bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Pharmacokinetics of Oral Formulations of MMV390048 Administered Fasted to Healthy Volunteers
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in a single centre, as an open single dose two parallel cohorts
      design with oral doses of MMV390048 administered in healthy male and female subjects between
      18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study.
      On Day 1 of the study each subject will receive one of the two MMV390048 prototype
      formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3
      after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14,
      19, 26 and 29.
    

Detailed description: 
      A Phase 1 exploratory study to evaluate the pharmacokinetics of selected oral formulations of
      MMV390048 administered in healthy volunteers. It is anticipated that eighteen (18) healthy
      male and female subjects are to be included in the study, however there is an option to
      include an additional cohort of 9 subjects. The optional cohort would receive a single dose
      of the formulation considered to have the least pharmacokinetic variability with a suitable
      safety and tolerability profile with food or milk. Timing of PK samples may be adjusted in
      accordance with evolving data and dosing schedule. Additional or fewer PK samples may be
      taken in accordance with evolving data and dosing schedule to establish full protocol
      specific PK profile. The study specific maximum blood volume taken will not be exceeded.
    

Intervention name(s): MMV390048 formulation A; MMV390048 formulation B
Intervention type(s): Drug; Drug
Intervention description(s): MMV390048 formulation A, tablet; MMV390048 formulation B, tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oral Lesions In Non-Celiac Wheat Sensitivity Patients
Condition: Non-celiac Wheat Sensitivity
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the
      spectrum of gluten-related disorders. No data are available on the prevalence of oral lesions
      in NCWS. Our study aims to evaluate the prevalence of oral lesions in NCWS patients and
      search for correlations with other clinical characteristics. This prospective observation
      study will include 90 NCWS patients with irritable bowel syndrome (IBS)- like symptoms, 90
      IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the
      Gastroenterology Units of the University of Palermo. Elimination diet and double-blind
      placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent
      oral examination to assess the presence or not of oral soft and hard tissue lesions
      potentially associated to NCWS and CD.
    

Detailed description: 
      Celiac disease (CD) has been reported to increase the risk of oral lesions. More recently, it
      has been reported that a consistent percentage of the general population consider themselves
      to be suffering from problems caused by wheat and/or gluten ingestion, even though they do
      not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten
      Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac
      Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms
      in NCGS patients, and the investigators also showed that these patients had a high frequency
      of coexistent multiple food hypersensitivity. That previous study also showed a percentage of
      NCWS patients had weight loss and anemia: whether these depended on the intestinal
      malabsorption or not remains unclear. As yet no data are available on the presence and
      prevalence of oral lesions in NCWS patients. The aims of the present study is: 1) to
      investigate the presence and prevalence of oral lesions in NCWS patient and 2) to search for
      a possible correlation between oral lesions and other clinical characteristics of NCWS
      patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include consecutive adult patients with irritable bowel syndrome (IBS)-like
        clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS,
        referred at the Internal Medicine and at the Gastroenterology Units of the University
        Hospital of Palermo, between may 2015 and may 2017.
      
Biospecimen description: 
      Biopsy specimens will be obtained from the bulb and the second duodenal portion.
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2
      when coadministered with SIIV compared to separate administration of the vaccines when given
      1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of
      30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1).

        -  Healthy adults 18 through 64 years of age will be randomized 1:1 to either the
           co-administration group, or the separate administration group

        -  The duration of the study for each participant will be approximately 2 months

        -  There are 3 scheduled study visits each about 1 month apart

        -  The study will be conducted in New Zealand and Australia.
    


Intervention name(s): BNT162b2; Placebo; Seasonal Inactivated Influenza Vaccine
Intervention type(s): Biological; Other; Biological
Intervention description(s): Intramuscular injection; Saline intramuscular injection; SIIV intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a three-year study in subjects with axillary hyperhidrosis involving injection of
      Botulinum Toxin Type A into the axilla to reduce sweating.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Axillary Hyperhidrosis
The STEPP Study: Sensors To Evaluate Physical Performance
Condition: Oncology
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This study assesses the association between digital functional measures of physical and
      patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).
    

Detailed description: 
      This study assess the association between digital functional measures from physical
      monitoring devices (devices like a watch tracking steps, a heart rate monitor) and
      patient-reported standard oncological assessments. The study will also test the feasibility
      of obtaining the measures in clinic and at home from the monitoring devices in participants
      with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks
      such as walking and standing with 7 digital devices recording movement data. The participants
      will also be asked to fill out survey data regarding their health. At-home data will be
      collected for 14 days. During this time participants will wear a watch to collect movement
      and step data, and a lumbar belt to collect movement data.

      Primary Objective:

      1. Assess the association of 5 main digital physical functional measures (mean steps per day,
      mean sedentary activity time, light activity time, moderate activity time, and vigorous
      activity time (in minutes) per day) recorded at home with patient-reported standard
      oncological assessment (e.g. KPS)
    

Intervention name(s): Digital Physical Measures and Survey Assessments
Intervention type(s): Other
Intervention description(s): Data from at home and in clinic visits will assess physical function and survey data will be collected
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator,
      Enbrel® 25 mg.
    


Intervention name(s): LBEC0101; Enbrel
Intervention type(s): Drug; Drug
Intervention description(s): Etanercept 25mg, single dose; Etanercept 25mg, single dose
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Etanercept; Enbrel; healthy volunteers
Erector Spinae Plane Block for Congenital Hip Dislocation Surgery
Condition: Congenital Hip Dysplasia
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
Study type: Interventional

Summary: 
      Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric
      population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of
      congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction
      or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed
      during this surgical treatment and cause severe postoperative pain. The aim of this study was
      to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) in
      pediatric patients undergoing CHD surgery.
    


Intervention name(s): Saline Solution; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 ml/kg saline; 0.5 ml/kg %0.25 bupivacaine
Other intervention name(s): saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Analgesia; Ultrasound guided erector spinae plane block
Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is
      inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of
      them can be severe in the context of being refractory to medication, daily function
      impairment, and having pain of severe degree. Novel therapeutic method is in need for pain
      alleviation for this particular phenotype. We have previously reported that PDM females may
      engage motor-cortex based descending pain modulation system in our resting-state functional
      Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the
      reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor
      cortex for various experimental painful conditions and clinical pain disorders, we reason
      that tDCS can be effective for the severe and medication-refractory PDM patients. This study
      aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic
      brain neuroplasticity in the context of functional connectivity (FC) of pain matrix after
      tDCS intervention. We will recruit 30 severe PDMs and randomly allocate them to either real
      or sham group in a triple-blind manner. rs-fMRI for functional connectivity analysis will be
      performed before and after the tDCS intervention. The imaging data will be correlated with
      behavioral and psychological measurements. This is the first study in the literature
      investigating the tDCS efficacy for severe PDM. The result can promise a new possibility for
      clinical application.
    


Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied continuously for 20 minutes.; The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied for 30 seconds at the beginning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: active, sham
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysmenorrhea; Neuromodulation; Transcranial direct current stimulation; Neuroimaging; Neuroplasticity
The Influence of IgY Max on Inflammatory Markers and the Gut Microbiome
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose of IgY as assessed by changes in
      the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut
      microbiome as assessed by 16s RNA sequencing of fecal samples.
    


Intervention name(s): Immunoglobulin Y; Placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): IgY Max; Maltodextrin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gastrointestinal; Microbiome; Inflammation
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV)
      gastroenteritis (GE) during the first efficacy period.
    

Detailed description: 
      The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy
      infants who are 6-14 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month
      schedule. Routine EPI vaccinations are given at the discretion of the investigator and
      according to local National Plans of Immunisation schedule in each participating country.
    

Intervention name(s): Rotavirus (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease
Condition: Obesity; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate potential metabolic effects of resveratrol in
      obese healthy men with non-alcoholic fatty liver disease.

      The investigators hypothesize that resveratrol will:

        -  decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion

        -  decrease liver fat content

        -  increase insulin sensitivity

      The investigators will look at changes in:

        -  lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)

        -  liver fat content (MR liver spectroscopy)

        -  insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)

        -  body composition (DXA and MRI)

        -  lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 500 mg 3 times daily for six month; 1 placebo tablet 3 times daily for six month
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Resveratrol; Nonalcoholic fatty liver disease; Insulin sensitivity; Lipid turnover; Liver fat content
Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults
Condition: Glycemic Response; Appetitive Behavior
Study type: Interventional

Summary: 
      Assess the impact of 100% grape juice with a meal on postprandial glycemic response and
      subsequent appetite, food intake and cognitive function.
    

Detailed description: 
      Investigators earlier studies and published literature suggest that the phenolic content and
      strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on
      blood sugar levels. Investigators aim to better understand the consumption of 100% grape
      juice with a meal modifies appetite and glycemia acutely and over the day using a 24 hour
      glucose monitor.
    

Intervention name(s): Concord Grape Juice; Low flavonoid low essence beverage; Low flavonoid beverage
Intervention type(s): Other; Other; Other
Intervention description(s): Concord Grape Juice; Low flavonoid low essence beverage; Low flavonoid beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
Condition: Perennial Allergic Rhinoconjunctivitis; Allergic Asthma
MeSH terms: Asthma; Dust Mite Allergy; Conjunctivitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to test the safety, tolerability, immunogenicity and clinical
      efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and
      asthma due to house dust mite allergy in a single-center, open-label setting.
    


Intervention name(s): CYT005-AllQbG10
Intervention type(s): Biological
Intervention description(s): Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chronic Pelvic Pain in Women - Conservative Group Treatment Compared to Standard Conservative Treatment.
Condition: Pelvis Pain Chronic
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a multidisciplinary group based
      treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The
      hypothesis is that multidisciplinary group based treatment is more effective than standard
      physiotherapy for women with CPP. The participants will be randomized to one of two treatment
      arms, and the treatment effect will be evaluated 12 months after start of intervention.
    

Detailed description: 
      Background: Chronic pelvic pain (CPP) is a common source of pain and reduced quality of life
      among women throughout the world. CPP is a complex condition, and the understanding of both
      etiology and effective treatment is limited. The newest/latest clinical guidelines recommend
      a holistic and multidisciplinary treatment approach to this condition.

      In accordance with the guidelines a multidisciplinary group based treatment for women with
      CPP has been started at the University Hospital of North Norway. The treatment is offered to
      patients who are considered to benefit from conservative treatment approach.

      Method: To investigate the effect of a group based treatment compared to standard
      conservative treatment by physiotherapists in primary or secondary health care, a randomized
      controlled trial will be conducted.

      Patients who are found eligible and consent to participate in the trial, will be randomized
      to one of the two treatment options. Data will be registered at baseline, 3, 6 and 12 months
      after start of treatment.
    

Intervention name(s): Multidisciplinary group treatment; Standard physiotherapy treatment
Intervention type(s): Other; Other
Intervention description(s): Multidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively.
The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months.; Standard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical
      trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of
      patients with osteoarthritis of the knee
    


Intervention name(s): Pelubiprofen CR 45mg tab.; Aceclofenac 100mg tab.
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aceclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment