bioihbjkbjnl/mcl2 huggingface dataset:
The Psychoneuroimmunology of Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      Chronic insomnia affects approximately 8-9% of the population. The prevalence of this
      disorder rises dramatically across the lifespan, especially so in women. When it is chronic,
      insomnia is associated with increased fatigue, cognitive impairment, mood disturbance,
      physical complaints, diminished quality of life and increased health care consumption. There
      is also more limited evidence (based on epidemiologic studies or experimental studies in
      healthy subjects) that insomnia and/or sleep loss may be a risk factor for hypertension
      and/or cardiovascular disease and increased mortality.

      Despite its prevalence and consequences, the pathophysiology of insomnia and, specifically,
      the pathway by which morbidity risk is conferred, has been relatively unstudied. With respect
      to medical illness in particular, insomnia may confer risk in several ways, including: 1) an
      inherent compromise in the restorative/conservative function of sleep, 2) the deleterious
      effects of "hyperarousal" and/or HPA axis abnormalities on end organ integrity and function,
      and/or 3) diminished immunocompetence. This study focuses on the last of these possibilities,
      the relationship between immune function and sleep.

      The study compares immune response to a vaccine challenge in two groups: good sleepers and
      patients with chronic insomnia. The primary study hypothesis is that the insomnia group will
      have a decreased rate of adaptive immune response to the vaccine challenge than that of the
      good sleeper group.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community Sample
      
Keywords: Primary Insomnia; Insomnia; Good Sleepers; Hep B; Vaccine
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Condition: TOBACCO USE CESSATION
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized double-blind, placebo-controlled will determine the relative efficacy of
      standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After
      completing the eligibility screening, 600 treatment-seeking smokers will be randomized to
      receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or
      extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral
      counseling. The primary outcome will be biochemically verified abstinence from smoking at the
      end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after
      treatment is discontinued), and time to failure. We hypothesize that ET will produce
      significantly higher quit rates than ST; however, the benefit of ET will last only so long as
      treatment is continued. Support for this hypothesis would indicate that maintenance therapy
      with TN should be considered.
    

Detailed description: 
      Please see brief summary.
    

Intervention name(s): Standard Patch Treatment; 24-weeks of nicotine patch
Intervention type(s): Drug; Drug
Intervention description(s): 8-weeks of nicotine patch + 16-weeks of placebo; 24-weeks of 21mg nicotine patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Randomized Trial to Evaluate the Effectiveness of a Mindfulness Based Intervention (MBSR) for Patients Suffering From Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Patients suffering from migraine will be randomly allocated to one of two different
      behavioral interventions:

        -  mindfulness based stress reduction (MBSR) an eight week intervention program based
           different meditation & yoga techniques and teaching information regarding the
           relationship between stress and health.

        -  into an active control group teaching three times within eight weeks relaxation
           techniques (progressive muscle relaxation PMR) and giving psychoeducation on migraine.
           The investigators will measure the frequency and intensity of migraine attacks before
           during and after the intervention as well as secondary variables on quality of life and
           psychological functioning. The hypothesis is that patients allocated to the MBSR
           intervention will reduce the frequency of their migraine attacks compared to the active
           control group and compared to their own baseline.
    

Detailed description: 
      Sixty patients suffering from migraine will be randomly allocated to one of two different
      behavioral interventions: (i) mindfulness based stress reduction (MBSR) an eight week
      intervention program based different meditation & yoga techniques and teaching information
      regarding the relationship between stress and health. or (ii) into an active control group
      teaching three times within eight weeks relaxation techniques (progressive muscle relaxation
      PMR) and giving psychoeducation on migraine. The investigator will measure the frequency and
      intensity of migraine attacks before during and after the intervention by headache diaries as
      well as secondary variables on pain sensation, psychological well being, generic quality of
      life, pain regulation, pain acceptance, mindfulness, compliance and satisfaction with the
      intervention. The hypothesis is that patients allocated to the MBSR intervention will reduce
      the frequency of their migraine attacks compared to the active control group and compared to
      their own baseline.
    

Intervention name(s): Mindfulness Based Stress Reduction MBSR; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness Based Stress Reduction: 8 weeks behavioral structured group programme teaching mindfulness skills; Psychoeducation on Migraine, Progressive Muscle Relaxation PMR, three group meetings within 8 weeks, daily home work
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Headache
Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Condition: Hyperthyroidism; Graves Disease
MeSH terms: Graves Disease; Hyperthyroidism
Study type: Observational

Summary: 
      The investigators want to investigate if a continuous heart rate monitoring with a wrist worn
      fitnesstracker can be useful in the treatment and surveillance of patients suffering from
      Graves' disease.The aim of our research project is two-fold: First, to evaluate the use of
      continuous heart rate monitoring as a potential substitute for hormone measurements during
      treatment of hyperthyroidism. Second, to use continuous heart rate monitoring as a tool for
      early detection of relapse after discontinuation of antithyroid drugs.
    


Intervention name(s): Continuous heart rate monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): Continuous heart rate monitoring with a wrist worn fitnesstracker
Other intervention name(s): Regular measurements of thyroid hormone levels
Intervention MeSH terms: Hormones
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Graves' disease at the beginning and after cessation of anti-thyroid drug
        treatment
      
Biospecimen description: 
      serum
    
Keywords: Heart rate; Pulse rate
Determining the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety of MLN9708 as maintenance therapy
      following allogeneic stem cell transplant in patients with multiple myeloma.
    

Detailed description: 
      Although multiple myeloma is considered fatal, survival has dramatically improved over the
      last two decades with the introduction of more effective treatment options. Proteasome
      inhibitors have an anti-myeloma effect and are often used as either initial treatment or at
      relapse in patients with multiple myeloma. MLN9708 is an orally bioavailable, potent,
      reversible inhibitor of the 20S proteasome. Phase I studies have shown MLN9708 to be very
      well tolerated with minimal peripheral neuropathy. It has also shown impressive anti-myeloma
      activity in both the relapsed/refractory setting and the upfront setting (Kumar et al. 2011,
      Berdeja et al. 2011, Richardson et al. 2011). These characteristics make MLN9708 an ideal
      proteasome inhibitor to use after allogeneic stem cell transplant. In this Phase II,
      open-label, multicenter, non-randomized study the investigators will investigate the role of
      MLN9708 as maintenance after allogeneic stem cell transplant in patients with high-risk
      multiple myeloma, and in patients with multiple myeloma who have relapsed after an autologous
      stem cell transplant.
    

Intervention name(s): MLN9708
Intervention type(s): Drug
Intervention description(s): Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive MLN9708 orally (PO) as monotherapy on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. Up to 18 patients will be enrolled in a dose-escalation phase to determine the maximum tolerated dose (MTD).
Dose-Escalation Phase: MLN9708 will be administered orally (PO) as monotherapy. Dosing will start at 2.3 mg. If acceptable tolerability is demonstrated, escalations will be made to 3 mg and to a maximum-planned dose (MPD) of 4 mg.
Other intervention name(s): ixazomib
Intervention MeSH terms: Ixazomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MLN9708; allogeneic stem cell transplant; multiple myeloma; ixazomib; autologous stem cell transplant
In Vivo Leptin Signaling in Humans After Acute Leptin Administration
Condition: Lean; Obese; Obese Diabetics
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to help us to better understand how leptin regulates
      blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells.
      Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and
      influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an
      investigational drug and has not yet been approved by the Food and Drug Administration (FDA),
      will be administered to participants in this study. The expected duration of your
      participation is 3 study visits, which will be spread over 3-4 weeks.

      This study involves having fat and muscle biopsies after receiving leptin under local
      anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or
      Endocrinology exam room at the Beth Israel Deaconess Medical Center.
    

Detailed description: 
      Screening Visit During this visit, you will have a complete medical history taken and have a
      physical examination performed by one of the study physicians. You will also have your height
      and weight measured. You will have a blood drawn (approximately 2 tablespoons)and will have
      an electrocardiogram (EKG). At the screening visit you will also meet with a dietician who
      will review your food preferences with you in order to design the meals that you will receive
      as part of the study.

      Study Day #1: You will pick up your meals designed with the dietician. You will be provided
      with meals for 48 hours prior to your fat biopsy. These meals will be designed by the
      dietician based upon what you like to eat. You will also have your Resting Metabolic Rate
      Measured.

      Study Day #2: A nurse will will insert two intravenous catheters (IV) into a medium size vein
      in each of your forearms. You will then have two fat and muscle thigh biopsy. One before and
      one after leptin is given. You will stay in the hospital for three hours of observation.
      During this time you will have your Resting Metabolic Rate measured and then you will be
      provided with a meal.

      Study Day #3: Seven to ten days after the biopsy, you will be asked to return to the hospital
      so that the surgeon can inspect the wound.

      Your participation in this study will involve 3 study visits, which will be spread out over
      3-4 weeks.
    

Intervention name(s): leptin
Intervention type(s): Drug
Intervention description(s): 0.01mg/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leptin; In Vivo; Diabetic; Obese; Lean
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate the efficacy and safety of a steroid avoidance regimen in
      comparison with steroid treatment in combination with an initially higher dose of
      enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal
      transplant recipients. Patients will be randomly allocated to receive either EC-MPS or
      steroids in combination with EC-MPS. Patients of both treatment groups will receive
      monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
    


Intervention name(s): Enteric-coated mycophenolate sodium (EC-MPS); Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.; Oral tablets
Other intervention name(s): Myfortic
Intervention MeSH terms: Mycophenolic Acid; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Steroids avoidance,; enteric-coated mycophenolate sodium (EC-MPS),; de novo renal transplantation
The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis
Condition: Patients
MeSH terms: Rhinitis; Ganglion Cysts; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in
      treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG
      acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind,
      controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants
      will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group.
      All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of
      4 week.

      Primary trial outcomes are change in symptoms and change in need for medication. The primary
      outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.
      Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal
      cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in
      neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory
      cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis
      factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal
      secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1,
      week4 and week 8.
    


Intervention name(s): Sphenopalatine ganglion acupuncture
Intervention type(s): Procedure
Intervention description(s): active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process
sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Sphenopalatine ganglion; Allergic rhinitis; Randomized Trial
Early Phase I Microdosing Study of ORM-14540 and ORM-12741
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and
      ORM-14540 in healthy volunteers.
    


Intervention name(s): ORM-14540; ORM-12741
Intervention type(s): Drug; Drug
Intervention description(s): i.v.; i.v.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers
Surgeons Can Avoid Lasting Pain Through Exercise Literacy
Condition: Neck Pain; Shoulder Pain
MeSH terms: Shoulder Pain; Neck Pain
Study type: Interventional

Summary: 
      The physical demands of surgery are in many ways similar to those of high-performance
      athletes. No professional athlete would consider performing without careful attention to
      strengthening and physical preparedness, yet surgeons routinely place rigorous demands on
      their bodies without any training plan specific to their work demands. A series of exercises
      were developed to help stretch and strengthen the key core muscles to support surgeons during
      operating to prevent neck pain. This study hypothesizes that Neck pain discomfort will
      decrease following an 8-week intervention program compared to baseline reported scores.
    

Detailed description: 
      Participant will be asked to fill out a series 5 questionnaires at beginning of the study,
      end of the 8-week intervention and 1 month later to determine how the exercise program
      affected their general health, neck pain, and function.

        1. Demographic information about their age, height, weight, sex, surgical experience,
           surgical frequency, level of pain, and exercise frequency and types. (21 items)

        2. A questionnaire about neck pain (10 items)

        3. A questionnaire about how pain interferes with their life (8 items)

        4. A questionnaire about general health (10 items)

        5. A questionnaire about how much the participant typically exercise. (4 items) All these
           questionnaires can be completed on a computer or tablet and the data will be stored on a
           secure site (RedCap). This should be completed in approximately 20 minutes at each
           assessment.

      Next participants will be instructed how to perform a series of 4 exercises described in the
      intervention

      Every week the participant will be sent a 3-item questionnaire to report their level of pain,
      surgical burden, and exercise compliance for the week. There are only 3 multiple choice
      questions which should take approximately 1 minute to complete per week.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Participants will be trained, by a physical therapist, to perform a set of four daily exercises requiring 1 sets of 2 minutes for each exercise totaling 8 minutes of targeted exercise per day for 8 weeks of the intervention. These exercises will be progressed or modified every 2-4 weeks to assure the participant is receiving maximal benefit for their exercise intervention.
Intervention model: Single Group Assignment
Intervention model description: Repeated Measure
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgeon
Garcinia Mangostana Extracts in the Management of Weight Loss
Condition: Severe Obesity
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity is one of the greatest public health challenges of the 21st century. Its prevalence
      has tripled in many countries of the European Region since the 1980s, and the numbers of
      those affected continue to rise at an alarming rate. In addition to causing various physical
      disabilities and psychological problems, excess weight drastically increases a person's risk
      of developing a number of noncommunicable diseases including cardiovascular disease, cancer
      and diabetes, in association or not to metabolic syndrome. The risk of developing more than
      one of these diseases (co-morbidity) also increases with increasing body weight. Every year a
      growing number of patient tend to suffer of more severe obesity and difficulty in losing
      weight even with a restricted diet and exercise.

      Garcinia mangostana (Sphaeranthus indicus extract) has known for its antioxidant properties;
      new evidence point out some promising effects in the prevention of lipogenesis and the
      promotion of lipolysis . Currently in the scientific literature there is only one paper, by
      Stern et al., showing the association of Garcinia mangostana assumption in low-calorie diet.
      This work has demonstrated a significant reduction in weight loss , compared to the placebo
      group,due to the use of Garcinia mangostana.

      Aim of the present study is the evaluation of safety and efficacy of weight loss in severe
      obese patients. Also cardiometabolic parameters and flogosys serum indicators will be
      evaluated before and after 6 month therapy of low calory diet alone or in association with
      Garcinia mangostana extract.
    

Detailed description: 
      After the screening visit for the evaluation of the inclusion / exclusion criteria and sign
      informed consent(Visit 1), each patient will be randomized (Visit 2; Time 0; Baseline) (1: 1)
      to receive two different treatment for the duration of 26 weeks:

        1. low-calorie balanced diet consistent exercise (control group)

        2. balanced low-calorie diet and regular exercise in combination with the assumption of
           Garcinia mangostana (treatment group)

      Throughout the duration of the study, every eight weeks, unless otherwise indicated from the
      specialists, for each subject was expected a nutritional and an endocrinological visit with a
      anthropometric parameter check (body composition) and compliance to therapy (dietary /
      physical activity diary).

      Also a bood sample test was performed to evaluate electrocardiogram, lipid profile, glucose
      tolerance, hormonal parameters, inflammatory and bone markers.
    

Intervention name(s): Garcinia mangostana; Control group
Intervention type(s): Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment