bioihbjkbjnl/mcl2 huggingface dataset:
Adaptive Goal-Directed Adherence Tracking and Enhancement
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which
      uses the text messaging and internet capabilities of modern cellular phones to address the
      problem of medication adherence in clinical care and clinical trial contexts. This trial will
      evaluate whether AGATE improves medication adherence in the context of a pharmacotherapy
      trial of naltrexone to treat problem drinking. All participants will be treatment-seeking
      problem drinkers who will receive naltrexone and medication monitoring over 8 weeks.
    

Detailed description: 
      The purpose of the naltrexone trial is to evaluate whether AGATE effectively measures and
      enhances medication adherence in the context of naltrexone treatment for problem drinking.
      Participants will be heavy/problem drinkers, recruited from the greater Albuquerque area, who
      are interested in either reducing or stopping their drinking and deemed to be candidates for
      naltrexone pharmacotherapy by the study psychiatrist, Dr. Arenella. All participants will be
      prescribed naltrexone, 50 mg, once daily, for eight weeks, and receive smartphones.
      Participants will be randomly assigned to receive either AGATE or SASED, a web-based alcohol
      and side-effects diary via smartphone. The primary outcome will be percent of scheduled doses
      that were taken during the eight week trial, as measured by the Medication Event Monitoring
      System (MEMS, Aardex Group, Union City, CA), pill counts, and using the timeline follow-back
      (TLFB) method.
    

Intervention name(s): AGATE; SASED
Intervention type(s): Other; Other
Intervention description(s): AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.; Participants will receive SASED, a web-based alcohol and side-effects diary via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Naltrexone; problem drinking; medication adherence; adherence; smartphone
Diabetic Retinopathy Vitrectomy Study (DRVS)
Condition: Diabetic Retinopathy; Retinal Detachment; Vitreous Hemorrhage
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Vitreous Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare two therapies, early vitrectomy and conventional management, for recent severe
      vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes
      vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if
      retinal detachment involving the center of the macula develops at any time.

      To compare early vitrectomy and conventional management in eyes that have good vision but a
      poor prognosis because they are threatened with hemorrhage or retinal detachment from very
      severe proliferative retinopathy.

      To study the natural history of severe proliferative diabetic retinopathy.
    

Detailed description: 
      Vitrectomy may not only remove vitreous hemorrhage but also prevent or relieve traction on
      the retina from contraction of the fibrovascular membranes that characterize severe
      proliferative diabetic retinopathy. It is important to determine whether early intervention
      with vitrectomy has a better visual outcome or instead produces a rate of serious
      complications higher than the rate associated with conventional management.

      Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had
      either insulin-dependent or non-insulin-dependent diabetes. In the first trial, the 616
      patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in
      at least one eye. Eligible eyes were randomly assigned either to early vitrectomy or to
      conventional management. In the conventional management group, vitrectomy was carried out 1
      year later if hemorrhage persisted; vitrectomy was carried out sooner if retinal detachment
      -involving the center of the macula occurred.

      In the second trial, 381 patients were recruited, all of whom had severe fibrovascular
      proliferations and useful vision in at least one eye. Eligible eyes were assigned either to
      early vitrectomy or to conventional management. Conventional management included
      photocoagulation when indicated, with vitrectomy if a severe vitreous hemorrhage occurred and
      failed to clear spontaneously during a 6-month waiting period or if retinal detachment
      involving the center of the macula -occurred. After randomization and treatment, all patients
      were examined at 6-month intervals for 2 years and annually thereafter. Comparisons of visual
      acuity distributions between experimental and control groups were made.
    

Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed analgesic efficacy of ASP0819 relative to placebo as well as the safety
      and tolerability.

      This study assessed treatment differences in physical function as well as the improvements in
      overall subject status (e.g., fibromyalgia symptoms and global functioning) of ASP0819
      relative to placebo.
    


Intervention name(s): ASP0819; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ASP0819; Fibromyalgia
0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia
Condition: Hospital-acquired Pneumonia
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Study type: Interventional

Summary: 
      Chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. However,
      it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of
      non-ventilator hospital-acquired pneumonia among hospitalized patients.
    

Detailed description: 
      Participants will be classified into three groups, applied twice a day by care givers. Oral
      colonization will be tested in the baseline, day-3, day-7, and at the discharge. Quantitation
      of colonization of the oral cavity by oral rinses and respiratory pathogens were measured.
    

Intervention name(s): 0.12% Chlorhexidine Oral Liquid Product; Listerine Oral Liquid Product; Normal Saline Product
Intervention type(s): Drug; Drug; Other
Intervention description(s): The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.; The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.; The control group received 10ml normal saline for oral rinse twice a day.
Intervention MeSH terms: Chlorhexidine; Listerine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: 0.12% chlorhexidine; Oral rinse; Hospital-acquired pneumonia
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
Condition: Adult Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy
      over one year, followed by randomized either intensified or conventional maintenance therapy.
      It includes a distinct protocol for the subgroup 'mature B-ALL',
    


Intervention name(s): Asparaginase; Vincristine; Daunorubicin, Adriamycin; Cyclophosphamide; Ifosfamide; Cytarabine; Mitoxantrone; Methotrexate; 6-Mercaptopurine; 6-Thioguanine; VM26; Dexamethasone / Prednisolone; CNS Irradiation; Mediastinal Irradiation; Stem Cell Transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Ifosfamide; Methotrexate; Vincristine; Doxorubicin; Daunorubicin; Asparaginase; Mitoxantrone; Mercaptopurine; Thioguanine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL; Treatment; De Novo; Adult
Threads Insertion in Forehead Static Wrinkles
Condition: Wrinkle
Study type: Interventional

Summary: 
      The main objective of this study is to analyze the efficacy and safety of PDO threads in
      correcting deep static wrinkles on the upper face.
    

Detailed description: 
      The upper face is a complex and dynamic part of the face, which conveys facial expression and
      emotion. As one age, youthful dynamic facial lines on the forehead and glabella change to
      static wrinkles, which remain on the face at rest. These permanent wrinkles can lead to the
      appearance of fatigue and negative facial expressions such as anger, which may influence
      psychological wellbeing, social confidence, and self-esteem.

      The two major factors involved in the formation of static wrinkles in the upper face are
      repetitive muscle contraction and aging (loss of dermal collagen and matrix material leading
      to reduced dermal support). Compared with other facial muscles, the frontalis and corrugator
      muscles usually retain their muscle volume and even undergo hypertrophy to compensate for
      age-related ptosis and loss in visual acuity, which intensify the wrinkles.

      Botulinum toxin and filler injections are currently the main treatment modalities in the
      management of facial wrinkles, especially for those on the upper third of the face.
      Conceptually, botulinum toxin addresses wrinkles by relaxing the muscles responsible for
      their creation (ie, the"dynamic" component), while soft tissue fillers provide necessary
      volume for the effacement of facial rhytids (ie, the "static" component). Although popular
      and widely accepted by the general population, some hesitate to receive toxin or filler
      injections due to the potential risk of unnatural facial expression, ptosis (associated with
      botulinum toxin), skin necrosis, and vision loss (from filler injection).

      This has created a demand for a minimally invasive technique with reduced side effects, where
      threads may be considered. Although more commonly known as a mean for facial lifting,
      polydioxanone (PDO) suture materials have been applied to static wrinkles with promising
      outcomes.
    

Intervention name(s): Botox then threads; threads only
Intervention type(s): Combination Product; Procedure
Intervention description(s): patients in which Botox injection then threads insertion were used; patients in which threads insertion only was used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Ferrous Sulfate Versus Iron Amino Acid Chelate
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      Iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and
      the leading cause of anemia in the world; this can occur at any age, but preschool children
      are at particular risk of developing it. This condition may cause serious repercussions for
      life, being a public health threat of considerable importance worldwide.

      Food fortification is considered the most effective solution to counter this situation,
      because it can help more people than other solutions. It is going to carry out a community
      trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a
      dietary supplement in preschool children of Medellin with depleted levels of iron; in terms
      of increasing ferritin levels in blood and maintain hemoglobin levels. It is hypothesized
      that at the end of the study the effect of milk fortified with iron amino acid chelate won't
      be less than the effect of fortified with ferrous sulfate.

      It is hoped that the results may contribute, albeit indirectly, to improve the health status
      of children with depleted levels of iron whom consume iron-fortified products.
    


Intervention name(s): Ferrous sulfate as dietary supplementation; Iron amino acid chelated as dietary supplementation
Intervention type(s): Other; Other
Intervention description(s): Ferrous sulfate as dietary supplementation; Iron amino acid chelated as dietary supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Iron Deficiency; Child, Preschool; Dietary Iron; Ferrous sulfate; Bis-glycino iron II
Cervicothoracic Junction Mobilization Versus Muscle Energy Technique in Chronic Neck Pain
Condition: Chronic Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study will be conducted to identify the difference between the effect of of
      cervicothoracic junction mobilization and autogenic Muscle Energy Technique. on neck pain,
      cervical range of motion, cervical proprioception and neck disability in mechanical neck pain
      patients with cervicothoracic junction hypomobility.
    


Intervention name(s): cervicothoracic junction mobilization in form of Maitland mobilization; autogenic muscle Energy Technique; conventional physical therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Group A: will receive cervicothoracic junction mobilization mobilization in form of Maitland mobilization to the C7-T1 level, according to their primary movement restriction (for flexion-extension restriction- central PA glide, for rotation restrictions (unilateral PA glide) for 3 sessions/week over 4 weeks periods.; the technique will applied to neck muscles that are prone to get short including anterior, middle and posterior Scaleni, Sternocleidomastoid, Levator Scapulae and upper fibers of the Trapezius muscle.
The AI MET group will given 3-5 repetitions of post isometric relaxation (PIR) (30-50% isometric contraction of the muscle to be stretched for 7-10 seconds, followed by rest period of 5 seconds and then a stretch of 10-60 seconds hold; conventional physical therapy only in form of: (superficial heat using hot pack for 10 minutes , Isometric Neck Exercises and Dynamic Neck Exercises)) for 3 sessions/week over 4 weeks periods
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: mobilization and conventional physical therapy
autogenic muscle Energy Technique and conventional physical therapy
conventional physical therapy only
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic mechanical neck pain; cervicothoracic junction mobilization; autogenic muscle energy technique; cervicothoracic junction hypomobility
Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder
Condition: Acute Mania in Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct
      therapy to lithium in the treatment of patients with acute mania in bipolar disorder.
      Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria
      (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single
      Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation
    


Intervention name(s): Quetiapine Fumarate; Lithium
Intervention type(s): Drug; Drug
Intervention description(s): Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator.
Tablets; Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Mania; Bipolar Disorder; Quetiapine Fumarate; Lithium
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily
      (QD), in the treatment of neuropathy caused by diabetes mellitus.
    

Detailed description: 
      Diabetic polyneuropathy is a frequent complication in individuals with type 1 and 2 diabetes
      mellitus, and can result in progressive functional and structural deficits in both somatic
      and autonomic nerves. Diabetic polyneuropathy is characterized by degenerative changes in
      nerve fibers resulting in progressive functional and structural deficits in both somatic and
      autonomic nerves.

      TAK-583 is a synthetic compound currently under development for the treatment of diabetic
      polyneuropathy. The purpose of this study is to evaluate the safety and efficacy of TAK-583
      for the treatment of mild to moderate diabetic polyneuropathy in subjects with type 1 or type
      2 diabetes mellitus. Study participation is anticipated to be about 8 months.
    

Intervention name(s): TAK-583; TAK-583; TAK-583; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-583 5 mg, tablets, orally, once daily for up to 6 months.; TAK-583 50 mg, tablets, orally, once daily for up to 6 months.; TAK-583 100 mg, tablets, orally, once daily for up to 6 months.; TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asymmetric Diabetic Proximal Motor Neuropathy; Diabetic Amyotrophy; Diabetic Autonomic Neuropathy; Diabetic Polyneuropathy; Neuralgia, Diabetic; Symmetric Diabetic Proximal Motor Neuropathy; Drug Therapy
Influence of Propofol on Alveolar Macrophage in Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The change of airway responsiveness and alveolar macrophage (AM) immunity occurs during the
      pathogenesis of asthma. Macrophage-associated airway protection in patients with asthma is
      affected positively or negatively by propofol general anesthesia. The investigators
      hypothesized that the effects of propofol on asthmatic AMs and corresponding airway
      reactivity in vivo is different from the in vitro research. Through in vivo airway
      hyperresponsiveness (AHR) observation and clinical investigation of AM immune functions from
      asthma patients undergoing propofol general anesthesia to clarify the precise effects of
      propofol on AM immunity, and to provide theoretical basis for the clinical administration of
      propofol in asthmatic patients. This would optimize the practice of clinical anesthesia,
      especially for those with the tendency of AHR.
    


Intervention name(s): 2,6-Diisopropylphenol
Intervention type(s): Drug
Intervention description(s): Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
Other intervention name(s): Diprivan
Intervention MeSH terms: Propofol
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with or without asthma undergoing general anesthesia
      
Keywords: General anesthesia; Propofol; Immunity; Alveolar Macrophages
Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      BCD-132 is a humanized monoclonal antibody against CD20. BCD-132-1 is a Multicenter
      Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics,
      Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients with
      Relapsing-Remitting Multiple Sclerosis.
    


Intervention name(s): BCD-132
Intervention type(s): Biological
Intervention description(s): Dose Escalation Study
Other intervention name(s): humanized monoclonal antibody against CD20
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: BCD-132; Multiple Sclerosis; anti-CD20