bioihbjkbjnl/mcl2 huggingface dataset:
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
Condition: Appetite; Dietary Intake; Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Prebiotics and probiotics are thought to play a role in appetite control and body weight
      regulation; but little is known about this topic. This study was planned to examine the
      effects of inulin and Lactobacillus casei 431 on short and long term fasting, satiety,
      dietary intake, and serum hunger and satiety hormone levels. The study consisted of 2 phases.
      In the first phase, a double-blind, randomized, crossover study design was used, and it was
      performed with 16 healthy male participants aged 19-30 years. In this phase, the prebiotic
      (200mL milk+16g inulin), probiotic (200mL milk + Lactobacillus casei 431 [>106 cfu/mL]+16g
      maltodextrin), synbiotic (200mL milk+16g inulin + Lactobacillus casei 431 [>106 cfu/mL]) and
      control (200mL milk+16g maltodextrin) test drinks were consumed with a standard breakfast on
      four separate test days by one week intervals, and their effects on dietary intake, hunger,
      satiety and appetite were assessed. The second phase was performed with 21 healthy male
      participants aged 19-30 years, using a placebo-controlled double-blind, randomized study
      design. Participants consumed the control (200mL milk+16g maltodextrin) or synbiotic (200mL
      milk+16g inulin+ Lactobacillus casei [>106 cfu/mL]) test drinks for 21 days with their
      habitual diet. At the beginning and end of the intervention, blood samples were collected at
      0., 30., 60. and 120. minutes following the test day protocol to analyse serum glucose,
      insulin, ghrelin, obestatin and PYY (peptide tyrosine tyrosine) levels. In addition, dietary
      intake, hunger, satiety and appetite of participants were compared.
    


Intervention name(s): Synbiotic test drink; Control drink
Intervention type(s): Other; Other
Intervention description(s): In a healthy male population, participants consumed a synbiotic test drink containing 200 mL milk + 16 g inulin + Lactobacillus casei431 [>106cfu/mL] per day for 21 days with their habitual diet.; In a healthy male population, participants consumed a synbiotic test drink containing 200 mL milk + 16 g maltodextrin per day for 21 days with their habitual diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has two phases. First phase had a randomised, double blind, placebo-controlled crossover study design.
The second phase had a randomized, double-blind, placebo-controlled parallel study design. The second phase is going to be described below.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: prebiotic; probiotic; synbiotic; hunger and satiety hormones
Telemedicine in Sleep Breathing Disorders: a Multicenter Study.
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      In recent years medicine has been enhanced by the incorporation of technological innovations
      from areas as diverse as cell biology, biochemistry, genetics, biophysics and bioengineering.
      One of the few exceptions in this rapid process of implementing technological advances occurs
      in clinical medicine, where its penetration is much less effective than in other scientific
      and professional fields, or even in everyday life. Attempts to tackle this problem have given
      rise to various initiatives in the US and Europe, including Spain.

      There is a surprising paucity of telemedicine systems in clinical practice, especially with
      respect to sleep-related breathing disorders, and most particularly obstructive sleep apnea
      (OSA), where protocols are urgently needed to alleviate this healthcare problem represented
      by its under-diagnosis and comorbidity, as well as the long waiting lists for treatment. In
      others words, the growing awareness of sleep disorders, especially OSA, has not been
      accompanied by strategic changes in the cost-effective diagnosis and/or treatment of these
      diseases.

      CPAP therapy compliance is not always appropriate. Helping patients during the first two
      months usually determines compliance. Therefore, the development of strategies to support the
      patient during the first weeks is essential. However, this "collides" with reality, where it
      is difficult to properly care all patients because of congested sleep units. It is therefore
      necessary to implement new and imaginative control schemes especially at the beginning of the
      treatment. Patients' follow-up performed by telemedicine technology is an option that aims to
      substitute the face-to-face visits or at least reduce them considerably. In a future context,
      the idea is that the professional in charge of CPAP patients monitoring has on his/her agenda
      face-to-face visits and televisits (at distance) and information which patient will provide
      through online questionnaires with a certain frequency.

      In this sense, this project aims to analyze whether CPAP treatment compliance of OSA patients
      monitored by telemedicine techniques (website and televisits) is similar to that achieved by
      standard monitoring but more cost-effective. The study design is a multicenter randomized
      trial with parallel groups and blind final evaluation after CPAP treatment following two
      different strategies: one through conventional monitoring in the hospital (face-to-face
      visiting) and another by telemedicine monitoring (non-contact visiting and website).
    


Intervention name(s): Telemedicine CPAP monitoring (webpage and televisit); Standard CPAP monitoring
Intervention type(s): Other; Other
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive
      pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4
      (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug
      therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical
      drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study
      will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when
      administered concomitantly with repeat doses of itraconazole in healthy males and females.
      Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed
      by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects
      will be enrolled such that approximately 16 evaluable subjects complete the study. Each
      subject will participate in the study for approximately 7 weeks including screening visit, 2
      treatment periods and a follow up visit.
    


Intervention name(s): Nemiralisib; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTA® is a registered trademark of GlaxoSmithKline group of companies.; Itraconazole will be given as 100 mg per capsule per day administered orally with water
Intervention MeSH terms: Itraconazole; Nemiralisib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will receive nemiralisib alone on Day 1 in Period 1 and itraconazole from Day 1 to Day 10 followed by nemiralisib on Day 5 in Period 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nemiralisib; Pharmacokinetics; Itraconazole; Drug-drug Interaction; Cross-over
Brief Group Psychotherapy for Anxiety and Depression
Condition: Affective Disorder
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      The present work aims to develop a randomized clinical trial with a sample of 100 patients
      diagnosed with anxiety and depression in primary care. All participants are tested by several
      self-reports related to emotional disorders in a repeated measures design, pre and post
      treatment. It is our aim this study will demonstrate that brief psychological treatments
      should be prioritized over pharmacological treatment in Primary Care. In addition, emotional
      regulation will be assessed and examined as a key factor in the clinical improvement.
    


Intervention name(s): Psychological treatment; Medication
Intervention type(s): Behavioral; Drug
Intervention description(s): Psychological treatment; Pharmacological intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of the Use of a Single Dose of Erythropoietin to Treat Acute Myocardial Ischemia
Condition: CABG; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 study that evaluates the effect of intravenous administration of a bolus
      EPO on the activation of EPOR-signal transduction cascades and myocardial apoptosis during
      cardiopulmonary bypass surgery. Human atrial and ventricular tissue will be collected during
      CABG surgery for 3-vessel disease for the assay of EPOR signaling and apoptosis. Two atrial
      specimens will be collected before and at the end of cardiopulmonary bypass (CPB).
      Concomitantly, two transmural ventricular biopsies will be obtained, at the start and at the
      end of CPB. Immediately after obtaining the first atrial biopsy, one bolus of EPO will be
      administered intravenously. The atrial tissue will be split and appropriate sections will be
      frozen for determination of baseline expression or activity of a number of molecules
      including Erk1/2, STAT5, Akt and caspase-3 or embedded in paraffin for immunohistochemistry.
      Ventricular tissue will only be processed for immunohistochemistry. Additionally, plasma will
      be collected before the procedure and for up to 30 days post-procedure to examine release of
      markers of both myocardial ischemia and stress (CK-MB, Troponin T and NT-proBNP) and renal
      dysfunction (cystatin C, creatinine for eGFR). Before initializing the randomised study, a
      pilot study will be performed with 5 subjects that will not be treated to evaluate the
      feasibility of myocardial sample collection. Initiation of the randomised study will only
      commence if baseline activity of EPOR-STC can be determined in the atrial tissue and
      caspase-3 positive cells can be identified in the second ventricular biopsy.
    


Intervention name(s): Epoetin alpha; NaCl 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of epoetin alpha during CABG for three vessel disease, 60.000 IU intravenously.; A single dose of NaCl 0.9% during CABG for three vessel disease, 1 ml intravenously.
Other intervention name(s): Eprex; Saline
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Apoptosis; CABG; Coronary Artery Disease; Three Vessel Disease; Erythropoietin; EPO-receptor signaling
Effects of Manual Lumbar and Prone Traction in Patients With Low Back Pain
Condition: Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The study determined the effects of manual Lumbar traction and prone traction on some
      clinical variables of patients with long standing low back pain.
    

Detailed description: 
      Traction therapy has been used in the management of low back pain (LBP) especially None
      Specific Low Back Pain. There are several recommendations on how lumbar traction should be
      performed, but the type of technique to be applied differs among the sources. Prone traction
      adapted from inversion therapy which is a form of gravitational traction has been reported to
      be effective in ameliorating disabilities of patients with low back pain as well reduce pain
      intensity. Manual lumbar traction is performed by the therapist, pulling at the patient's
      ankles and has been reported to be effective in relieving pain and reducing disability of
      patient with None Specific Low Back Pain (NSLBP). Documented evidences on the efficacy of
      traction in non-specific low back pain are still inconclusive. While manual lumbar traction
      seems more commonly used, probably owing to its positional advantage, its relative
      effectiveness compared with manual prone traction is still unknown, hence this study.
      Therefore, the aim of this study was to examine the efficacy of manual lumbar traction and
      prone traction on pain intensity, disability, spinal range of motion and quality of life in
      patients with None Specific Low Back Pain.
    

Intervention name(s): Manual lumbar traction; Prone traction
Intervention type(s): Other; Other
Intervention description(s): Patient in the group were treated with manual traction; Patient in the group were placed on prone traction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The group underwent manual lumbar traction with the patient lying prone on a couch using a manual technique by pulling from the ankles of the patient. Manual traction was performed by the therapist, pulling at the patient's ankles.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Manual Lumbar Traction; Prone Traction; Pain Intensity; Low back pain; Disability
Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function
Condition: Contact Lens Disinfecting Solutions
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to measure the relative "barrier" function of the top layer of
      the cornea (called the epithelium), or the degree to which the cornea can prevent the
      penetration of the colored dye sodium fluorescein into the eye. This is a clinical
      investigation of the effect on corneal barrier function following wear of two contact lens
      materials and two contact lens care systems, approved for marketing in the US by the Food and
      Drug Administration. These contact lenses will be worn for two hours, following soak in one
      of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact
      lens wearers will participate.
    


Intervention name(s): ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution; Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution; Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution; ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours; Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours; Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours; Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: staining; epithelial barrier function
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of experimental medication BMS-986165
      in healthy male participants.
    


Intervention name(s): BMS-986165; MMF
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Mycophenolate Mofetil
Intervention MeSH terms: Mycophenolic Acid; Deucravacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
Condition: Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The aim of this study was to determine whether segmental re-examination of the each segment
      (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate
      (ADR) and to evaluate the time-effectiveness of this approach.
    

Detailed description: 
      The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were
      scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced
      colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or
      polyposis syndrome, or were unable to provide informed consent. In addition, if the quality
      of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in
      any segment of the colon), or if the cecum could not be intubated during the colonoscopy,
      patients were excluded.

      A randomization list was generated with the randomization algorithm of random sorting, using
      Excel program. Included patients were randomly assigned to one of the two groups: segmental
      re-examination group, in which the each segment (right colon, mid-colon, and left colon) was
      examined twice segmentally; or control group, in which the withdrawal time in the each
      segment was about 2 minutes.
    

Intervention name(s): segmental reexamination
Intervention type(s): Other
Intervention description(s): segmental reexamination during colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
A First-in-human Study of Multiple Doses of Topically Administered PF-07295324 and PF-07259955
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, (local and systemic) tolerability, and
      pharmacokinetics following multiple doses of topically applied, maximum feasible formulations
      of PF-07295324 (0.12% w/w) or PF-07259955 (2% w/w), on approximately 20% body surface area
      (BSA), in healthy adult participants.
    


Intervention name(s): PF-07295324; PF-07259955
Intervention type(s): Drug; Drug
Intervention description(s): Ointment; Cream
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of a Patient Education Tool For Leiomyoma
Condition: Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The goal of this study was to assess whether using a multimedia tool would enhance patient
      education and counseling on uterine leiomyomata.
    

Detailed description: 
      Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology
      clinic at a single institution were randomized to receive either standard counseling or
      multimedia counseling using the drawMD OB/GYN iPad application. Participants completed a
      pre-counseling questionnaire, received the designated method of counseling, and then
      completed a post-counseling questionnaire.
    

Intervention name(s): iPad counseling; Standard Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive multimedia counseling using the drawMD OB/GYN iPad application.; Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive standard counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation Onset Time of DWP450-004 and Safety in Moderate-severe Glabellar Lines
Condition: Moderate-severe Glabellar Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate onset time and safety of improvement effect of each group's forehead wrinkles after
      2, 3, 4, 5, 14 days from administration of 20U dosage of DWP450-004 for adult patients who
      need more than moderate improvement of forehead wrinkles.
    

Detailed description: 
      Currently, botulinum type A toxin related products are used not only in treatment areas but
      they are used often in cosmetic area as well and frequency of usage is increasing as well.
      Daewoong Pharmaceutical Co., Ltd. has developed a safe product by identifying wild-type
      Clostridium botulinum (type A) strain and purifying high purity, high quality botulinum toxin
      type A proteins from the strain. As a result of characteristic analysis (genotype analysis,
      morphological / biochemical characteristic verification test, toxicity test, etc) of the
      identified fungi, it was confirmed that the biological and chemicophysical properties are
      equal to those of wild-type Clostridium botulinum (type A, Hall strain).

      Regarding treatment satisfaction of those patients who were administered with botulinum toxin
      product, onset time plays an important role as a factor. Limitation found when reviewing the
      existing publications was in defining onset time solely on the determination of effect simply
      on response to whether there was an improvement. However, this study defines improvement rate
      of glabellar lines as ratio of reduction of more than 1 point from the baseline by
      investigator and thus it appears more objective data can be obtained than existing studies.
      Therefore, with this background, we intend to conduct phase 4 clinical study to explore onset
      time for DWP450-004 injection's glabellar lines improvement effect.
    

Intervention name(s): Single group, open-label
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment