bioihbjkbjnl/mcl2 huggingface dataset:
HORMA: Hormonal Regulators of Muscle and Metabolism in Aging
Condition: Sarcopenia; Muscle Weakness; Frailty
MeSH terms: Muscle Weakness; Sarcopenia; Frailty
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the relationship of deficiencies in testosterone
      and growth hormone to loss of muscle mass (sarcopenia) and functional impairment during aging
      and whether there is an interaction of these two hormone systems in maintaining normal
      skeletal muscle mass and physical function.
    

Detailed description: 
      Elderly persons experience progressive loss of skeletal muscle mass, muscle strength, and
      functional capacity for activities of daily living. Aging is also associated with a loss of
      hormones believed to be related to muscle and strength, namely testosterone and growth
      hormone (GH). The hypothesis being tested is that both hormone systems regulate
      musculoskeletal protein mass and contractile fibers by different and complimentary mechanisms
      and that optimal levels of both testosterone and GH are necessary to maintain skeletal muscle
      mass, muscular strength and power, and full functional activities of daily living during the
      aging process.

      This is a controlled, 16 week study to evaluate the independent effects and interaction of
      these two anabolic hormone systems in community dwelling elderly men 65-90 years of age who
      are hyposomatotropic (deficiency of growth hormone) with low eugonadal status (total
      testosterone of 150-550 ng/dL). The study will utilize a two tiered randomization in which
      108 study participants will first be randomized to either the low or high eugonadal level of
      testosterone using a novel Leydig cell clamp method (GnRH (gonadotropin-releasing hormone)
      agonist plus topical testosterone supplementation) to achieve target levels of testosterone.
      Low gonadal status (150-550 ng/dL) will be maintained with 5 g daily doses of topical
      testosterone, whereas high gonadal status (650-950 ng/dL) will be achieved with 10 g daily
      doses. Within these two groups, participants will be randomized to receive placebo or one of
      two doses of rhGH (recombinant human growth hormone) therapy (0, 3.0, 5.0 mcg/kg/day) in a
      double blinded fashion.
    

Intervention name(s): Topical testosterone; Recombinant human growth hormone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hormones; Testosterone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: andropause; hormone therapy; HRT
Effect of Revival Soy on Fibromyalgia Pain
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is characterized by widespread pain that can lead to significant patient
      dysfunction and economic burden to society. The management of patients with fibromyalgia is
      difficult and no single treatment modality has been successful. We propose to study the
      effect of dietary soy supplement on quality of life associated with fibromyalgia.
    

Detailed description: 
      Fibromyalgia syndrome is a chronic, generalized pain syndrome that affects the
      musculoskeletal system (1). This syndrome is typically diagnosed in patients who experience
      generalized musculoskeletal pain and have excessive tenderness in at least 11 of 18 specific
      points (2). Although the primary cause of fibromyalgia syndrome is unclear, a growing body of
      evidence indicates that the widespread pain associated with this syndrome is due to
      abnormalities in the central nervous system. Therefore, drug therapy for fibromyalgia
      syndrome is most often aimed at the central nervous system and includes tricyclic
      antidepressants, selective serotonin reuptake inhibitors, dual serotonin and norepinephrine
      reuptake inhibitors, analgesics, and anticonvulsants (1).

      In addition to medical therapies, complementary and alternative medicine therapies have been
      used to treat fibromyalgia syndrome symptoms (3). Soy is a widely used dietary supplement
      that has not been previously tested for treating fibromyalgia syndrome.
    

Intervention name(s): Soy; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.; Drink a shake (vanilla and chocolate taste) once a day for 6 weeks.
Other intervention name(s): Isoflavone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; Dietary Supplements; Rheumatologic Diseases; Complementary and Alternative Medicine
Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the drug octreotide acetate in a new intranasal
      formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The
      two octreotide acetate formulations will be evaluated following separate administrations for
      safety and tolerability including any side effects, the speed at which the drug is absorbed
      and eliminated in the body, and the ability of the drug to lower the levels of growth hormone
      (GH) and insulin-like growth factor 1 (IGF-1).
    

Detailed description: 
      Octreotide is a synthetic octapeptide analog of naturally occurring somatostatin, with
      similar pharmacological effects but a longer duration of action. It inhibits the pathological
      secretion of GH from pituitary adenomas, and of serotonin and other hormones by tumors of the
      gastroenteropancreatic endocrine system. Currently, only injectable octreotide and
      somatostatin analogs have been approved, for the indications of acromegaly, carcinoid tumors,
      and vasoactive intestinal peptide tumors.

      DP1038, an intranasal formulation of octreotide, is being developed for the treatment of
      acromegaly, a rare chronic disorder arising from the overproduction of GH, predominantly by
      pituitary adenomas. Excess GH and associated IGF-1 levels are responsible for multiple
      symptoms (e.g., headache, tissue swelling, perspiration, joint pain) and significant
      comorbidities (e.g., diabetes, sleep apnea, cardiovascular abnormalities such as
      hypertension). In most patients with acromegaly, octreotide consistently normalizes GH and
      IGF-1 serum concentrations, thereby markedly reducing clinical symptoms.
    

Intervention name(s): Intranasal octreotide acetate; Subcutaneous octreotide acetate; Growth hormone-releasing hormone; Arginine hydrochloride
Intervention type(s): Drug; Drug; Diagnostic Test; Diagnostic Test
Intervention description(s): Intranasal spray of octreotide acetate; Subcutaneous injectable solution of octreotide acetate; Part of the well established GHRH/Arginine challenge to detect GH deficiency.; Part of the well established GHRH/Arginine challenge to detect GH deficiency.
Other intervention name(s): DP1038; Sandostatin Injection; GHRH; R-Gene 10
Intervention MeSH terms: Octreotide; Hormones; Growth Hormone-Releasing Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study consists of two study parts. In Study Part 1, 12 subject will be randomized into one of four study arms using a 4x4 modified latin square design.
In Study Part 2, subjects will be randomized into one of two arms using a 2x2 crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This project is designed to examine the impact of tailored feedback on site performance.

      The investigators' objective is to evaluate whether a 'personalized and targeted' feedback,
      education and performance improvement intervention has a greater impact on adherence to
      recommended guidelines than standard feedback.

      The investigators hypothesize that a site-specific report with centrally identified targets
      for improvement paired with target specific interventions will enable sites to quickly
      identify and prioritize salient problem areas, have ready access to an analysis of factors
      that underlie problems, and formulate an effective action plan. The investigators also
      hypothesize that those hospitals randomized to receive intervention will be more likely to
      improve their overall performance, as well as their target specific performance, during the
      period of observation in direct response to activated QI processes.

      Outcomes:

      The primary outcome is improvement in the overall composite of all metrics eligible for
      intervention regardless of their selection as targets.

      The secondary outcome is improvement in the composite of targeted metrics.

      Outcomes will be assessed in all participating sites, and in among relevant performance
      subgroups (low performers, academic centers, full service, and among medication versus
      process metrics).
    


Intervention name(s): Targeted Feedback Reports; Targeted Feedback Report
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sites randomized to this arm will receive specialized feedback summarizing their adherence to the guidelines and suggestions on ways to improve performance.; Report designed to target areas for local hospital-specific improvement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: quality improvement
Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This
      MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered
      AZD7268 after multiple ascending doses.
    


Intervention name(s): AZD7268; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, Oral, BID; Capsule, Oral, BID
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase I; Japanese Healthy volunteer
Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
Condition: Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a video shown using an iPad,
      compared to a standard treatment, to reduce preoperative anxiety in children who have to
      undergo to elective surgery procedure
    


Intervention name(s): Video; Standard care
Intervention type(s): Procedure; Other
Intervention description(s): The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.; In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Neuro-psychosocial Teleassistance for Neuromuscular Diseases
Condition: Social Competence; Self Esteem; Quality of Life; Social Skills; Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of
      telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The
      intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1
      session per week of 1h duration. The intervention is aimed at strengthening aspects of social
      cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general
      improvement of psychological well-being.
    

Detailed description: 
      Development of a neuro-psychosocial tele-assistance programme for groups of children and
      adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular
      dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and
      intervention include social cognition, quality of life, psychological symptomatology and
      coping strategies. The aim of this study is to test whether this programme improves the
      indicators in the mentioned variables.
    

Intervention name(s): Neuro-psychosocial teleassistance program
Intervention type(s): Behavioral
Intervention description(s): The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
Masking: None (Open Label)
Primary purpose: Treatment
Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction
Condition: Smoking Cessation; Harm Reduction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This open-label study will explore the impact of varenicline on the process of switching from
      combustible cigarettes (CC) to an e-cigarette. Varenicline is currently the most efficacious
      single pharmacotherapy for smoking cessation, and through its actions as an agonist or
      partial agonist at various nicotinic acetylcholine receptor subtypes, serves to diminish the
      rewarding effects of cigarette smoking. Diminishing the rewarding effects of smoking might
      facilitate the transition from CC to e-cigarettes. On the other hand, varenicline might
      attenuate the rewarding effects of nicotine-containing e-cigarettes as well, which could
      hamper the transition. Thus, the study will provide important information about the actions
      of varenicline on CC as well as e-cigarettes. There is no therapeutic intent in that smokers'
      nicotine/tobacco dependence will not be treated; the goal is to switch from one form of
      nicotine/tobacco dependence (CC) to dependence on a different tobacco product (e-cigarettes).
    


Intervention name(s): Varenicline; e-cigarette
Intervention type(s): Drug; Other
Intervention description(s): 0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.; Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Other intervention name(s): Chantix; Halo G6
Intervention MeSH terms: Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Age-Related Effects of THC
Condition: Tolerance; Adolescent Behavior; THC
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Increased accessibility to cannabis and its primary psychoactive constituent THC has raised
      public health concerns. One major concern surrounds the potential risks associated with acute
      THC intoxication and who might be most at risk. A second major concern is the need to develop
      sensitive measures that can detect THC intoxication after recent use and enable robust
      comparisons of intoxication to determine sources of risk. One potential source of risk is
      age, specifically during the period of adolescence.
    

Detailed description: 
      There is limited knowledge on the effects of THC in adolescents vs adults. One recent report
      compared responses to vaporized cannabis in heavy adolescent vs adult cannabis users and
      found that the adolescents were less sensitive to the drug on most measures. However, their
      findings were complicated by several factors: i) the study used vaporized cannabis, which may
      have other constituents and does not offer full control of the dose, ii) the participants
      were heavy users, making it difficult to determine the influence of prior drug exposure, and
      iii) the participants were not drug-free at the time of testing. Prior exposure to THC can
      lead to tolerance, and adolescents and adults may differ in the rate at which they develop
      tolerance, consistent with changes in CB1R receptor function. Our study will compare
      adolescent (here, aged 18 to 20) and adult (here, aged 30 to 40) responses to THC in
      relatively light cannabis users who are drug-free at the time of testing.
    

Intervention name(s): Dextrose; Dronabinol; Dronabinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administering dextrose to healthy volunteers for our placebo group; THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users.; THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users.
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Next Generation Sequencing Detection of Lyme Disease
Condition: Lyme Disease; Pediatric Infectious Disease; Erythema Migrans; Lyme Arthritis; Lyme Carditis; Lyme Disease Meningitis
MeSH terms: Communicable Diseases; Infections; Lyme Disease; Erythema Chronicum Migrans; Glossitis, Benign Migratory; Meningitis; Erythema
Study type: Observational

Summary: 
      Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a
      single blood sample, potentially improving its sensitivity compared to PCR testing, which
      only detects predetermined larger strands of DNA. We will test the ability of NGS to detect
      Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease. We will
      conduct an observational study of NGS testing on pediatric patients at all stages of Lyme
      disease. Study involvement will require a single study visit for clinical data collection and
      blood draw. We will enroll patients at all phases of suspected Lyme disease, collect
      clinically relevant information, and test for Lyme disease using Next Generation Sequencing
      and standard Lyme serologic testing. If the patient has multiple erythema migrans, Lyme
      meningitis, facial nerve palsy, arthritis, or carditis, a B. burgdorferi serum PCR will also
      be sent. Enrollment and Next Generation Sequencing blood draw will occur before or up to 24
      hours after the first dose of antibiotics is administered. We will also study the impact of
      antibiotics on NGS testing by running the test 6-24 hours after antibiotics are started among
      a small subset of patients with a multiple erythema migrans rash. Collected data will be
      analyzed with basic descriptive statistics.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cases will include pediatric patients age 1 to <18 years old who currently have a specific
        Lyme disease syndrome and have been on antibiotics for less than 24 hours prior to blood
        draw
      
Biospecimen description: 
      Whole blood samples for detection of infectious pathogens by next generation sequencing
    
Keywords: Next Generation Sequencing
Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure
Condition: Optic Nerve Sheath; Hypertonic Saline
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a
      variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of
      the skull results in increased ICP, which may lead to life-threatening structural alterations
      in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the
      brain.

      Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In
      fluid-based systems, external ventricular drainage (EVD) has been considered the gold
      standard.

      Clinicians have found several noninvasive methods that can be used as surrogates for invasive
      methods for ICP measurement. The optic nerve, as part of the central nervous system, is
      wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the
      subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid
      space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter
      (ONSD).

      Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in
      the management of ICH after severe TBI . They provide therapeutic benefit along with a wide
      therapeutic margin. The most recent BTF guidelines stated "although hyperosmolar therapy may
      lower intracranial pressure, there was insufficient evidence about effects on clinical
      outcomes to support a specific recommendation, or to support use of any specific hyperosmolar
      agent".
    


Intervention name(s): intermittent boluses of Hypertonic saline; continuous infusion of Hypertonic saline
Intervention type(s): Drug; Drug
Intervention description(s): intermittent boluses every 6 hours over 30 min for 48 hours; continuous infusion over a period of 48 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment