments at the Screening visit. Those subjects who meet all
      inclusion criteria and none of the exclusion criteria will enter a one to two week Screening
      period to confirm eligibility and to capture Screening data prior to Randomization. At the
      Randomization visit, all eligibility requirements will be reconfirmed. The subjects who meet
      all criteria will be randomized to study medication and enter into a six-week treatment
      period and a subsequent one week Follow-Up period. The total duration of participation for
      subjects who complete all phases of the study will be approximately 8-9 weeks. During the
      treatment period, clinic visits will occur at Week 1, Week 2, Week 4, and Week 6. A
      subsequent clinic visit will occur at the end of the one week Follow-Up period. The clinical
      site will contact the subjects via telephone at Weeks 3 and 5 to inquire about their
      wellbeing, query about adverse events and administer the suicidality scale.

      Eligible subjects will be randomized (1:1) to receive:

        -  CX157 60mg three times a day (TID) for a total daily dose of 180 mg, or

        -  Placebo administered three times a day.

      Subjects who discontinue from the study for any reason will not be replaced.
    

Intervention name(s): CX157 (TriRima); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Six capsules administered three times a day for six weeks.; Six capsules administered three times a day for six weeks.
Other intervention name(s): Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with
      relapsing forms of multiple sclerosis. This will be an open label upward dose titration
      involving injections on 9 occasions, each two weeks apart. After dosing is complete there
      will be a 22 week follow up period. Blood samples will be drawn throughout the study to
      monitor safety and the body's response to the injections and MRI scans will be performed on
      several occasions to follow the course of the multiple sclerosis during the trial.
    


Intervention name(s): ATX-MS-1467
Intervention type(s): Biological
Intervention description(s): Disease specific immune modulating treatment for multiple sclerosis
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Immunomodulation; Phase 1
A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, 2-cohort, multiple dose, fixed-sequence, DDI study
      in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of
      ATI-2173 in combination with tenofovir disoproxil fumarate and assessed for safety and
      tolerability including blood tests to show how the body metabolizes and eliminates the
      investigational drug as well as how the investigational drug interacts with tenofovir
      disoproxil fumarate.
    


Intervention name(s): ATI-2173 50 mg; Tenofovir 300Mg Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): ATI-2173 is a liver-targeted phosphoramidate oral prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth; Tenofovir is an oral nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus. It will be dosed as a tablet by mouth
Other intervention name(s): Viread 300 mg
Intervention MeSH terms: Tenofovir
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in
      patients with binge-eating disorder (BED), with or without obesity.
    

Detailed description: 
      Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated
      strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with
      BED are needed that can produce sustained clinical outcomes. This study aims to test the
      efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for
      the treatment of BED in patients with and without obesity. The RCT will provide new findings
      regarding the efficacy of NB medication for reducing binge-eating episodes among patients
      with BED, for reducing weight among patients with BED and obesity, and whether patients with
      and without obesity derive differential benefit from NB.
    

Intervention name(s): Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination; Placebo
Intervention type(s): Drug; Other
Intervention description(s): NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.; Placebo will be inactive and taken daily in pill form.
Other intervention name(s): Contrave
Intervention MeSH terms: Bupropion hydrochloride, naltrexone hydrochoride drug combination; Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment