bioihbjkbjnl/mcl2 huggingface dataset:
Nicotinamide in the Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine if combination of topical calcipotriol and nicotinamide is more
      effective than calcipotriol alone in treatment of psoriasis.
    

Detailed description: 
      Current treatment strategies of psoriasis are not completely satisfactorily. By inhibiting
      inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments.
      Preliminary studies have shown that nicotinamide, which is a vitamin B derivative, is
      effective in the treatment of psoriasis. According to lack of data, we will investigate the
      beneficial effects of adding nicotinamide to calcipotriol for patients with mild to moderate
      psoriasis.
    

Intervention name(s): Calcipotriol plus Nicotinamide; Calcipotriol
Intervention type(s): Drug; Drug
Intervention description(s): Patients applied calcipotriol 0.005% and nicotinamide 4% in combination (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of one side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.; Patients applied calcipotriol 0.005% (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of the other side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.
Intervention MeSH terms: Calcitriol; Niacinamide; Niacin; Nicotinic Acids; Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Arterio-venous ECMO on Severe Sepsis and ARDS
Condition: Patients With Respiratory Failure and Shocked
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate and compare the effect of immunoadsorption effect of A-V ECMO on course of sepsis
      weaning from inotropes, weaning from the ventilator, duration of ICU stays and effect on
      mortality rate in patients with septic shock and respiratory failure due to ARDS followed
      severe lung contusion.
    

Detailed description: 
      100 patients with respiratory failure without improvement after 10 days ventilation due to
      development of VAP with ARDS, had >2 SOFA score and >6 CPIS score included in two groups 50
      patients in each. Only patients of group B put on A-V ECMO while patients of group A continue
      on traditional way of management. Improvement of ARDS &VAP, weaning from ventilation,
      duration of ICU stays, improvement of one/all parameters of both SOFA and CPIS scores,
      morbidity and mortality recorded and compared within 14 days.
    

Intervention name(s): Meropenem Injection; A-V ECMO
Intervention type(s): Drug; Device
Intervention description(s): patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture; Only patients of group B connected to A-V ECMO for two weeks
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 100 patients from those who showed no improvement after 10 days ventilation and still had respiratory failure and in need of high ventilatory parameters (as mentioned before), fulfilled > 2 parameters on SOFA score as illustrated in table (2), > 6 on CPIS score as illustrated in table (3) and developed circulatory failure (septic shock) with nor-adrenaline infusion and only on high dose of nor-adrenaline included in our study (>5microgram/kg/minute intravenous infusion as circulatory support). Since the parameters of those 100 patients selected are considered indication for arteriovenous extracorporeal membranous (A-V ECMO), so patients randomly allocated in two groups 50 patients in each. Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time
Masking: Single (Participant)
Primary purpose: Screening
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. This study is designed to evaluate the long-term immunogenicity and
      safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV
      vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals
      with objectives & outcome measures of the extension phase from Month 60 to Month 120. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month
      48 are presented in a separate protocol posting (NCT00316706).
    

Detailed description: 
      Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will
      be administered in this extension study.

      Results on outcome measures describing analyses on other studies are not reported in this
      record. Please refer to the records mentioned in the respective outcome measure titles.
    

Intervention name(s): Blood sampling
Intervention type(s): Procedure
Intervention description(s): Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine; cervical cancer
A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients
Condition: Vitamin D Deficiency; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml,
      is highly prevalent not only in the general population but also in chronic kidney disease
      (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease
      Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D
      supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with
      ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum
      levels-based titration regimen. However, this protocol has not been studied in end stage
      kidney disease patients treated with maintenance dialysis.
    

Detailed description: 
      The investigators plan to conduct a randomized study comparing the two different protocols
      between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol
      supplementation among dialysis patients for a total period of 6 months. At the study
      completion, investigators also plan to compare the proportion of participants achieving serum
      25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as
      non-skeletal effect of vitamin D supplementation for each group.
    

Intervention name(s): ergocalciferol supplementation; dialysis techniques; sunlight exposure time
Intervention type(s): Other; Other; Other
Intervention description(s): Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.; Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.; Both groups will be advised to receive similar hours of daily sunlight exposure time.
Other intervention name(s): nutritional vitamin D supplementation; mode of dialysis
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D insufficiency; dialysis; ergocalciferol
Safety, Tolerability, and Pharmacokinetics of MK-8266 in Elderly Participants With High Blood Pressure (MK-8266-003)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled study. The hypothesis for this study
      is that single oral doses of MK-8266 selected for this study are sufficiently safe and well
      tolerated by elderly male and elderly female participants with hypertension to permit
      continued clinical investigation.
    

Detailed description: 
      Two panels, each consisting of eight participants (8 elderly males with mild to moderate
      hypertension in Panel A and 8 elderly females with mild to moderate hypertension in Panel B)
      will be randomized to receive either MK-8266 or matching placebo in a 3:1 ratio. Participants
      will receive single doses of MK-8266 or matching placebo in three treatment periods (Periods
      1 through 3). In both Panel A and Panel B, doses will escalate in a rising, fixed sequence.
      In Period 1 (0.3 mg), Period 2 (0.6 mg), and Period 3 (0.7 mg and then 0.3 mg 10 hours later)
      once daily doses of MK-8266 or matching placebo will be administered.

      All participants will receive at least 2 doses of MK-8266. Participants completing placebo
      treatment in Period 1 will flow to the MK-8266 arm in the next period, with 2 participants
      from the MK-8266 arm receiving placebo in the next period.

      Blood samples will be obtained pre-dose and at selected time points up to 48 hours post-dose
      for determination of MK-8266 plasma concentrations.
    

Intervention name(s): MK-8266; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsules, 0.1 mg potency; Oral placebo capsules to match MK-8266 capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension
Validating a New Point-of-care Device for Estimation of Blood Count in Pregnant Women
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      Postpartum hemorrhage is a well-known complication of delivery and the leading cause of
      maternal mortality worldwide. In developed nations, a complete blood count (CBC) is commonly
      collected as a means to assess or base treatment for blood loss. The Hemi device is a
      point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic
      shock using artificial intelligence algorithms. The ultimate goal of the product is to
      provide an accurate hematocrit from easily attainable samples such as vaginal blood during
      hemorrhage to remove yet another barrier to access for actively bleeding women. The purpose
      of this study is to compare the hematocrit of vaginal blood using the Hemi device with
      standard venipuncture.
    

Detailed description: 
      This will be a prospective cohort study. The investigators will recruit 41 pregnant women
      admitted for delivery. Following delivery, a sample of vaginal blood will be collected and
      the Hemi device will be used to obtain hematocrit. These results will be masked to the
      clinical team until the time of data collection. A CBC will also be collected via
      venipuncture at this time. This study will be comparing hematocrit levels by standard
      clinical laboratory versus results from the device.
    

Intervention name(s): Hemi device
Intervention type(s): Device
Intervention description(s): A sample of vaginal blood will be collected following delivery and analyzed by the device to provide a hematocrit level, which will be masked to the clinical team.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes pregnant women admitted to the Labor & Delivery unit for
        delivery.
      
Keywords: Vaginal delivery
MR Images Variation With or Without Denture Wear
Condition: Magnetic Resonance Imaging
Study type: Interventional

Summary: 
      The objective of this study was to compare level of artifact while tongue at rest and in
      motion of dentulous subjects.
    

Detailed description: 
      The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially
      to detect cancer and disk displacement with temporomandibular disorders. The prevalence of
      tongue cancer may increase with ageing population. A clear MR image is indispensable for
      clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue
      movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be
      prominent with the patients without the occlusal support. The objective of this pilot study
      was to compare level of artifact while tongue at rest and in motion of dentulous subjects.
    

Intervention name(s): denture wear.
Intervention type(s): Device
Intervention description(s): MR Imaging was collected with or without denture wear.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Transcranial Direct Stimulation in Chronic Pelvic Pain
Condition: Pelvic Pain; Healthy
MeSH terms: Pelvic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether transcranial direct current stimulation
      (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is
      that tDCS will decrease pain significantly when compared to sham stimulation.
    

Detailed description: 
      The study encompasses two experiments: The first one involves patients with chronic pain,
      receiving 10 sessions of stimulation, active or sham (parallel design).

      The second experiment involves involves healthy subjects, receiving active or sham tDCS over
      the primary motor cortex (crossover design).
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes.
Other intervention name(s): tDCS, electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial direct current stimulation; Chronic Pelvic Pain
Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with
      Attention- Deficit/Hyperactivity Disorder
    


Intervention name(s): atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Group B Streptococcus Vaccine in Healthy Females
Condition: Group B Strep Infection
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study
      to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus
      vaccine.
    

Detailed description: 
      There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL
      injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24
      subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections,
      4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or
      placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®.

      Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at
      which point the decision will be made as to whether proceeding with administration of the
      doses in cohort 2 is appropriate.
    

Intervention name(s): GBS-NN/NN2 with Alhydrogel® 25; Placebo GBS-NN/NN2 with Alhydrogel® 25; Placebo GBS-NN/NN2 with Alhydrogel® 50; GBS-NN/NN2 with Alhydrogel® 50
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart; GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart; GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart; GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bracing During Infantile Scoliosis: Airways Study
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may
      impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal
      deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent
      curve progression, which may affect respiratory function.

      The acoustic reflection method is based on the analysis of the reflection of a single
      transient planar wave giving the longitudinal cross-sectional area profile of the examined
      cavity. It is noninvasive and harmless.

      The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with
      thoracic 3D reconstruction.

      The aim of the study is to evaluate the impact of bracing on the upper airways patency (by
      means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles
      assessment), and on the thoracic penetration index (by means of the EOS™)
    


Intervention name(s): Acoustic reflection method evaluation; EOS™; Non invasive respiratory muscle assessment
Intervention type(s): Device; Radiation; Other
Intervention description(s): Evaluation of airways by acoustic relection method, with and without the bracing device; Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device; Non invasive respiratory muscles assessment, with and without the bracing device.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with evolutive juvenile thoracic scoliosis requiring either a Milwaukee or a
        Cheneaux brace
      
Keywords: Infantile scoliosis; bracing; acoustic reflection method; EOS™; noninvasive; upper airways; thoracic penetration index; Idiopathic juvenile evolutive thoracic scoliosis
A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture
Condition: Zygomatic Fractures
MeSH terms: Zygomatic Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      In this study, a new method was proposed to calculate the length of sideburns mini incision
      for zygomatic arch fracture. The purpose of this study was to compare the sideburns mini
      incision calculated by this method with the coronal scalp incision, so as to determine the
      therapeutic effect and advantages of sideburns mini incision calculated by this method.
    

Detailed description: 
      Eighty patients with zygomatic arch fracture were treated with surgical intervention. Forty
      patients were treated with sideburns mini incision, and the other forty patients were treated
      with coronal scalp incision. Data such as incision length, operation time and postoperative
      complications were recorded. The follow-up periods were 6 months.
    

Intervention name(s): sideburns mini incision; coronal scalp incision
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators present a new method to calculate the shortest incision for zygomatic fracture, and use this method to calculate the sideburns mini incision for the surgical treatment of zygomatic arch fracture.; Coronal scalp incisions were used as control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zygomatic Arch; Fracture Fixation
To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
Condition: Growth and Development
Study type: Interventional

Summary: 
      To investigate the effect of nutritional supplement on bone turnover markers (which are
      sensitive and respond quickly to nutrition or drug intervention) in Indian healthy
      premenopausal women after 6 months of intervention.
    

Detailed description: 
      This will be a double blind, single-center, randomized-controlled trial testing the effect of
      fortified beverage on bone turnover markers as compared to placebo control in 25-45 years old
      premenopausal women. The study will consist of two groups: Group 1 (Test) - Protein rich
      beverage powder fortified with MMN and Group 2 (control) - Low protein non-fortified
      iso-caloric beverage powder.
    

Intervention name(s): Fortified Beverage Powder; Non fortified beverage Powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.; The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention