bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)
Condition: Chikungunya Fever
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I dose escalation study to assess the safety and immunogenicity of the candidate
      vaccine ChAdOx1 Chik in healthy volunteers.

      Volunteers will be recruited and vaccinated in Oxford, England.

      All vaccinations will be administered intramuscularly. Three different doses will be tested
      (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp).

      The total duration of the study will be 26 weeks from the day of enrolment for all
      volunteers.
    

Detailed description: 
      This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity
      of the ChAdOx1 Chik vaccine in healthy volunteers

      There will be 3 study groups with a total of 24 volunteers. ChAdOx1 Chik will be administered
      intramuscularly as a single vaccination at 3 different doses: 5x10^9 vp (group 1), 2.5x10^10
      (group 2) and 5x10^10 vp (group 3)

      Vaccination of groups will be sequential from Group 1 to Group 3 with interim safety reviews
      prior to dose escalation

      Volunteers will be recruited and undergo screening, vaccination and follow-up visits at the
      trial site. Blood samples for safety and immunology purposes will be performed on the visit
      time points indicated in the schedule of attendances.

      Safety will be assessed by the frequency, incidence and nature of adverse events and serious
      adverse events arising during the study.

      Immune responses will be assessed pre and post vaccination procedure at different time points
      throughout the trial
    

Intervention name(s): ChAdOx1 Chik
Intervention type(s): Biological
Intervention description(s): ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccine; Chikungunya Virus; Chikungunya Fever
Lifestyle Intervention in Pregnant Women With PCOS
Condition: Polycystic Ovary Syndrome; Overweight and Obesity; Gestational Diabetes
MeSH terms: Polycystic Ovary Syndrome; Diabetes, Gestational; Overweight; Syndrome
Study type: Interventional

Summary: 
      Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of
      childbearing age and is also associated with metabolic abnormalities including obesity, type
      2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in
      pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia
      and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This
      study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant
      women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.
    

Detailed description: 
      A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of
      gestation util delivery. Participants will be randomly assigned to the control group
      (standard care) or the intervention group (intensive lifestyle intervention). The
      intervention will focus on restricting energy intake combined with behavioral lifestyle
      modification through participation in group sessions and individual counseling. The primary
      outcome will be GWG and secondary outcome will be the incidence of GDM.

      Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women
      with PCOS will decrease GWG and reduce the incidence of GDM.
    

Intervention name(s): Intensive Lifestyle Intervention; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Dietary intervention combined with healthy lifestyle counseling; Standard prenatal care on diet, nutrition and physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
DDI Study of Orelabrutinib
Condition: Healthy Person
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary
      objective was to evaluate the effects of multiple administrations of rifampin or itraconazole
      on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in
      healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability
      of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese
      subjects.
    


Intervention name(s): Orelabrutinib + Rifampin; Orelabrutinib + Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Orelabrutinib + Rifampin; Orelabrutinib + Itraconazole
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block
Condition: Rotator Cuff Injury
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The investigators compared the results of sono-guided interscalene brachial plexus block
      (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB
      alone within the first 48 h after arthroscopic rotator cuff repair.
    

Detailed description: 
      Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff
      repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB;
      the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's
      satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain
      score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever
      experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very
      satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of
      VAS pain score after postoperative 1 hour.
    

Intervention name(s): Ultrasound-guided ISB; Arthroscopy-guided SSNB; Placebo; Ropivacaine
Intervention type(s): Device; Device; Drug; Drug
Intervention description(s): ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.; At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. The suprascapular ligament was found using the lateral portal for visualization. The supraclavicular ligament was visualized at the end of the conoid ligament when the arthroscope was advanced following the coracoclavicular ligament. A 23-gauge spinal needle was introduced in a posteroanterior direction at a 20° angle percutaneously and 7 cm medial to the lateral margin of the acromion. Then, the needle was placed at the upper margin of the suprascapular ligament and advanced slightly under arthroscopy-guidance. After suctioning the saline from the portal, the injection material was administered according to the random assignment.; All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline); All the regional blocks in this study were performed using 10mL ropivacaine.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: sono-guided interscalene brachial plexus block; arthroscopy-guided suprascapular nerve block; arthroscopic rotator cuff repair; postoperative pain
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma
Condition: Asthma; Eosinophilic
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 4

Summary: 
      Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who
      have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.
    

Detailed description: 
      Monoclonal antibody therapies targeting the interleukin-5 (IL-5) pathway, critical for
      maintaining eosinophil homeostasis, have been developed as adjunct therapy for severe asthma
      with an eosinophilic phenotype. Reslizumab/Cinqair is an approved/marketed product
      administered monthly by intravenous to severe eosinophilic asthmatics at 3mg/kg. However some
      patients do exhibit sputum eosinophilia at this dosage. We are investigating whether those
      that receive 3mg/kg that have persistent sputum eosinophils would benefit at a higher dose of
      4mg/kg and those that still exhibit sputum eosinophils at this elevated dose would show
      improvement at 5mg/kg.

      The overall aim of this study is to determine whether dose escalation of reslizumab can
      ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia
      despite treatment with reslizumab at the standard dose.
    

Intervention name(s): Reslizumab
Intervention type(s): Biological
Intervention description(s): Reslizumab 3,4, or 5 mg/kg IV q4 weeks
Intervention MeSH terms: Reslizumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will initially all receive 3 mg/kg of reslizumab. After 16 weeks of treatment, those patients that have uncontrolled sputum eosinophilia will be escalated to 4 mg/kg; the remaining patients will continue on 3 mg/kg. After a further 16 weeks of therapy, those that still have uncontrolled sputum eosinophilia will receive 5 mg/kg; the remaining patients will continue on the dose they were receiving (i.e., either 3 or 4 mg/kg).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Eosinophilic bronchitis; Reslizumab
The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia
Condition: Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      Traditional sodalime CO2 absorbers are known to not only react with CO2 but also with
      sevoflurane. Therewith, a potentially harmful compound (compound A) is formed that can be
      nephrotoxic. In the United States, the sevoflurane manufacturer therefore recommends keeping
      the FGF (FGF) at >2.0 L min-1 if a sodalime CO2 absorbent is used. Amsorb Plus® (Datex-Ohmeda
      Inc., Madison, WI, USA), is a novel type of CO2 absorbent that does not react with
      sevoflurane. This allows the FGF to be reduced to 0.5 L min-1. This has two important
      advantages: (i) less fresh sevoflurane is added to the circle system, and (ii) the
      sevoflurane that is in the system does not react with the CO2 absorber.

      Sevoflurane is a potent greenhouse gas with a 100 year CO2-equivalents of 120. Measures that
      can reduce the consumption of volatile anaesthetics could make a significant contribution to
      reducing the carbon footprint of the operative process. Additionally, Amsorb Plus® canisters
      seem to have a longer life span than sodalime canisters and do not need to be disposed of via
      toxic waste stream, but via domestic waste.

      In this study, we were interested if (i) the use of Amsorb Plus leads to a reduction in
      sevoflurane usage and therefore contribute to a reduction in the CO2 footprint of general
      anaesthesia with sevoflurane, (ii) Does the use of Amsorb Plus® lead to a reduction in the
      amount of (toxic) waste produced by operating theatres?

      Comparator: a traditional sodalime CO2 absorber (Medisorb™ Multi-Absorber Original,
      CareFusion, Helsinki, Finland).
    


Intervention name(s): Comparing two CO2 absorbers in the ventilator circuit
Intervention type(s): Other
Intervention description(s): General anaesthesia will be induced with a standardised regimen (propofol 0.8-2.5 mg·kg-1, sufentanil 0.2 - 0.5 µg·kg-1 and rocuronium 0.5 - 1 mg·kg-1). After tracheal intubation, anaesthesia will be maintained with sevoflurane targeted at 1 MAC end tidal concentration (corrected for age using the formula by Mapleson) in 40% O2. Different ventilator settings will be compared for 30 minutes (in randomised order):
I. Sodalime, FGF 2.0 L min-1. II. Amsorb Plus®, FGF 2.0 L min-1. III. Soda lime, FGF, 0.5 L min-1. IV. Amsorb Plus®, FGF 0.5 L min-1. FGF=fresh gas flow.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing general anesthesia with sevoflurane for > 2 hours.
The Effects of a High-fiber Formula in Children With Failure to Thrive
Condition: GI Tolerance
MeSH terms: Failure to Thrive
Study type: Observational

Summary: 
      The present study is designed to determine the gastrointestinal tolerability of enteral
      nutritional products, physicians and parents' overall perception of enteral nutrition
      products as well as providing basic demographic information on pediatric populations
      prescribed these formula for supportive treatment as part of the routine healthcare service
      in Turkey.
    


Intervention name(s): pediatric formula
Intervention type(s): Other
Intervention description(s): high-fiber enteral formula
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children diagnosed with failure to thrive who are receiving a high-fiber enteral formula
        for supportive treatment as part of the routine healthcare service in Turkey.
Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)
Condition: Dyslipidemia
MeSH terms: Renal Insufficiency; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in
      subjects with impaired renal function and healthy matched control subjects.
    


Intervention name(s): anacetrapib
Intervention type(s): Drug
Intervention description(s): single dose administration of anacetrapib (MK0859) 100 mg oral tablet
Intervention MeSH terms: Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Insufficiency
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses
           in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler
           (ECD) and transcranial color Doppler (TCD)

        2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).

        3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by
           clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and
           MRI/MRV parameters.

        4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty

        5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic
           angioplasty are associated with brain changes as measured by functional MRI (fMRI).
    


Intervention name(s): Venous Angioplasty; Sham Angioplasty
Intervention type(s): Other; Other
Intervention description(s): venous angiogram to look for lesions or flaps and then plastying vessels open.; Patients will be brought to the angio suite and will not know if they are having the venous angioplasty or not.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
Condition: Gout; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in
      gout patients with hyperuricemia
    


Intervention name(s): URC102 0.25mg; URC102 0.5mg; URC102 1.0mg; URC102 2.0mg; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
Condition: Pain, Postoperative; Irreversible Pulpitis; Apical Periodontitis
MeSH terms: Periodontitis; Pulpitis; Periapical Periodontitis; Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of continuous rotation and reciprocation
      kinematics on post operative pain and difference in substance P levels in patients with
      irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly
      distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation
      using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation
      group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system
      (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP)
      levels were measured using radioimmunoassay and postoperative pain was measured using
      Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.
    


Intervention name(s): EdgeEndo x7 continuous rotation files; EdgeOne Fire reciprocating files
Intervention type(s): Device; Device
Intervention description(s): endodontic files operating in continuous rotation; endodontic files operating in reciprocating motion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: pain; substance P; continuous rotation; reciprocation
Multi-Center Pilot Study of Cutera truSculpt Device
Condition: Treatment for Cellulite on the Stomach and Flanks
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
    

Detailed description: 
      This study will evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
    

Intervention name(s): Cutera truSculpt Device
Intervention type(s): Device
Intervention description(s): The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.
Intervention model: Single Group Assignment
Intervention model description: A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the
      treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum
      Disorder. The main goal of this study is to begin to address the void of information on
      safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar
      Disorder.
    

Detailed description: 
      Initial clinical evidence suggests that carbamazepine (CBZ) may play a therapeutic role in
      the management of pediatric bipolar disorder. A recent study found that nearly 50% of
      patients taking immediate-release CBZ had side effects while only 20% of patients had
      side-effects after switching to an extended release (ER) version of the drug, despite high
      doses. In addition, with an ER formulation of CBZ there is a potential for decrease in
      peak-related side effects and improved efficacy with higher blood levels. Thus, an ER
      formulation of CBZ may improve effectiveness and adherence to treatment.

      The goal of this pilot study is to evaluate the safety and effectiveness of Equetro in the
      treatment of bipolar I, bipolar II, and bipolar spectrum disorder in children ages 6-12 over
      the course of 8-weeks. We propose that during this exploratory study there will be sufficient
      safety, tolerability, and effectiveness of Equetro in the treatment of Pediatric Bipolar
      Disorder. The results of this study will be used to generate hypotheses for a larger
      randomized controlled clinical trial with explicit hypotheses and sufficient statistical
      power.
    

Intervention name(s): carbamazepine ER (Equetro)
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; children; mania; Equetro
A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this Phase III study is to compare the efficacy, safety and tolerability of
      dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic
      alopecia in the vertex region, types IIIv, IV and V according to the modified
      Norwood-Hamilton Classification.
    


Intervention name(s): Dutasteride 0.5mg oral tablets
Intervention type(s): Drug
Intervention description(s): Dutasteride
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dutasteride; Androgenic alopecia; phase 3