bioihbjkbjnl/mcl2 huggingface dataset:
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Condition: Acne; Healthy
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to characterize the shift in the diversity and abundance of the skin
      microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl
      peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.
    

Detailed description: 
      With the advent of 16S rRNA sequencing, scientific community is beginning to understand the
      critical importance of the microbiome in human health. In dermatology, researchers have begun
      to lead the effort to not only better understand how the microbiome contributes to the
      pathogenesis of skin disease, but also harness its power to develop novel therapies. Acne is
      a common inflammatory skin disorder. P. acnes on the skin has been traditionally thought of
      as the culprit bacteria in the pathogenesis of acne.

      Recent studies demonstrate that the skin microbial composition dynamically changes in
      response to systemic acne therapy. Using 16 rRNA gene sequencing, a prior study has confirmed
      that systemic antibiotic treatment decreased the abundance of P. acnes, which returned to
      baseline after discontinuation of the therapy. In contrast, the systemic therapy increased
      the abundance of Pseudomonas species, which returned to baseline after therapy cessation.
      Based on the opposing response to the therapy, it can be speculated that these two species
      compete for the same microenvironment within the skin microbiome. Interestingly, the same
      systemic therapy decreased the abundance of lactobacillus genus, the "good bacteria" that is
      protective against skin infection, and that decrease was sustained even after cessation of
      the therapy. Similarly, another study has demonstrated that systemic isotretinoin therapy
      disturbed the skin microbiome in acne patients with increased bacterial diversity on the
      cheeks. It is unclear the potential therapeutic role of the increased bacterial diversity in
      the management of acne patients.

      The study aims to characterize the shift in the diversity and abundance of the skin microbial
      community in response to Altreno in acne patients. Understanding the role of the skin
      microbiome in response to therapy can help clinicians to develop tailored, targeted treatment
      options, including reconstitution of "good bacteria." Furthermore, it can lead to development
      of novel topical pre and probiotics.
    

Intervention name(s): Altreno; Benzoyl peroxide
Intervention type(s): Drug; Drug
Intervention description(s): Acne patients will be assigned to Altreno once daily.; Acne patients will be assigned to BPO leave-on gel once daily.
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Abdominal Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo/positive drug parallel controlled design was used to
      evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection
      using different dosing regimens in subjects with moderate to severe pain after abdominal
      surgery.
    


Intervention name(s): LPM3480392 Injection; Placebo; morphine hydrochloride injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PCA administration; PCA administration; PCA administration
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Labetalol on Human Cocaine Use - 8
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of labetalol treatment on the subjective
      and physiological effects of cocaine.
    

Detailed description: 
      The goal of this study was to investigate the safety and utility of labetalol an alpha and
      beta adrenergic block, for cocaine dependence in humans. A total of 12 subjects were enrolled
      in this double blind, placebo controlled outpatient study. After baseline measures are
      obtained, three experimental sessions were held at least 2 days apart. Subjects were
      administered a single low (100 mg) or high dose of labetalol (200mg) or placebo on each of 3
      experimental sessions. The labetalol doses were given in ascending order and the placebo
      treatment were randomly inserted into the sequence. A single dose of smoked cocaine (0.4
      mg/kg) was administered 2 hrs after labetalol or placebo treatment. During the sessions,
      several subjective, behavioral and physiological measures were obtained.
    

Intervention name(s): Labetalol
Intervention type(s): Drug
Intervention MeSH terms: Labetalol
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections
Condition: Musculoskeletal Infection; Acute Hematogenous Osteomyelitis; Septic Arthritis; Osteomyelitis; Pyomyositis
MeSH terms: Infections; Communicable Diseases; Osteomyelitis; Arthritis, Infectious; Pyomyositis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of a blood test: Karius® plasma-based
      next-generation sequencing test (Karius Test), to see if we can detect and measure the
      infection causing agent in children with musculoskeletal infections (MSKI).
    

Detailed description: 
      children admitted to Riley Hospital for Children (RHC) with musculoskeletal infections
      (osteomyelitis, septic arthritis, or pyomyositis) over a 12-month period will be
      prospectively enrolled. Eligible subjects will be identified by referral from the infectious
      diseases and orthopedic services at RHC. Blood samples will be obtained on the day of
      admission (within 48hrs), and 24 hours after the admission sample for real-time NGS
      (next-generation sequencing) testing at Karius Laboratory (Redwood City, CA). If a pathogen
      is identified by NGS, in either of the first two samples, subsequent samples will be sent
      every 48-72 hours while inpatient, and then collected every 1-2 weeks after hospital
      discharge, while being treated for MSKI (maximum 3 follow-up samples). If both of the initial
      inpatient NGS samples are negative, no further samples will be sent for NGS. Pathogen
      identification by NGS will be compared to standard cultures methods, and quantitative cfDNA
      (cell-free DNA) will be evaluated over time.
    

Intervention name(s): Karius Test
Intervention type(s): Diagnostic Test
Intervention description(s): Next-generation sequencing of blood and synovial fluid samples for pathogen identification in children with musculoskeletal infections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: infection; plasma based next generation sequencing; blood culture; tissue culture; joint fluid culture; pathogen identification
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical trial is to determine the safety and efficacy of scopolamine
      utilized in conjunction with naltrexone for the treatment of major depression.
    

Detailed description: 
      The study will be a double blinded, randomized controlled trial. The medications will be
      administered orally. The sample size will be 40 participants, 20 in the treatment group and
      20 in the control group. The study period will be 4 weeks. Eligible participants will have
      major depression by history for at least 8 weeks, between 18-65 years old, and in generally
      good health other than depression. The MADRS questionaire will be utilized to determine the
      response to the medications.
    

Intervention name(s): Scopolamine and naltrexone; placebo arm
Intervention type(s): Drug; Drug
Intervention description(s): participants will receive scopolamine and naltrexone in buccal drops; participants will receive placebo medications
Intervention MeSH terms: Scopolamine; Naltrexone; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized, controlled parallel design
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      In this prospective, intervention study, participants with diagnosed Parkinson's disease will
      be instructed to follow a Mediterranean diet for five weeks. Gut permeability will be
      assessed using food-grade sugar molecules. Participants will provide urine and stool samples
      to assess gut permeability and microbial communities.
    


Intervention name(s): Mediterranean Diet
Intervention type(s): Other
Intervention description(s): Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consumption of ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fresh fruits (including natural juices); d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish or seafood (at least one serving of fatty fish); f) ≥3 weekly serving of nuts or seeds; g) select white instead of red meats or processed meats (burgers, sausages); h) cook at least twice a week with a tomato herb sauce.
Participants will be instructed to eliminate or limit the consumption of the following foods: cream, butter, margarine, cold meat, paté, duck, carbonated and/or sugared beverages, pastries, industrial bakery products and desserts, French fries or potato chips, and out-of-home pre-cooked cakes and sweets. For usual drinkers, the main source of alcohol should be wine.
Intervention model: Single Group Assignment
Intervention model description: A prospective intervention study in which participants with diagnosed Parkinson's disease are instructed to follow the Mediterranean diet for a 5-week intervention period.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intestinal Permeability; Mediterranean Diet; Leaky Gut; Intestinal Barrier Function
Digital Subtraction Radiography Evaluation of SMART Restoration With Partial Caries Removal in Primary Teeth
Condition: Dental Caries Extending Into Dentine
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The objective of this study was to analyze the radiographic density of digital subtraction
      radiographs after SMART restoration with partial caries removal in primary molars at 6 and 12
      months.
    

Detailed description: 
      In management of deep caries in primary teeth, the partial caries removal approach favored
      the arrest of dentin carious lesions, reduced cariogenic micro-organisms and the risk of pulp
      exposure. The carious tissue at the lateral walls of the cavity at the enamel dentin junction
      (EDJ) was removed by a spoon excavator without carious tissue removal at the pulpal site.
      After caries removal, restoration using glass ionomer cement (GIC)(GC Fuji IX™GP extra) was
      completed. Such an approach is called SMART restoration. The serial radiographs of each
      restoration consisted of three radiographs; immediately after restoration, at the 6-month
      follow-up and at the 12-month follow-ups. Digital subtraction radiography(DSR) was used to
      evaluate dentin remineralization following partial caries removal. Image-Pro Plus software
      was used to evaluate DSR. For evaluating the changes in DSR, areas with increase density show
      higher radiopacity, whereas areas with decreased density show higher radiolucency. The
      6-month and 12-month follow-up radiographs were subtracted from the baseline radiograph.
    

Intervention name(s): partial caries removal only at enamel dentin junction.
Intervention type(s): Procedure
Intervention description(s): Partial caries removal only at enamel dentin junction (EDJ) without carious dentin removal at the pulpal site and restoration with glass ionomer cement(SMART restoration)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dentin remineralization; caries regression
Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether NAC added to prednisone, and azathioprine
      has a better effect on lung function, radiology and clinical condition than placebo +
      prednisone in combination with azathioprine after 6 and 12 months.
    


Intervention name(s): n-acetylcysteine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg x 3, for 12 months; Placebo
Other intervention name(s): Flumucil
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idiopathic Pulmonary Fibrosis
Effect of Red Ginseng Extract on Changes in Indicators of Immune Function in Vietnamese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a placebo-controlled, randomized, double-blind, multiple dose study that evaluated
      the safety, tolerability, and changes in indicators of immune function of Korean Red Ginseng
      Extract in Vietnamese healthy subjects following oral administration of multiple dose of
      Korean Red Ginseng Extract as hard capsules or placebo to healthy adult men.
    


Intervention name(s): KRG hard capsule; Placebo hard capsule
Intervention type(s): Drug; Drug
Intervention description(s): Each subject was given orally 2 KRG hard capsules/day for 12 weeks; Each subject was given orally 2 placebo hard capsules/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
A FAMILY Program for Childhood Overweight and Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Childhood overweight and obesity is a health problem with lifelong implications related to
      diabetes, hypertension, cardiovascular disease, psychological disorders as well as other
      chronic conditions.
    

Detailed description: 
      In Taiwan, the nationwide prevalence of overweight and obesity among school-age children aged
      7 to 11 years has also increased over the past years. Sleep and weight are intricately
      related. School-age children requires at least 10 hours of sleep per night but children in
      Asian countries are on average obtaining shorter sleep than children in Caucasian countries.
    

Intervention name(s): Behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention has an intensive phase and a maintenance phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%.
      This stems from the prevalence of trainee operators coupled with the non-specific nature of
      loss-of-resistance. In the current randomized trial, we will set out to compare conventional
      and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research
      hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease
      the failure rate of thoracic epidural blocks.
    


Intervention name(s): Waveform-confirmed loss-of-resistance
Intervention type(s): Procedure
Intervention description(s): Using waveform analysis to confirm thoracic epidural space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural waveform analysis; Loss of resistance
Recollection Training in Healthy Older Adults and Older Adults With Amnestic Mild Cognitive Impairment
Condition: Amnestic Mild Cognitive Impairment; Aging
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      We have developed a training intervention that successfully improves older adults' memory. We
      have also shown that older adults whose memory is as good as younger adults' memory (Hi-Old)
      use an altered pattern of memory-related brain activity compared to younger adults, whereas
      healthy older adults with poorer memory (Lo-Old) do not. We have also shown that individuals
      with amnestic Mild Cognitive Impairment (aMCI) have impairments of conscious, effortful,
      Recollection-based memory processes, whereas their automatic, Familiarity-based memory
      processes are intact. Our primary current goal is to investigate whether our successful
      memory intervention will improve Recollection and produce induce altered patterns of brain
      activity in the Lo-Old and aMCI.

      Young, Lo-Old, Hi-Old, and aMCI will be scanned using functional magnetic resonance imaging
      while performing two memory tasks. Half of the Lo-Old and half of the aMCI will then receive
      the memory intervention, while the other half in each group will receive a control program
      consisting of information and games about aging. The Lo-Old and aMCI will then be rescanned
      while performing the two memory tasks. We predict that the memory intervention will improve
      performance on a number of memory tasks, and will induce altered patterns of brain activity.
      In the Lo-Old, their brain activity after the memory intervention will look more like the
      Hi-Old, while brain activity will become more focal in the aMCI.
    


Intervention name(s): Recollection Training; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are exposed to long lists of words. Each word is presented either visually or auditorily, and each word is repeated after a variable number of intervening words (the lag), in each the same modality, or the other modality. Participants are instructed to respond "yes" only to words repeated in the same modality. If a performance criterion is met, the lag is increased for the next session; if the performance criterion is not met, the same lag is repeated in the next session.; Participants view PowerPoint presentations on various topics related to memory and aging (e.g., structural brain changes, diet, stress, depression) and how each of these topics affect memory, and after each presentation, play a Jeopardy-like game to test their knowledge gain
Other intervention name(s): Memory training; Educational Control
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: recollection training; aging; amnestic mild cognitive impairment; fMRI
Guided Bone Regeneration Using Bovine-derived Xenograft in Combination With or Without Injectable Platelet-rich Fibrin
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      The aim of the study was to compare the change in augmentation thickness after guided bone
      regeneration (GBR) using bovine-derived xenograft in combination with or without injectable
      platelet-rich fibrin (i-PRF).

      This randomized-controlled clinical trial was conducted on patients with horizontal bone
      deficiency in the posterior regions of mandible. After implant placement, GBR procedures were
      randomly performed using i-PRF enriched bovine-derived xenograft (test group) or bovine
      derived xenograft alone (control group). Cone-beam computed tomography was taken at the
      implant sites immediately, and 6 months after surgery for assess the change in augmentation
      thickness as the primary outcome of the study. The secondary outcomes included marginal bone
      level and implant survival rate.
    

Detailed description: 
      The study was conducted on patients who had partially edentulism with horizontal deficiency
      of the alveolar bone in the posterior regions of mandible.

      All patients were informed about treatment protocol of the study and also, the risks and
      benefits associated with participation. Each patient provided written informed consent prior
      to enrollment.

      Randomization was performed after the dental implant surgeries and the patients were randomly
      assigned to one of the study groups:

      Test group included 22 patients treated with GBR using i-PRF-enriched bovine-derived
      xenograft + resorbable membrane Control group included 22 patients treated with GBR using
      bovine-derived xenograft + resorbable membrane All patients underwent two-stage surgical
      protocol that performed by the same experienced surgeon. Following implant placement,
      i-PRF-enriched bovine-derived xenograft for the test group and bovine-derived xenograft alone
      for the control group was carefully positioned with light compression around the implants.
      Finally, the resorbable membrane was placed to cover the augmented area.

      As the second stage of surgery, healing caps were placed and the implant-supported fixed
      prosthesis were completed in approximately one to two months.
    

Intervention name(s): bovine-derived xenograft with i-PRF; bovine-derived xenograft alone
Intervention type(s): Procedure; Procedure
Intervention description(s): Bovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site.; Bovine-derived xenograft was placed in the augmentation site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Guided bone regeneration; Bovine-derived xenograft; Injectable platelet-rich fibrin
Safety of AEB071 in Healthy Volunteers and to Compare the Ethnicity, Metabolic, and Safety Effects Between Caucasian and Japanese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the safety effects after multiple doses of AEB071 in healthy
      volunteers and to compare the ethnicity, metabolic, and safety effects between Caucasian and
      Japanese healthy subjects receiving single and multiple doses of AEB071.
    


Intervention name(s): AEB071
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Healthy Caucasians; Healthy Japanese subjects; Immunosuppressant; early T-cell activation blockers; inhibition of protein kinase C