bioihbjkbjnl/mcl2 huggingface dataset:
Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients Compared to Usual Care
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of COPD self-management interventions compared to usual on
      Quality of life, functional status, patient education, depression, and anxiety in primary
      healthcare users in the prefecture of Heraklion, Greece.
    

Detailed description: 
      To the best of our knowledge, no previous study has examined the effects of self-management
      programs on patients with COPD in Greece. Therefore, the investigators conducted a randomized
      controlled trial with a post-test design, to evaluate the implementation and clinical
      effectiveness of a COPD self-management intervention compared to usual care in terms of the
      following outcomes: Quality of life, functional status, patient education, depression, and
      anxiety.
    

Intervention name(s): Self Management
Intervention type(s): Behavioral
Intervention description(s): A "training book" was given to this group, which was created for the study. The implementation process followed a five-step approach including sessions once a month for five consecutive months with a coach and follow-up phone calls after the end of the sessions.To inspire and engage patients, the sessions included a variety of educational techniques, including knowledge transfer, discussion, hands-on training, and homework. Additionally, coaches received training in motivational interviewing methods. The self-management program and all the process of data collection is described in detail on the supplementary file.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Clinical and Radiological Effect Of Platelet Rich Fibrin on the Healing of Periodontal Intrabony Periodontal Defects
Condition: Chronic Periodontitis; Intrabony Periodontal Defect
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The aim of this split mouth, single-center, controlled study is to compare the healing of
      intrabony defects treated with a combination of Anorganic Bovine Bone Mineral (ABBM)/Platelet
      Rich Fibrin (PRF) or Anorganic Bovine Bone Mineral alone. The hypothesis being tested in the
      study was that PRF would augment the regenerative effects of ABBM in human intrabony defects.
    

Detailed description: 
      Anorganic bovine bone mineral (ABBM) is extensively used in the treatment of intrabony
      defects. Platelet rich fibrin (PRF) is a new generation platelet concentrate with a
      simplified technique. Although there are some studies on the use of PRF in the treatment of
      intrabony defects, to date none of them evaluate its additive effects with ABBM. Therefore, a
      randomized, split mouth clinical trial was conducted to compare the healing of intrabony
      defects treated with a PRF/ABBM combination and to those obtained with ABBM alone. Using a
      split mouth design, 15 paired intrabony defects were randomly treated with either ABBM alone
      (control group) or with ABBM- PRF combination (test group). The following clinical parameters
      and radiographic measurements were recorded at baseline and six months postoperatively:
      plaque index (PI), gingival index (GI), probing depth (PD), gingival recession (GR), clinical
      attachment level (CAL), vertical bone loss, the depth of the defect and defect angle
    

Intervention name(s): Anorganic Bovine Bone Mineral (ABBM); Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)
Intervention type(s): Other; Other
Intervention description(s): In the control group, periodontal intrabony defects were treated with ABBM alone.; In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anorganic bovine bone mineral;; Graft; Intrabony periodontal defect; platelet rich fibrin
Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
Condition: Amyloidosis; Amyloid Cardiomyopathy; Transthyretin Amyloidosis; Cardiomyopathies; Heart Diseases
MeSH terms: Heart Diseases; Cardiomyopathies; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered
      orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid
      Cardiomyopathy (ATTR-CM).
    

Detailed description: 
      Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed condition believed to
      affect more than 400,000 people worldwide. In ATTR-CM, the accumulation of transthyretin
      (TTR) amyloid results in thickening and stiffening of the heart, which often leads to heart
      failure or even death.

      There are two forms of ATTR-CM:

        -  Wild Type* This form of the condition primarily develops in older individuals who do not
           carry gene mutations.

        -  Hereditary* This form of the condition comes from gene mutations passed down in
           families.

      In this study we are researching the investigational drug acoramidis HCl 800 mg administered
      orally twice a day. Through the study, we want to evaluate the efficacy and safety of
      acoramidis in patients with ATTR-CM versus placebo.

      This is a 30 month, randomized, double-blind, placebo-controlled study. This means that,
      during the 30 month study, investigators conducting the research and study participants will
      not know whether the study participant is receiving acoramidis or placebo.

      The primary outcomes of the study are:

        1. The impact of acoramidis versus placebo on the change in distance walked on the 6 minute
           walk test (6MWT) after 12 months of treatment compared to baseline.

        2. The impact of acoramidis versus placebo on the hierarchical combination of All-Cause
           mortality, cumulative frequency of cardiovascular-related hospitalizations, change from
           baseline in NT-proBNP, and change in from baseline in 6MWT over a 30-month fixed
           treatment duration.

      At the end of 30 months, participants may be eligible to receive investigational acoramidis,
      and there is no placebo. This is called an "open label extension." This separate study may
      help us better understand the safety related to taking acoramidis over a longer period of
      time.
    

Intervention name(s): acoramidis; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): TTR stabilizer administered orally twice daily (BID); Non-active control administered orally twice daily (BID)
Other intervention name(s): AG10; ALXN2060
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyloidosis; ATTR-CM; Transthyretin; Amyloid; TTR
Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluated the feasibility of an 8-week physical therapy program for persons with
      chronic low back pain provided entirely using telehealth with real-time, interactive video
      sessions with a physical therapist.
    

Detailed description: 
      At the time of the onset of the COVID pandemic, the research team was conducting a clinical
      trial (the OPTIMIZE trial) investigating different nonpharmacologic treatments for persons
      with chronic low back pain (NCT03859713). One intervention arm in this trial is in-person
      physical therapy. COVID-related restrictions on in-person care prompted suspension of the
      OPTIMIZE trial. In order to accommodate persons in the midst of receiving treatment at the
      time of suspension, the study team adapted the in-person protocol for physical therapy for
      telehealth delivery using two-way, real-time video sessions. Because of the lack of research
      examining the feasibility of telehealth physical therapy provided in this manner, the study
      team decided to conduct a pilot study to examine the feasibility of the telehealth protocol.

      This study was a prospective, longitudinal cohort of persons with chronic LBP seeking care in
      one of three healthcare systems; University of Utah Health and Intermountain Healthcare in
      Salt Lake City, Utah, and Johns Hopkins Medicine in Baltimore, Maryland. All participants
      were offered up to 8 weekly sessions of telehealth physical therapy. Outcomes included
      measures of acceptability, appropriateness, feasibility and fidelity as well as effectiveness
      measures including the Oswestry Disability Index and the PROMIS-29 health domains.
      Assessments occurred at baseline and after 10- and 26-weeks.
    

Intervention name(s): Telehealth Physical Therapy
Intervention type(s): Behavioral
Intervention description(s): Weekly sessions of physical therapy provided using two-way, interactive, video technology consisting of education, advice and exercise instruction.
Intervention model: Single Group Assignment
Intervention model description: Prospective, longitudinal cohort design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telehealth; Physical therapy; Chronic pain
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in
      healthy infants. This study will include both full-term infants (≥37 weeks gestational age)
      and premature infants (<37 weeks gestational age). Premature infants will be included in a
      Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety
      following administration of V114 or Prevnar 13™.
    


Intervention name(s): V114; Prevnar 13™
Intervention type(s): Biological; Biological
Intervention description(s): V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose; Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis
Condition: Scleroderma, Systemic; Skin Sclerosis; Lung Fibrosis; Autoimmune Diseases; Collagen Diseases
MeSH terms: Rheumatic Diseases; Pulmonary Fibrosis; Scleroderma, Systemic; Scleroderma, Diffuse; Collagen Diseases; Autoimmune Diseases; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the efficacy and safety of rituximab compared with placebo in SSc
      patients. This study consists of a 24-week, double-blind, placebo-controlled period followed
      by a 24-week active drug treatment period.
    


Intervention name(s): Double-Blind Placebo; Double-Blind Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.
In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered.; The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.
In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered.
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Term Extension Safety Study in Patients With Dementia of the Alzheimer's Type Who Completed Study CPC-001-07
Condition: Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a long-term-safety roll-over extension study for a Phase II Study (Protocol
      CPC-001-07).
    

Detailed description: 
      This is a long-term-safety roll-over extension study for a Phase II Study (Protocol
      CPC-001-07). Patients having safely completed the 12-week maintenance phase of Study
      CPC-001-07 will be eligible for admission. Subjects will remain on their CPC-201 MTD as
      determined in Study CPC-001-07. The dose of CPC-201 will be increased from 15 mg/day
      (administered in Study CPC-001-07) to 20mg/day starting on Day1. For those patients who do
      not tolerate 20mg/day CPC-201, the dose of CPC-201will be decreased to its previously
      tolerated level of 15mg/day.

      This protocol allows to increase patients' MTD of CPC-201, as previously determined in the
      Phase II Study (CPC-001-07 protocol) by, 5mg or 10mg increment up to a maximum of 60 mg/day
      starting on Day7 or Month 3 visits of this extension protocol per Investigator's judgment and
      patient's tolerability.

      This extension study is intended to continue for each enrolled patient for up to 6 months
      unless medically contraindicated. Patients may withdraw from this study at any time. Upon
      termination of this study, patients will return to their original daily donepezil dose of 10
      mg/day and will continue to receive CPC-201 mg/day for one final week.
    

Intervention name(s): CPC-201
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      the primary objective of the study is to compare the onset and recovery times of sensory and
      motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary
      objectives of the study are to observe hemodynamics, side effects profile, and duration of
      postoperative analgesia
    

Detailed description: 
      The current study is undertaken to compare the effect of two drugs
      intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the
      adequacy of the block, side effect profile and postoperative analgesia. The two drugs have
      been studied separately but the comparative data is scarcely available both at national and
      international level. A particular agent is a dexmedetomidine that has been introduced in the
      investiagator's setup for the first time so this research will be of great importance in
      adding its multiple uses other than being used as ICU and procedural sedation agent.
    

Intervention name(s): Bupivacaine, fentanyl; Bupivacaine, dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,; Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomize controlled trial (RCT)
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Elective low segment caesarean section; Intrathecal; bupivacaine-fentanyl; bupivacaine-dexmedetomidine; sensory block; complications; hemodynamics
A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348
Condition: Hypertension; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to compare the pharmacokinetics and tolerability of CKD-348
    

Detailed description: 
      A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the
      pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult
      volunteers
    

Intervention name(s): CKD-348 F1; CKD-348 F2; CKD-828, D097, D337
Intervention type(s): Drug; Drug; Drug
Intervention description(s): QD, PO; QD, PO; QD, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-348
Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)
Condition: HIV/AIDS; HIV Infections; Substance Use; Substance Abuse; Substance Use Disorders; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional

Summary: 
      This research study proposes to embed HIV testing outreach workers from a young adult focused
      medical and HIV treatment program into an alternative sentencing program to deliver a new
      service delivery model (Link2CARE) that integrates evidence-based protocols for
      justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk
      screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU
      care. Phase 1 has already been completed. In phase 1, the intervention components were
      adapted for use among justice involved young adults and the resulting protocols were piloted
      with justice involved young adults, finalizing the resulting 4-session Link2CARE
      intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults
      enrolled at the alternative sentencing program and conduct process evaluations with N=15
      alternative sentencing program staff.
    


Intervention name(s): Link2CARE
Intervention type(s): Behavioral
Intervention description(s): The Link2CARE intervention consists of 4 sessions. Session 1 consists of a one-on-one meeting with a Health Coach, during which participants will be offered an oral rapid HIV test and STI test. Sessions 2, 3, and 4 are group-based. During these sessions, participants will engage in discussions and activities regarding sexual and substance use risk behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if patients with lung cancer and their main informal
      caregiver (person providing physical, emotional, or financial support) are helped by getting
      information, support, and decision making tools through a computer system called CHESS(the
      Comprehensive Health Enhancement Support System)
    

Detailed description: 
      Many patients and their family/friends use the internet for obtaining information regarding
      the cancer diagnosis and treatment. In this study, the main caregiver of patients with
      advance (stage III or IV) non-small cell lung cancer is provided with a computer and internet
      access. Approximately one-half of the participants will also receive CHESS.
    

Intervention name(s): Comprehensive Health Enhancement Support System
Intervention type(s): Device
Intervention description(s): computer based support and education
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lung cancer, caregivers, support, resources, education
Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise
      training mode is still unclear. In this study, the investigators compared the health-related
      effects of high intensity interval training versus endurance training in obese children.
    


Intervention name(s): Endurance training; High intensity interval training
Intervention type(s): Other; Other
Intervention description(s): 30 to 60-minute continuous exercise at 80% of the peak heart rate; 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: exercise; overweight; children
Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies
Condition: Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic; Leukemia, Lymphoblastic, Acute; Lymphocytic Leukemia, Chronic; Myelodysplastic Syndromes; Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease
MeSH terms: Leukemia; Multiple Myeloma; Hematologic Neoplasms; Hodgkin Disease; Lymphoma, Non-Hodgkin; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if peripheral blood cells collected following
      AMD3100 mobilization can be used safely for hematopoietic cell transplantation into
      HLA-matched recipients.
    

Detailed description: 
      This study will determine if peripheral blood cells collected following AMD3100 mobilization
      can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
    

Intervention name(s): AMD3100; Stem Cell Transplant
Intervention type(s): Drug; Procedure
Other intervention name(s): Plerixafor
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plerixafor; Stem cell transplantation; Stem cells; Mobilization