bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Probiotic on Modulation of the Intestinal Microbiota in Constipated Patients
Condition: Intestinal Bacteria Flora Disturbance; Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM,
      Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis
      HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will
      be correlated with the Quality of Life Questionnaire answers obtained from participants with
      intestinal transit problem. The Increase in the number of evacuations, as well as the
      improvement of complaints related to intestinal transit alteration will be evaluated during
      the study. The participants will use probiotic or placebo for a period of 28 days and the
      gastrointestinal function questionnaire and collect stool will be performed before the study
      and after period of treatment
    

Detailed description: 
      It is a double-blind, randomized, placebo control study that evaluated the action of a
      probiotic in relation to a placebo in the human intestinal microbiome by the technique of
      metagenomics, as well as evaluated the effects of this probiotic on the gastrointestinal
      transit of constipated participants.

      One hundred and twenty constipated patients will be randomized into two groups:Probiatop or
      Placebo. The first 22 patients from each group will also perform a metagenomic evaluation
      through the stool sample collection before and after of treatment. Besides these procedures,
      all patients will fill out a symptom assessment questionnaire at baseline of the study, and
      then after 14 and 28 days after the beginning of the treatment.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiatop is a live microbial preparation saches containing 1g of the formulation composed by Lactobacillus acidophilus NCFM, 10⁹, Lactobacillus rhamnosus HN001 10⁹, Lactobacillus paracasei LPC-37 10⁹, Bifidobacterium lactis HN019 10⁹ combined with Polydextrose.
Subjects will take two sachets per day after diluting them in 100 ml of water; The placebo sachets were prepared by substituting equivalent amounts of Maltodextrin for the probiotic powder.
Subjects will take two sachets per day after diluting them in 100 ml of water
Other intervention name(s): Probiatop
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: probiotic; metagenomic; constipation
A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, open-label, active-controlled, dose-finding, phase II study to
      evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with
      breast cancer receiving myelotoxic chemotherapy.

      Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose
      of F-627 or Filgrastim, in an equal ratio.
    

Detailed description: 
      This phase II study was conducted at 16 clinical centers in China and planned to enroll 150
      women with breast cancer who will receive chemotherapy that includes up to 4 cycles of
      epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively. Subjects would be
      randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or
      Filgrastim, in an equal ratio on Day 1 of the study. Patients will remain on their randomized
      study drug dose and regimen for each of the following 3 chemotherapy cycles. The chemotherapy
      to be administered for chemotherapy cycles 2-4 should be the same therapy administered to the
      subject on Day1.

      Chemotherapy will be administrated through intravenous IV) injection on Day 1 of each 21-day
      cycle and be repeated every 3 weeks for up to four cycles unless a dose delay is necessary.
      Approximately 48 hours after chemotherapy completion in cycle (day 3 of the cycle), patients
      will either receive a subcutaneous (SC) injection of F-627 (either 10 mg/dose or 20 mg/dose)
      or 5 μg/kg/dose filgrastim used up to two weeks or stopped while ANC more than 5 × 109/L.

      To track ANC concentration post chemotherapy, subjects returned to their study site for blood
      draws either daily (Cycle 1) or 3 times per week (every other day; Cycles 2-4) until ANC
      levels reached ≥2.0 × 109/L, post-nadir, and then every 3 days until the next chemotherapy
      cycle.

      All subjects returned for an End of Study visit approximately 3 weeks after their final study
      drug administration (Study Day 84) and had a follow-up phone call 30 days after the last
      study drug.
    

Intervention name(s): F-627; Filgrastim
Intervention type(s): Biological; Biological
Intervention description(s): F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles.; Filgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles.
Other intervention name(s): rh G-CSF
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia; Myelotoxic Chemotherapy; G-CSF
Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
Condition: Whiplash Associated Disorders; WAD; Whiplash
MeSH terms: Whiplash Injuries
Study type: Interventional

Summary: 
      This study is investigating whether changes in the shape and size of bodily muscles and
      spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC).
      The objective is to demonstrate that the presence of muscle and spinal cord degeneration and
      associated muscle weakness is the consequence of a mild MVC-related injury involving the
      cervical spinal cord.
    

Detailed description: 
      Whiplash is a condition that consists of patients that display varying degrees of pain and
      disability. Most patients should expect full-recovery within the first 2-3 months post
      injury. At the other end of the spectrum is a group of patients (~ 25%) who continue to have
      moderate-severe pain-related disability in the long-term. Reasons for this transition to
      chronicity are largely unknown. The situation would benefit if there were radiological
      findings of the disorder. However, clear and consistent findings of injured tissues on
      standard radiological exams remain elusive.

      As part of this study, the investigators will innovatively investigate measures to 1)
      quantify the temporal development of widespread muscle degeneration, 2) identify quantifiable
      markers of altered cervical spinal cord physiology, 3) quantify reductions in central
      activation and fatigue 4) evaluate potential genetic variants that may be associated with
      chronic pain after a MVC and 5) determine the mediational influence of psychosocial factors
      on recovery rates following whiplash injury, as a potential mechanism underlying the
      transition to chronic pain.
    

Intervention name(s): Pedometer; MRI
Intervention type(s): Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: whiplash; neck pain; chronic pain; motor vehicle accident; car accident; MRI; DNA; RNA
Advanced MRI in Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      Depression is the most common psychiatric disorder.

        -  3-5% of a given population has major depression.

        -  Less than 50% of the depressed in Denmark are diagnosed with major depression.

        -  25-50% of the depressed have a relative with major depression-underlying brain
           pathology?

      The purpose of this study is to use MRI to evaluate cerebral morphology and function in
      ambulant patients with major depression
    

Detailed description: 
      Previous studies within major depression, have often included hospitalized patients with
      severe symptoms and imaging have been performed with PET and SPECT, which uses ionizing
      radiation. This study focus on ambulant patients(with or without medication/ECT treatment),
      to find patients in an earlier stage. Cerebral perfusion with the MR sequence Arterial Spin
      Labelling, concentrations of different metabolites with MR spectroscopy and brain volumetry
      with BRAVO 3D T1 ax will be performed.

      MR protocol: T2 sag, T2 FLAIR ax, ASL ax, MRS and 3D T1 ax. Scan time 45 min.
    

Intervention name(s): Magnetic Resonance Imaging
Intervention type(s): Other
Intervention description(s): Morphological sequences
Arterial Spin Labelling (Perfusion)
Spectroscopy: anterior cingulate cortex Naa, Cho, Cr, Myo-inositol, glutamate TE 30 Reference voxel in Parietal white matter
Other intervention name(s): 3 Tesla GE Scanner HDx
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulant patients with major depression, selected from the Department of Psychatry, Aalborg
        hospital-Århus University Hospital.
      
Keywords: Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, Perfusion, brain
Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a IIa phase IIa open-label, non-randomized clinical trial of Antroquinonol, capsule,
      100 mg (Golden Biotechnology Corporation, Taiwan) in patients with AML.
    

Detailed description: 
      The given pilot clinical trial of a medicinal product for medical use, is held to evaluate
      preliminary efficacy and safety/tolerability profiles of antroquinonol in adult patients with
      relapsed AML or at initial diagnosis when no intensive treatment is possible.
    

Intervention name(s): Antroquinonol
Intervention type(s): Drug
Intervention description(s): Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
Other intervention name(s): Hocena
Intervention model: Single Group Assignment
Intervention model description: Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation.
Condition: Rosacea
MeSH terms: Rosacea; Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the role of topical Ivermectin 1% cream and its effect on protease and
      antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on
      the skin) in rosacea. This is a single-site 16-week open-label study at University of
      California, San Diego. The investigators will do this by first measuring serine protease
      activity and cathelicidin and skin microbiome of all subjects. All subjects will receive
      Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks.
      Participants will return for monthly visits during which their clinical symptoms of facial
      redness and number of facial papules will be scored, and they will have repeat tape stripping
      and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to
      determine serine protease activity and skin microbiome of participants at each of their
      visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at
      changes in serine protease activity and LL-37 expression and skin microbiome over time, and
      they will also determine whether or not these changes correlate with disease severity.
    


Intervention name(s): Ivermectin
Intervention type(s): Drug
Other intervention name(s): Soolantra
Intervention MeSH terms: Ivermectin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the impact on overall survival of an intensive
      follow-up protocol (as practiced today at TMH) against a more cost effective follow-up
      protocol in patients operated for extremity sarcoma.
    

Detailed description: 
      Follow up studies are performed for a variety of reasons. The detection of a recurrence of
      the index lesion is the foundation of surveillance. Detection of other medical conditions is
      a secondary benefit. Psychologically, follow up testing can serve as a source of reassurance.
      Whether an increased frequency of follow up and the use of various expensive imaging
      modalities for screening and early detection of recurrence actually results in improving
      overall survival of patients with extremity sarcomas is a question that remains as yet
      unanswered. Currently followed post -operative surveillance regimes are empirical and vary
      widely from centre to centre. Allocation of limited health funding should be guided by
      evidence based recommendations rather than empirical beliefs. An ideal surveillance regime
      should meet the criteria of easy implementation, accuracy and cost effectiveness.

      In a vast country like India where patients often travel thousands of kilometers in their
      search for quality medical care the frequency of routine follow up visits is as important as
      studying the role of expensive screening modalities while drawing up guidelines for cost
      effective follow up strategies.

      This study, a prospective randomized controlled trial, attempts to outline guidelines
      regarding the role of follow up vis a vis frequency and the use of various imaging modalities
      for early detection of recurrence in improving overall survival of patients with extremity
      sarcomas.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients operated for primary or recurrent extremity bone & soft tissue sarcomas
      
Keywords: bone tumor; soft tissue tumor
Comparing OTC Acne Treatment to Prescription Regimen
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This research is being done to find out the safety and efficacy of two acne creams, Effaclar
      and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA
      approved for the treatment of acne.
    

Detailed description: 
      There are many products on the market to treat facial acne. The medication that this study
      will be evaluating, Benzaclin and Retin-A have been approved by the FDA and is available by
      prescription, Effaclar is an over the counter product. This study will hopefully recognize a
      treatment combination that is effective in reducing acne vulgaris in adults 18-50.
    

Intervention name(s): BenzaClin; Effaclar
Intervention type(s): Drug; Drug
Intervention description(s): Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks; Topical, Bid, 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
AVAPS-AE Efficacy Study
Condition: Obesity Hypoventilation Syndrome
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of using of the Average Volume
      Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP)
      and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed
      with Obesity Hypoventilation syndrome (OHS).

      The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will
      yield daytime gas exchange values which are equivalent or no worse when compared to using
      CPAP and bilevel PSV modes of ventilation in the OHS population.
    


Intervention name(s): AVAPS-AE Mode of Therapy; Respironics OnmiLab BiPAP S mode; Respironics OmniLab Advanced CPAP mode
Intervention type(s): Device; Device; Device
Intervention description(s): AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.; Currently cleared Non-Invasive Ventilation (NIV) therapy modality; Currently cleared NIV therapy modality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: OHS
Levetiracetam 750 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of a test
      formulation of Levetiracetam and the reference Keppra® administered as a 1 x 750 mg tablet
      under fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): Levetiracetam; Keppra®
Intervention type(s): Drug; Drug
Intervention description(s): 750 mg Tablet; 750 mg Tablet
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects
Hemoglobin and INR Out of Nose Blood
Condition: Epistaxis
MeSH terms: Epistaxis
Study type: Observational

Summary: 
      Nose bleeding (epistaxis) is a common emergency. It is often difficult to estimate blood loss
      and the current hemoglobin of patients. In patients with oral anticoagulation, it is
      important to measure the level of hemodilution. Several situations with the importance of the
      fast determination of these parameters have been identified in previous studies [1,2]. The
      blood sampling from the venous punction is the standard in these investigations. However,
      this requires the corresponding painful puncture and also the time required at the
      laboratory.

      Since many patients present themselves with active bleeding, it is obvious that this blood
      could be used for determining the following parameters: Hemoglobin and INR/Quick. The nose
      blood can be analyzed with commercial rapid test devices. If these devices could generate
      same or similar results and after further validation of the method, painful punctures could
      be waived.
    

Detailed description: 
      Patients with active epistaxis are verbally elucidated about the study and the verbal consent
      is obtained. According to the agreement a few drops of nose blood are preserved. Subsequently
      the standard therapy is performed. This blood sample is promptly analyzed with the rapid test
      devices.

      We successfully applied the exception to the analysis of blood samples prior to obtaining the
      written consent due to following reasons: Analysis with the rapid test devices needs to be
      immediate and without delay in order to satisfy quality standards prescribed by the
      manufacturers. In addition, patient's treatment should not be delayed.

      Simultaneously, a venous blood sample for the corresponding values is carried out according
      to medical indications. After the treatment of the acute emergency and thus after the
      greatest stress situation, we ask the patient again whether he agrees to the study
      conditions. The written consent is obtained in the end of the acute treatment.

      Both inception and termination of the research project will be reported within 90 days of the
      Ethics Committee.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Potential candidates with active epistaxis are recruited consecutively at the Polyclinic.
      
Biospecimen description: 
      Nose blood
Acceptability and Tolerance Study of a Thickener
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and
      compliance of a thickener for the management of reflux, GORD and dysphagia
    

Detailed description: 
      To evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the
      submission to the Advisory Committee for Borderline Substances (ACBS).
    

Intervention name(s): Resource Thicken up Junior
Intervention type(s): Dietary Supplement
Intervention description(s): Each infant and child will be switch over to receive for a period of 7 days (new thickener)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infants and children
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or
      greater severity treated with CORT118335 will report decreased craving for alcohol following
      alcohol exposure in the laboratory and report significantly less drinking under naturalistic
      conditions, than those treated with placebo.
    


Intervention name(s): Miricorilant; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks; Six placebo tablets taken orally once daily for two weeks
Other intervention name(s): CORT118335; Sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment, Double-Blind, Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Alcohol-Related Disorders