bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003
      injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate
      the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B
      treated with nucleos(t)ide reverse transcriptase inhibitors.
    


Intervention name(s): NrtIs; HH-003; HH-003+NrtIs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive NrtIs therapy for 24 weeks.; Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks.; Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks. Subjects will receive NrtIs therapy for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Retrospective Evaluation of Posterior Direct Restorations
Condition: Dental Caries Class II
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      This retrospective study aims to evaluate the clinical performance of posterior multi-surface
      Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a
      five-year period.
    

Detailed description: 
      Purpose: The aim of this retrospective study is to evaluate the clinical performance of
      posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by
      dental students over a five-year period. Materials and Methods: A total of 119 multi-surface
      Class II restorations (three or more surfaces) placed by third and fourth year students will
      be evaluated (AM: n = 69 and RC: n = 50). Restorations were assessed clinically according to
      the USPHS criteria by two independent evaluators using mirrors and probes. Data will be
      analyzed using Chisquare, Mann-Whitney and Wilcoxon tests at a 0.05 level of significance.
    

Intervention name(s): Retrospective evaluation of amalgam and composite restorations
Intervention type(s): Other
Intervention description(s): Multi-surface restorations that were performed by dental students and that are in function for the last five years will be clinically evaluated with mirrors and probes according to the modified USPHS criteria.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults patients who had complex amalgam or resin composite restorations (three or more
        surfaces) placed on molar or premolar areas by dental students in the Adult Dental Clinic
        over a five-year period.
      
Keywords: Amalgam, Dental; Composite Resin
Clinical Significance of Heterozygosity for Mutations of the SLC12A3 Gene Coding for the Thiazide Sensitive Na-Cl Cotransporter
Condition: Heterozygous Carriers of Gitelman Syndrome
MeSH terms: Gitelman Syndrome
Study type: Interventional

Summary: 
      Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene
      coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the
      chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to
      normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to
      determine whether the heterozygous carriers present the metabolic risks and/or the benefits
      of this disease.
    

Detailed description: 
      Gitelman syndrome (GS), is an autosomal recessive salt wasting tubulopathy caused mainly by
      loss of function mutations in the SLC12A3 gene coding for the thiazide sensitive
      sodium-chloride cotransporter (NCC). Thus, GS mimics a chronic treatment with high doses of
      thiazide diuretics. NCC is expressed in the distal convoluted tubule, which is responsible
      for 7% of NaCl reabsorption. GS is the more frequent hereditary tubulopathie with estimated
      prevalence of 1/40000, which implicates that 1% of general population are heterozygous
      carriers (600 000 in France). Previous publications suggest that the apparently asymptomatic
      heterozygous carriers could present some clinical traits of GS or chronic thiazide treatment.
      These including: beneficial aspects (low blood pressure, low urinary calcium excretions) or
      metabolic risks (hypokalemia, insulin resistance). Nevertheless, these studies do not
      evaluate all the aspects and blood pressure was evaluated once in hospital setting. This
      study aims to compare home monitoring blood pressure; salt balance; potassium, glucose lipid
      and mineral metabolism and vascular function in 80 heterozygous carriers, 80 GS patients and
      80 controls persons (without mutations in SLC12A3 gene).
    

Intervention name(s): Samplings of blood; Sampling of urine; Measure of the blood pressure; glycemia test
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gitelman; Heterozygous SLC12A3 mutation; Blood pressure; Hypokalemia
Virtual Mindfulness Rounds in the Time of COVID-19 Pandemic
Condition: Chronic Stress
Study type: Interventional

Summary: 
      Mindfulness education will be provided via a virtual platform to see if staff stress can be
      decreased during this time of pandemic.
    

Detailed description: 
      Healthcare workers have been front and center in battling the COVID crisis. This is a
      situation the researchers could never have envisioned before it happened. Of course, this has
      triggered an inordinate amount of stress. Research shows that chronic stress leaves one
      imbalanced and one's health and happiness to suffer. Research has also demonstrated that how
      one thinks about stress determines how the body responds to it. Simple mindfulness practices
      provide healthier ways to deal with stress. In this study, the researchers will introduce
      modified mindfulness practices that can be practiced in the healthcare setting or at home.
      All of the practices are based on mindfulness principles. Mindfulness refers to a state of
      being present in the moment, on purpose, and without judgment. "Mindfulness Based Stress
      Reduction" is an 8 week, 2 hours/week curriculum that has shown results for over 40 years.
      All the practices in this study are adapted from that protocol.

      The intervention includes several mindfulness practices including an awareness of breath
      focus instruction, breath-and-body coordination and awareness instruction, and instruction in
      identifying times to practice these exercises. The intervention will be delivered virtually
      2-day/week, twice/day, for four weeks.

      Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress
      Scale, a validated survey tool to determine an individual's perceived stress level.

      Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital
      system.
    

Intervention name(s): Mindfulness Rounds
Intervention type(s): Other
Intervention description(s): Virtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stress mindfulness
Waterpipe Marketing Aim 3
Condition: Waterpipe Tobacco Smoking
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the impact of marketing claims commonly found on
      waterpipe, also known as hookah, tobacco packages and in digital marketing on young adults'
      willingness to try hookah tobacco. Participants will complete two tasks, in random order.
      Participants will view six sample waterpipe tobacco packages, randomized at the package level
      to contain a prohibited or potentially-prohibited claim or not (Packaging Task). In the other
      task, they will view 10 digital marketing advertisements (i.e. Instagram posts or website
      pages) either with or without prohibited or potentially-prohibited claim, randomized at the
      advertisements level (Digital Marketing Task).
    

Detailed description: 
      Background/Objectives The Food and Drug Administration (FDA) has begun to prohibit certain
      claims on Waterpipe Tobacco (WT) packaging and advertising. Under Section 911 of the Family
      Smoking Prevention and Tobacco Control Act, manufacturers and retailers are prohibited from
      making unauthorized modified risk tobacco product (MRTP) claims, including statements that
      the product or its smoke: (1) results in reduced harm; (2) contains a reduced level of a
      substance or presents a reduced exposure to a substance; (3) does not contain or is free of a
      substance; and (4) statements that use modified risk descriptors such as light, mild, low, or
      similar descriptors. Some prohibited claims are easily identifiable, but others are more
      difficult to identify due to lack of specificity in the law and the implicit nature of some
      claims. Evidence is needed specific to WT packaging and marketing to determine which claims
      may be associated with consumer harm misperceptions to inform future regulatory actions. The
      study will address this gap by assessing how such claims influence consumer perceptions and
      behavioral intentions.
    

Intervention name(s): Package/Advertisement With Claim; Package/Advertisement Without Claim
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Waterpipe tobacco packages and digital marketing advertisement images with claim of interest as part of design; Waterpipe tobacco packages and digital marketing advertisements shown without claim of interest as part of design
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to see 6 packages and 10 advertisements, with or without the claim of interest on each.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Waterpipe tobacco smoking; hookah tobacco warning; hookah tobacco
Inspiratory Muscle Training With Powerbreath Device in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Context/background: people affected by fibromyalgia see their own life totally disturbed
      after the diagnosis. This disease also courses, apart from the functional and depressing
      worsening, with internal damage manifested by a cardio respiratory deterioration. There are
      not many clinical studies publications about this disease given that is considered a weird
      illness with short prognosis.

      Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory
      muscle strength, lumbar pain, quality of life, phase angle and body composition in patients
      with Fibromyalgia.

      The participants of experimental group will conduct 5 sets of 10 inspirations per day, 5 days
      per week, through 8 weeks.
    

Detailed description: 
      Methods: 40 volunteer patients, female, with fibromyalgia will take part of the
      cuasi-experimental study and they will be divided into two groups: an experimental group (n =
      20) and a control group (n = 20). The Maximum Inspiratory Pressure (PIM), the quality of
      life, lumbar pain, phase angle and body composition will be measured.

      Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day,
      each subject perform 5 sets of 10 inspirations, 5 days a week. The endurance of the device
      increases along the study, initiating with the 50% of their own maximum inspiratory pressure
      (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th
      week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP

      After 8 weeks, all participants will fill up again all scales and post training measurements
      will be taken.
    

Intervention name(s): Inspiratory Muscle Training with Powerbreath IMT device.
Intervention type(s): Other
Intervention description(s): Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 repetitions, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
Condition: Arthroplasty, Replacement, Knee; Nerve Block; Anesthesia, Regional; Ambulatory Surgical Procedures
Study type: Interventional

Summary: 
      This is a randomized, double-blinded pilot study to determine whether patients undergoing
      ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition
      of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal
      approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale
      (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome
      as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of
      catheter effectiveness, and complications.
    


Intervention name(s): Normal Saline; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect; This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Evaluation of Physical Fitness After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study aims to examine the evolution and determinants of physical fitness after stroke.
    

Detailed description: 
      Stroke is a major cause of chronic severe disability. More than 50% of stroke survivors have
      residual motor and functional deficits which have an impact on their participation and
      quality of live (Patel et al, 2006). Limitations on daily functioning may lead to physical
      inactivity and a sedentary lifestyle. Sustained physical inactivity (deconditioning) induces
      a reduction in aerobic capacity, which may further increase the risk of cardiovascular
      diseases in these individuals above that associated with stroke itself. Therefore, improving
      aerobic capacity may be essential in prevention of secondary diseases due to lack of fitness
      in the stroke population. Previous studies have also indicated that a critical level of
      aerobic capacity must be met in order to function independently (Cress et al, 2003).
      Therefore, in addition to disease prevention, enhancing aerobic capacity in individuals with
      stroke may also have beneficial effects on promoting functional abilities and independent
      living. It is also known that a limitation in functional performance is mostly associated
      with a restriction in social activities (ICIDH-2-model). Clearly, stroke survivors can
      benefit from counseling on participation in physical activity and exercise training. A recent
      meta-analysis (Pang et al, 2006) showed that there is good evidence to support the use of
      aerobic exercise to improve aerobic capacity in individuals with stroke. However, before
      going on that road, one needs to know more about the level of physical activity and physical
      fitness in the stroke population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects with a first ever stroke
      
Keywords: stroke; physical fitness; evolution; determinants
Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Condition: Breast Cancer; Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the
      efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy
      treatment.
    

Detailed description: 
      This is a randomized, multi-center, single dose, double-blind, placebo controlled phase III
      study of the efficacy and safety of once-per-cycle of F-627 in women with stage II-IV breast
      cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) +
      Adriamycin(doxorubicin)). F-627 is designed to treat neutropenia, an abnormally low number of
      neutrophils (a type of white blood cell) in the blood. Neutropenia is often seen in cancer
      patients receiving myelotoxic chemotherapy.

      The primary objective of this study is to evaluate the efficacy and safety of single fixed
      dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to
      placebo. F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in
      each 21-day cycle of chemotherapy treatment (up to 4 cycles). Patients randomized to placebo
      arm will receive F-627 except in cycle 1. The primary endpoint will be the duration of grade
      4 (severe) neutropenia - the number of days in which the patient has had an absolute
      neutrophil count (ANC < 0.5 x 10^9/L) observed in chemotherapy cycle 1.
    

Intervention name(s): F-627; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study; Placebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Radial and Focused ESWT in the Treatment of Coccydynia According to Age and Body Mass Index
Condition: Coccyx Disorder
Study type: Interventional

Summary: 
      To date, focused and radial types of ESWT have been effectively used in the treatment of
      coccydynia. However, studies directly addressing a comparison between radial and focused
      types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate
      comparative effects of radial and focused ESWT options on coccydynia.
    


Intervention name(s): ESWT (wave type: focused); ESWT (wave type: radial); ESWT (wave type: sham)
Intervention type(s): Device; Device; Device
Intervention description(s): Extracorporeal Shock Wave Therapy, device: Electronica, Pagani, Italy; Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy; Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Kinesio Taping on the Stability of Knee in Soccer Players
Condition: Injury of Musculoskeletal System
Study type: Interventional

Summary: 
      Objective: The general objective of this study is to determine the possible beneficial effect
      of the application of kinesiotaping, as well as the performance of proprioceptive exercises
      on parameters related to knee stability, such as the incidence of injuries, pain, static
      stability Or dynamics, and flexibility, in amateur soccer players, with a workload of 3 days
      per week plus the match.

      Material and methods: Amateur soccer players are divided into 3 groups.

      Group 1 (G1) performs proprioceptive exercises plus the application of kinesiotaping without
      tension in the knee.

      Group 2 (G2) performs proprioceptive exercises plus the application of kinesiotaping with
      tension in the knee.

      Group 3 (G3) is placed kinesiotaping with tension in the knee, without proprioception
      exercises.

      The treatment will last four weeks and three evaluations, one before treatment, another at
      two weeks and the last one at the end of treatment.
    


Intervention name(s): Kinesio Taping placebo and exercises; Kinesio Taping with tension and exercises; Kinesio Taping with tension
Intervention type(s): Other; Other; Other
Intervention description(s): Kinesio Taping placebo and exercises; Kinesio Taping with tension and exercises; Kinesio Taping with tension
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of
      DBPR108 in subjects with mild, moderate, severe renal impairment and subjects with kidney
      failure compared to the matched control subjects with normal renal function.
    

Detailed description: 
      This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, safety,
      and tolerability of a single dose of DBPR108 100 mg in subjects with mild, moderate, and
      severe renal impairment (RI), subjects with kidney failure and the control subjects with
      normal renal function. This study consists of a screening period (Day -14 to Day -1), a
      baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6.

      Subjects will be enrolled in the following groups:

      Estimated glomerular filtration rate (eGFR) will be calculated based on Modification of Diet
      in Renal Disease (MDRD) equation at screening.

      (A) mild renal impairment (60 ≤ eGFR≤ 89 mL/min/1.73m2); (B) moderate renal impairment (30 ≤
      eGFR≤ 59 mL/min/1.73m2); (C) severe renal impairment (15 ≤ eGFR≤ 29 mL/min/1.73m2); (D)
      kidney failure (<15 mL/min/1.73m2, not on hemodialysis); (E) control subjects with normal
      renal function will be matched with subjects with HI by weight, age, and sex (eGFR≥90
      mL/min/1.73m2).

      Approximately 8 subjects will be enrolled in each group.
    

Intervention name(s): DBPR108 tablets
Intervention type(s): Drug
Intervention description(s): Drug: DBPR108, tablet, oral
Other intervention name(s): DBPR108
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment