bioihbjkbjnl/mcl2 huggingface dataset:
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Condition: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      This trial will test, in a representative group of IBD patients, the acceptability of - and
      adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of
      inflammatory bowel disease (IBD)).
    

Detailed description: 
      Crohn's disease (CD) and ulcerative colitis (UC) are forms of inflammatory bowel disease
      (IBD) that require long-term monitoring. People with these conditions require regular and
      repeat testing, sometimes with endoscopy, to assess the state of the disease. Many centres
      worldwide now use a stool test called faecal calprotectin (FCALP) as an accurate reflection
      of endoscopic disease activity - meaning that people with IBD do not need 'routine' endoscopy
      to assess their disease. FCALP can also be used to give a prediction of what will happen to a
      person's IBD in the near future.

      As such, FCALP is an excellent and highly cost-effective test in IBD. However, uptake is
      often low (as with all stool tests) particularly because the sample needs to be taken at home
      and delivered in to the laboratory or hospital to be tested. People still therefore need to
      make an effort to submit samples and find this inconvenient. Furthermore, treatments for IBD
      are increasingly being given at home (usually self-administered injections). While beneficial
      for people with IBD, it is more difficult to keep track of such patients in the hospital
      service as they attend less regularly. A test that can be done at home, while making results
      available to the hospital team, is therefore desirable.

      New technology allows reliable testing of FCALP at home, using a smartphone app (IBDoc-TM,
      Buhlmann Laboratories) within a few minutes. The test kit is packaged with everything
      required (including gloves, sample 'capture' paper, disposal bag, etc). An instructional
      video is available within the app itself.

      Apart from testing whether patients adhere to the testing schedule, the investigators will
      also compare their experiences of the IBDoc test, health anxieties, locus of control, and
      satisfaction vs postal and traditional 'drop-off' test. Validated questionnaires will
      include: GAD7, PHQ9, IBDC, CBRQ and MHLC as well as a proprietary satisfaction questionnaire
      at the end of the study.
    

Intervention name(s): IBDoc home test for faecal calprotectin
Intervention type(s): Device
Intervention description(s): IBDoc home test for faecal calprotectin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Unselected patients with any form of inflammatory bowel disease on any treatment and at any
        stage of disease activity (diagnosed more than 6 months prior to study entry)
Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to evaluate the plasma amphetamine concentration/time profile
      of amphetamine extended release oral suspension in children aged 4 to 5 years with
      attention-deficit/hyperactivity disorder, following a single 2.5 mg dose of amphetamine
      extended release oral suspension.
    

Detailed description: 
      DYANAVEL® XR is an extended-release oral suspension that contains 2.5 mg/mL amphetamine base
      (amphetamine extended-release oral suspension; AMPH EROS). Drug-resin complexation is formed
      with the amphetamine and sodium polystyrene sulfonate, an ion exchange resin. The extended
      release feature of the product is achieved by coating a portion of the drug/resin complexes
      with an extended release coating. AMPH EROS contains approximately a 3.2:1 ratio of
      d-amphetamine compared to l-amphetamine.

      The objective of this study was to evaluate the plasma amphetamine concentration/time profile
      of AMPH EROS in children aged 4 to 5 years with attention-deficit/hyperactivity disorder,
      following a single 2.5 mg dose of AMPH EROS.

      These data will guide appropriate dosing in planned safety and efficacy studies with AMPH
      EROS in a preschool population with attention-deficit/hyperactivity disorder.
    

Intervention name(s): Amphetamine Extended Release Suspension [Dyanavel]
Intervention type(s): Drug
Intervention description(s): 1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
Other intervention name(s): DYANAVEL XR, amphetamine extended release oral suspension
Intervention MeSH terms: Amphetamine
Intervention model: Single Group Assignment
Intervention model description: This was an open-label, single-site, single-dose one-period, one-treatment study in 5 pediatric subjects diagnosed with ADHD, otherwise healthy. Subjects received a single, 1 mL dose of AMPH EROS 2.5 mg/mL, from which PK was assessed over a 28 hour period.
Masking: None (Open Label)
Primary purpose: Treatment
Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain
Condition: Fibromyalgia; Neck Pain; Healthy
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Neck Pain; Kinesiophobia
Study type: Observational

Summary: 
      Kinesiophobia which is described as fear of movement reduces physical activity levels and
      increases the risk of chronic pain. We consider that kinesiophobia levels were higher in
      patients with fibromyalgia syndrome and chronic neck pain so that physical activity levels
      were lower in this patients groups. Because there are not enough studies, we aimed to
      evaluate kinesiophobia and physical activity levels in this patients.
    

Detailed description: 
      Objective: To evaluate pain, kinesiophobia, physical activity, depression, disease severity,
      and fatigue in patients with fibromyalgia syndrome or chronic neck pain and healthy controls.

      Design: Cross-sectional study. Setting: Tertiary Health Care Center, Aksaray, Turkey
      Participants: 30 patients with fibromyalgia syndrome (Group 1), 30 patients with chronic neck
      pain (Group 2), and 30 healthy individuals (Group 3) were included.

      Main Outcome Measures: Outcome measures were Visual Analogue Scale (VAS)-pain and fatigue,
      Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), International Physical
      Activity Questionnaire (IPAQ) Short Form, Fibromyalgia Impact Questionnaire (FIQ), Neck Pain
      Disability Index (NPDI).
    

Intervention name(s): fibromyalgia syndrome and chronic neck pain
Intervention type(s): Diagnostic Test
Intervention description(s): We assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.
Other intervention name(s): physical activity level; pain intensity; disability; fatigue; depression
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patients were recruited from a physical medicine and rehabilitation outpatients clinic
        of Aksaray University Training and Research Hospital, Aksaray, Turkey. The healthy control
        group was consisting of doctors, nurses, medical secretaries who work in Aksaray University
        Training and Research Hospital, and patient care providers that have no pain and additional
        diseases
      
Keywords: kinesiophobia; physical activity; disability
Differential Immune Effects of Natalizumab
Condition: Multiple Sclerosis, Relapsing Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene
      4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade
      of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also
      with central nervous system (CNS) immune surveillance.
    

Detailed description: 
      Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency
      of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+
      regulatory T cells (Tregs).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients initiating natalizumab for treatment of relapsing remitting MS
      
Biospecimen description: 
      full blodd
    
Keywords: natalizumab; multiple sclerosis
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin
Condition: LUTS; Benign Prostatic Hyperplasia; Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic drug interaction between
      Solifenacin and Tamsulosin in healthy male volunteers.
    

Detailed description: 
      Pharmacokinetic Drug Interaction Between Solifenacin 10mg and Tamsulosin 0.4mg in Healthy
      Male Volunteers
    

Intervention name(s): Tamsulosin; Solifenacin; Tamsulosin and solifenacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily; Tamsulosin and solifenacin: Solifenacin 10 mg, once daily; Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily
Other intervention name(s): Harnal-D tablet; Vesicare tablet; Harnal-D and Vesicare tablet
Intervention MeSH terms: Tamsulosin; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: α1-blockers; antimuscarinic agent
Disulfiram as a Modulator of Amyloid Precursor Protein-processing
Condition: Alcohol Addiction
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      A causal therapeutic approach for treatment of Alzheimer's disease has not been established
      so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing
      strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical
      routine for recrudescence prevention of alcohol dependency, revealed an increased expression
      of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The
      investigators' research purpose aims at the verification of the results obtained in cell
      culture experiments in the human organism. Therefore, include alcohol addicted patients were
      included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients
      are recruited from the patient-collective of the University Medical Center Mainz and the
      Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the
      participants before the intake of Disulfiram and about two weeks after treatment. Demographic
      data are collected (such as age or onset of addiction). Gene expression is analyzed via
      reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger
      ribonucleic acid (mRNA).
    


Intervention name(s): Disulfiram
Intervention type(s): Drug
Intervention description(s): alcohol addicted patients receive an oral Disulfiram application as recrudescence prevention after successful detoxication
Other intervention name(s): Antabus
Intervention MeSH terms: Disulfiram
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recruited are alhohol addicted patients, which take Disulfiram as recrudescence prevention
        after successful detoxication. Patients between 20 and 60 years of age are included in the
        study independent from gender or ethnic background
      
Biospecimen description: 
      blood samples of each participant are retained and stored at -80.
    
Keywords: APP-processing; Disulfiram; ADAM10; Alzheimer's disease; blood
A Drug Interaction Study of Danicopan
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed
      sequence, 2-period study in healthy adult participants.
    

Detailed description: 
      This study was conducted to assess the 2-way interaction between danicopan and warfarin (Part
      1), bupropion (Part 2), and ethinyl estradiol/norethindrone (EE/NET) as an oral contraceptive
      (Part 3).
    

Intervention name(s): Danicopan; Warfarin; Bupropion; Ethinyl Estradiol/Norethindrone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Danicopan was dosed as 2 x 100 milligram (mg) tablets.; Warfarin was dosed as 2 x 10 mg and 1 x 5 mg warfarin sodium tablets (Coumadin or generic equivalent).; Bupropion was dosed as Wellbutrin (or generic equivalent) as 1 x 100 mg tablet.; EE/NET (0.035 mg/1 mg) was dosed as Ortho-Novum-1/35 (or generic equivalent) fixed-dose combination tablets.
Other intervention name(s): ACH-0144471; ALXN2040; Coumadin; Bupropion HCl; Wellbutrin; Ortho-Novum
Intervention MeSH terms: Bupropion; Warfarin; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1, Part 2, and Part 3 could be conducted concurrently or separately.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Factor D Inhibitor; Complement; Danicopan; Oral Contraceptive; Pharmacokinetics; Pharmacodynamics
Breast Versus Bottle Study
Condition: Breastfeeding; Bottle Feeding
Study type: Observational

Summary: 
      The objective of the proposed research is to conduct a within-subject experimental study that
      will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and
      outcome of infant feeding interactions.
    


Intervention name(s): Mode of Feeding (breastfeeding versus bottle-feeding)
Intervention type(s): Behavioral
Intervention description(s): Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of mother-infant dyads residing within 50 miles of California
        Polytechnic State University.
      
Keywords: infant feeding; feeding interactions; maternal feeding practices; breastfeeding; bottle-feeding
The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep
Condition: Postoperative Sleep Quality; General Anesthesia; Propofol; Sevoflurane; Dreaming
Study type: Interventional

Summary: 
      Adequate sleep is necessary for physical and mental health of human being. Although surgery
      and anesthesia techniques have improved in resent years, postoperative sleep disturbance
      remains a challenging problem in surgical procedures1. Postoperative sleep fragmentation and
      poor sleep quality can not only result in hyperalgesia and a delay in postoperative
      recovery2, lack of sleep after surgery can also bring many potential adverse effects such as
      cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic
      disorders, and pro-inflammatory changes3-5. Previous studies have reported that age,
      preoperative comorbidity and severity of surgical trauma were independent factors that
      associated with postoperative sleep disturbance6,7. Our prior studies have also found that
      patients are more likely to experience decreased sleep quality after receiving general
      anesthesia, which was characterized by a decrease in each sleep stage8. Propofol and
      sevoflurane are commonly used general anesthetics in clinical practice. The choice of
      anesthetic may also affect the cognitive outcome after surgery, but the results of clinical
      studies have always been contradictory. Some studies report that the cognitive results after
      inhalation are worse than those after intravenous anesthesia. And the incidence of dreaming
      was significantly higher in the sevoflurane anesthesia group compared to the propofol
      group9-11. Another study conduct among infants proved that compared with
      propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in
      the first weeks after surgery12. Based on these conflicts, the aim of the current study was
      to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and
      complications of patients receiving laparoscopic surgery after general anesthesia.
    


Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation; Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation；
Other intervention name(s): Intravenous Anesthetics; Inhaled Anesthetics
Intervention MeSH terms: Propofol; Anesthetics, Intravenous; Anesthetics; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors
Condition: Breast Cancer; Ovarian Cancer; Gynecological Cancer; Head and Neck Carcinoma; Non-small Cell Lung Cancer; Small Cell Lung Cancer; Non-squamous Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in
      patients with solid tumors
    

Detailed description: 
      Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of
      PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a
      recommended dose is defined for the PM01183 and weekly paclitaxel combination, the
      feasibility of adding bevacizumab to this combination will be explored in a selected cohort
      of patients to characterize the safety profile and feasibility of this combination, to obtain
      preliminary information on antitumor activity, to obtain preliminary information on quality
      of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect
      major drug-drug PK interactions and PK(pharmacokinetic)/PD(pharmacodynamic) correlation and
      to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced
      solid tumors.
    

Intervention name(s): PM01183 + paclitaxel +/- bevacizumab
Intervention type(s): Drug
Intervention description(s): PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion
paclitaxel: 6 mg/ml concentrate for solution for infusion
bevacizumab: 25 mg/ml concentrate for solution for infusion
Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients
Intervention MeSH terms: Paclitaxel; Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Intrathecal Morphine for Nephrectomy
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      To evaluate the efficacy and the safety of the intrathecal morphine injection in the open
      nephrectomy.
    

Detailed description: 
      The open nephrectomy is the treatment of choice for live donor kidney transplantation and
      renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A
      single dose of intrathecal morphine(ITM) has been used for the postoperative pain of
      prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for
      open nephrectomy has not been studied. Therefore, this prospective, randomized study will
      evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient
      controlled analgesia(IV-PCA), comparing to IV-PCA alone.
    

Intervention name(s): The intrathecal morphine injection; The intravenous patient-controlled analgesia; Demerol on demand
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single injection of morphine intrathecally; The intravenous injection of morphine using the patient-controlled analgesia machine; Demerol 25 mg intravenously when pain scores more than 5.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Injection, Spinal; Morphine; Analgesia; Patient-Controlled; Pain; Postoperative; Combined Modality Therapy; Nephrectomy
Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary
      research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography
      (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of
      peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP
      pancreatitis.
    

Detailed description: 
      Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a
      rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after
      procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the
      Holliday-Segar method given peri-procedurally as described earlier (standard hydration).
      Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were
      assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP
      pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation
      of amylase or lipase >3 times the upper limit of normal.
    

Intervention name(s): Lactated Ringer's solution
Intervention type(s): Drug
Intervention description(s): Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid
Other intervention name(s): Ringer's Lactated solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention