bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in
      the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages
      ranged between 20 and 50 years old.
    

Detailed description: 
      They were divided randomly into three groups by lottery method. Group A (n=30) received
      conventional therapy, group B (n=30) received TENS in addition to conventional therapy, group
      C received cupping therapy with conventional therapy and group D (n=30) received TENS and
      cupping therapy plus conventional therapy. All patients read and signed a consent form before
      participation in this trial. This study was approved by the Ethical Committee of the Faculty
      of Physical Therapy, October 6 University, Egypt. Patients with pain in the lateral
      epicondylar region, increased pain with pressure and resistance to wrist extension,
      persistence of symptoms for more than three months, no physical therapy interventions during
      the last three months were included in the study while patients with bilateral tennis elbow,
      proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy,
      other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect
      the outcome measurement and previous injury or surgery in the region of common extensor
      origin were excluded from this study.
    

Intervention name(s): conventional therapy; cupping therapy; TENS; TENS and cupping therapy
Intervention type(s): Other; Other; Device; Other
Intervention description(s): conventional therapy; cupping therapy; transcutaneous electrical nerve stimulation; TENS and cupping therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans
Condition: Adherence, Patient
Study type: Interventional

Summary: 
      This is a pilot study for identifying plasma and/or urine-derived adherence/surrogate
      biomarker candidates for verifying Immulina™ ingestion by human volunteers (collected before
      and after consumption of Immulina™, a natural dietary supplement).
    

Detailed description: 
      This pilot study is interventional, and all participants will receive one 800 mg dose of
      Immulina™ (four 200 mg capsules), a natural supplement, after a baseline blood and urine
      collection, then follow with 1 hour, 3 hour and 6 hour post-Immulina™ blood and urine
      collections. Samples will be sent to UM National Center for Natural Products Research (NCNPR)
      to analyze and compare timed blood and urine samples using gas chromatography and liquid
      chromatography to detect volatile and non-volatile compounds, gamma-linolenic acid (GLA),
      sulfoquinovose (SQ), 5'-methylsulfinyladenosine (MSA), palmitic acid, linoleic acid,
      palmitoleic acid and oleic acid to screen the chemical fingerprints of the human samples. The
      mean of the 7 biomarkers for the 4 time points will be measured and compared.
    

Intervention name(s): Immulina
Intervention type(s): Dietary Supplement
Intervention description(s): Immulina is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.
Other intervention name(s): Spirulina
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Immulina TM; Healthy Participants; Natural Dietary Supplement
A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric
      cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1
      year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as
      5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase
      II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination
      of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4
      months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective
      response rate of 50%, which included a 4% complete response. The preclinical studies,
      oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines,
      thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA
      modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied
      previously in the phase I setting in patients with metastatic breast and non-small cell lung
      cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated
      regimen. Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on
      day 2 without G-CSF support. The aim of this trial is to determine the dose limiting
      toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as
      combination chemotherapy in patients with advanced gastric cancer.
    

Detailed description: 
      Primary objectives :

      To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate
      the overall response rate in phase II study

      Secondary objectives :

        1. To evaluate the safety and tolerability of the treatment combination.

        2. To estimate overall survival.

        3. To estimate the time to progression and the duration of overall response.
    

Intervention name(s): docetaxel, oxaliplatin
Intervention type(s): Drug
Intervention description(s): Oxaliplatin will be administered in combination with docetaxel as a first-line chemotherapy in advanced gastric cancer patients. Each cycle is repeated every 3 weeks.
Docetaxel Oxaliplatin Level 1 60 mg/m2/day 1 100 mg/m2/day 1 Level 2 75 mg/m2/day 1 100 mg/m2/day 1 Level 3 75 mg/m2/day 1 130 mg/m2/day 1
Intervention MeSH terms: Docetaxel; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Docetaxel,Oxaliplatin; Phase I/II study; Advanced gastric cancer; First line treatment; Advanced gastric cancer with measurable disease
Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study will evaluate the short term effects of respiratory-gated transcutaneous vagus
      nerve stimulation on the regulation of cardiovagal activity, depressive symptomatology and
      immune function in subjects with major depression and determine the optimal stimulation
      frequency for this population.
    

Detailed description: 
      This study will compare the acute effects of respiratory-gated transcutaneous vagus nerve
      stimulation (tVNS) at different stimulation frequencies and sham stimulation during five
      sessions within a 2 week period. Heart rate variability (HRV) point process adaptive
      filtering estimation algorithms will be used to evaluate changes in cardiac autonomic
      physiology in subjects with major depression in response to tVNS. The effects of tVNS on
      cardiovagal regulation will be evaluated at rest and in response to an emotion reactivity
      task. Depression rating scales (Beck's Depression Inventory) will be used to evaluate short
      term effects of tVNS on depressive symptoms in these subjects. In addition, the study will
      evaluate the acute effects of the stimulation on serum levels of pro-inflammatory cytokines.
      The stimulation frequency that produces the greatest regulatory effects on depressive
      symptoms and physiological variables in this population will be used in a second longitudinal
      phase of the study.
    

Intervention name(s): Active transcutaneous vagus nerve stimulation; Sham transcutaneous vagus nerve stimulation
Intervention type(s): Other; Other
Intervention description(s): respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes; stimulation of the auricle for 30 minutes
Other intervention name(s): Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS); transcutaneous vagus nerve stimulation; transcutaneous vagus nerve stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Transcutaneous Vagus Nerve Stimulation; Cardiac autonomic function; Depressive symptomatology
Ovarian Reserve in Diabetes Mellitus
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages
      including reproductive years. Hyperglycemic condition in diabetes can cause organ damage.
      This study aims to measure serum hormones including FSH, LH, E2, AMH, ovarian volume and
      antral follicle count (indicators of ovarian reserve) in women with and without type 1
      diabetes mellitus.
    

Detailed description: 
      Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages
      including reproductive years. It is showed that hyperglycemic state in diabetes results in
      organ damage like kidneys and eyes. Ovarian reserve is important for the reproductive period.
      The measurements of serum hormones including follicle stimulating hormone (FSH), luteinizing
      hormone (LH), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the
      ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients
      diagnosed with type 1 diabetes mellitus and to compare them to healthy controls. Serum FSH,
      LH, E2 and AMH will be measured on the 3rd day of the cycle. Antral follicle count and
      ovarian volume measurement will be done with ultrasonography. Ovarian reserve markers will be
      compared between the groups.
    

Intervention name(s): hormone panel and ultrasonography
Intervention type(s): Other
Intervention description(s): Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH, LH, E2 and AMH hormone levels and ultrasonography for antral follicle count and ovarian volume measurement will be done.
Intervention MeSH terms: Hormones
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be reproductive age women diagnosed with type 1 diabetes
        mellitus. The control population will be aged and BMI matched women without type 1 diabetes
        mellitus.
Mitochondrial Capacity in Pregnant Women
Condition: Pregnancy Related; Physical Activity
Study type: Observational

Summary: 
      This Pilot & Feasibility study will test the hypothesis that pregnant women who are more
      active will have better functioning mitochondria in vivo (higher ATPmax, via 31P-MRS), which
      will be positively related to maternal and infant mitochondrial function in vitro (higher
      oxygen consumption rates in primary myotubes and umbilical cord derived mesenchymal stem
      cells, respectively). Twenty pregnant women (10 active and 10 sedentary) will be recruited in
      the first trimester of pregnancy determined from self-reported physical activity and
      assessment by activity monitors. Placental biospecimens will be collected during delivery for
      other molecular mitochondrial analyses.
    


Intervention name(s): Active; Sedentary
Intervention type(s): Behavioral; Behavioral
Intervention description(s): No behavioral intervention included but the exposure is level of physical activity. Individuals in the Active group will be categorized by their own routine physical activity levels.; No behavioral intervention included but the exposure is level of physical activity. Individuals in the Sedentary group will be categorized by their own routine physical activity levels.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women that are classified as either physically active or sedentary in early
        pregnancy.
      
Biospecimen description: 
      Placental biospecimens (placenta, umbilical cord, cord blood). Leg muscle tissue.
    
Keywords: Pregnancy; Mitochondrial metabolism; Placenta
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Condition: Postural Orthostatic Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans,
      but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating
      tachycardia upon postural changes such as standing that impairs their quality of life.
      Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS
      patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120
      beats/min within the first ten minutes of a diagnostic tilt table test without postural
      hypotension. There are currently no effective treatment methods for POTS. However, several
      studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine
      specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the
      heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart
      failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has
      been also used for treatment of inappropriate sinus tachycardia with good benefit. The
      hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve
      functional status in patients with POTS.
    


Intervention name(s): Ivabradine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.; A substance that has no therapeutic effect and will act as a control.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 20 patients with POTS will receive Ivabradine treatment vs placebo for one month. Then there will be a one-month wash out period prior to the cross over in which patients who received Ivabradine will receive the placebo, and patients who initially were on placebo will now receive Ivabradine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: POTS; tachycardia; ivabradine
Cue Induced Imaging in Nicotine Dependent Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the relationship between craving to smoke and areas
      activated in brain. The researchers are using functional magnetic resonance imaging (MRI)
      that measures brain blood flow, or perfusion, to study this brain activation.
    

Detailed description: 
      Functional magnetic resonance imaging has demonstrated that the same types of environmental
      cues that induce craving activate an integrated network of brain areas involved in the
      appetitive and motivational process of addiction to drugs of abuse including nicotine (
      Brieter 119; Koob 2001, Volkow 2003).In nicotine deprived smokers both mesolimbic dopamine
      reward pathways (amygdala, ventral tegmental area, and medial thalamus) and areas related to
      visuospatial attention (bilateral prefrontal cortex and parietal cortex and right fusiform
      gyrus) are activated by exposure to smoking images (Due 2002, David 2005).

      In line with the National Institute on Drug Abuse's (NIDA) emphasis on novel methods for
      investigating substance use disorders, the current study proposes to use fMRI to better
      understand the neurological correlates of cue reactivity among nicotine dependent smokers.
      This approach will permit the isolation of pathways that are relevant to cue induced craving.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult nicotine dependent smokers
      
Keywords: nicotine; addiction; fMRI; neuroimaging; neurobiology; craving
BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who
      have non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the overall response rate, including partial and complete response, in
           patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862.

        -  Determine the overall survival of patients treated with this drug.

        -  Determine duration of response and time to progression in patients treated with this
           drug.

        -  Determine the quantitative and qualitative toxic effects of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the
      absence of disease progression or unacceptable toxicity. Patients with responding disease
      receive 2-4 additional courses beyond maximal response.

      Patients are followed every 3 months for 2 years and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 14-84 patients will be accrued for this study.
    

Intervention name(s): ortataxel
Intervention type(s): Drug
Intervention MeSH terms: IDN 5109
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Condition: Pain
Study type: Interventional

Summary: 
      One dose of either gabapentin or placebo will be given to patients prior to thoracotomy.
      Patients will also receive an epidural infusion, intravenous patient-controlled analgesia
      with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal
      analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and
      will also be assessed at 3 months postoperatively to determine whether the patients who
      received gabapentin had improved analgesia and/or required less supplemental medication than
      the placebo group.
    

Detailed description: 
      The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075%
      with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl
      patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour
      maximum.
    

Intervention name(s): Gabapentin; Diphenhydramine
Intervention type(s): Drug; Drug
Intervention description(s): gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.; Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain.
Other intervention name(s): Neurontin; Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preoperative gabapentin; Acute pain; Post-thoracotomy pain; Epidural analgesia
Enhancing Treatment Adherence in Pediatric Asthma With a Problem Solving Intervention
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a tailored problem solving
      intervention in increasing adherence to asthma management behaviors in African American
      adolescents with asthma.
    

Detailed description: 
      BACKGROUND:

      Children and adolescents who are unable to adhere to their medical regimen for the management
      of chronic illness present considerable challenges to health care providers and researchers.
      Pediatric asthma is a chronic illness where the consequences of non-adherence are
      particularly detrimental and widespread, especially among economically disadvantaged minority
      children and their families. Studies of intervention of asthma management are needed for this
      population.

      DESIGN NARRATIVE:

      The aim of the proposed study is to test the efficacy of a problem solving intervention that
      is tailored to the observed adherence behaviors and identified barriers to increasing
      adherence in African American children and adolescents with asthma, and their families.
      Patients are randomized to either a Tailored Problem Solving Intervention, or a control group
      who will receive Family Education Intervention. Duration of the intervention is four months.
    

Intervention name(s): Tailored Problem Solving Intervention; Family Education Intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Examination of the efficacy of a tailored problem-solving intervention compared with family-based education in improving adherence to treatment regimens for children diagnosed as having asthma and their caregivers
Masking: Single (Investigator)
Primary purpose: Other