bioihbjkbjnl/mcl2 huggingface dataset:
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
Condition: Children; Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Tramadol is a centrally acting analgesic, is primarily Indicated for the treatment of acute
      pain, moderate to severe. The hernioplasty in children is an outpatient procedure, and the
      possibility of postoperative analgesia with fewer systemic adverse effects such as nausea and
      vomiting make the tramadol infiltration a technique of interest. There is controversy about
      its effectiveness.

      The local effect of tramadol in hernioplasty was also studied by researchers with some better
      postoperative analgesia than with local anestetic .

      There are few studies with administration of tramadol for hernioplasty, Which led to the
      interest in this study.
    

Detailed description: 
      The primary objective of the study was to evaluate the analgesic effect of tramadol injected
      into the surgical incision in patients undergoing hernioplasty.

      The study is a prospective, comparative, double covered. The distribution of patients in the
      groups was randomly drawn prior to starting the project and the groups were identified in
      envelopes numbered 1-40.

      Criteria for inclusion and exclusion After approval by the Ethics Committee of UNIFESP and
      signature of consent by those responsible, and the term of assent by patients over six years,
      40 children of both sexes will be evaluated, aged between 3 and 12 years who underwent
      hernioplasty.

      Children with bleeding disorders, using analgesic or sensitivity to any drug will be
      excluded.

      The patients will be randomly divided into one of two groups. Patients in group 1 will
      receive local infiltration with 2 mg / kg of tramadol diluted in 5 ml of 0.9% saline solution
      and 20ml of 0.9% saline solution intravenously at the end of the surgical procedure Patients
      in group 2 will receive 2 mg.kg-1 tramadol intravenously diluted in 20 ml of 0.9% saline
      solution and local infiltration with 5 mL of saline solution 0.9% at the end of the surgical
      procedure.

      All patients will undergo general anesthesia, and will receive additional analgesia with
      dipyrone and morphine as needed in post operative period.
    

Intervention name(s): tramadol; 0.9% saline
Intervention type(s): Drug; Drug
Intervention description(s): The volume of the solution was adequate to maintain the concentration of 2% tramadol
Other intervention name(s): tramal
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tramadol; Children; Hernioplasty; Wound infiltration
A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effects of erenumab on central sensitization
      and brain networks connectivity of migraine patients
    

Detailed description: 
      This is a randomized, double blind, placebo-controlled trial with a 2-sequence, 2-period,
      2-treatment crossover design. The study population will consist of adult male and female
      subjects with a documented history of episodic migraine (4 to 14 baseline migraine days), who
      have failed at least 2 previous migraine prophylactic treatment for lack of efficacy or
      tolerability. After a run-in phase of 4 weeks, patients will be randomized, according to a
      1:1 ratio, to a 24 weeks of treatment, as follow:

        -  Sequence 1: A/B

        -  Sequence 2: B/A where: A=monthly subcutaneous erenumab 140 mg for 12 weeks; B=monthly
           subcutaneous masked placebo for 12 weeks
    

Intervention name(s): erenumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): erenumab 140 mg sc every 4 weeks; placebo sc every 4 weeks
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After a run-in phase of 4 weeks, patients will be randomized, according to a 1:1 ratio, to a 24 weeks of treatment, as follow:
Sequence 1: A/B
Sequence 2: B/A where: A=monthly subcutaneous erenumab 140 mg for 12 weeks; B=monthly subcutaneous masked placebo for 12 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AMG334; erenumab; functional MRI; connectivity
First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      subcutaneous and single oral dose of GLPG0187 compared to placebo.

      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous
      and oral administration will be evaluated, and, if applicable, the maximum tolerated dose
      determined.
    


Intervention name(s): GLPG0187; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution); Matching subcutaneous or oral placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
A Single-dose Study of Octreotide Injection in Healthy Adult Subjects
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, single-dose, dose-escalation, placebo and positive drug-controlled
      Phase I clinical study in healthy Chinese subjects to evaluate the safety, tolerability,
      pharmacokinetic and pharmacodynamic profile of octreotide injection in healthy Chinese
      subjects.
    

Detailed description: 
      This single centre study will be comprised of 6 cohorts. The single ascending dose part is
      comprises of 4 cohorts（5 mg, 10 mg, 20 mg, 30 mg).

      The other 2 cohorts are octreotide long-acting release ( Sandostatin LAR® ) 20 mg and
      Sandostatin® 0.1 mg.
    

Intervention name(s): SYHX2008 injection; Octreotide Acetate Microspheres for Injection injection; Sandostatin ® injection; Placebo to SYHX2008 injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous administration on Day 1.; Intramuscular administration on Day 1.; Subcutaneous administration on Day 1.; Subcutaneous administration on Day 1.
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cross-cultural Adaptation of the Greek Version of Disability Assessment for Dementia
Condition: Dementia
MeSH terms: Dementia
Study type: Observational

Summary: 
      The main purpose of this study is primarily the translation and cross-cultural adaptation
      into Greek and then the investigation of validity and reliability in the Greek target
      population.
    

Detailed description: 
      Two investigators will do the translation into Greek, then a third person independent of the
      first two will translate the scale backward, i.e. into English. Then, the three investigators
      will meet with another independent investigator who is familiar with the field of Greek
      translations of foreign language rating scales. Thus, the final translation and Greek version
      of the scale will be created. Then, the process of finding the participants will begin and
      the first assessment with the scale will be carried out initially. After two days will take
      place reassessment for the reliability of the measurement tool. In order to find the validity
      of the scale in the Greek population, in the first assessment will be used also Katz index
      for Basic Activities of Daily Living and the Lawton scale for Instrumental Activities of
      Daily Living.
    

Intervention name(s): Disability Assessment for Dementia (DAD)
Intervention type(s): Diagnostic Test
Intervention description(s): The scale consists of 40 items and assesses patients' independence in basic and instrumental activities. The scale is completed by the patient's caregiver with the assistance of the assessor-therapist.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will include patients with dementia of good cognitive level and necessarily have
        a caregiver. Patients may also live independently or with relatives or in a public or
        private care facility.
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the second clinical study of NOX-A12. This study intends to provide information on
      the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated
      intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of
      hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination
      with filgrastim in healthy subjects. A single center, open-label, repeated dose study design
      is selected to best address the study objectives.The results from this study will establish
      the basis for further development of NOX-A12 in lymphoma patients undergoing autologous
      hematopoietic stem cell transplantation
    


Intervention name(s): NOX-A12; NOX-A12; Filgrastim; NOX-A12 in combination with Filgrastim
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 mg/kg daily IV for 5 days; 2 mg/kg daily IV for 5 days; 5 µg/kg SC daily for 5 days; Safe and efficacious dose regimen according to results of groups A and B
Other intervention name(s): olaptesed pegol; olaptesed pegol; olaptesed pegol; olaptesed pegol
Intervention MeSH terms: Lenograstim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem Cell Transplantation; SDF-1; L-oligonucleotide Aptamer; Spiegelmer; Hematopoietic Stem Cells
Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare
      the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU
      Synagis® in healthy subjects.

      During the course of the study, the similarity in pharmacokinetics will be assessed by
      sampling the levels of drug in the blood, and by comparing these levels among the different
      administration arms. Safety, tolerability, and immunologic response to the administered drugs
      will also be evaluated throughout.
    


Intervention name(s): MB05 (Proposed palivizumab biosimilar); EU-Synagis®; US-Synagis®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single IM dose of 3 mg/kg; Single IM dose of 3 mg/kg; Single IM dose of 3 mg/kg
Intervention MeSH terms: Palivizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Promoting Healthy Lifestyle Behaviors in Schoolchildren: an Online Video Intervention for Parents
Condition: Physical Activity; Sedentary Behavior; Healthy Diet; Primary Schoolchildren; Parents; Parenting
Study type: Interventional

Summary: 
      1. Development of a method for parents of primary schoolchildren to teach parents parenting
           skills to obtain health gain in the family through videos and online feedback.

        2. Effect- and procesevaluation of this methodology.

        3. Development of an implementation guide together with VIGEZ as primary partner and in
           association with partner organisations on the field.
    

Detailed description: 
      The current project aims to develop, test and implement online videos to teach effective
      parenting skills to parents of primary schoolchildren. This way we want to achieve health
      profit by stimulating PA en healthy diet, and reducing SB in children. The online videos,
      based on existing literature and focus group research, show parents via modeling how they can
      react in difficult parenting situations related to PA, SB and healthy diet. In the current
      study, these videos will first be tested in an effect and process evaluation study. 300
      families with at least one primary schoolchild will be recruited and randomized into an
      intervention/control group. By using a survey at the pre-, post- and follow-up test, we will
      examine if parenting practices become more effective, if related parental self-efficacy
      enhances and if children perform more healthy behaviors after their parents watched the
      videos.
    

Intervention name(s): Movie Models
Intervention type(s): Behavioral
Intervention description(s): The intervention group got acces to a private website for 4 weeks on which the online videos were placed (Week 1: fruit + water, week 2: vegetables + breakfast + supermarket, week 3: PA, week 4: SB)
After each week, parents received a link for an online process evaluation questionnaire in which we asked how many times they watched each video, if they discussed the videos with other people, if they found them interesting, boring…
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; screen time; vegetables; fruit; snacks; softdrink; water; fruit juice; parenting practices; online videos; intervention mapping protocol
Efficacy of Pimozide Augmentation for Clozapine Partial Response
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but
      continue to experience symptoms. The purpose of this project is to find out if small doses of
      pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms
      (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life
      events and social activities), compared to placebo (an inactive substance, "sugar pill"),
      when added to clozapine in patients with schizophrenia.

      The participant will be asked to come in once a week to meet with the research staff and
      study doctor. The participant will continue to see your regular clinician during this study
      for all normal appointments. The participant will remain on your current medications
      throughout the study. During the study you will be randomly selected to be put on a small
      dose of Pimozide or placebo.
    

Detailed description: 
      If you choose to participate, you will first have screening tests to find out if you are
      eligible. The study physician will do a number of tests including a physical examination, a
      routine medical history, lab tests for blood and urine, and EKG (to monitor your heart) and
      interviews about your physical and mental health.

      At each visit you will complete an EKG (to monitor your heart), vital signs, and discuss how
      you are feeling with the research staff and doctor. Once a month, we will also conduct a
      slightly longer interview with you about your symptoms and draw one tube of blood to check
      your Clozapine level. At the beginning and end of the study, you will do some pencil and
      paper games called "Neurocognitive tests".

      If you are interested in participating in this study, we will go over it in greater detail
      with you, including the possible benefits and risks associated with participating. We will
      make sure you understand the study before you begin. This study is completely voluntary,
      which means that you can choose to stop participating in the study at any time.
    

Intervention name(s): Pimozide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): half of the subjects are randomized to the active drug group; half of the subjects are randomized to placebo group
Intervention MeSH terms: Pimozide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; pimozide; clozapine
A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 4

Summary: 
      Dry eye is a very common condition that most often affects women and the elderly, and can be
      caused when the eyes do not produce enough tears, or when the tears evaporate too quickly.
      Although there isn't a simple cure for dry eye, there are numerous products on the market
      that attempt to help relieve some of the discomfort caused by this condition. Some of these
      products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications.
      The purpose of this study is to evaluate the performance of a combination of TheraTears®
      products, and to compare them with the product(s) you have been using.
    


Intervention name(s): TheraTears® Lubricant Eye Drop; TheraTears® preservative-free single-use containers; TheraTears® Nutrition; TheraTears® TheraLid® Eyelid Cleanser
Intervention type(s): Drug; Drug; Dietary Supplement; Other
Intervention MeSH terms: Vitamin E; alpha-Tocopherol; Tocopherols; Carboxymethylcellulose Sodium; Ophthalmic Solutions; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance
Condition: Exercise Performance
Study type: Interventional

Summary: 
      Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to
      improve nitric oxide (NO) bioavailability, in humans, by influencing both the
      nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is
      designed to assess the efficacy of a newly developed product containing a mixture of these
      compounds. Specifically, the study will assess if the product is capable of increasing NO
      bioavailability and if this results in positive effects on exercise economy and intermittent
      exercise performance. These outcome measures have been chosen because they have previously
      been positively impacted by an increase in NO bioavailability.
    


Intervention name(s): Active Nitrate Bar; Placebo Bar
Intervention type(s): Other; Other
Intervention description(s): Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione; No active ingredients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up
      and broken down by the body when given by short infusion into a vein and when given by the
      mouth in the form of a tablet and an oral solution.
    


Intervention name(s): GLPG3970 film-coated tablet; [14C]GLPG3970 solution for infusion; [14]GLPG3970 oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of GLPG3970.; Participants will receive an i.v. microtracer microdose.; Participants will receive a single oral dose [14C]GLPG3970.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Sage on Memory and Mental Performance in Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effectiveness of the herb sage in improving the
      mental function of individuals with Alzheimer's disease.

      Study hypothesis: The administration of sage will improve cognitive function in patients with
      mild Alzheimer's disease.
    

Detailed description: 
      The herb sage has been shown to enhance memory and mental function in healthy, young adults.
      However, studies assessing the herb's effectiveness in older adults with symptoms of
      Alzheimer's disease are limited. This study will determine the effect of sage extract on the
      cognitive function of patients with mild Alzheimer's disease.

      This study will last 6 weeks and will comprise 4 study visits, approximately 10 days apart.
      Participants will be randomly assigned to receive either sage pills or no treatment during
      each 10-day period. The treatment assignments will be switched in 10-day intervals, so that
      during the course of the study, each participant will undergo two periods of sage treatment
      and two periods without treatment. At each study visit, participants will undergo cognitive
      testing, including tests to determine attention, memory, and visual cognition. Participants
      will also undergo an electroencephalogram (EEG) and an electrocardiogram (ECG) at each visit.
    

Intervention name(s): Salvia officinalis (sage)
Intervention type(s): Drug
Intervention description(s): oral dosage
Other intervention name(s): sage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Massage for Low Back Pain in Nursing Staff
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage
      for lower back pain occupational as well as to assess the influence of technique in
      performing work activities and life in the team nursing.
    

Detailed description: 
      Method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol
      points. Data were collected on baseline, after one and two months and they responded 2
      questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and
      Transfer Scale) and the Numeric Pain Scale.
    

Intervention name(s): Massage
Intervention type(s): Other
Intervention description(s): Massage Anmá: 7-8 sessions, twice per week, kneading and pressure points on the bladder meridian
Other intervention name(s): Anmá; Oriental Massage; Acupressure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back Pain