bioihbjkbjnl/mcl2 huggingface dataset:
Conservative Treatment of Acute Appendicitis in Children
Condition: Appendicitis; Child
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      This is a feasibility study that will be performed at the Astrid Lindgren Children´s
      Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients,
      randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The
      study will test an computerized randomization system, the availability of patients willing to
      participate in the trial and the trial protocol. The investigators will assess the
      characteristics of the patients who agree to participate in the study and those who do not.
      The investigators will explore short term outcome and design suitable long term outcome
      measures.
    


Intervention name(s): Appendectomy; Conservative, non-surgical treatment
Intervention type(s): Procedure; Drug
Intervention description(s): Standard surgical treatment, normally laparoscopic appendectomy; Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.
Other intervention name(s): Open appendectomy; Laparoscopic appendectomy; Meronem®; Meropenem; Flagyl®; Metronidazol; Ciproxin®; Ciprofloxacin
Intervention MeSH terms: Ciprofloxacin; Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Appendectomy; Nonsurgical treatment with antibiotics
Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine if there is a difference in how SB-773812 is
      distributed through the bloodstream before and after multiple doses of ketoconazole have been
      given and to determine if there is a difference in how safe and well tolerated SB-773812 is
      when given on its own and given with ketoconazole.
    


Intervention name(s): SB773812; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): SB-773812 20 mg will be available as white round film coated tablets.; Ketoconazole will be available as 200mg tablets.
Other intervention name(s): SB773812
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: safety; pharmacokinetics,
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate how well the immuno response against meningococcal
      serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
    


Intervention name(s): MenACWY-CRM197; Blood test
Intervention type(s): Biological; Biological
Intervention description(s): Blood test, 40-months and 60-months children; Blood test, 40-months and 60-months children
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of Meningococcal disease
A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar
Condition: Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, within-subject placebo controlled study to evaluate the
      safety and efficacy of various doses of STP705 administered as intradermal Injection in
      subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the
      pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common
      to the scar formation pathway.
    

Detailed description: 
      This single-center, randomized, double-blind, within-subject placebo controlled study is
      designed to evaluate the safety and efficacy of various doses of STP705 administered as
      intradermal injection in subjects with linear hypertrophic scar.

      Twenty four subjects will be divided equally among 3 cohorts (20, 30 and 40 μg/cm2/day dose
      level) of 8 subjects each. Each subject will receive both active (STP705) and control
      (Placebo) treatment twice a week for a total of 4 weeks. The total length of linear
      hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and
      Placebo will be injected intradermal every 1 cm length on the hypertrophic scar.

      Subjects will be confined to clinic or research unit for 24 hours post-dosing after the first
      treatment administration for the serial PK assay and the blood sample will be collected at
      the following post-dosing times: 30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs, 5hrs, 6 hrs, 8 hrs, 12
      hrs, 16 hrs, 24 hrs, 32 hrs and 36 hrs. Post-dosing ECG will be performed 6 hours (±1 hr)
      after the first study drug administration and vital signs will be monitored every 2h till 12h
      post-administration. Adverse events and medications will be monitored throughout the study.
    

Intervention name(s): STP705; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The Cotsiranib drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and Cox-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine co-Polymer (HKP) peptide at a ratio of 1:4 in mass weight (siRNA:peptide), which is further formulated into a dry powder drug product. The administration route would be intra-dermal injection.; Normal Saline
Other intervention name(s): COTSIRANIB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Learning Through Play (LTP) in My Own Way Plus CBT
Condition: Intellectual Disability; Depression
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      Aim of the study is to evaluate the acceptability and feasibility of LTP in My Own Way Plus
      with depressed mothers of ID children.
    

Detailed description: 
      Having a child with a chronic medical problem or an intellectual disability increases anxiety
      and depression in parents. There is some growing evidence that families of ID children are
      able to meet the challenges. The purpose of the present study is to adapt LTP in my own way
      plus to test its acceptability and determine if it improves mothers knowledge about their
      child development and reduce their level of distress.

      The study has two phases: quantitative phase and qualitative phase. Quantitative phase: A
      single blind randomised controlled trial in school settings in Karachi Pakistan.

      Objectives:

        1. Help mothers cope better with their depression.

        2. Teach mothers play activities that will stimulate their children's development and
           improve mother-child interaction.

      Qualitative Phase: This will help to determine acceptability of the intervention and identify
      perceived mechanisms of change and any barriers and facilitators to LTP in my own Plus
      intervention. In-depth digitally recorded interviews and focus groups will be conducted with
      the parents and teachers to understand their beliefs, views, and feelings about caring for ID
      children.
    

Intervention name(s): LTP in My Own Way Plus
Intervention type(s): Behavioral
Intervention description(s): LTP in My Own Way Plus is a 12-session integrated intervention-Learning through Play in My Own Way Plus Cognitive Behaviour Therapy (CBT). LTP in My Own Way is the extension of the parent education program called 'Learning Through Play' developed by Toronto Public Health (1993) revised by The Hincks-Dellcrest Centre (2000). LTP aims for the healthy growth of young children (birth to 6 years) using the stages of development incorporating Piaget's theory of cognitive development and Bowlby's theory of attachment. The objective of this program is to strengthen parent-child attachment by encouraging parental involvement and teaching parents how to use play activities to enhance their children's development. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation
      study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
    

Detailed description: 
      Total duration of the study period per subject is about 4 months broken down as follows:

      The screening period is up to 28 days, one dose treatment, and follow- up period is up to
      71±7 days (90±9 days for Cohorts 1 and 2).
    

Intervention name(s): Placebo; 611
Intervention type(s): Drug; Drug
Intervention description(s): placebo as a single SC injection on Day 1;; 611 as a single SC injection on Day 1;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Relative Bioavailability and Pharmacodynamics of Dabigatran With Enoxaparin in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability and the pharmacodynamics of dabigatran after
      switching from enoxaparin to dabigatran etexilate as compared to dabigatran etexilate alone
    


Intervention name(s): Enoxaparin prefilled syringes; Dabigatran etexilate capsules
Intervention type(s): Drug; Drug
Intervention MeSH terms: Enoxaparin; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      We want to investigate how lack of glucagon suppression during an oral glucose tolerance test
      in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.
    

Detailed description: 
      Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon
      secretion after a meal or after ingestion of glucose. Previous studies have shown that
      gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been
      possible to determine whether this lack of glucagon suppression postprandially results in an
      increased endogenous glucose secretion, and thus is a factor in the patients postprandial
      hyperglycemia.

      We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions
      with and without a continuous glucagon infusion in patients with T2DM and healthy control
      subjects. The glucagon infusion is aiming at copying the inappropriate "physiological"
      glucagon response observed in patients with T2DM.
    

Intervention name(s): isoglycemic intravenous glucose infusion and Glucagon infusion, day C; Oral glucose tolerance test, day A; intravenous iv glucose infusion, day B
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Infusion of 0.8ng/kg/min glucagon from time 0-25min
Intervention MeSH terms: Glucagon
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 2 diabetes Healthy control subjects
      
Biospecimen description: 
      hole blood, serum, white cells, urine
    
Keywords: Diabetes mellitus; Glucagon; Endogenous glucose production; Incretin hormones
A Single Center 2-way Crossover Study to Investigate the Mechanism of Action of Etoricoxib in Subjects With Osteoarthritis Knee Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate which pain mechanisms that can be affected by
      etoricoxib compared to placebo (inactive medication)in subjects with painful knee
      osteoarthritis af 4 weeks of treatment.
    

Detailed description: 
      Study Rationale: The purpose of this study is to investigate which pain mechanisms in
      subjects with painful knee osteoarthritis can be affected by the peripheral and central
      actions of etoricoxib as compared to placebo during a 4 week treatment therapy period.

      The present study will utilize a set of quantitative mechanism based pain biomarkers to
      assess peripheral and central pain manifestations in OA and the influence of etoricoxib on
      those individual manifestations in an attempt to understand and explain clinical pain
      alleviation.

      Study Treatment: Subjects will be randomized to one of the 2 sequences of treatment: Sequence
      1 (60 mg/day etoricoxib followed by placebo) or Sequence 2 (placebo followed by 60 mg/day
      etoricoxib). The two treatment periods of 4 weeks each are separated by a washout period of
      at least 6 days.

      Primary Objective: To assess which pain mechanisms are modulated by 60 mg daily
      administration of etoricoxib compared to placebo in subjects with osteoarthritic (OA) knee
      pain during two treatment periods of 4-weeks each.

      Secondary Objectives: To evaluate if changes in any of the mechanism based experimental pain
      assessment parameters can explain changes in clinical outcome parameters.

      To profile drug responders- versus non-responders based on pain mechanisms involved.

      To investigate if change in inflammatory, bone and cartilage related bio-chemical biomarkers
      can explain changes in either experimental or clinical pain parameters.
    

Intervention name(s): Etoricoxib, followed by placebo (matching tablet, without active ingredient); Placebo (matching tablet, without active ingredient), followed by etoricoxib
Intervention type(s): Drug; Drug
Intervention description(s): Sequence 1: 1 tablet of 60 mg etoricoxib daily for 4 weeks, for oral use. Sequence 2: 1 tablet of matching placebo daily for 4 weeks, for oral use.; Sequence 1: 1 tablet of matching placebo daily for 4 weeks, for oral use. Sequence 2: 1 tablet of 60 mg etoricoxib daily for 4 weeks, for oral use.
Other intervention name(s): Acoxia®; Acoxia®
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: knee; osteoarthritis; central sensitization; mechanical detection; pain threshold; quantitative sensory testing; pain biomarkers; COX-2 inhibitors; etoricoxib.
Master Study Investigating the Guiding Catheter Selectra 3D
Condition: Pacemaker DDD
Study type: Interventional

Summary: 
      Study investigating the guiding catheter Selectra 3D
    

Detailed description: 
      The guiding catheter 'Selectra 3D' is a catheter that is intended to support the implantation
      of a pacemaker lead in untypical positions in the heart like in the His- bundle area.

      This study is designed as post market clinical follow-up (PMCF) study to identify and
      evaluate residual risks associated with the use of the guiding catheter Selectra 3D that
      remained unrevealed even after risk analysis, risk mitigation and successful conformity
      assessment. Moreover, the study aims at providing additional PMCF data, as required by
      regulatory authorities. Furthermore, the performance and efficacy of the Selectra 3D shall be
      assessed. The results will be used for updating the clinical evaluation.
    

Intervention name(s): "Selectra 3D" guiding catheter
Intervention type(s): Device
Intervention description(s): His lead measurements
Intervention model: Single Group Assignment
Intervention model description: Guiding catheter Selectra 3D
Masking: None (Open Label)
Primary purpose: Other
Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Selecting acupoints along meridians is the predominant principle in acupuncture treatment,
      and it is also considered to ensure acupuncture efficacy. This experiment is to investigate
      whether specific brain networks gradually come in formation in accordance with this kind of
      acupoint selection methods.
    

Detailed description: 
      Every participants in the four intervention groups will go through functional magnetic
      imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd
      scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be
      performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.

      Volunteers in waiting list group will undergo the above scans at the same time points in
      exception of acupuncture treatment.
    

Intervention name(s): manual acupuncture
Intervention type(s): Other
Intervention description(s): thirty minutes duration every time, five times per week for one course, a total four courses
Other intervention name(s): acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; migraine; specific acupoints; brain network
Role of Hematological Parameters in the Stratification of COVID-19 Disease Severity
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The hemostatic abnormalities in COVID-19 are related with disease progression, severity and
      mortality. The Objective of our study is to evaluate the role of hematological parameters in
      determination of COVID-19 disease severity.
    

Detailed description: 
      Objective:

      COVID-19 virus involves respiratory as well as other body systems including cardiovascular,
      gastrointestinal, neurological, immunological and hematopoietic system. Patient of covid-19
      pneumonia presents with wide range of hemostatic abnormalities. These hemostatic
      abnormalities in COVID-19 are related with disease progression, severity and mortality. The
      Objective of our study is to evaluate the role of hematological parameters in determination
      of COVID-19 disease severity.

      Material and Method:

      This was a retrospective study, conducted in Department of Pathology and Department of
      medicine, FMH college of Medicine and Dentistry from May 2020 to July 2020. Total of 101,
      confirmed cases of covid-19 disease, both genders between 17 to 75-year age were included.
      Hematological parameters were compared in mild, moderate, severe and critical disease group.
      Continuous variables were analyzed by using non parametric, Kruskal Wallis test while
      categorical variables were analyzed by chi-square test.
    

Intervention name(s): not required
Intervention type(s): Diagnostic Test
Intervention description(s): Diagnostic tests( hematological parameters) were assessed.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        diagnosed cases of covid-19
      
Biospecimen description: 
      blood test
    
Keywords: Covid-19 disease; Neutrophil to Lymphocyte ratio; hematological manifestations
Evaluation of MT-12 Implant Survival and Marginal Bone Loss
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      The trial is designed as a consecutive enrollment prospective one-center study. A minimum of
      30 patients will be included in the study. At implant installation, the patient will be
      randomized to receive one of the two types of implants (Control: internal hexagon connection
      implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant
      crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage
      surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12
      months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks
      after the impressions are taken.
    


Intervention name(s): MT-12 dental implant; CON.INT dental implant
Intervention type(s): Device; Device
Intervention description(s): Placement of the MT-12 dental implant with Morse taper implant-abutment connection; Placement of the CON.INT dental implant with internal hexagon implant-abutment connection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
MEDITOXIN® in Treatment of Crow's Feet Line
Condition: Crow's Feet Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line
    


Intervention name(s): botulinum toxin type A; botulinum toxin type A
Intervention type(s): Drug; Drug
Intervention description(s): 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas; 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
Other intervention name(s): MEDITOXIN; BOTOX
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and
      potential treatment for patients with kinds of musculoskeletal disorders. Although few
      clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral
      neuropathy, the effect of combined PRP and ESWT is absent so far.
    

Detailed description: 
      We perform a prospective randomized, double-blinded study to investigate the combined effect
      of PRP and ESWT in patients with carpal tunnel syndrome.

      Patients were randomized into intervention and control group. Participants in intervention
      group received sono-guided injection with 3cc PRP and one-session active ESWT and control
      group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation
      was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the
      treatment.
    

Intervention name(s): Platelet rich plasma; shock wave
Intervention type(s): Procedure; Device
Intervention description(s): Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.; Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: platelet rich plasma; extracorporeal shock wave