bioihbjkbjnl/mcl2 huggingface dataset:
Response of Clostridium Difficile Infection to Metronidazole Therapy
Condition: Clostridium Enterocolitis; Pseudomembranous Colitis; Antibiotic-Associated Colitis
MeSH terms: Clostridium Infections; Enterocolitis, Pseudomembranous; Colitis; Enterocolitis
Study type: Observational

Summary: 
      In this record review study, our objective is to determine the rates of cure, failure and
      relapse following treatment of C. difficile colitis with metronidazole.
    

Detailed description: 
      Clostridium difficile is a major cause of nosocomial infection. When this organism
      proliferates in the colon, usually as a result of prior antibiotic therapy in a hospitalized
      or otherwise debilitated person, a variety of potentially serious consequences follow, such
      as fever, leukocytosis, abdominal pain, diarrhea and ileus. Some patients require surgical
      exploration and colectomy, and our hospital has had several deaths attributable to C.
      difficile colitis in the past year.

      C. difficile colitis is treated with metronidazole, and earlier literature on this subject,
      written in the 1980's and early 1990s, suggests that the response rate is excellent,
      exceeding 90-95%. Our clinical observation has suggested that treatment with metronidazole is
      followed by a surprisingly high rate of failure, perhaps 25-30%. The clinical problem is that
      there are, at present, no desirable alternatives. Vancomycin, given orally, is said to be
      highly effective in treating this infection, but this may not be true, and the administration
      of this drug is associated with emergence of vancomycin-resistant bacteria, a major problem
      in modern hospitals. No other drug is approved for treatment of C. difficile infection.

      We believe it is important to determine the actual rate of failure of treatment with
      metronidazole. This will provide an impetus for developing new therapeutic approaches.

      We will review the records of patients who have been treated for confirmed C. difficile
      infection with metronidazole at the VAMC for the past 12 months in order to determine the
      rates of cure, failure, and relapse following therapy. This is a simple record review study
      to determine if our clinical suspicion is correct, namely, if the rate of failure of
      metronidazole therapy is much higher than that reported in the medical literature of 10-15
      years ago.
    

Intervention name(s): Metronidazole
Intervention type(s): Drug
Intervention MeSH terms: Metronidazole
Keywords: Clostridium difficile
Changes in Brain Activity (Functional MRI Study) Before and After Behavioral Therapy of Height Phobia
Condition: Height Phobia; Fear of Heights
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      We are interested in investigating the functional brain abnormalities of height phobia.
      Subjects will be have a functional MRI scan before and after a course of treatment with
      behavioral therapy.
    

Detailed description: 
      The purpose of this study is to investigate the effects of in vivo exposure therapy on the
      functional brain activity of subjects with height phobia using a fear provocation paradigm.
      We expect differential activation of the fear circuitry in height phobics compared to
      non-phobic controls, and that successful behavioral therapy will normalize the heightened
      fear response in height phobia.
    

Intervention name(s): Behavior therapy
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Height phobia; fear of heights; specific phobia
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of IH636 grape seed extract may prevent breast cancer.

      PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed
      extract in preventing breast cancer in postmenopausal women at risk of developing breast
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of
           suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of
           developing breast cancer.

        -  Determine the safety and tolerability of this dietary supplement, in terms of symptoms
           and changes in markers of bone and lipid metabolism and in markers of nonspecific
           adrenal suppression, in these participants.

        -  Determine, preliminarily, an optimum biologic dose of this dietary supplement, as
           defined by suppression of serum estradiol, in these participants.

        -  Determine a minimum duration of use of this dietary supplement to achieve aromatase
           inhibition in these participants.

      OUTLINE: This is a pilot, dose-finding, placebo-controlled study.

      Participants receive oral placebo once or twice daily on days -14 to 0. Participants then
      receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85.
      Treatment continues in the absence of toxicity.

      Cohorts of 6 participants receive one of four dose levels of IH636 grape seed
      proanthocyanidin extract up to an established safe dose.

      PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12
      months.
    

Intervention name(s): IH636 grape seed proanthocyanidin extract
Intervention type(s): Dietary Supplement
Intervention description(s): Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
Condition: T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
MeSH terms: Liver Diseases; Fatty Liver
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study
      performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and
      dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (>5.5% as
      measured with magnetic resonance imaging (MRI))
    


Intervention name(s): placebo; Omega-3 carboxylic acids; Dapagliflozin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo matching to Omega-3 carboxylic acids (olive oil); 4 g administered as 4 x 1 g capsules; 10 mg administered as 10 mg tablet; Placebo matching to dapagliflozin 10 mg
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: omega-3 carboxylic acid
Smoking Cessation Treatment With Transdermal Nicotine Replacement Therapy - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at how feasible it is to incorporate a state-of-the-art
      smoking cessation treatment program into community substance abuse treatment programs and its
      impact on substance abuse and cigarette smoking.
    


Intervention name(s): nicotine transdermal system
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Primary purpose: Treatment
Keywords: nicotine dependence
Conservative Management of DeQuervain's Tendinopathy With an Orthopaedic Manual Therapy Approach Emphasizing First CMC Manipulation: A Retrospective Case Series
Condition: DeQuervain's Tendinopathy
MeSH terms: Tendinopathy
Study type: Observational

Summary: 
      This is a retrospective review of three patients with DeQuervain's Tendinopathy (DQT) that
      had successful outcomes with a manual therapy focused approach provided by Physical Therapist
      management.
    

Detailed description: 
      DeQuervain's tendinopathy (DQT) is a musculoskeletal disorder that limits hand function of
      affected individuals. Management of DQT can include splinting, activity modification,
      medications, corticosteroid injections, Physical Therapy, and surgery. There is limited
      evidence to support the combination of manual therapy and exercise interventions within an
      Orthopaedic Manual Physical Therapy (OMPT) approach when managing patients with DQT. Three
      patients identified with DQT underwent a multi-modal treatment regimen including
      carpometacarpal (CMC) thrust and non-thrust manipulation, end range radiocarpal mobilization,
      mobilization with movement (MWM), strengthening exercises, and grip proprioception training.
      Outcomes were assessed using the numeric pain rating scale (NPRS), Jamar hand dynamometer
      grip strength, and the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH)
      questionnaire. These measures were administered at baseline and discharge.
    

Intervention name(s): Physical Therapist management
Intervention type(s): Other
Intervention description(s): Physical Therapist management included joint manipulation, mobilization with movement, strengthening exercises, and grip proprioception training.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with DeQuervain's tendinopathy.
      
Keywords: DeQuervain's tendinopathy; CMC manipulation; Physical Therapy
Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda
Condition: Respiratory Infections in Children
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      This is a stepped wedge, cluster randomized study of a clinical algorithm that includes
      point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village
      health workers for children presenting with acute respiratory illness in the Bugoye
      sub-county of the Kasese District in southwestern Uganda.

      The purpose of this study is to assess the impact of the algorithm on antibiotic use.
    


Intervention name(s): STAR Sick Child Job Aid
Intervention type(s): Other
Intervention description(s): The STAR Sick Child Job Aid is a modified ICCM protocol that includes the addition of a point-of-care C-reactive protein (CRP) test to inform antibiotic treatment decisions for children presenting with febrile acute respiratory illness who do not have any danger signs. If CRP ≥ 40 mg/L, the village health worker (VHW) will dispense amoxicillin per local guidelines. If CRP < 40 mg/L, the VHW will advise symptomatic care alone including acetaminophen for fever and additional fluids to maintain hydration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Stepped wedge, cluster randomized trial with 5 clusters or treatment sequences of 3 villages each. Villages are first stratified by altitude, proximity to the local health center, and size (based on approximate number of children seen by the village health workers per year) into one of three strata: (1) low altitude, proximal, large, (2) low altitude, mid-distance, medium, (3) high altitude, distal, small. One village is then randomly selected from each strata for each of the 5 clusters. All clusters start in the control condition and one cluster crosses over from control to intervention each month.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Community health workers; C-reactive protein
Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates whether OROS-methylphenidate improves performance on different
      aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder
      (ADHD).
    

Detailed description: 
      This study investigates the effect of Osmotic-Release Oral System (OROS)-methylphenidate, a
      long-acting stimulant, on multiple dimensions of attention and on working memory.
      Specifically, we will investigate the following two hypotheses: (1) OROS-methylphenidate will
      result in improved performance on measures assessing multiple domains of attention, including
      sustained attention, attentional control, selective attention, and divided attention, and (2)
      OROS-methylphenidate will result in improved performance on measures of working memory. In
      addition we will use the study to collect pilot data on whether the magnitude of the effect
      of OROS-methylphenidate varies across the different components of attention and working
      memory and whether improvement across any of these measures is helpful in predicting parent
      or teacher ratings of improvement.
    

Intervention name(s): Placebo; OROS-methylphenidate
Intervention type(s): Drug; Drug
Intervention description(s): Placebo (sugar pill); 18 mg to 54 mg once a day for 1 week
Other intervention name(s): Concerta; Osmotic-Release Oral System -methylphenidate
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate; Attention; Working Memory
Bioavailability of Diosmin/Hesperidin (90/10) 500 mg Tablets With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pilot study investigated the bioavailability in adult human subjects of 1 tablet
      formulations containing Diosmin/Hesperidin (90/10) 500 mg. The Pilot study was performed at a
      single site with 12 subjects. Participants took 1 tablets of the test product and reference
      product in 2 periods and 2 sequences (either test after reference or reference after test).
      There was a washout of 7 days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of

      Diosmin/Hesperidin (90/10) of 1 tablet formulations with Diosmin/Hesperidin (90/10) 500 mg to
      demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Daflon [Trademark], product of Les Laboratoires Servier, France.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to infinite
      (AUC0-inf), and maximum plasma concentration (Cmax) for total metabolite Diosmetin and
      Hesperetin was determined. Participants were confined in the study site for approximately 42
      hours during each study period (for 10 hours pre-dosing and for 32 hours post dosing) during
      which pharmacokinetic (PK) blood samples were obtained. 21 blood samples were taken up to 32
      hours after the administration in each period. Participants returned to the site to provide
      additional blood samples at 48 h, and 72 h postdose. The washout period between the two study
      periods was 7days. The samples from each participant were analyzed with validated LC-MS/MS
      method used for estimation of Diosmetin and Hesperetin in plasma.

      The safety objective was to evaluate the tolerability of both formulations in subjects by
      collecting adverse events.
    

Intervention name(s): Diosmin/Hesperidin (90/10) 500 mg Test Drug; Diosmin/Hesperidin (90/10) 500 mg Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Daflon (Trademark)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fasting Condition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate bioequivalence between Test Product (A):
      Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding
      Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg, manufactured by Astellas Pharma,
      Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.
    

Detailed description: 
      Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 240 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to dose
      administration and for at least 4 hours post dose. Standardized meals will be provided in
      each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours
      Post dose in each period. A total of 23 blood samples will be withdrawn for pharmacokinetic
      profiling. The whole blood concentrations of Tacrolimus will be measured by a validated
      LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log
      transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on
      log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence
      interval will be constructed for the ratio of geometric least square mean of the Test and
      Reference products, obtained from the log-transformed data. Bioequivalence will be concluded
      if the ratio estimate as well as its 90% confidence interval, both falls within the
      acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
    

Intervention name(s): Tacrolimus 1 mg capsule
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
Other intervention name(s): Tacrolimus Capsule
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain
Condition: Functional Abdominal Pain Syndrome; Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      This trial aims to compare two training programs for children suffering functional abdominal
      pain. These two programs are comparable in number of sessions and group sizes, but show
      differences in content (very focused on pain management vs. more general information and
      support). Focus of the trial is the evaluation of "Stop the pain", which has shown high
      effectiveness in one first trial. This time, five clinics, experienced in diagnosis and
      treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are
      eligible. The programs imply six weekly group sessions for the children and 2 parent
      evenings. The study group assumes that participation in "Stop the pain" will reduce pain
      experience and will improve the children's quality of life and coping strategies - up to 12
      months after training.
    

Detailed description: 
      The trial aims to assess the efficacy of a cognitive-behavioral self-management program
      (intervention group, IG) compared to an equally extensive information-only control group
      (CG). The interventions contain 6 weekly group sessions and 2 parent meetings according to
      the cognitive-behavioral, manualized program "Stop the pain with Happy Pingu". Follow up per
      patient: 3- and 12 months. Children aged 7-12 years suffering functional abdominal pain
      (according to Rome III criteria H2a, H2b, H2d, H2d1) are eligible. Our primary hypothesis is
      that for patients in the IG the frequency and intensity of pain will be reduced more
      successfully and more sustainable than for children in the CG. Secondary hypotheses state
      that the IG will experience a higher increase in quality of life and psychosocial well-being
      compared to the active CG.
    

Intervention name(s): Intervention group; Active control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive-behavioral intervention; Education and information
Other intervention name(s): Stop the pain with Happy Pingu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional abdominal pain; psychological intervention; quality of life; Randomized controlled trial; children
The Effect of Covid-19 Process
Condition: Covid19; Participation, Patient
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      Objective: The purpose of this study was to investigate the effect of the Covid-19 process on
      time management, participation, and leisure time activity.

      Methods: 531 individuals aged between 18-65 were included in the study. The individuals were
      evaluated with the Assessment Of Time Management Skills (ATMS) in terms of time management,
      with the Social Isolation Questionnaire (SIQ) in terms of participation, and with the
      Interest Checklist (IC) in terms of leisure time activities.
    


Intervention name(s): Time management & participation & the leisure time activity
Intervention type(s): Behavioral
Intervention description(s): evaluated in terms of leisure time activities, time management and participation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        aged between 18-65, signed "Informed Consent Form" and fulfilled the inclusion criteria
      
Keywords: Covid-19; leisure time activities; participation; time management