bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
Condition: Volunteers; Healthy Volunteers; Human Volunteers; Normal Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is therefore to evaluate the effect of concomitant drugs through an
      increase of intra-gastric pH levels on the bioavailability of entinostat.

      The primary objectives of this study are to evaluate the effect of multiple doses of
      omeprazole, famotidine, and the effect of an acidic beverage in combination with omeprazole
      on the single-dose PK profile of entinostat.

      The secondary objectives are to evaluate the safety and tolerability of a single dose of
      entinostat when administered with multiple doses of omeprazole, famotidine, and when
      administered with an acidic beverage in combination with omeprazole.
    

Detailed description: 
      This is a 3-part study. A total of 204 subjects will be dosed in this study if Parts 2 and 3
      are conducted.

      In Part 1, in Period 1, a single dose of entinostat will be administered. In Period 2,
      multiple doses of omeprazole will be administered for 5 days with a single dose of entinostat
      co-administered. If preliminary results in Period 2 of Part 1 indicate that omeprazole
      exhibits clinically significant drug-drug interaction (DDI) with entinostat, then Parts 2 and
      3 will be conducted. If no DDI interaction is concluded between entinostat and omeprazole in
      Part 1, then neither Part 2 nor 3 will be conducted.

      Part 2 will investigate the effect of multiple doses of famotidine administration on
      entinostat PK. In Period 1, a single dose of entinostat will be administered. In Period 2,
      oral doses of famotidine with a single dose of entinostat co-administered.

      Part 3 will evaluate the effect of an acidic beverage co-administered with entinostat in
      subjects with increased gastric pH due to omeprazole treatment. In Period 1, multiple oral
      doses of omeprazole will be administered with a single dose of entinostat co-administered
      with water. In Period 2, multiple doses of omeprazole will be administered with a single dose
      of entinostat co-administered with an acidic beverage.

      In all parts, PK samples will be taken.
    

Intervention name(s): entinostat; Omeprazole; Famotidine
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): HDAC (histone deacetylase inhibitor); Proton pump inhibitor; Histamine-2 blocker
Other intervention name(s): SNDX-275; MS-275; Prilosec; Zegerid; Pepcid
Intervention MeSH terms: Entinostat; Omeprazole; Famotidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: entinostat; Histone Deacetylase Inhibitor; HDAC
Pulsatility Index, Vasomotor Reactivity and Leukoencephalopathy in Fabry Patients
Condition: Fabry Disease
MeSH terms: Fabry Disease; Leukoencephalopathies
Study type: Observational

Summary: 
      We hypothesize that Fabry disease - FD is associated with elevated vascular resistance
      induced by cerebral small-vessel disease, indicating increased distal resistance to blood
      flow. The findings of this study may be used as a precursor for neuroimaging manifestations
      related to stroke in FD patients.
    


Intervention name(s): Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography will be performed in consecutive FD patients. All TCD and TCCD studies will be performed by stroke neurologists experienced in vascular sonography.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Consecutive patients with genetically confirmed FD and healthy individuals will be
        prospectively enrolled as part of routine clinical examination.
      
Keywords: pulsatility index; vasomotor reactivity; leukoencephalopathy; transcranial ultrasound
Evaluation of Improvement in Mobility Skills for Sub-acute Stroke Patients, Using the Selfit System.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is a leading cause of mobility disability for adults. Selfit is an advanced practice
      system that enables a wide range of exercises to improve patient mobility in the sub-acute
      stage after a stroke. The system collects, measures and analyzes the patient's activity in
      practice.
    

Detailed description: 
      Objectives of the study: An evaluation of the improvement of mobility after a stroke using
      the Selfit system.

      Type of study: Case Control Study. Study population: 30 patients, after stroke (men and women
      aged 18-85). Criteria for Inclusion: Stroke patients who are capable to walk with a little
      help or no help at all, with or without any assitive device, for a distance of 10 meters.

      Intervention: Random distribution of the study participants into two groups - Case: stroke
      patients (15 patients) - evaluation of patients using Selfit for 2 sessions per week, for a
      period of at least 30 minutes per session, during 3 weeks.

      Control: Stroke patients (15 patients) - continuing with current therapy with no use of the
      Selfit system.

      Measurement tools and outcome measures:

      Duration of each treatment session, the duration of the actual treatment, the number of
      technical failures in the system during the exercise and the duration of each session will be
      recorded. At the end of the intervention, questionnaires describing the experience of using
      the system will be completed with a rating of the degree of satisfaction, convenience and
      simplicity of using the Selfit system. The following tests will be carried out : 10 meter
      walk test, Timed up and go test, Dynamic Gait Index (DGI).

      Analysis of the data: For each patient's treatment, a personal activity profile will be
      established that includes the timing and speed of walking, the number of steps, the length
      and width of each step, the elevation of the leg at each step and the accuracy of the
      patient's performance. Statistical analysis will examine the various levels of activity
      throughout the intervention period for each patient and for the entire study population
      before and after the intervention. At the same time, the correlation between the level of
      activity in the treatment and the scores on the neurological tests will be examined. The data
      will be presented descriptively for the therapist and patient. For statistical analysis, the
      SPPS version 21 (IBM) will be used.
    

Intervention name(s): Intervention plus therapy
Intervention type(s): Device
Intervention description(s): Task oriented exercise plan to improve mobility for stroke patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Sub-acute; Mobility; Movement therapy; Exercise
Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effects of Konjac on satiety and subsequent food intake in healthy
      individuals.
    


Intervention name(s): Konjac noodles; Carbohydrate and Konjac Noodles; Carbohydrate noodles
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)
Other intervention name(s): Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015; Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cervical Recuperation After Vaginal Delivery
Condition: Cervix
Study type: Observational [Patient Registry]

Summary: 
      Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine
      the process of cervical recuperation post delivery.
    

Detailed description: 
      Patients after vaginal delivery will be recruited after receiving a full explanation and
      signing an informed consent.

      The goal of the study is to examine cervical length after vaginal delivery at 3 different
      time intervals:

        1. 8 hours post delivery.

        2. 24 hours post delivery.

        3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed,
           evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will
           finish her participation in the study/ Information regarding obstetric conditions such
           as labor induction, gestational age at the time of delivery etc. will be collected from
           patients' electronic files.
    

Intervention name(s): Trans-vaginal ultrasound
Intervention type(s): Device
Intervention description(s): Three trans-vaginal ultrasounds, the 1st to be performed 8 hours post delivery, the 2nd 24 hours after delivery and the 3rd 48 hours after delivery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients after vaginal delivery.
Comparison of Subjective Outcomes and Changes of Ultrasonographic Morphology of Median Nerves of Mini-open and Endoscopic Carpal Tunnel Release in Patients With Idiopathic Carpal Tunnel Syndrome
Condition: Idiopathic Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      A few studies have shown that the mini-incision release technique decreases the pathologic
      swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening
      ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic
      release technique similarly reverses these pathological changes in the median nerve along the
      carpal tunnel in patients with CTS compared with the mini-incision release.

      Investigators therefore conducted the current study to compare the subjective outcomes and
      US-measured morphological changes in the median nerve in patients with CTS who received
      either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective
      outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function
      scores and the DASH scores, would be similar 24 weeks after either mini-incision or
      endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each
      level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks
      after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes
      would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or
      endoscopic carpal tunnel release.
    


Intervention name(s): Mini-incision carpal tunnel release; Endoscopic carpal tunnel release
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carpal tunnel syndrome
A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
Condition: Obesity
Study type: Interventional

Summary: 
      Safety and effectiveness of the BIB® System in conjunction with a behavior modification
      program compared to the behavior modification program alone for weight loss in obese
      subjects.
    


Intervention name(s): BioEnterics® Intragastric Balloon; Behavioral modification
Intervention type(s): Device; Other
Intervention description(s): Inflatable balloon inserted into the stomach.; Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Other intervention name(s): BIB®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of a Mindfulness Programme on Competitive Athletes With Physical Disabilities
Condition: Athletic Injuries; Physical Disability; Chronic Pain
MeSH terms: Chronic Pain; Athletic Injuries
Study type: Interventional

Summary: 
      Pain affects the athlete's sporting career directly or indirectly. Directly, the injury
      affects other areas of the body causing a physical decompensation in the athlete and this
      affects the correct execution of the sporting technique, or how technical gestures can cause
      pain. Indirectly, through the psychological consequences of pain that generate a series of
      negative consequences and feelings. Some studies suggest that psychological skills are an
      important tool for pain management. For that reason, a mindfulness intervention programme
      would be a useful tool for manage pain in this population.
    

Detailed description: 
      The study hypothesised that the Mindfulness Sports Performance Enhancement (MSPE) programme
      adapted for this population, was more effective than mindfulness-based relaxation training as
      a treatment for chronic pain and associated emotional disturbances in Para athletes with
      physical disabilities, and that it contributes more to modifying psychological variables that
      have been shown to be related to or have modulatory value in the experience of chronic pain.
    

Intervention name(s): Experimental group (MSPE programme group).; Control group (relaxation group).
Intervention type(s): Other; Other
Intervention description(s): Experimental group. MSPE Programme. This group will receive a face-to-face mindfulness MSPE programme for 6 weeks, once a week for 1h 50min-2 hours. In addition to doing mindfulness activities at home. Each session contains the following exercises: (1) intention meditation, sultana exercise, diaphragmatic breathing and sitting meditation with a focus on breath, body and sound; (2) diaphragmatic breathing, Body Scan; (3) sitting meditation, dynamics of emotions, Mindful Yoga on the floor; (4) letting go of attachments, mindful Yoga on the floor walking meditation; (5) sports meditation, sitting meditation with a focus on breath, body and sound; (6) intention meditation, body scan analysis and review of sports meditation.; These instructions included a combination of tension-relaxation of specific muscles and simple breathing techniques. They were recommended to do this on a daily basis, with a minimum of 4 sessions per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Athlete Injuries; Physical disability; Chronic pain; Psychological abilities; Mindfulness
Vanderbilt-Zambia Innovations in Global Health Technologies
Condition: Malaria Diagnosis
MeSH terms: Malaria
Study type: Observational

Summary: 
      Investigators will evaluate approaches using magnetic bead capture, isolation, and surface
      tension valve transfer of biomarkers to process capillary blood in order to improve the
      sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria
      infection. Results will be compared to those obtained using unenhanced capillary blood
      specimens directly applied to approved malaria RDTs. Participants seeking care for possible
      malaria in Zambia will be recruited to enroll in the study.
    


Intervention name(s): mBEADS
Intervention type(s): Other
Intervention description(s): Evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those seeking care for suspected malaria in Zambia
Study Evaluating Aerosol and Intradermal Administration of a Candidate Tuberculosis (TB) Vaccine, MVA85A, as a Way to Increase Immune Response and Avoid Anti-vector Immunity
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Boost vaccinations sometimes have no effect because the body has got used to the vaccine and
      no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised
      MVA85A (a candidate tuberculosis vaccine) followed by a boost MVA85A intradermal vaccination
      (or vice versa) avoids this and increases the immune response to vaccination.
    


Intervention name(s): MVA85A
Intervention type(s): Biological
Intervention description(s): Modified vaccinia virus Ankara (MVA) is a highly attenuated strain of vaccinia with an antigen 85A insert.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine; Immunogenicity
A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of the study is to check for side effects from icatibant in children and
      teenagers with hereditary angioedema (HAE). Other aims are to check how well icatibant
      controls HAE symptoms in these children and teenagers, and how much icatibant stays in their
      blood.

      At the first visit, the study doctor will check if each child or teenager can take part. For
      those who can take part, participants and their parents or caregivers will visit the clinic
      or hospital when they have their next HAE attack. Participants will receive 1 injection
      (shot) of icatibant in a vein and will stay at the clinic or hospital until their HAE
      symptoms are under control. Participants can receive up to 2 more injections of icatibant
      over time if their HAE symptoms don't improve or get worse.

      After the participants go home, the study staff will follow up with them by a telephone call
      1 to 2 days later. Then, the participants will visit the clinic or hospital 1 week after they
      received the icatabant injection.

      The participant can visit the clinic or hospital and be treated with icatibant in the same
      way for up to 3 HAE attacks in total.
    

Detailed description: 
      The drug being tested in this study is called TAK-667. TAK-667 is being tested to treat
      Japanese Children and Adolescents who experience acute attack of HAE. This study will look at
      safety, efficacy and pharmacokinetics (PK) of people who take TAK-667.

      The study will enroll at least up to 3 participants. Participants will take TAK-667 with SC
      administration on the abdomen. The dose of TAK-667 will be dependent on the participant's
      body weight (Up to 30 mg; 10 mg for 12 kg to 25 kg, 15 mg for 26 kg to 40 kg, 20 mg for 41 kg
      to 50kg, 25 mg for 51 kg to 65 kg, 30 mg for >65 kg).

      This multi-center trial will be conducted in Japan. The overall time to participate in this
      study is 25 days as a maximum (screening day for initial attack plus 8 days post dose for
      each 3 attacks as a maximum). Participants will make multiple visits to the clinic and will
      be closely monitored in the hospital/study center for at least 8 hours after administration
      and receive physical examination and assessment to evaluate safety, efficacy and PK.
      Hospitalization may be prolonged until, in the opinion of the investigator, the participant
      is clinically stable and onset of HAE attack is completely resolved.
    

Intervention name(s): TAK-667
Intervention type(s): Drug
Intervention description(s): TAK-667 single SC administration
Other intervention name(s): Icatibant
Intervention MeSH terms: Icatibant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine and Postoperative Depressive Symptom-PASSION
Condition: Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Perioperative depression symptom (PDS) is one of the common mental comorbidity, and
      influences the clinical outcomes and prognosis. However, there is no rapid acting treatment
      to deal with it during the limited hospital stay. This study aims to determine whether
      ketamine could improve the depressive symptom of peirioperative patients. It will also
      examine the safety for administrating ketamine as an antidepressant intraoperatively.
      Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium.
      This trial also will bring great concerns on patients with perioperative mental health and
      explore the measures to improve their psycho-related prognosis.
    


Intervention name(s): Ketamine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine will be administrated intravenously at dural opening, with the total dose of 0.5 mg/kg and continual infusion for 40 minutes.; Normal saline will be administrated intravenously at dural opening, with the total dose of 0.5 ml/kg and continual infusion for 40 minutes.
Other intervention name(s): Ketamine hydrochloride
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an extension study to evaluate the safety, tolerability and immunogenicity of one
      booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612
      vaccine 10, 30, and 100 μg in V-122 study.
    

Detailed description: 
      This is an extension study to evaluate the safety, tolerability and immunogenicity of one
      booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612
      vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of
      UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6
      months after first vaccination. In this study, there will be 3 clinical visits. Subjects will
      come to the clinics at Day 1, Day 15, and Day 85.
    

Intervention name(s): UB-612
Intervention type(s): Biological
Intervention description(s): UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention