bioihbjkbjnl/mcl2 huggingface dataset:
Dietary Fish Protein in Subjects With Insulin Resistance
Condition: Insulin Resistance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of our research project is to determine the effects of fish protein, present in
      fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of
      action on glucose metabolism. Our hypothesis is that fish protein improves insulin
      sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary
      defect in insulin signaling in overweight and insulin-resistant subjects.
    

Detailed description: 
      Recent data show that cod protein prevents the development of insulin resistance in rats.
      Dietary fish protein may also enhance insulin sensitivity in overweight insulin-resistant
      subjects by improving a primary defect in insulin signaling to PI 3-kinase, leading to
      reduced activation of the downstream effectors Akt and PKC. To determine whether this is the
      case, we will study the effects of fish protein on insulin sensitivity in humans, and how it
      improves the ability of muscles to use glucose. Such studies will help to advise individuals
      with insulin resistance or type 2 diabetes about eating fish.
    

Intervention name(s): Cod protein NCEP-diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cod protein; insulin sensitivity; plasma lipids; glucose tolerance; plasma inflammatory markers; skeletal muscle insulin signaling; type 2 diabetes; humans
A Study of LY3502970 in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety of LY3502970 and any side
      effects that might be associated with it. Blood tests will be done to measure how much
      LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it
      affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits
      (including three overnight stays) in the study center.
    


Intervention name(s): LY3502970; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Exopulse Mollii Suit and Fibromyalgia
Condition: Fibromyalgia, Primary
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence
      of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low
      threshold to noxious stimuli. The topography of pain is widespread, although it could be more
      pronounced in some bodily regions. Besides pain, patients suffer from a wide range of
      symptoms, including fatigue, anxiety and depression manifestations, and altered quality of
      life. Facing these debilitating symptoms, the available therapeutic strategies for treating
      pain and associated manifestations are usually faced with limited efficacy and numerous side
      effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous
      stimulation by means of Exopulse Mollii suit, might be of help in this context.

      The investigators designed a randomized sham controlled double-blind trial to demonstrate the
      improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia
      following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week
      washout period should be enough to prevent a potential carry over effect. After this phase
      (phase 1), a second open label phase (phase 2) will be proposed for patients to understand
      the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied
      outcomes.
    


Intervention name(s): Exoplulse Mollii suit; Exopulse Mollii suit (sham)
Intervention type(s): Device; Device
Intervention description(s): Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.; In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phase 1: randomized sham controlled crossover study (active versus sham condition)
Phase 2: Open label study (active condition)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Randomized Study of Pergolide in Children With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the
      dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette
      syndrome (GTS).

      II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic
      therapy via naturalist assessment after 3-6 months of treatment using matched historical
      controls on neuroleptics.

      III. Determine efficacy of pergolide for tic control in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE:

      This is a three part study: part I is a randomized, double blind, fixed single dose study;
      part II is a randomized, open label, stratified study; and part III is a randomized, double
      blind, placebo controlled study.

      Part I patients are randomized to receive oral pergolide at one of three dose levels or
      placebo for 10 weeks. Part II patients are randomized to receive either low or high dose
      pergolide for 4 weeks.

      Part III patients are randomized to first receive either pergolide or placebo by oral fixed
      doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after
      a 2-week placebo run-in. Patients then cross over to receive the other treatment after
      another 2 weeks of placebo run-in. Total treatment duration is 16 weeks.

      Patients are followed at 6 months.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): pergolide
Intervention type(s): Drug
Intervention MeSH terms: Pergolide
Allocation: Randomized
Primary purpose: Treatment
Keywords: Tourette syndrome; neurologic and psychiatric disorders; rare disease
Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx
      when given at increasing single doses and to assess the safety and tolerability of the same
      doses when given multiple times.
    

Detailed description: 
      To evaluate the safety and tolerability of a single subcutaneous injection of ISIS-SGLT2Rx
      administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety
      and tolerability of multiple doses of ISIS 388626 administered subcutaneously of either 6 or
      13 weeks.
    

Intervention name(s): ISIS 388626
Intervention type(s): Drug
Intervention description(s): 4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg
Placebo: 0.9% sterile saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; SGLT2 inhibitor
Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.
    

Detailed description: 
      To study the potential benefits of intraoperative methylene blue use in pilonidal sinus
      surgery in detecting the borders of the disease, the histopathologic correlation between the
      specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene
      blue was investigated. The branches that distinctly exceeded the planned dyed excision
      borders will tried to be detected histopathologically, if any.
    

Intervention name(s): Pilonidal sinus excision
Intervention type(s): Procedure
Intervention description(s): The dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pilonidal sinus; Methylene blue; Histopathology; Surgery
Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study were to:

        -  Examine the tolerability of two formulations and two dose concentrations of epinastine.

        -  Select formulation(s) of epinastine for future studies by evaluating the individual
           sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected
           after each study drug administration and the subject preference ranking assessed at the
           completion of the study.

        -  Compare the preference of two formulations and two dose concentrations of epinastine
           compared to azelastine following a single dose of each in a randomized, double-blind,
           two-cohort, three-period crossover design.
    


Intervention name(s): epinastine 0.1%; epinastine 0.1% with taste masking agent; epinastine 0.2%; epinastine 0.2% with taste masking agent; azelastine 0.1%
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): nasal spray 2 sprays to each nostril for a total of 3 doses; nasal spray 2 sprays to each nostril for a total for a 3 doses; nasal spray 2 sprays to each nostril for a total of 3 doses; nasal spray 2 sprays to each nostril for a total of 3 doses; nasal spray 2 sprays to each nostril for a total of 3 doses
Intervention MeSH terms: Azelastine; Epinastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
Condition: Alcohol Dependence
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on
      alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind
      placebo controlled clinical trial with parallel group design(N=59).
    


Intervention name(s): mirtazapine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet, 30 mg daily; oral tablet, 1 daily
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol dependence; anti-depressant; 5-HT; NE
Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
Condition: Healthy
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to investigate the effect of spices on gene expression of pathways associated
      with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in
      healthy human subjects.
    


Intervention name(s): Fat challenge breakfast; Fat challenge breakfast+spices; Carbohydrate challenge breakfast; Carbohydrate challenge breakfast+spices
Intervention type(s): Other; Other; Other; Other
Intervention description(s): In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20; In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20; In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20; In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Spices; Functional food; Cardiometabolic risk; Metabolic syndrome; Inflammation; Peripheral blood mononuclear cell; Acute
19F Thoracic Radiotherapy for Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR
      functional lung imaging into the routine assessment of lung cancer patients prior to thoracic
      radiotherapy.
    

Detailed description: 
      Primary Objective:

      Determine feasibility by evaluating if:

      PO1: Patients diagnosed with lung cancer are able to successfully complete pre- and
      post-radiotherapy 19F MR imaging scans as scheduled.

      Secondary Objective:

      Determine efficiency by evaluating if:

      SO1: Determine efficiency by evaluating if 19F MRI data can be successfully analyzed and
      incorporated into the radiation planning system.

      SO2: Determine efficiency by evaluating if the incorporated 19F MRI functional data can be
      successfully used to generate radiotherapy plan in a timely manner.

      SO3: Determine if pre- and post radiotherapy 19F MRI scans can be readily compared to observe
      changes in pulmonary function.

      Hypotheses Investigators hypothesize that functional 19F MR imaging assessment is feasible in
      the lung cancer patient population and that the acquired images can be efficiently analyzed
      and integrated into radiotherapy planning.
    

Intervention name(s): Perfluorinated Gas/Oxygen Mixture
Intervention type(s): Drug
Intervention description(s): 19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas and Mixture of 30% perfluoropropane and 70% oxygen to measure perfusion single visit, < 1 hour
Other intervention name(s): Perfluorinated Propane Imaging
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: thoracic Radiation therapy; Lung Function
Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      Postdural puncture headache (PDPH) is a common complication after spinal anesthesia. The role
      of pregabalin and hydrocortisone in the treatment of PDPH is unclear. The aim of this work is
      to assess and compare the efficacy of both drugs in severe cases of PDPH after spinal
      anesthesia for elective cesarean section.
    

Detailed description: 
      The study will be done on 30 patient with PDPH with VAS score ≥ 5 after spinal anesthesia for
      elective cesarean section. Patients will be divided into three groups: Control group (group
      C):will receive conventional treatment in the form of good oral hydration, 500 mg of
      acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg
      of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours.
      Pregabalin group (group P): will receive the conventional treatment plus 100 mg of pregabalin
      oral tablet every 8 hours for 48 hours. Hydrocortisone group (group H): will receive the
      conventional treatment plus 100 mg of hydrocortisone IV every 8 hours for 48 hours. The three
      groups will be compared regarding the headache intensity using a visual analog scale.
    

Intervention name(s): Pregabalin 100Mg Oral Cap; Hydrocortisone; Acetaminophen; oral fluids; Caffeine; Diclofenac
Intervention type(s): Drug; Drug; Drug; Other; Drug; Drug
Intervention description(s): giving a drug to relieve post-dural puncture headache; Giving drug to relieve post-dural puncture headache; giving a drug to relieve post-dural puncture headache; giving oral fluids to maintain good hydration; giving a drug to relieve post-dural puncture headache; giving a drug to relieve post-dural puncture headache
Other intervention name(s): Paracetamol; good hydration
Intervention MeSH terms: Acetaminophen; Hydrocortisone; Diclofenac; Pregabalin; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spinal; cesarean; pregabalin
T1DM Immunotherapy Using Polyclonal Tregs + IL-2
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in
      patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2.
    

Detailed description: 
      The investigators hypothesize that ex vivo expanded human autologous CD4+CD127lo/-CD25+
      polyclonal regulatory T cells (Polyclonal Tregs) plus Interleukin-2 (IL-2) administered to
      patients with Type 1 Diabetes Mellitus (T1DM) will be safe and biologically active. A Phase I
      trial with this cellular therapy plus IL-2 will lead the way for Phase II trials that test
      for efficacy based on preservation of C-peptide, reduced exogenous insulin requirements and
      improved glycemic control.

      This is a Phase I safety/dosing study of Polyclonal Tregs + IL-2 in patients with T1DM.

      The Tregs will be expanded using an established protocol utilizing anti-CD3/anti-CD28 beads
      plus IL-2. The study will involve 2 dosing cohorts of 6-8 T1DM patients each. The primary
      objective of this study is to assess the safety of Tregs + IL-2 and survival of Tregs in
      patients with recent onset T1DM who receive infusions of autologous Tregs + IL-2. The study
      will also assess potential effects of Tregs on beta cell function and the autoimmune
      response.

      Subjects will receive Polyclonal Tregs at doses of 3 or 20x10^6 cells/kg. The dose of Tregs
      is selected based on a combination of considerations of manufacturing capacity, a predicted
      efficacious dose, and the available safety data of the Treg product currently in clinical
      trials. The IL-2 dose will be 1 x10^6 IU subcutaneously, given daily for 5 consecutive days
      at the completion of the cell infusion and again after 1 month. This dose is based on recent
      studies from Klatzmann et al. in T1DM, where the dose was found to be effective in a
      selective Treg expansion, well tolerated, and without an acute decline in beta cell function
      (Rosenzwajg et al., 2015).
    

Intervention name(s): PolyTregs+IL-2
Intervention type(s): Biological
Intervention description(s): PolyTregs will be infused into the patient in a single infusion. The first cohort will receive 3 x10^6 cells. The second cohort will receive 20x10^6 cells. Following the day 0 infusion of polyclonal Tregs, subjects will receive two 5-day courses of IL-2 (1 x 106 IU daily), the first on days 3-7 and the second on days 38-42. Administration of the second course of IL-2 may be delayed or withheld depending on threshold criteria for peripheral blood Treg frequencies and MMTT-stimulated C-peptide levels determined on day 28.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Treg; Proluekin
Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a combination of intensive training of
      visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation
      (tDCS) leads to an improvement in learning and memory in patients with mild cognitive
      impairment (MCI) and to examine the underlying neuronal mechanism.
    


Intervention name(s): tDCS; training
Intervention type(s): Device; Behavioral
Intervention description(s): transcranial direct current stimulation (tDCS); intensive training of visual-spatial abilities (in LOCATO task)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: mild cognitive impairment (MCI); tDCS; LOCATO task; visual-spatial learning
Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer
Condition: Locally Advanced Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed
      alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective
      drug for advanced breast cancer. The combination of these two drug may have a synergy with
      each other in treatment of advanced breast cancer.
    

Detailed description: 
      combination of pemetrexed and cisplatin to treat advanced breast cancer. Previous regimen no
      more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)
    

Intervention name(s): pemetrexed plus cisplatin
Intervention type(s): Drug
Intervention description(s): pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression
Other intervention name(s): Alimta
Intervention MeSH terms: Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: progress free survival; response rate; safety