bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Efficacy of a Novel Moisturizer Across Eight Weeks
Condition: Skin Health
Study type: Interventional

Summary: 
      Skin moisture is critical to avoid long-term skin damage. Without the necessary moisture,
      skin is unlikely to have the properties most commonly associated with healthy skin. Recent
      research has recently highlighted that rambutan extract, niacinamide, and glycoin can all
      help promote skin moisture and health. To help people experience better skin health, Thu
      Brulé has developed a serum designed to be used twice daily. Specifically, the test product
      in this trial was designed to help moisturize the skin and help lock in that moisture. The
      purpose of this trial is to examine the efficacy of the test product across an eight-week
      hybrid trial. The outcomes of interest include participants' perceptions of skin health and
      photographs/images taken of the skin.
    


Intervention name(s): Moisturizer
Intervention type(s): Other
Intervention description(s): The test product is a novel moisturizer, that contains active ingredients, including rambutan extract, niacinamide, and glycoin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Deep Brain Stimulation for the Treatment of Traumatic Brain Injury
Condition: TBI (Traumatic Brain Injury)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      This study involves the treatment of cognitive impairment secondary to moderate to severe
      brain injury using central thalamic deep brain stimulation. Although all patients will
      receive stimulation continuously through a surgically implanted pacemaker-like device, half
      of the patients will have the device deactivated during a blinded assessment phase. The
      device will be reactivated following this assessment and patients will have the option to
      continue stimulation in an open-label continuation.
    

Detailed description: 
      This preliminary safety study evaluates the use of the Medtronic Activa PC+S system and
      Medtronic Nexus-E system for central thalamic deep brain stimulation (CT-DBS) in the
      treatment of cognitive impairment secondary to traumatic brain injury (TBI). It involves a
      neurosurgical procedure in which electrodes are implanted in the brain, connected to an
      implanted pacemaker-like device in the chest. The proposed study, if successful, will provide
      supporting evidence for the development of a novel therapeutic approach utilizing CT-DBS to
      improve these enduring cognitive impairments arising in persons with multi-focal structural
      brain injuries. This research will address the critical gap of the lack of any available
      treatments. CT-DBS targets well-defined neuronal populations within the central thalamus that
      have known anatomical and physiological specializations, which not only provide a key role in
      arousal regulation during cognitively-mediated behaviors, but also exhibit a particular
      vulnerability to dysfunction in the setting of multi-focal, non-selective brain injuries.

      Our proposed study aims to support development of CT-DBS as a novel therapeutic avenue for
      accessing cognitive reserve in patients with acquired brain injuries. In the proposed
      feasibility study of 6 subjects at a single investigational site, we will test the safety of
      CT-DBS in the severe traumatic brain injury (STBI) population with GOSE 6-7 level recovery
      and collect data to establish the translation of preclinical studies into human application
      of CT-DBS.
    

Intervention name(s): Deep brain stimulation
Intervention type(s): Device
Intervention description(s): Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
Other intervention name(s): DBS; CT-DBS; Central Thalamic DBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep brain stimulation; DBS; Central thalamus; TBI; Traumatic brain injury
A Study to Assess Thymic Function Using PET/CT and MRI
Condition: CD34 Selected Peripheral Blood Stem Cell Graft
Study type: Observational

Summary: 
      The purpose of this study is to see if a positron emission tomography/computed tomography
      (PET/CT) scan and a magnetic resonance imaging (MRI) of the chest can assess changes in the
      thymus size and function. The researchers would like to monitor the thymus with a PET/CT scan
      and a MRI before and after the participants transplantation.
    


Intervention name(s): PET/CT scans; MRI
Intervention type(s): Device; Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MSK BMT clinic
      
Keywords: PET/CT; MRI; Assess Thymic Function; 16-1244
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the excretion kinetics and mass balance of
      fenebrutinib in healthy male subjects.
    


Intervention name(s): Fenebrutinib
Intervention type(s): Drug
Intervention description(s): 200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib
Other intervention name(s): RO7010939
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Randomized, Double-blinded Placebo-controlled Study to Investigate Antimicrobial Efficacy and Safety Following Topical Application of DPK-060
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study was to evaluate microbial density in eczematous lesions
      during two weeks of twice daily therapy with the investigational product, DPK-060 1%
      ointment, compared with placebo in patients with atopic dermatitis. This randomized,
      double-blind, placebo-controlled part of the study was preceded with an open-label
      investigation in a small group of patients (n=5) treated with two applications of DPK-060 1%
      ointment per day for four days to assess safety, local tolerability and systemic absorption
      of DPK-060.

      The secondary objectives were to evaluate severity of eczema and pruritus, to assess the
      tolerability and safety of the treatment and to assess the degree of systemic absorption of
      DPK-060 in blood on Day 7 and Day 21 in a sub-set of 10 patients.
    


Intervention name(s): DPK-060 1% ointment; Placebo for DPK-060 ointment
Intervention type(s): Drug; Drug
Intervention description(s): DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2; Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of High Voltage Pulsed Current (HVPC) and Low Level Laser Therapy (LLLT) on Wound Healing in Diabetic Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effects of high voltage pulsed current and low
      level laser therapy on the healing process of diabetic foot ulcers.
    

Detailed description: 
      Based in the literature review we concluded that LLLT and HVPC are effective in the healing
      wound. We did not meet outcomes of previous clinical studies, where compare the effectivity
      of two physical technologies. For the high prevalence of diabetic foot ulcers, the amputation
      risk and the consequent impairment and dysfunction in the quality of life, and the associated
      high costs for this health problem, it is important that new studies that identified
      effective treatment alternatives for promoting wound closure.
    

Intervention name(s): High voltage pulsed current; Low level laser; Standard nursing care
Intervention type(s): Device; Device; Other
Intervention description(s): The patient´s wounds were treated for 45 minutes with HVPC three times a week for 16 weeks or until their ulcers closed. The active electrode made of aluminum foil was secured directly over the wound, which previously had been loosely packed with sterile gauze soaked with 0.9% saline solution. The dispersive electrode was placed 5 cms proximal to the wound.The electrical stimulator Intelect 340 stim model (Chattanooga Group) produces a twin peaked pulse and was applied with the following parameters: continuous mode, submotor level, 100 Hz pulse frequency and 100microseconds pulse duration. Prior to the beginning the study the electrical stimulator was calibrated with oscilloscope (Tektronix TDS 1002 model).; Wavelenght 633 nm (DMC - Brazil), power 30 mW, continuous, 2 J/cm2 in the edge of the ulcer and 1.5 J/cm2 in the bed, punctual application in direct contact, 3 times a week, 1 every alternate day, for 16 weeks or until the ulcer closed. The laser device was calibrated before each treatment session with a research radiometer (International Light).; It was based to nursing intervention classification (NIC)46. These interventions were performed by a qualified nurse and included ulcer irrigation with physiological saline, sharp debridement as needed and maintenance of a moist wound environment with appropriate wound dressing. Patients were all educated regarding pressure off loading of the involved foot. All patients received standard wound care seven times a week for 16 weeks or until their ulcers closed.
Other intervention name(s): -electric stimulation; -high voltage stimulation; Soft laser; Laser therapy; LLLT; Standard wound care; Wound care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complications of Diabetes Mellitus; Electric stimulation; Low-Level Laser Therapy
Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the
      change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
    


Intervention name(s): Rivoglitazone HCl; rivoglitazone HCl; rivoglitazone HCl; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg tablets once daily for 12 weeks; 1.0 mg tablets once daily for 12 weeks; 1.5 mg tablets once daily for 12 weeks; Matching placebo tablets once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rivoglitazone HCl; thiazolidinedione; peroxisome proliferator-activated receptor gamma (PPARgamma); diabetes mellitus, type 2
Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of 'IL-YANG
      Quadrivalent Seasonal Influenza Vaccine' in healthy Korean children and adolescents.
    

Detailed description: 
      The study is an open-label(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part
      2), Active comparator(Part 2) Phase III study.

      Before initiation of any protocol-specific activities, written informed consent is obtained
      from each patient and their legally acceptable representatives. Subjects who meet all of the
      eligibility criteria after screening assessments as specified in the protocol, are randomized
      into the test group or the comparator group in a ratio of 4 :1 and receive a single dose or
      two doses of the study vaccine. The investigator perform the efficacy (immunogenicity) and
      safety assessments throughout the study. Efficacy data are collected at Visit 1 (prior to
      vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for
      safety assessment, subjects and their legally acceptable representatives are instructed to
      record any treatment-emergent adverse event in Patient Diary cards.

      For all randomized subjects, blood sample is obtained prior to vaccination, and the study
      vaccine 0.5mL is administered. For children aged from 3 years to <9 years of age who have not
      previously received influenza vaccine, another dose of the study vaccine is administered 4 to
      5 weeks after the first dose. Blood samples are collected 4 to 5 weeks after the last dose of
      the study drug for the assessment of antibody titer. All subjects are followed for 6 months
      after the last dose of the study drug for the safety assessments, and Month 6 follow-up visit
      is the end-of-study visit.
    

Intervention name(s): IL-YANG Quadrivalent Influenza Vaccine; IL-YANG Flu Vaccine Pre-filled Syringe
Intervention type(s): Biological; Biological
Intervention description(s): A single 0.5mL dose administrated as an intramuscular injection.; A single 0.5mL dose administrated as an intramuscular injection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine
Uterine Massage After Vaginal Delivery
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The participants will be randomized into an oxytocin plus uterine massage group and an
      oxytocin-only group in the third stage of the labor. Women allocated to the uterine massage
      group will be provided with trans-abdominal uterine massage starting promptly after delivery
      of the fetus until delivery of the placenta. The amount of postpartum hemorrhage and
      placental delivery time will be recorded and compared between the groups.
    

Detailed description: 
      Women allocated to oxytocin only group will be given 10 units of oxytocin intramuscularly
      immediately after delivery of the fetus. Women allocated to the oxytocin plus uterine massage
      group will be will be given 10 units of oxytocin intramuscularly immediately after delivery
      of the fetus and will be provided with trans-abdominal uterine massage starting promptly
      after delivery of the fetus until delivery of the placenta. Collection of blood loss will be
      initiated immediately after delivery of the fetus by putting a drape under the woman's
      buttocks. Collected blood will be weighed and the amount will be recorded in grams.
    

Intervention name(s): active management of third stage of labor
Intervention type(s): Procedure
Intervention description(s): Active management of the third stage of the labor will be done administering oxytocin and cord traction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Condition: Pediatric Brain Stem Glioma
MeSH terms: Glioma
Study type: Interventional

Summary: 
      This Trial offers a reduction in patient burden, which is especially preferable in children
      with a poor compliance and poor performance status. This prospective randomized trial was
      extension to the previous controlled prospective study performed in Children's Cancer
      Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this
      work is to demonstrate noninferiority of the hypofractionated regimens relative to the
      conventional regimen in a controlled randomized clinical study.
    

Detailed description: 
      In this study will add a third arm in which we will increase in the total dose to 4500 cGy in
      15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free
      Survival.
    

Intervention name(s): Hypofractionated Arm (1); Hypofractionated Arm (2); Conventional Arm (3)
Intervention type(s): Radiation; Radiation; Radiation
Intervention description(s): A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week; The total dose to 4500 cGy in 15 fractions in 3 weeks; A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse Intrinsic Pontine Glioma (DIPG); Hypofractionated Radiotherapy; Radiotherapy; Median survival
Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Condition: PreDiabetes; Obesity
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin
      A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that
      programs such weight management classes and one-on-one counseling with registered dieticians
      can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser
      Permanente Colorado members in these activities is low. The purpose of this study is to
      determine which of three outreach methods is most effective in increasing engagement in these
      activities.
    


Intervention name(s): EHR gaps; Bulk outreach; Dietician call
Intervention type(s): Other; Other; Other
Intervention description(s): Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; A bulk letter or email will be sent; Patients will receive a personalized call by a registered dietitian
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index >=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.
Masking: None (Open Label)
Primary purpose: Health Services Research
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
Condition: Zinc Deficiency; Inflammation; Metabolic Diseases; Vascular Diseases
MeSH terms: Vascular Diseases; Metabolic Diseases; Inflammation
Study type: Interventional

Summary: 
      The objective of the current study is to test the overarching hypothesis that the beef
      nutritive matrix is uniquely suited to direct dietary zinc to cellular compartments for
      improved metabolic function, leading to a greater effect on health outcomes. Specifically,
      whether beef, as a component of a healthy meal, will promote the absorption of zinc into
      cells, where the zinc will have greater effects on zinc-dependent metabolic processes
      supporting cardiovascular health. To maximize the observability of these beef-related
      effects, individuals who are 55- to 70-year-old who generally have a higher risk of zinc
      deficiency and cardiovascular disease will be enrolled.
    

Detailed description: 
      This study will examine whether daily beef intake will promote the absorption of dietary zinc
      into cells, leading to improved cellular zinc status and microvascular function. The study
      design will be a crossover comparison of a mixed diet including green leafy vegetables,
      fruits, whole grains, seeds, and nuts; with beef versus non-meat sources of additional
      protein and zinc, over two 4-week metabolic study periods.

      Outcomes will include cellular zinc status determined by erythrocyte zinc tracer exchange
      (primary), and microvascular function expressed as reactive hyperemia index (RHI). Previous
      studies have demonstrated that zinc tracer exchange with red blood cells (RBC) is highly
      sensitive to changes in zinc nutriture. Thus, cellular zinc status will be determined using a
      novel and cost-effective adaptation of this approach, modeling zinc tracer exchange with
      freshly-sampled RBC. As intracellular zinc can regulate vascular tone, microvascular function
      will be measured, using digital peripheral tonometry, will be used as a functional index of
      both cellular zinc status and vascular health.
    

Intervention name(s): Beef protein
Intervention type(s): Other
Intervention description(s): Animal protein source
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover comparison of a mixed diet including green leafy vegetables, fruits, whole grains, seeds, and nuts; with beef versus non-meat sources of additional protein and zinc, over two 4-week metabolic study periods.
Masking: None (Open Label)
Primary purpose: Prevention
Secular Trends in the Prevalence of Diabetes in India
Condition: Type2 Diabetes; PreDiabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Observational

Summary: 
      Series of epidemiological studies have been carried out by the research team since 1988
      studying the changes in the prevalence of type 2 diabetes, prediabetes and associated risk
      factors. These studies have shown that the determinants to rising prevalence of diabetes vary
      among populations and with time. Comparative studies from the same region can help to
      understand the secular changes occurring in a specific population. In this proposal we intend
      to conduct a cross-sectional survey with varied levels of urbanisation and compare the
      findings with our earlier reported data to assess the degree of changes in dysglycaemic
      prevalences. The primary aim of the proposal is to study the secular changes and the
      prevalence of diabetes, prediabetes and associated cardio-metabolic risk factors with varying
      levels of urbanization.

      A multi-stage random selection method will be used. Field workers will conduct an enumeration
      of the individuals above 20 years of age. In each location, streets will be randomly selected
      to have an equal representativeness from different socio-economic strata. All eligible family
      members of the selected households are invited for the survey. The study outcomes will be of
      relevance in public health research in modeling effective national healthcare policies.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Households of selected families of a city, town and peri-urban village