bioihbjkbjnl/mcl2 huggingface dataset:
Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
Condition: Major Depressive Disorder; Advanced Cancer
MeSH terms: Neoplasms; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of
      sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite
      alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue,
      guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).

      MD is a frequent complication in patients who are diagnosed with advanced cancer.
    


Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study; Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
Condition: Nasal Polyps
MeSH terms: Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone
      Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the
      ages of 6 and less than 18 years old. Safety will be the primary focus of this study.
    


Intervention name(s): Mometasone Furoate Nasal Spray (MFNS); Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): 100 mcg nasal spray; One spray of placebo nasal spray in each nostril once daily for 4 months.
Other intervention name(s): Nasonex
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children
Condition: Early Childhood Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      Propolis is a natural product collected by bees to seal holes and repair structures in their
      hives. Recently it has attracted much attention as useful substance applied in medicine and
      cosmetics thanks to its antimicrobial properties. Contemporary dentistry is an inseparable
      part of medicine and therefore attempts were made to use propolis in dentistry, as well.

      Purpose of the study: to investigate the effect of propolis administered in chewing gum as
      compared to that incorporated in mouthwash on plaque accumulation, microbial population and
      patient acceptance.
    

Detailed description: 
      The study is a two parallel arms randomized controlled clinical trial where 60 high caries
      risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and
      Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing
      the necessary consents. The children will be divided randomly into two equal groups (30
      children each).
    

Intervention name(s): Propolis chewing gum; Propolis mouthwash
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Children who will use chewing gum will be instructed to chew a gum for 20 minutes once after breakfast and another before bed time for two weeks.; Children who will use mouthwash will be instructed to rinse with 10 ml for 60 seconds twice daily once after breakfast and another before bedtime for two weeks.
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Propoplis; chewing gum; mouthwash; high caries risk children; antimicrobial
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      40 pregnant females at term diagnosed with morbidly adherent placenta and planned for
      elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac
      ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.
    


Intervention name(s): Internal iliac artery ligation; cesarean hysterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Internal iliac artery ligation and cesarean hysterectomy; cesarean hysterectomy
Other intervention name(s): cesarean hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Internal iliac artery; Internal iliac artery ligation; Placenta previa; Placenta accreta; cesarean hysterectomy
Faster Back Home: Efficacy of a High-intensity Endurance Training
Condition: Healthy
Study type: Interventional

Summary: 
      Sports medical experts recommend considerable amounts of regular physical activity in order
      to improve strength, motor control, endurance and flexibility. However, only a small share of
      the population is able to meets the corresponding international guidelines. One reason for
      this is supposed to consist in private scheduling problems and the high time expenditure.
      Against this background, high-intensity intermittent training methods with short durations
      have become popular.

      The present study aims to evaluate the effectivity of a high -intensity functional circuit
      training (the FIT15 program) in improving body function.

      Thirty healthy individuals will be included in the randomized, controlled two-armed parallel
      group trial. In the intervention group, the participants will perform the FIT15 program, a
      group-based high-intensity circuit training based on functional movement patterns (e.g.
      squats, push-ups, burpees, jumps, rope-skipping). The training will be carried out three
      times a week, each 15 minutes for a total of six weeks. In the control group, the
      participants will exercise three times a week (in total for six weeks) at moderate intensity
      on an ergometer according to the cardiopulmonary exercise guidelines of the American College
      of Sports Medicine. Outcomes assess prior and following the six-week training period
      encompass body fat and muscle mass (bio impedance analysis), aerobic exercise capacity
      (spirometric exercise testing including lactate analysis), postural control (force plate),
      maximum strength of the leg extensors and shoulder muscles (1 repetition maximum) and
      psychometric variables (e.g. physical activity readiness questionnaire).
    


Intervention name(s): Fit15; Endurance
Intervention type(s): Other; Other
Intervention description(s): Group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, ropeskipping).
Total duration 15 minutes circle training: 20s workout, 10 rest; Moderate intensity ergometer training. Total duration 50 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Male Volunteers
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of MB12066 after
      multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after
      multiple dose.
    


Intervention name(s): MB12066 200mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg bid (multiple dose, day 8); 100mg bid (multiple dose, day 8)
Intervention MeSH terms: Beta-lapachone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Obesity
Role of Serotonin in Acute and Subacute MDMA Effects
Condition: MDMA Mechanism of Action
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effects of MDMA (particularly its emotional
      effects) and to determine the role of serotonin in these effects. Serotonin is a
      neurotransmitter, which is a chemical that is released by some brain cells to communicate
      with other brain cells. Many of the effects of MDMA are thought to be the result of increased
      serotonin release.

      In order to understand the effects of MDMA and role of serotonin in these effects, we will
      administer MDMA alone and in combination with the antidepressant citalopram (one trade name
      for this is Celexa). Citalopram decreases the ability of MDMA to release serotonin.
      Citalopram will therefore decrease any of MDMA's effects that are the result of serotonin
      release; we want to measure this.
    


Intervention name(s): MDMA and citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MDMA 1.5 mg/kg and citalopram 20 mg; drug: placebo subjects also get citalopram and placebo in a 2x2 crossover design
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MDMA; citalopram; serotonin; psychedelic
Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction
Condition: Labor Induction; Cervical Ripening
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of a transcervical Foley catheter with
      and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.
    

Detailed description: 
      In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to
      21% in 2004. Although the indications for labor induction vary, labor inductions as an
      obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the
      rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time
      high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents
      in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical
      methods are currently available for cervical priming. Methods available for mechanical
      dilation include, but are not limited to transcervical foley catheter alone and transcervical
      foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of
      EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin
      release by membrane stripping and supplying additional mechanical force. It may be
      disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins
      that are released by membrane stripping. There have been two randomized trials comparing
      foley alone to foley with EASI. Because the results of these two trials are conflicting, we
      chose to conduct a randomized clinical trial of foley catheter compared to foley catheter
      with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.
    

Intervention name(s): Transcervical Foley Catheter; Transcervical Foley Catheter with an EASI
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labor Induction; Cervical Ripening; Foley Catheter
Neuropeptides in the Humane Intra- og Extracerebral Circulation.
Condition: Healthy; Migraine
Study type: Interventional

Summary: 
      The study aim at examining whether Sumatriptan changes the plasma values of the neuropeptides
      vasoactive intestinal polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary
      adenylate cyclase activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2
      og PGF2α.
    

Detailed description: 
      The study is meant to give a better understanding of the basic mechanisms behind migraine,
      and a better understanding of the effects of sumatriptan on the trigemino vascular system.

      The endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal
      polypeptide (VIP), calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase
      activating peptide (PACAP) and the prostanoids 6-keto-PGF1α, and PGE2, PGD2 og PGF2α.
    

Intervention name(s): sumatriptan
Intervention type(s): Drug
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Keywords: VIP; PACAP; CGRP; Prostanoids
Efficacy and Safety From a Recombinant Folding Variant of Bet v 1
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and Safety from a recombinant folding variant of Bet v 1
    


Intervention name(s): recombinant birch pollen allergen; placebo
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram; subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Recombinant birch pollen allergy; IgE-mediated allergic disease attributed to birch pollen
Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia
Condition: Lewy Body Dementia; Non-DLB Dementia; Alzheimer's; Vascular Dementia
MeSH terms: Dementia; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to determine the diagnostic efficacy of the visual assessment of SPECT
      scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB
      dementia subjects determined by the clinical diagnosis of an independent expert consensus
      panel used as the standard of truth.
    

Detailed description: 
      GEHC had decided notto provide this detail
    

Intervention name(s): DatSCAN
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lewy Body Dementia; non-DLB dementia; Dopamine Transporter; Striatal Uptake
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this study is that subcutaneous administration of tanezumab results in
      lower drug exposure compared to intravenous administration of tanezumab.
    


Intervention name(s): tanezumab; tanezumab; tanezumab; tanezumab
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Drug solution given intravenously only once at dose of 10 mg; Drug solution given subcutaneously only once at dose of 5 mg.; Drug solution given subcutaneously only once at dose of 10 mg.; Drug solution given subcutaneously only once at dose of 19 mg.
Intervention MeSH terms: Tanezumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II
      questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability
      Index, ODI) at 6 months.
    

Detailed description: 
      The secondary objectives are:

      A. To search for correlations between the acceptance score (AAQ-II Questionnaire) and scores
      for coping (CSQ), avoidance (FABQ), understanding (BBQ), anxiety and depression (HADS) and
      quality of life (SF-12) at baseline.

      B. To describe the kinetics of changes in various parameters (acceptance, coping, avoidance,
      understanding, anxiety and depression, quality of life, ODI) over 6 months.

      C. To evaluate the agreement between two methods of questionnaire presentation: Paper
      collection versus collection by Tablet PC.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population corresponds to inpatient rehabilitative care for lumbar spine pain in
        the Departments of Physical Medicine and Functional Rehabilitation at the Nîmes and
        Montpellier University Hospitals.
Trial of Asthma Self-Management Education in Patients With Depressive Symptoms
Condition: Asthma; Depression; Anxiety
MeSH terms: Asthma; Depression
Study type: Interventional

Summary: 
      Although depressive and anxious symptoms are common in asthma patients and are associated
      with worse clinical and resource utilization outcomes, there have been no studies focusing on
      the particular challenges of improving asthma self-management in this population. The
      investigators hypothesize that a tailored intervention to improve asthma self-management in
      patients with a known history of depressive and anxious symptoms will be effective in
      improving asthma-related quality of life.
    

Detailed description: 
      Depressive and anxious conditions are common during the lifetime of asthma patients and have
      been shown to be associated with worse asthma as defined by more symptoms, more
      hospitalizations and greater use of medications. There have been few studies trying to
      improve asthma outcomes in patients with known depression. One method to improve outcomes is
      to instruct patients in ways to better self manage asthma. The goal of this study is to test
      a comprehensive intervention to improve asthma self-management by increasing knowledge and
      self-efficacy in patients with a known history of a positive screen for depression. Patients
      will be randomized to two groups - a control group and an intervention group. Patients in the
      control group will receive an asthma workbook, will make a contract to adopt behaviors they
      think will improve asthma, and will receive telephone follow-ups approximately every week for
      8 weeks and then approximately every 2 months. Patients in the intervention group will
      receive these components plus they will be taught how to use a peak flow meter and specific
      chapters of the workbook will be used as templates for focused instruction during telephone
      follow-ups. The primary outcome will be a comparison of within-patient change in
      asthma-related quality of life between groups.
    

Intervention name(s): Asthma self-management
Intervention type(s): Behavioral
Intervention description(s): Patients in the intervention group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups which will occur every week for 8 weeks and then approximately every 2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: asthma; depression; anxiety
A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines
Condition: Moderate to Severe Glabellar Lines
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and
      placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the
      treatment of moderate to severe glabellar lines in male and female subjects of Chinese
      origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and
      compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate
      to severe glabellar lines.
    


Intervention name(s): YY001; OnabotulinumtoxinA; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.; Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.; Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo and active controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: YY001; Botulinum Toxin; Glabellar Lines
Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease
Condition: Crohn´s Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was
      developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development
      Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were
      conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both
      confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and
      immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively.

      The current study is designed to provide a systematic and consistent overview of the
      real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The
      data collected in this observational trial will be used to increase the knowledge of the
      effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with
      moderate-to-severe CD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        It is planned to enroll a total of 1,600 patients.

        The following patient groups will be observed:

          -  Patients with moderate-to-severe CD receiving Hyrimoz™ treatment according to the
             Hyrimoz™ label at the discretion of the investigator

          -  Patients with moderate-to-severe CD receiving Zessly™ treatment according to the
             Zessly™ label at the discretion of the investigator
      
Keywords: Crohn´s Disease; Inflammatory Bowel Disease; Adalimumab; Infliximab; Biosimilar; IBD-Index