bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
Condition: Drug Reactions
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will help determine which types of drugs that may interact with Lu AF35700
    


Intervention name(s): Lu AF35700; Midazolam; Cocktail of CYP450 substrates
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablets for oral use, 10 mg/day; syrup for oral use, 4mg/day; Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SURVEY ABOUT STRESS-COVID IN HEALTH CARE WORKERS IN NORTH AFRICA COUNTRY
Condition: HEALTH CARE WORKERS
Study type: Observational

Summary: 
      This study aimed to investigate the psychological impact of the COVID-19 outbreak on
      healthcare workers (HCWs) and to identify ways of coping with this unprecedented stressful
      situation.
    

Detailed description: 
      This was a cross-sectional study based on an online questionnaire that included 62 questions
      (scores, 0 - 3). The chi-square (χ²) test was used to compare the responses between
      professional groups, age groups, and genders.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HEALTH CARE WORKERS all
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability and Pharmacokinetics of multiple doses of BV100 in healthy volunteers
    

Detailed description: 
      The study will investigate the safety and tolerability of increasing multiple intravenous
      doses of BV100 by assessing the Incidence of treatment-emergent adverse events (TEAEs). In
      addition the goal is to characterize the multiple dose pharmacokinetic profiles of rifabutin
      in plasma.
    

Intervention name(s): BV100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rifabutin for Infusion; Saline intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study are:

        -  To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in
           subjects with Friedreich's ataxia (FA). [Primary]

        -  To characterize the pharmacokinetics of VP 20629 by investigation of the plasma
           concentration-time profile following single and multiple oral doses in subjects with FA.
           [Secondary]

        -  To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and
           malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple
           oral doses in subjects with FA. [Exploratory]
    


Intervention name(s): VP 20629; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Indole-3-propionic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nocturnal Hypertension and Nocturia in African American Men
Condition: Hypertension
MeSH terms: Hypertension; Nocturia
Study type: Observational

Summary: 
      This study to obtain pilot data on Nocturnal Hypertension and Nocturia. In Dr. Victor's
      current NIH grant (Cut Your Pressure Too: The LA Barbershop Blood Pressure Study) the results
      show that uncontrolled systolic hypertension is independent determinantal of nocturia in
      African American men.

      We now went to pursue this correlation by designing a new NIH grant Proposal to determine
      whether replacing short acting with long acting drugs and dosing them at bed time rather than
      in the morning will:

      A. Lower the systolic Blood pressure during sleep B. Improve Nocturia and results in better
      sleep quality. The results suggest that short acting hydrochlorothiazide may contribute to
      nocturia in some patients.
    

Detailed description: 
      AIMS AND SIGNIFICANCE OF PILOT DATA

      Determine:

        1. The feasibility of Southern California registry as an effective measure to recruit
           African American men to participate in a new research program.

        2. If men will comply with the study procedures including Actigraphy and ambulatory blood
           pressure monitors.

        3. The within subject coefficient of variation for repeated measures of nocturnal blood
           pressure by ambulatory blood pressure monitoring, vertical activity at night by
           Actigraphy monitors.

        4. Whether the ambulatory Blood pressure itself affects the sleep pattern on Actigraphy.

        5. Nocturnal systolic blood pressure and nocturnal vertical activity are higher in men with
           self-reported nocturia ≥2 at night than in men with no reported nocturia.

      Purpose:

      Obtain key pilot data to show feasibility and document the reproducibility of the proposed
      measurements.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit men between 35 and 79 years old who are able to give informed consent, and
        are willing to be contacted for future research. Protocol will be approved by our
        Institutional Review Board and informed written consent will be obtained from all subjects.
Trial of Alternating Current Stimulation in Optic Neuropathy
Condition: Optic Nerve Diseases; Optic Nerve Injuries; Optic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Nervous System Diseases; Optic Nerve Injuries
Study type: Interventional

Summary: 
      Non-invasive brain stimulation can increase cortical excitability in the visual system, but
      it is not known if this is of clinical value. The investigators now assessed if repetitive,
      transcranial alternating current stimulation (rtACS) can improve visual field size in
      patients with optic nerve damage. The investigators hypothesized that rtACS would improve
      visual functions within the defective visual field sectors of the visual field (primary
      outcome measure).
    

Detailed description: 
      In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients
      with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10).
      Visual field measures, visual acuity and EEG-recordings were collected before and after a
      daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was
      detection accuracy (DA) in defective visual field sectors of computer-based high resolution
      perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry,
      reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
    

Intervention name(s): Repetitive transorbital alternating current stimulation
Intervention type(s): Device
Intervention description(s): Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.
Other intervention name(s): EBS Alpha Synch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: optic neuropathy; alternating current stimulation; vision recovery; restoration; plasticity
Noncontact, Handheld Device for Measurement of Respiratory Rate
Condition: Children
Study type: Observational

Summary: 
      In the emergency department, a sick child is usually seen first by a nurse. Their job is to
      quickly assess how sick the child is and what immediate care is needed. The nurse will
      usually use electronic devices to check vital signs, such as body temperature, pulse rate and
      blood oxygen levels. However, the nurse normally has to manually count the respiration rate
      (this is the number of breaths taken each minute) because there is no suitable device which
      can do this automatically. Knowing the respiration rate is very important because if it is
      not normal, the nurse knows that the child may be seriously ill. Counting the respiration
      rate of sick children can be difficult and takes up a lot of time, especially if the child is
      upset, crying or moving about. To overcome this problem we are developing a device that
      automatically measures respiration rate in children. It works by directly sensing the air
      coming from the nose or the mouth when held at a small distance (about 30 cm) from the face.
      So far, the device has been shown to work in a research laboratory at Sheffield Hallam
      University. The aim is to develop it into a handheld, userfriendly device, ensuring that it
      complies with strict safety regulations. This application is to carry out an evaluation of
      our new device against its gold standard, on adult volunteers and on children attending
      Sheffield Children's Hospital for sleep studies as part of their clinical care. In the
      future, when nurses use the device they will easily be able to measure each child's
      respiration rate so that the most seriously ill children will be identified earlier and get
      correct treatment more quickly. This will ensure that the right children get admitted to
      intensive care units sooner and, in some cases, child deaths will be prevented.
    


Intervention name(s): Contactless Portable Respiratory rate Monitor
Intervention type(s): Device
Intervention description(s): Novel hand-held respiratory rate monitor
Other intervention name(s): "Breatheasy"
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults or children requiring a respiratory rate measurement
A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and
      Clinical Activity of HRS-7085.
    


Intervention name(s): HRS-7085 tablets; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration; Single oral administration
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual
      reference drugs in healthy volunteers.
    


Intervention name(s): RIN 150; reference drugs
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.; Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; RIN 150; Healthy volunteers
Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial
Condition: Patient Satisfaction; Surgical Wound; Incision; General Surgery
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      While some studies have suggested that subumbilical and transumbilical incisions have a
      similar clinical efficiency and safety, no study has yet evaluated their respective impact on
      patient's postoperative aesthetic satisfaction.

      The objective of this randomised trial is to compare patient's postoperative aesthetic
      satisfaction depending on the type of incision which is performed during surgeries.
    


Intervention name(s): Transumbilical incision; Subumbilical incision
Intervention type(s): Procedure; Procedure
Intervention description(s): While both types of incision were considered equal regarding the potential clinical outcome, the investigators considered the transumbilical incision to be the ''intervention'' and the subumbilical incision to be the ''standard care comparator'' since the transumbilical incision take a few more minutes to be completed.; Considered here as the ''control'' intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women
Condition: Healthy Aged Women
Study type: Interventional

Summary: 
      This study is based on assess and contrast isometric and isokinetic core strength, static and
      dynamic balance, the number of falls, and functional autonomy in three different old women
      groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured
      exercise program, and 3) nonexercising.
    

Detailed description: 
      Real life conditions require concurrent attention-demanding tasks, increasing the risk of
      falling and contributing to disability. Pilates-based exercise is proposed as a combined core
      and mental training program grounded on learning functionally effective postural sets and
      motor patterns, that will provide better results than a muscular exercise program in old
      women trunk strength, the risk of falling, functional autonomy and other complementary
      physical and mental functions. This is a 30-weeks quasi-experimental randomized controlled
      trial in which 80 independent old women will be allocated to a Pilates-based exercise
      program, a muscular exercise program, and a no-exercise control group. The intervention is
      divided into 18 weeks of supervised exercise and a 12 weeks follow-up. Primary outcome will
      be isokinetic and isometric trunk and hip flexion-extension strength, static and dynamic
      balance, the number of falls, and functional autonomy. Secondary outcome will include body
      composition, habitual physical activity and a standardized gerontological evaluation composed
      of body composition, daily physical activity, the independence to develop basic and
      instrumental activities of daily living, and the cognitive, affective and social function
      assessment. Every item will be measured at baseline, 18 and 30 weeks.
    

Intervention name(s): Pilates exercise; Muscular exercise; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): 2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).; 2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).; No exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study testing SABER-Bupivacaine (an experimental pain-relieving
      medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common
      local anesthetic, for a few days in order to treat local post-surgical pain.

      The purpose of this study is to investigate safety (if there are any side effects) associated
      with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related
      side effects following shoulder surgery.
    


Intervention name(s): SABER-Bupivacaine; SABER-Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once; Injectable Solution; 5.0 mL SABER-Placebo/Once
Other intervention name(s): POSIMIR® bupivacaine solution
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; shoulder surgery; opioid
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in Gaza
Condition: Posttraumatic Stress Disorder
MeSH terms: War-Related Injuries; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The objective of this study is to determine whether participation in a mind-body skills
      program by war-traumatized adolescents in Gaza will result in improvement of posttraumatic
      stress symptoms, depression, and levels of aggression compared to a control group.
    


Intervention name(s): Mind-Body Skills Group
Intervention type(s): Behavioral
Intervention description(s): Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2201 and Co-administration of Each Component in Healty Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety
      between HCP2201 and co-administration of each component in fasting condition in healthy male
      volunteers.
    


Intervention name(s): HCP2201; RLD2205; RLD2206
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take 2 tablets once per period; Take 2 tablets once per period; Take 1 tablet once per period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China
Condition: Stress; Anxiety and Fear
MeSH terms: COVID-19; Anxiety Disorders; Stress, Psychological
Study type: Interventional

Summary: 
      The objective of this observational study was to assess whether music and sports play
      interventions were effective in reducing stress, anxiety and fear of COVID-19 among secondary
      school students in Gansu Province; The effects of music, sports games, and music combined
      with sports games were compared.
    


Intervention name(s): Music intervention only; Sports games intervention only; Music and sports games intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Music only (120-130 bpm) The effect was achieved by playing music selected by the researchers during originally physical education classes in school; twice a week for eight weeks; Sports games intervention only The effect was achieved by replacing the school's originally physical education classes with sports games of the researchers' choice; twice a week for eight weeks; Music and sports games intervention, the effect was achieved by replacing the school's physical education classes with sports games of the researchers' choice, and then by playing music of the researchers' choice during class; twice a week for eight weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 200 people tested were randomly divided into 4 groups of 50 each during the intervention phase, with three groups carrying out a intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress, anxiety and fear of COVID-19
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional

Summary: 
      This study will help to show the efficacy of vitamin D and address the optimal strategy to
      minimize renal injury in IgAN patients.
    


Intervention name(s): Calcitriol
Intervention type(s): Drug
Intervention description(s): Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
Intervention MeSH terms: Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Stem Cell in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard
      treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted
      via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group
      will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million
      cells for each subject. All groups will be observed until 1 year.
    


Intervention name(s): Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic Mesenchymal Stem Cells; Umbilical Cord Mesenchymal Stem Cells; Intravenous Mesenchymal Stem Cells; Intracoronary Mesenechymal Stem Cells