bioihbjkbjnl/mcl2 huggingface dataset:
Mindfulness - Based Stress Reduction and the Relationship on Inflammation in Autoimmune Hepatitis
Condition: Autoimmune Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune; Inflammation
Study type: Interventional

Summary: 
      The study is a 'pilot study' to assess the effect of a mindfulness-based stress reduction
      (MBSR) intervention on patients with autoimmune liver disease specifically autoimmune
      hepatitis type I. MBSR is a standardized intervention that has shown benefit in addiction
      disorders and other psychiatric disorders. There has been no study evaluating or showing the
      benefit of the use of MBSR in autoimmune liver disease. With published data showing the
      evidence of an association of stress and relapse in autoimmune hepatitis, it is hypothesized
      that such an intervention such as MBSR may have therapeutic effect in patients with
      autoimmune liver disease.
    

Detailed description: 
      With the understanding that autoimmune hepatitis has a relationship with psychological
      stress, the use of a strategy such as mindfulness stress based reduction (MBSR) may similarly
      have a substantial impact as seen in other disease conditions. The proposed hypothesis is
      that undergoing MBSR has potential to benefit patients with autoimmune hepatitis in relation
      to decreased relapse rate and ultimately improved quality of life.

      The focus of this study is surrounding the possibility of psychosocial stress for relapse in
      AIH. The investigators, however, would like to also understand the role of serological
      testing at the time of these relapses and during states of psychosocial stress to demonstrate
      if the association can be found. During active disease activity or relapses of autoimmune
      hepatitis, there is an expected rise in alanine aminotransferase (ALT) and immunoglobulin G
      (IgG) levels. Demonstrating the correlation of ALT and IgG with disease status and possible
      improvement with stress modifications is also key for this proposed study.
    

Intervention name(s): mindfulness based stress reduction
Intervention type(s): Behavioral
Intervention description(s): The intervention will be delivered in a group setting and the group will meet for 2 hours once per week for 8 weeks. The intervention is based on new neuroscience of stress and resilient adaptive behaviors, mindfulness based stress reduction, therapeutic breath and synchronized yogic movement with a focus on the lower abdomen, integrated with cognitive and behavioral strategies for self-control and healthy decision making.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare two different tablet formulations of AZD8931 in healthy males and females.
    


Intervention name(s): AZD8931; AZD8931
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg AZD8931 wet granulation tablet formulation; 40 mg AZD8931 roller compacted tablet formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Phase I; Healthy male and non-fertile female volunteers; Bioavailability; AZD8931
Examining the Impact of Sirolimus on Ketamine's Antidepressant Effects
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to provide insight into the impact of the immunosuppressant drug
      sirolimus, on the antidepressant effects of the prototypal rapid-acting antidepressant
      medication, ketamine.
    

Detailed description: 
      This is a double blind, placebo-controlled, crossover, randomized controlled trial
      investigating the impact of sirolimus on ketamine's antidepressant effects in participants
      with antidepressant-resistant depressive symptoms.

      Prior to this, there was a phase 1 which included monitoring 3 subjects over the course of 7
      days after a single dose of sirolimus and ketamine in order to inquire about side effects or
      interaction effects.
    

Intervention name(s): Ketamine; sirolimus; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): . Subjects will receive an infusion of ketamine (0.5 mg/kg infusion over approximately 40 minutes). All subjects will receive two ketamine infusions-once with a placebo and once with a single dose of sirolimus (6 mg, oral administration).; Subjects will receive a single 6 mg oral dose via oral solution of sirolimus or a dose of placebo approximately two hours prior to the infusions. As above, the order of placebo and sirolimus is randomized. The sirolimus dose as well as the placebo solution will be given in 6 ounces of orange juice.; Placebo oral dose
Other intervention name(s): Rapamune
Intervention MeSH terms: Sirolimus; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
Condition: Poliomyelitis; Acellular Pertussis; Tetanus; Diphtheria; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The new formulation administered as a 4th consecutive dose will be compared to the current
      formulation of the vaccine in this partially double blind study.

      The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study
      will be open with respect to the DTPa-HBV-IPV group.
    


Intervention name(s): Infanrix™ penta; Infanrix™ hexa
Intervention type(s): Biological; Biological
Intervention description(s): Subjects received a booster dose; Subjects received a booster dose
Other intervention name(s): Pediarix
Intervention MeSH terms: PENTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Infanrix hexa; combined vaccine
Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Condition: Sacroiliac Joint Dysfunction
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      This research aimed to ascertain the combined and individual efficacies of MCE and BT in
      alleviating SIJD symptoms.
    

Detailed description: 
      The study will be based on a four-arm parallel group randomized control design. one hundred
      and twenty participants with SIJD will be recruited from the Physiotherapy department, at
      Integral University, India. Study objectives and procedure will be properly explained and
      written informed consent will be obtained at the beginning of the study. All the participants
      will be randomly divided into four groups A, B, C, and D. Experimental group A will be
      receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the
      hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack,
      Stretching exercise, and MCE & BT intervention, control group D will receive the hot pack,
      Stretching exercise intervention.
    

Intervention name(s): Motor Control Exercise; Balance Training; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): Motor control exercises focusing on the activation and control of deep spinal muscles; Balance training exercises on to enhance proprioception and stability; Participants received hot pack and stretching exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial to Evaluate Drug-drug Interactions and Safety Between "BR1015-1" and "BR1015-2" in Healthy Volunteers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetic interactions (Drug-Drug interaction)
      and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.
    

Detailed description: 
      *Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy
      volunteers, the pharmacokinetic interactions and safety are evaluated.

      *Investigational Product (and regimen)

        1. BR1015-1: Administration of BR1015-1 60 mg once a day for 5 days

        2. BR1015-2: Administration of BR1015-2 1.5 mg once a day for 5 days

        3. BR1015-1+BR1015-2: Co-administration of BR1015-1 60 mg and BR1015-2 1.5 mg once a day
           for 5 days
    

Intervention name(s): BR1015-1; BR1015-2; BR1015-1 + BR1015-2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): - Administration to the BR1015-1 group: 60 mg of BR1015-1 will be administered one tablet once a day, five-day repeated doses.; - Administration to the BR1015-2 group: 1.5 mg of BR1015-2 will be administered one tablet once a day, five-day repeated doses.; - Co-administration to the BR1015-1+BR1015-2 group: 60 mg of BR1015-1 one tablet and 1.5 mg of BR1015-2 one tablet will be co-administered once a day, five-day repeated doses.
Other intervention name(s): Fimasartan 60 mg; Indapamide 1.5 mg; Fimasartan and Indapamide
Intervention MeSH terms: Indapamide
Intervention model: Single Group Assignment
Intervention model description: One-sequence, 3-period study.
Masking: None (Open Label)
Primary purpose: Other
2014TP001 - Assessing the Biology of the Injured Lung - Version 1
Condition: Respiratory Diseases
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      Respiratory diseases are very common and are the third leading cause of death in England. As
      such, there is strong interest in understanding how respiratory disease occurs.

      This study intends to understand the changes that occur within diseased/injured lungs
      obtained from humans. The end goal of this will be to create new drugs to help treat these
      disorders.

      Diseased lungs will be obtained from patients receiving a lung transplant. Lungs will either
      be placed onto a heart-lung machine, or surgically cut in order to create a model of the lung
      that can be used experimentally in the laboratory. Using a heart-lung machine, lungs can be
      maintained outside of the human body for a maximum of 12 hours, allowing the direct
      assessment of the organ. Using this procedure, we aim to understand the processes that occur
      within a disease, as well as during repair. Using the model of the lung, we will look at how
      the body's immune system interacts within a diseased lung.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Respiratory disorders - lung transplantation
Ischemic Preconditioning Claudication Study
Condition: Intermittent Claudication; Ischemia Vascular; Peripheral Arterial Disease; Peripheral Vascular Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Intermittent Claudication; Ischemia
Study type: Interventional

Summary: 
      This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking
      distance in patients with intermittent claudication.
    

Detailed description: 
      This study proposes ischemic preconditioning (IPC) as a novel intervention to improve walking
      distance in patients with intermittent claudication. Peripheral arterial disease (PAD) is a
      circulatory condition in which large supply blood vessels narrow, reducing oxygen and
      nutrient distribution to peripheral tissues. IPC protects against tissue damage caused by
      ischemia and can improve functional capacity in patients recovering from stroke; however, the
      benefit of ischemic preconditioning in patients with peripheral arterial disease remains
      unclear.

      The investigators predict that ischemic preconditioning (IPC) will delay claudication onset
      time (COT), increase peak walking time (PWT) and improve muscle strength in patients with
      intermittent claudication.

      The investigators will determine whether IPC improves claudication onset time (COT) and peak
      walking time (PWT) in patients with intermittent claudication. A motorized treadmill will be
      employed to assess COT and PWT.

      The investigators will determine whether IPC can improve muscle strength and time to pain
      onset in the affected leg of patients with intermittent claudication. These metrics will be
      assessed quantitatively using a Biodex™ dynamometer.
    

Intervention name(s): Ischemic Preconditioning; Control Group
Intervention type(s): Other; Other
Intervention description(s): See Ischemic Preconditioning Experimental group description; See Control group description
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ischemic preconditioning
Vitamin D for Cognition in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Conduct randomized double-blind controlled trial (RCT), to examine the effects of vitamin D
      on cognitive performance in euthymic BD.
    

Detailed description: 
      Bipolar disorder (BD) is a chronic mental disease related to recurrent episodes along with
      cognitive or functional decline. Comparing efficacy of pharmacological interventions
      targeting to treat cognitive deficit in BD is unexplored. The majority of the observational
      studies demonstrate a significant association between low serum vitamin D and compromised
      cognition in a wide range of neuropsychiatry diseases. Recent survey further revealed the
      high prevalence of hypovitamin D in BD. The effect of supplement and association between
      vitamin D and cognition in BD and the underlying mechanism is unclear.

      The investigators will collect vitamin D levels and assess their association with cognition
      in a euthymic bipolar cohort (N=200) for screen. Then, the investigators estimate to recruit
      120 of participants with cognitive deficits and combined vitamin D deficiency, to conduct a
      RCT. Participants will keep their usual treatment and will be randomized to receive either
      vitamin D supplement or a placebo for eight weeks. Cognitive test, adverse side effect, mood
      status and blood 25(OH)D levels and biomarkers will be measured before and after
      intervention.
    

Intervention name(s): solubilized vitamin D3; medium chain triglyceride
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): solubilized vitamin D3; MCT with same amount
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blinded RCT
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: bipolar disorder; vitamin D; cognition
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fed Condition
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of the study is to compare the bioavailability and characterise the
      pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India
      and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA
      in normal, healthy, adult human subjects under fed conditions, and to assess the
      bioequivalence.
    

Detailed description: 
      72 + 12 (stand-by) normal healthy adult subjects will be enrolled in the study. Subjects will
      be administered either the Test or the Reference Product with 240 mL of water in each period
      as per the randomization schedule. Subjects will fast for at least 10 hours prior to High Fat
      Breakfast half an hour before administration of the study drug and for four (4) additional
      hours each, post dose during each study period. Standardized meals will be provided in each
      study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours Post
      dose in each period.A total of 27 blood samples will be withdrawn for pharmacokinetic
      profiling. The concentration of mycophenolate mofetil and mycophenolic acid will be
      quantitated using validated LC-MS / MS method.ANOVA, two one-sided tests for bioequivalence,
      power and ratio analysis for un-transformed and ln-transformed pharmacokinetic parameters
      Cmax, AUC0-t AUC0-inf will be computed and reported for Mycophenolic acid. Bioequivalence of
      the test product with that of the reference product under fasting conditions will be
      concluded if the 90% confidence interval falls within the acceptance range of 80.00-125.00%
      for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Mycophenolic
      acid.
    

Intervention name(s): Mycophenolate Mofetil Capsule 250 mg
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
Other intervention name(s): Mycophenolate Mofetil Capsule
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
Condition: To Determine Bioequivalence Under Fasting Conditions
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg
      capsules verses Marinol.
    

Detailed description: 
      To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle
      active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of
      the test formulation with those produced after administration of a marketed reference
      product, under fasted conditions.
    

Intervention name(s): Dronabinol; Marinol
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, 10 mg, single dose, fasting conditions; Capsules, 10 mg, single-dose, fasting conditions
Other intervention name(s): Marinol; Dronabinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; dronabinol; fasting
Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the
      2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side
      of the face will remain non-treated to serve as a control.
    

Detailed description: 
      This is a single-blind (blinded expert grader), parallel group, randomized, half-face study
      being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the
      2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side
      of the face will remain non-treated to serve as a control. Approximately 25-30 male and
      female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each
      product.

      The eligible subjects who qualify will be entered into a 2-week treatment phase. The first of
      application of the study medication will be supervised at the site, Monday through Friday of
      each week. Any additional applications should be applied by the subjects at home each evening
      and the times of application recorded on a diary card. Subjects will apply the study product
      at home on Saturdays and Sundays and record the times of application on a diary card.

      A blinded expert grader will rate comparative product tolerance during the study before study
      product is applied.

      Instrumentation measurements of TEWL will be utilized to evaluate product mildness.

      Duplicate sebum samples will be taken from the left and right forehead areas and assessed.

      Subject will complete questionnaires and all adverse events will be recorded.
    

Intervention name(s): clindamycin and benzoyl peroxide; Dapsone gel
Intervention type(s): Drug; Drug
Intervention description(s): Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide; Twice-daily applications of dapsone gel
Other intervention name(s): Duac® gel; ACZONE® (dapsone) Gel; 5%
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dapsone; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Aim: The aim of this study was to determine whether the combined connective tissue graft
      (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
      improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone
      with CAF.

      Methods: Seventy-two patients with Miller class I and II gingival recessions were enrolled.
      Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group
      (CAF+CTG). Clinical evaluations were made at 6 months
    


Intervention name(s): CAF+CTG+i-prf
Intervention type(s): Procedure
Intervention description(s): combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: connective tissue graft