bioihbjkbjnl/mcl2 huggingface dataset:
LDN and tDCS in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and
      pharmacological approaches are widely used to relieve pain and increase life quality. In this
      context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients
      with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current
      Stimulation (tDCS), have been shown effective for pain management. This study aims to
      evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in
      fibromyalgia patients. This is a randomized, double-blinded, parallel,
      placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be
      included included and signed the informed consent. Patients will be allocated into 4 groups:
      tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN
      or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or
      active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale
      (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia
      Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale
      (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain
      Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic
      Factor (BDNF) serum levels.
    


Intervention name(s): Low-Dose Naltrexone; Transcranial Direct Current Stimulation; Placebo; Sham Transcranial Direct Current Stimulation
Intervention type(s): Drug; Device; Drug; Device
Intervention description(s): 4.5mg daily dose, orally, during 26 days; An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.; The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.; Sham-tDCS stimulation consists of an active current during 30 seconds
Other intervention name(s): LDN; tDCS; Sham tDCS
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blinded, parallel, controlled with placebo and sham stimulation, clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; LDN; Transcranial Direct Current Stimulation; Low Dose Naltrexone
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase
      cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled
      clinical studies investigating the independent effects of OSA in the development of
      cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders
      such as inflammatory response, oxidative stress and vascular changes. The investigators
      hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular
      consequences in OSA patients would be less important.

      The purpose of this study is to analyze the effects of OSA in the absence of MS, on
      inflammatory, oxidative stress and vascular markers; to verify the influence of excessive
      daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal
      continuous positive airway pressure (nCPAP)in theses parameters.
    


Intervention name(s): continuous positive airway pressure (CPAP)
Intervention type(s): Procedure
Intervention description(s): CPAP pressure is individually prescript according to polysomnography for CPAP titration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; inflammation; oxidative stress; arterial stiffness
Functional Connectivity in Mood Regulating Circuit In Bipolar Depression and Mania
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out what parts of the brain have increased or decreased
      activity with individuals who have bipolar disorder and how medicine changes this activity in
      bipolar subjects. Another purpose of this study is to compare data obtained from bipolar
      depressed subjects with data obtained from healthy subjects. In this study we will measure
      activity in different parts of the brain, while participants see pictures, using Magnetic
      Resonance Imaging (MRI) scan. We will do two MRI scans with each subject before and after
      treatment for eight weeks with a standard bipolar disorder medication called lithium.
    

Detailed description: 
      Aim 1: Our first aim is to use a novel fMRI experimental paradigm to investigate the
      pathophysiology of bipolar disorder (BD) in terms of the strength of connectivity (as
      measured by LFBF correlations) between the different emotion regulating areas of the brain
      rather than in terms of increase or decrease in localized brain activity.

      Specific Aim 2: Our second aim is to investigate whether lithium works by altering the
      connectivity of areas of the brain implicated in the pathophysiology of BD, thereby leading
      to changes in the abnormal positive or negative emotional reactions to the environment seen
      in mania and depression respectively.

      Specific Aim 3: Out third aim is to investigate whether patients with the s/s or s/L alleles
      of the 5-HTTLPR polymorphism will have greater amygdalar activation and decreased
      cortico-amygdala connectivity compared to patients with L/L genotype. We will also
      investigate whether lithium treatment differentially affects these fMRI measures in the s/s
      or s/L and L/L genotypes.

      Methods:

      We will study unmedicated subjects satisfying DSM-IV criteria for Bipolar Disorder current
      episode depressed or hypomanic/manic or who are euthymic. Subjects will undergo fMRI before
      and after 8 weeks of treatment with lithium a mood stabilizer that is known to be effective
      in both phases of BD. Healthy subjects will have a scan at baseline and after 8 weeks but
      will not be treated with any medication. We will also test for the serotonin transporter gene
      (the gene that controls the availability of a chemical called serotonin in the brain), which
      has been shown to effect how lithium works.
    

Intervention name(s): Lithium
Intervention type(s): Drug
Intervention description(s): starting dose 600 mg increase as tolerated
Intervention MeSH terms: Lithium Carbonate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mood Regulating Circuit; Lithium; fMRI
Icing Effects on Neck Functions of the Boxers
Condition: Balance
Study type: Interventional

Summary: 
      Most boxing injuries occurs over head and neck which leads to potentially acute or chronic
      head and neck injuries. Patients with whiplash injury has been reported, reflected by
      increased body sway and reduced ability to overcome challenging balance tasks. The purpose of
      this research is to evaluate the fitness and balance outcomes between the boxers and the
      control group, and boxers undergoing posterior-neck icing effects.
    

Detailed description: 
      Injuries are common in boxing, occurring most often to the head, neck, face, and hands.
      Traumatic minor cervical strains are common place in high-impact sports and premature
      degenerative changes have been documented in sports people exposed to recurrent impact trauma
      or repetitive forces. Whiplash injury may result in extensive trauma to muscles and
      ligamentous structures within the cervical spine . Many of these structures, particularly the
      muscles, contain mechanoreceptors that play a key role in position sense. Studies have shown
      that head and neck position sense may become impaired following whiplash injury.
      Subsequently, poor movement patterns, together with the perpetuation of pain and other
      symptoms may develop.

      Posture control is achieved by integration of sensory inputs emanating from somatosensory,
      vestibular, and visual systems. Patients with whiplash injury has been reported, reflected by
      increased body sway and reduced ability to overcome challenging balance tasks. In this study
      we have attempted to evaluate the influence of boxing on balance performances, isometric
      strength and flexibility; furthermore, evaluate the therapeutic effect of ice massage on
      boxers.
    

Intervention name(s): icing massage
Intervention type(s): Other
Intervention description(s): The intervention, ice massage, was conducted by replacing a bag of crushed ice (100 cc) inside a moistened towel and lightly rubbed over lumbosacral region for 10 minutes. The moisture towel increased the intensity of the cooling sensation more than the dry wrappings
Other intervention name(s): serial number:200800018; code name:9700018
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: icing; boxer; balance; neck range of motion; neck isometric strength; balance performance
Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 50 mg of Dr.
      Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing
      Lamotrigine) Extended Release tablets 50mg of GlaxoSmithKline Research Triangle Park, NC in
      healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other intervention name(s): LAMICTAL XR
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lamotrigine Extended Release; crossover
Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of
      intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia
      with neutropenia.

      A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous
      drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.

      All patients will receive chemotherapy for their AML according to local clinical standard of
      care as well as antifungal prophylaxis.

      APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of
      chemotherapy
    


Intervention name(s): APX001 with Standard of Care anti-fungal agent
Intervention type(s): Drug
Intervention description(s): safety assessment
Intervention MeSH terms: Antifungal Agents; Clotrimazole; Miconazole
Intervention model: Sequential Assignment
Intervention model description: The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001
Masking: None (Open Label)
Primary purpose: Other
Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the use of slush nitrogen results in higher
      post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.
    

Detailed description: 
      The study is a randomized, controlled trial which seeks to characterize oocyte survival rate
      following vitrification and subsequent warming with both slush nitrogen and liquid nitrogen.
      After warming, fertilization and embryology outcomes will be assessed.

      Oocyte donors and a single donor sperm source will be utilized. Following enrollment, oocyte
      donors will undergo ovarian stimulation and oocyte retrieval. The mature (MII) oocytes
      obtained for each patient will then be assigned a number and randomized via block
      randomization to one of two treatment groups (liquid nitogen or slush nitrogen). Through
      block randomization, this will create a paired population of oocytes so that half of each
      patient's oocytes will undergo cryopreservation with liquid nitrogen and half will undergo
      cryopreservation with slush nitrogen. Timing of hyaluronidase stripping and vitrification
      will be consistent with current institutional clinical practice for oocytes.

      Following cryopreservation, oocytes will be warmed and intracytoplasmic sperm injection will
      be performed and subsequent embryology outcomes tracked.
    

Intervention name(s): Vitrification via slush nitrogen; Vitrification via liquid nitrogen
Intervention type(s): Other; Other
Intervention description(s): oocytes will be vitrified using slush nitrogen; oocytes will be vitrified using liquid nitrogen which is currently routine practice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial in a paired design
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Blue Note Therapeutics Product BNT 103 Usability and User Engagement
Condition: Breast Cancer Female
Study type: Interventional

Summary: 
      This test aims to explore product development-focused usability and user engagement.
    

Detailed description: 
      Sponsor is testing an innovative peer-to-peer communication tool during this trial.
    

Intervention name(s): BNT103
Intervention type(s): Device
Intervention description(s): BNT-103™ is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer. There are 10 sessions provided over approximately 10 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Brock Exercise And Supplement Trials
Condition: Untrained; Healthy
Study type: Interventional

Summary: 
      This study will analyze the effects of Greek yogurt consumption and an 12 week exercise
      intervention on muscle size, body composition and bone health in untrained, university-aged
      males.
    

Detailed description: 
      Introduction: Previous research has shown the effectiveness of dairy milk and whey protein on
      increasing muscle size, optimizing body composition and increasing strength in adult males.
      However, evidence on the use of high protein/Greek yogurt on muscle size, body composition
      and bone health is limited in this population. Yogurt contains similar muscle and bone
      supporting nutrients as milk, yet it offers a host of additional benefits including;
      increased satiety, probiotic cultures, greater stability, increased variety, more affordable
      and versatile features such as acting as a vehicle for consumption of other healthful foods.
      The proposed research will investigate the use of Greek yogurt as an effective post-exercise
      food to promote healthy body composition and bone health changes in young adult males.

      Design: Parallel, randomized controlled trial.

      Participants: 30 (n=15 YOG, n=15 PLA) healthy, untrained university-aged males.

      Methods: Subjects will undergo a 12-week resistance and plyometric training program
      (exercising 3 days/week). The YOG group will consume a 200g dose (pro= 20g, carbs= 8 grams,
      ~110 kcals) of plain 0% Greek yogurt, while the PLA group will consume an isoenergetic,
      protein-void beverage comprised mainly of maltodextrin (pro= 0g, carbs= 26g, ~110 kcals).
      Each group will consume 3 doses per day (immediately and 1 hour post-exercise, and bedtime).
      Markers of bone health (CTx and P1NP) will be taken at baseline, 1 week and 12 weeks to
      determine acute and total changes. Muscle size, body composition, strength, vertical jump
      height and nutritional diaries will be measured pre and post intervention and habitual diet
      maintenance will be encouraged throughout the intervention.

      Anticipated Results: It is hypothesized that each group will undergo positive changes in the
      aforementioned measures, however due to the increase in protein and calcium consumption, the
      yogurt group is predicted to have significantly greater increases in these variables than the
      placebo group.
    

Intervention name(s): Resistance and Plyometric Exercise; Greek Yogurt (0% Plain); Placebo - Study Designed Supplement
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): 12 weeks of Resistance (twice weekly) and Plyometric (once weekly) training; 200g 3x/day for 12 weeks.; Iso-energetic to yogurt. 3x/day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Greek Yogurt; Muscle Size; Bone Health; Body Composition; Exercise
To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure
Condition: Gastroesophageal Disease
MeSH terms: Sleep Deprivation
Study type: Observational

Summary: 
      The purpose of this study is to determine if sleep deprivation results in increased
      esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD)
      patients.
    

Detailed description: 
      To determine if increased esophageal acid exposure is mediated by altering appetite
      regulation. To assess if there is any relationship between sleep deprivation and the serum
      level of TNF-alfa (a protein that can be elevated in inflammation).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        25 subjects w/ GERD 25 subjects w/o GERD
      
Biospecimen description: 
      Serum samples collected and stored -80 freezer in GI lab.
    
Keywords: GERD; SLEEP DEPRIVATION; APPETITE REGULATION; GHRELIN; LEPTIN
Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the efficacy of AZD7442 for the post-exposure prophylaxis of COVID-19
      in Adults.
    

Detailed description: 
      SARS-CoV-2 is the causative agent of the ongoing COVID-19 pandemic that, as of 29 September
      2020, has resulted in a high death toll to date. Unlike the majority of coronaviruses that
      cause mild disease in humans and animals, SARS-CoV-2 can replicate in the lower respiratory
      tract to cause acute respiratory distress syndrome and fatal pneumonia. Effective
      interventions to prevent or treat COVID-19 remain limited in number and clinical experience
      is limited. Clinical management is limited to supportive care, consequently overwhelming
      resources of healthcare systems around the world. As a response to the ongoing pandemic,
      AstraZeneca is developing mAbs to the SARS-CoV-2 S protein. The SARS-CoV-2 spike protein
      contains the virus's RBD, which enables the virus to bind to receptors on human cells. By
      targeting this region of the virus's spike protein, antibodies can block the virus's
      attachment to human cells, and, therefore, is expected to block infection. Amino acid
      substitutions have been introduced into the antibodies to both extend their half-lives, which
      should prolong their potential prophylactic benefit, and decrease Fc effector function in
      order to decrease the potential risk of antibody-dependent enhancement of disease. AZD7442, a
      combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration
      to prevent and/or treat COVID-19. There is currently one ongoing Phase I study with AZD7442.
    

Intervention name(s): AZD7442; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.; Single dose (× 2 IM injections) of saline placebo on Day 1.
Other intervention name(s): A combination of 2 mAbs (AZD8895 and AZD1061)
Intervention MeSH terms: Cilgavimab and tixagevimab drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Post exposure COVID-19
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
Condition: Breast Cancer; Obesity; Overweight
MeSH terms: Breast Neoplasms; Overweight
Study type: Interventional

Summary: 
      Obesity among breast cancer survivors is known to be associated with recurrence and other
      co-morbidities. However, there have been no studies on weight reduction program combining
      diet and anti-obesity drug for obese breast cancer survivors. The purpose of this randomized
      clinical trial is to examine the effects of Mediterranean Diet and naltrexone/bupropion
      treatment on inflammation and metabolic risk factors in overweight or obese breast cancer
      patients after breast cancer treatment.
    


Intervention name(s): naltrexone/bupropion; Mediterranean Diet
Intervention type(s): Drug; Behavioral
Intervention description(s): Naltrexone hydrochloride (HCl) 8 mg/Bupropion hydrochloride (HCl) 90 mg extended release (ER) combination tablets, orally, one tablet, in the morning, daily, for 1 week, followed by Naltrexone HCl 8 mg/Bupropion HCl 90 mg ER combination tablets, orally, one tablet in the morning and one in the evening, daily, for 7 weeks.; Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention