bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects
Condition: Healthy Volunteers; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the drug interaction between fostamatinib and
      digoxin by comparing the safety, tolerability and plasma concentration of digoxin when
      administered alone and with fostamatinib in healthy subjects.
    


Intervention name(s): Digoxin; Fostamatinib
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15; oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; pharmacokinetics; Rheumatoid arthritis; RA, Fostamatinib; Digoxin, drug-drug interaction; Scientific terminology: Rheumatoid arthritis; Fostamatinib; Digoxin; drug-drug interaction; Laymen terminology: Rheumatoid arthritis; Amount of Digoxin in blood
Text Messaging Adherence to Stimulant Medication
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an individualized text messaging intervention
      for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in
      improving medication adherence and disease management.
    


Intervention name(s): Text- Messaging; Treatment as usual
Intervention type(s): Other; Other
Intervention description(s): Text messages will be sent to the parents of children enrolled in the study.; Children will receive stimulant treatment for ADHD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Attention Deficit Hyperactivity Disorder; Medication adherence; Disease management; Text message; ADHD; Children; Reminder systems; Text Messaging; Telemedicine
Pilot Study of a Decision Aid Intervention for Family-building After Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      This study tests a web-based decision aid and planning too to help young female cancer
      survivors manage fertility and family-building issues in post treatment survivorship.
    

Detailed description: 
      The overall goal of this work is to pilot test a single-arm intervention of a decision aid
      and planning tool (website) to assist young adult female cancer survivors in making decisions
      and preparing for family-building after cancer.

      Primary Objective: Examine feasibility and acceptability of a decision aid intervention in a
      single-arm pilot trial.

      Secondary Objective: Obtain preliminary effect sizes of the decision aid intervention using a
      pre-post study design.
    

Intervention name(s): Web based decision aid intervention
Intervention type(s): Behavioral
Intervention description(s): Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
PEG-IFN in HBV Patients With Incomplete Response to NA
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment with a nucleoside analogue and subsequent viral decline has shown to partially
      restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies
      investigating whether the effect of lowering viral load with nucleoside analogue therapy
      prior to the initiation of peginterferon results in higher sustained off-treatment responses
      showed contradictory findings.

      The aim of this study is to investigate sustained off-treatment response to peginterferon
      alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide
      analogues, thereby lowering viral load
    


Intervention name(s): Nucleos(t)ide analogue treatment with a peginterferon add-on strategy; Nucleos(t)ide analogue treatment
Intervention type(s): Drug; Drug
Intervention description(s): peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues; Treatment with one of the approved nucleos(t)ide analogues
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; sustained response; peginterferon; nucleos(t)ide analogues
Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults
Condition: Hypotension During Surgery
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for
      Injection for induction and maintenance of general anesthesia in elective short-term surgery
      in adults.

      Main research indicators:(1)Success rate of sedation during induction and maintenance of
      general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in
      the induction and maintenance phases Study design: Multi-center, randomized, double-blind
      clinical study. Subject population: patients undergoing elective short-term surgery. Research
      data collection period: The subject signs the consent form until discharge or death in the
      hospital or withdrawal from the research.

      Number of research centers/sample size: It is planned to enroll 600 patients from 11
      hospitals.

      Research process: The researchers will include patients who meet the enrollment criteria and
      agree to participate in the investigation of the support laryngoscope surgery and minor head
      and neck surgery patients from the elective surgery patients.
    

Detailed description: 
      The data collected in this study is recorded by the researcher in the eCRF, including:

        1. Data to be collected during the screening period and before the operation: the basic
           characteristics of the patient and demographic data;

        2. Data to be recorded during and/or postoperatively: main research indicators, secondary
           indicators and other indicators.
    

Intervention name(s): Remimazolam Tosilate for Injection 0.1mg/kg; Remimazolam Tosilate for Injection 0.15mg/kg; Remimazolam Tosilate for Injection 0.2mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Remimazolam Tosilate for Injection 0.1mg/kg at induction; Remimazolam Tosilate for Injection 0.15mg/kg at induction; Remimazolam Tosilate for Injection 0.2mg/kg at induction
Other intervention name(s): low dose group; medium dose group; high dose group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome
Condition: Diet Modification
Study type: Interventional

Summary: 
      The primary purpose of this study is to assess whether consuming foods from animals raised
      with antimicrobial medications influences gut health in adults between the ages of 21-69
      years old. Antimicrobial medications are commonly used to help animals avoid infections while
      growing.
    

Detailed description: 
      The researchers plan to investigate differences in the resistome (i.e., populations of
      antimicrobial resistance genes) and microbiome (populations of bacteria) in feces obtained
      from people when they consume diets containing beef derived from cattle raised conventionally
      (i.e. using antimicrobial drugs(AMDs)) vs. those produced in raised without antibiotics (RWA)
      systems. In addition, the researchers will investigate whether specific antimicrobial
      resistant (AMR) genes are transmitted from food to people.

      The hypothesis is that beef is not a significant source of resistant bacteria, and there is
      no difference in the likelihood of gut colonization with resistant bacteria in people eating
      beef derived from cattle raised conventionally (i.e. using AMDs) vs. those eating beef
      produced in RWA systems.
    

Intervention name(s): Controlled diet with beef raised without antibiotics; Controlled diet with beef produced in conventional systems
Intervention type(s): Other; Other
Intervention description(s): The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised without antibiotics.; The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised with antibiotics.
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 16-week randomized, cross-over, controlled, blinded study. During weeks 2 and 9, participants usual, unrestricted dietary intakes will be assessed. At week 3 the participants will be randomized and assigned to consume either the controlled U.S. Healthy Eating Pattern with beef produced in conventional systems or to an identical controlled U.S. Healthy Eating Patter with beef produced in RWA (raised without antibiotics) systems. Week 10 will be the second 3- week long dietary intervention period. A total of 14 stool samples will be collected during the study (two after baseline, washout 1 and washout 2, and 4 during the two dietary interventions). Two fasting state serum samples and a psychological questionnaire will be collected during study weeks 2, 5, 9, and 12.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: antibiotics; gut microbiome; antimicrobial resistance; beef
Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
Condition: Urethrocystoscopy Skills
Study type: Interventional

Summary: 
      Develop a tool to objectively quantify technical skills necessary to perform diagnostic
      cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).

      Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or
      judged.

      Develop an intervention (1.5 hour workshop) which can be replicated by other residency
      programs in order to enhance learning of diagnostic cystoscopy. The workshop should be
      adequate for practicing Gynecologists as well as they already have experience with diagnostic
      hysteroscopy which uses many of the same concepts.
    

Detailed description: 
      The OSATS and a written examination will be used to assess residents skills and knowledge
      pertinent to diagnostic urethrocystoscopy. All residents will be tested on anatomic replica
      of human bladder for baseline competency using the above tools. Then approximately half will
      be randomly selected to undergo an educational intervention (a workshop teaching diagnostic
      urethrocystoscopy). As we are interested in short-term acquisition, about a week later all
      residents will be retested using the same methods. Grades on the exam will be kept
      confidential.
    

Intervention name(s): educational workshop; no intervention (usual resident activities)
Intervention type(s): Other; Other
Intervention description(s): The intervention group will view a 20 minute video, receive a 30 minute didactic lecture on urethrocystoscopy, and 30 minute coaching/practice performing diagnostic cystoscopy on anatomic replicas.; usual activities
Other intervention name(s): Objective structured assessment of surgical skills (OSATS), diagnostic cystoscopy,; urethrocystoscopy skills intervention, objective evaluation of procedure skills intervention,; educational workshops, cystoscopy classes, cystoscopy certificate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: urethrocystoscopy; cystoscopy; objective structured assessment of surgical skills (OSATS)
Flurbiprofen Tape for Treatment of Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen
      tape for chronic low back pain (lasting greater than 3 months).
    

Detailed description: 
      This study is a multi-center, randomized, double-blind, placebo-controlled study in patients
      with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration.
      Patients also had an average daily pain score of 4 or greater on an 11-point categorical pain
      scale for the last 3 days of the baseline phase. The study began with a 14-day washout period
      of previously used pain medications. At the end of the 14-day baseline phase, patients were
      randomized to 1 of 4 treatments: Flurbiprofen tape applied once daily for 12 hours,
      Flurbiprofen tape applied once daily for 24 hours, placebo tape applied once daily for 12
      hours, or placebo tape applied once daily for 24 hours. During the 7-day treatment phase,
      patients applied 2 treatment tapes once daily for 7 days. The tapes remained on for 12 or 24
      hours of continuous treatment, depending on the treatment to which they were randomized.
      Patients were provided with rescue medication. After 7 days of tape treatment, patients
      returned to the clinic for a study exit visit.
    

Intervention name(s): Placebo Tape (Arm 1); Flurbiprofen Tape (Arm 2); Placebo Tape (Arm 3); Flurbiprofen Tape (Arm 4)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.; Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.; Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.; Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
Intervention MeSH terms: Flurbiprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Flurbiprofen, low back pain, chronic low back pain
Osteoprotegerin Before and After Periodontal Surgery
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The study hypothesis:

      Is Osteoprotegerin a diagnostic and/or prognostic marker of periodontal disease?
    

Detailed description: 
      assessment of osteoprotegerin in patients with chronic periodontitis before and after
      periodontal surgery in gingival crevicular fluid, saliva and gingival tissues.
    

Intervention name(s): Open flap debridement
Intervention type(s): Procedure
Intervention description(s): an access flap
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Osteoprotegerin; Biomarker; Chronic periodontitis; Open flap debridement
Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse
Condition: Posttraumatic Stress Disorder; Substance Abuse
MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and
      substance abuse among persons with serious mental illness (SMI) treated in a community
      setting.

      Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use
      disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center,
      served through the Orange Person Chatham (OPC) Area Program.

      Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the
      CBT intervention plus treatment as usual; or, 2) treatment as usual.
    


Intervention name(s): CBT and exposure therapy for PTSD; Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): The CBT intervention will be administered twice weekly in group therapy sessions for 7 weeks, and then twice weekly individual sessions for 4 weeks.; Participants in the treatment as usual condition will receive their usual services at the community clinic where they receive mental health and substance abuse services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP
      20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg
      (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical
      Co. Fort Washington, PA 19034 USA under fasting conditions.
    

Detailed description: 
      Following an overnight fast of at least 10 hour, a single oral dose of famotidine tablets,
      USP 20 mg or Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg)
      was administered during each period of the study, along with 240 mL of drinking water at
      ambient temperature and under supervision of trained study personnel.

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study for all the subjects.
    

Intervention name(s): Famotidine
Intervention type(s): Drug
Intervention description(s): Tablets
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Famotidine tablets fasting study
Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone
Condition: Corticotropin Deficiency; Fasting
Study type: Interventional
Phase: Phase 4

Summary: 
      Selected patients will be randomised to either hydrocortisone or prednisolone. Each treatment
      period is of 14 days. Abnormal clinical symptoms, blood glucose and quality of life will be
      monitored.
    

Detailed description: 
      -  Selection of the patients who meet the inclusion and non inclusion criteria.

        -  Detailed explanations about the study to the patients.

        -  Signature of the informed consent by the patients.

        -  Randomisation of the patients by drawing lots into two groups; group AB who will receive
           treatment A during 14 days (period 1) then treatment B during 14 days (period 2) and
           group BA who will receive treatment B during 14 days (period 1) then treatment A during
           14 days (period 2).

        -  Each patient will receive a daily follow-up sheet, a quality of life questionnaire, a
           glucometer with test strips and the treatment in different bottles for each period of
           the study.

        -  The daily follow-up sheet concerns habits during Ramadan (eating, sleeping), the
           occurrence of complications and blood glucose monitoring. Daily blood glucose monitoring
           is requested at midday, before dinner and if a malaise occurs. A detailed questionnaire
           on abnormal symptoms that might occur during fasting have to be fulfilled for each
           malaise.

        -  Quality of life will be evaluated using AddiQol questionnaire translated in Tunisian
           dialect. Patients have to complete the questionnaire before the fasting month and at the
           end of each period of treatment.

        -  Treatment is presented in the form of capsules with the same colour and size. Patients
           have to take one capsule at dinner and one capsule at pre-dawn meal. Patients will
           receive either hydrocortisone 15mg at pre-dawn meal and 5mg at dinner (sunset)
           (treatment A) or prednisolone 5mg at pre-dawn meal and a placebo (starch) at dinner
           (treatment B).

        -  During the study, patients will be in regular phone contact with a responsible of the
           study for any information or problem.

        -  At the end of the study, the completed follow-up sheets and questionnaires will be
           picked up.
    

Intervention name(s): Hydrocortisone; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): at a substitutive dosage; at a substitutive dosage
Other intervention name(s): Cortef*; Vitapred*
Intervention MeSH terms: Prednisolone; Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: crossover clinical trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: treatment; quality of life; hypoglycemia