bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia
Condition: Hypertension; Dyslipidemias
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypertension and dyslipidemia are very prevalent diseases in general population, and the
      prevalence is keep increasing especially on population with advanced age. Both diseases are
      major risk factor of cardiovascular disease, and many complication could be induced if not
      managed properly. Also, these diseases need consistent medication for long time, so the
      compliance to the treatment is an important issue for these diseases.

      Treatment effect of olmesartan to hypertension and rosuvastatin to dyslipidemia is already
      proven in previous studies, and these medication does not have interaction with each other.
      By using fixed-dose combination of these drugs, the investigators could improve the
      compliance to medication, and may have better treatment effect.

      In this single center, randomized, phase 4 clinical trial, the investigators divided patients
      into 2 groups, one with fixed-dose combination of 2 drugs, while another with 2 separated
      drugs. Each patient in this study was evaluated at first visit, and outcomes are evaluated at
      26 weeks after the start point of medication. The primary outcome of this study was
      compliance of prescribe medication, and the secondary outcome was blood pressure (systolic,
      diastolic), cholesterol, and low density lipoprotein cholesterol.
    


Intervention name(s): Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination)); Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)
Intervention type(s): Drug; Drug
Intervention description(s): In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.; In control group, patients had two separated pills for hypertension and dyslipidemia. One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin, Pravastatin, Fluvastatin and Atorvastatin/Ezetimibe).
Intervention MeSH terms: Olmesartan; Angiotensin II; Giapreza; Rosuvastatin Calcium; Angiotensinogen; Angiotensin Receptor Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are divided into 2 group, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs.
Masking: None (Open Label)
Primary purpose: Other
Surgical Face Mask Effects in Patients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The use of personal protective equipment is mandatory for healthcare workers caring patient
      with COVID-19. To maximise the reduction of virus spread during clinical procedures involving
      the presence of healthcare workers, it is also recommended to patients to wear surgical
      facemask. Routine clinical procedures include cardio-pulmonary and strengthening exercises.
      During these exercises, the wearing of a face mask may be difficult to tolerate by patients,
      especially since they experience breathing difficulties due to the illness. Therefore, this
      study aims to verify the effects of the surgical facemask on breathing difficulties and
      exercise performance during a 1-minute sit to stand test.
    


Intervention name(s): Sit-To-Stand test
Intervention type(s): Other
Intervention description(s): The 1-minute sit-to-stand test will be realized with or without a surgical facemask covering the face of the patient with COVID-19
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Sit-To-Stand test; Surgical Facemask; Dyspnea
Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The study will be testing metformin in patients with breast cancer who are about to undergo
      surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their
      surgery date. It is hypothesized that metformin will reduce cell proliferation rates in
      tumour tissue.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): 500 mg tablet, taken 3 times a day for 2-3 weeks
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; metformin; breast surgery
Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to compare the PK/PD of a single injection of investigational Medicinal
      Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult
      subjects.
    


Intervention name(s): MSB11456; US-licensed Actemra; EU-approved RoActemra
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive a single injection of MSB11456 on Day 1.; Subjects will receive a single injection of US-licensed actemra on Day 1.; Subjects will receive a single injection of EU-approved RoActemra on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MSB11456; Actemra®; RoActemra®
Regulation of Arginine-vasopressin (AVP)
Condition: Schizophrenia; Depression
MeSH terms: Diabetes Insipidus; Schizophrenia
Study type: Interventional

Summary: 
      This study aims to develop a method for the assessment of central NMDA receptor functioning
      in patients with depression and schizophrenia. For this purpose a transitional approach is
      used based on preclinical studies that show a dose-dependent relationship between the
      activity of hypothalamic NMDA receptor and plasma AVP response to increasing plasma
      osmolality. Patients with schizophrenia, depression and healthy controls participated in this
      study. The Investigators found that in a subgroup of patients with schizophrenia the AVP
      response was low and that in a subgroup of subjects with depression the AVP response was high
      compared to healthy controls.
    

Detailed description: 
      Evidence suggests that altered N-methyl-D-aspartate (NMDA) receptor activity and glutamate
      signaling may underlie the pathogenesis of both schizophrenia and depression at least in
      subgroups of patients. In schizophrenia, pharmacologic modeling, postmortem and imaging data
      suggest reduced NMDA signaling. In contrast, recent clinical trials demonstrating the
      efficacy of the NMDA antagonist ketamine in severely depressed patients suggest increased
      NMDA receptor signaling. The Investigators have conducted a proof of concept study to assess
      whether there is any in vivo evidence for an inverse association in depression and
      schizophrenia with respect to the NMDA receptor function. For this purpose the investigators
      used a translational approach, based on findings from animal studies that NMDA receptor is a
      key mediator of arginine-vasopressin (AVP) release into the bloodstream. Using hypertonic
      saline to induce AVP release, as done in animal studies, it was found that in a subgroup of
      depressed patients, NMDA receptor mediated AVP release was significantly increased, whereas
      in a subgroup of schizophrenia patients, the same response was abnormally low. Previous
      research has demonstrated that this response is well conserved. These findings are consistent
      with implicated NMDA receptor related abnormalities in depression and schizophrenia in
      subgroups of patients, and provide the first in vivo evidence towards this dichotomy.
    

Intervention name(s): Procedural
Intervention type(s): Other
Intervention description(s): All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: vasopressin; AVP; NMDA; osmolality
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

        -  To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from
           baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure.

      Secondary Objective:

        -  To determine the change in glycemic control, safety, and treatment satisfaction in
           insulin glargine use in patients following GLP-1 failure.
    

Detailed description: 
      1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
    

Intervention name(s): INSULIN GLARGINE HOE 901
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous
Intervention MeSH terms: Insulin Glargine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion
Condition: Diabetes Mellitus, Type 1; Insulin Pump, Programmable
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1
      diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may
      improve glycemic control, glycemic variability and quality of life.
    

Detailed description: 
      This study was designed as a randomized, controlled (versus standard education), open,
      one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin
      preprandial bolus, while the patients in group 2 followed standard education. Primary outcome
      (glycosylated hemoglobin, HbA1c) and secondary outcomes (fasting glucose, glycemic
      variability, insulin requirement, body mass index (BMI), waist circumference, quality of
      life) were measured at baseline, 3, and 6 months.
    

Intervention name(s): Carbohydrate counting training
Intervention type(s): Behavioral
Intervention description(s): Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carbohydrate counting; continuous subcutaneous insulin infusion; type 1 diabetes mellitus
Evaluation Of The Pillcam™ Colon Capsule Endoscopy (Pcce-2) In Pediatric Ulcerative Colitis
Condition: Pediatrics, Colon Capsule Endoscopy
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Observational

Summary: 
      This prospective pilot study of 30 pediatric subjects, that are indicated for standard
      colonoscopy due to follow-up of ulcerative colitis (UC), examines the Given Diagnostic System
      and the PillCam Colon Capsule in comparison to standard colonoscopy.

      This study aims

        1. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with
           standard colonoscopy in the evaluation of colon in pediatric ulcerative colitis.

        2. To evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE) in pediatric age.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The Given® Diagnostic System offers an alternative approach for endoscopic visualization of
        the colon using capsule endoscopy, a swallowable device which contains imagers, light
        sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System
        include the elimination of the need for conscious sedation, the minimally invasive,
        painless nature of the exam, and the ability to pursue normal daily activities immediately
        following the procedure. This prospective pilot study will evaluate the performance of PCCE
        in visualizing the colon of children with UC. All subjects to be enrolled will be
        appropriate candidates for standard colonoscopy based on their clinical indication.

        Each subject will undergo PCCE. PCCE results will be compared with that of a colonoscopy
        procedure.
Psychological Variables in Physiotherapy Treatment of Low Back Pain: A Comparison of Group and Individual Treatment
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of the study is to determent whether there is a difference between two types of
      treatments in physiotherapy (individual vs group) for patients with low back pain (LBP), in
      terms of their sensation of how they have been helped and their treatments' outcomes
      measures. The study hypothesizes are: a) Based on the results of literature review which does
      not reveal a clear difference between group and individual treatments' outcomes for LBP, it
      is hypothesized that no difference will be found in treatment results for the two types of
      group treatments in the present study also, b) The assumption is that different distribution
      of therapeutic factors will be found in the two types of treatments (individual, group), C)
      Patients' sensation of how they have been helped will be connected to treatment results.
    

Detailed description: 
      200 patients with LBP looking for physiotherapy treatment in 15 clinics at Maccabi Healthcare
      Service in Israel will be recruited. (100 after competion individual therapy, 100 after
      competion of group therapy). As part of the regular routine in these clinics, patients will
      be asked to fill the LFSQ, a questionnaire which deals with their back functional status,
      their level of pain and fear avoidance of physical activity before and after treatment. In
      the present study, patients will be asked to fill the LFSQ again, 6 months after treatment
      completion. In two weeks from treatment completion, patients will be interviewed on the
      telephone. The interview will focuse on their sensation of how they have been helped. It will
      include an open-ended question and 18 closed questions.

      The main study variables will include: participants' perception of functional status, level
      pain, level of fear avoidance of physical activity, patient-therapist bonding, and helpful
      therapeutic impacts (client's sense of how she or he has been helped).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adults (18 years old and older) seeking for physiotherpy treatment for low back pain in one
        of the 15 clinics participating in this study
      
Keywords: low back pain; lumbar pain
Mindfulness Training for Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Mindful Parenting
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of an 8-week mindfulness group training for children
      (8-16 years old) with ADHD in combination with a parallel mindful parenting training for
      their parents. Half of the participants will be randomly assigned to the mindfulness training
      in addition to care-as-usual (CAU); the other half to CAU-only.

      The hypothesis is that compared to care-as-usual only, the addition of the mindfulness
      training will improve self-control of youth with ADHD.
    


Intervention name(s): MYmind mindfulness training; Care-as-usual for children (8-16 years old) with ADHD
Intervention type(s): Other; Other
Intervention description(s): The MYmind mindfulness training uses a standardised protocol based on mindfulness-based cognitive therapy. It consists of 8 weekly group sessions of 90 minutes for youth with ADHD, and parallel mindful parenting training for the parents. Eight weeks after the last session there is a single 90 minutes booster session.; According to the Dutch Multidisciplinary guidelines for the diagnosis and treatment of ADHD, care-as-usual for children aged 8-16 years with ADHD consists of psycho-education and the prescription of medication approved for ADHD and/or evidence-based parent and/or teacher-administered behaviour therapy, preferably both medication and behaviour therapy. First-line option for medication is a psychostimulant, second-line option is atomoxetine, and third-line options are alpha-2 presynaptic agonists or tricyclic antidepressants (imipramine).
Other intervention name(s): Mindfulness for children with ADHD and mindful parenting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Self-control; Well-being
A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the effectiveness and safety of long-acting injectable
      risperidone in the treatment of patients in the early stage of psychosis
    

Detailed description: 
      Although many schizophrenia patients currently take oral antipsychotic medications, it is
      estimated that up to 75% of them have difficulty adhering to the daily oral regimen.
      Long-acting injectable formulations may eliminate the need for daily medication and enhance
      patient compliance with the treatment regimen. This study is a pilot project to demonstrate
      that long-acting risperidone can be used safely and effectively in treating patients in the
      early stage of psychosis. It is an open-label, single-arm study in patients with recent onset
      of schizophrenia, schizophreniform disorder, or schizoaffective disorder. There are 3 phases:
      Wash-out Phase of 7 days, during which current psychotropic medications are discontinued;
      Oral Treatment Phase, beginning 1 week before the first injection and continuing 3 weeks
      thereafter, during which risperidone tablets are taken; and Long-Acting Injectable Treatment
      Phase, during which injections are given every 2 weeks for 24 months. Assessments of
      effectiveness include Positive and Negative Syndrome Scale (PANSS), a scale for the
      measurement of symptoms of schizophrenia; time from initiation of treatment to relapse;
      Calgary Depression Scale for Schizophrenia (CDSS), which assesses symptoms of major
      depressive disorder in patients with schizophrenia; and Clinical Global Impression (CGI)
      scales. Safety assessments include the incidence of adverse events and Extrapyramidal Symptom
      Rating Scale (ESRS) scores throughout the study; clinical laboratory tests (hematology and
      chemistry) and vital signs (pulse, blood pressure, temperature) at stated intervals.
      Risperidone oral tablets once daily (1 milligram[mg], 2mg, or 3mg [maximum]) from 1 week
      before first injection through 3 wks after. Risperidone injections (25mg, 37.5mg, or 50mg
      [max]) every 2 weeks for 24 months. Doses may be increased or decreased at investigator's
      discretion.
    

Intervention name(s): Risperidone, long-acting injectable
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Intramuscular injection; Antipsychotic agents; Long-acting risperidone; Schizophreniform disorders; Schizoaffective disorder
Technology-Assisted Prescription Opioid Safety Education
Condition: Opioid Use
Study type: Interventional

Summary: 
      This study will develop a technology-based brief educational intervention for hospitalized
      patients that will be discharged with an opioid prescription. The Investigators will conduct
      a small randomized clinical trial of T-POSE to determine whether it improves patients:
      knowledge and reduces the incidence of Non-Medical Prescription Opioid Use (NMPOU).
    

Detailed description: 
      Non-medical use of prescription opioids (NMPOU) can be generally defined as not taking
      opioids as prescribed, which could occur unintentionally or intentionally. In 2014, 4.3
      million adults in the United States (U.S.) were estimated to engage in NMPOU (Center for
      Behavioral Health Statistics and Quality 2014). Some patients may take a dose more frequently
      than prescribed because they were not receiving adequate pain relief from the prescribed
      dosage. While others may continue to take opioids longer than prescribed because their pain
      is persistent and/or they like the euphoric effects of opioids. According to a recently
      released Truven Health Analytics-NPR Health Poll, the majority (57%) of Americans have taken
      a prescription opioid and 35% of those had concerns (e.g., addiction, effectiveness, side
      effects) about prescription opioids. These findings suggest that while Americans are aware,
      some even concerned, of the potential dangers associated with prescription opioids that their
      utilization patterns continue to increase (Boddy 2017). Because opioids are prescribed by a
      physician, patients may believe that these medications are safe and they may be unaware of
      the risks associated with misuse and abuse of opioids. NMPOU may lead to increased risk of
      drug overdose, addiction, diversion and use of heroin. Many individuals with opioid use
      disorders initiated NMPOU before transitioning to heroin (Banerjee et al. 2016; Cerda et al.
      2015) and report that their first exposure to an opioid was prescribed by a physician. This
      underscores the need for empirically-tested educational interventions that can potentially
      reduce NMPOU and diversion. Prescription opioids have an important role to play in health
      care and blanket policies to restrict access to prescription opioids are not appropriate,
      rather the hypothesis is that harm can be reduced by fundamentally changing our approach to
      opioid medication safety.
    

Intervention name(s): T-POSE; Usual Care
Intervention type(s): Other; Other
Intervention description(s): Tablet based education and videos on opioid safety, use, and storage/disposal of the drug.; Printed instruction sheets on prescribed opioid.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A small pilot study using a randomized clinical trial of T-POSE compared to usual care.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non-Medical Prescription Opioid Use