bioihbjkbjnl/mcl2 huggingface dataset:
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is
      associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential
      safety and efficacy profile in COPD.
    


Intervention name(s): PH-797804; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg oral tablet once daily for 12 weeks; Placebo oral tablet once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Vitamin A and Carotenoids on Iron Absorption
Condition: Iron Absorption
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of vitamin A and carotenoids on iron
      absorption in healthy subjects with low and normal vitamin A status. Vitamin A and
      carotenoids have been reported to enhance the nonheme iron absorption, but the results from
      human isotope studies are equivocal. Radio-iron studies in Venezuelan adults have
      consistently reported an increase in iron absorption, whereas stable and radio isotopes
      studies conducted in Sweden and Switzerland reported no influence. Differences in vitamin A
      status of the subjects may be a possible explanation for the contradictory findings. In this
      study, iron absorption will be measured from an iron-fortified maize bread meal with or
      without retinyl palmitate or β-carotene by using both stable- and radioactive-isotope
      techniques in Venezuelan women with a range of vitamin A status.
    


Intervention name(s): Labeled iron solutions
Intervention type(s): Other
Intervention description(s): Labeled iron as FeSO4 (4 mg/test meal)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Retinyl palmitate, beta-carotene, stable isotopes, radio isotopes
Safety and Tolerability Study of Multiple Doses of PF-06305591
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young
      healthy volunteers toghether with food effect on relative bioavailability of solid
      formulation after single dose.
    


Intervention name(s): PF-06305591; Placebo; PF-06305591; Placebo; PF-06305591; Placebo; PF-06305591; PF-06305591
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 14 day repeated 20mg BID doses; 14 day repeated BID doses; 14 day repeated 80mg BID doses; 14 day repeated BID doses; 14 day repeated 40mg BID doses; 14 day repeated BID doses; 14 day repeated BID doses; relative bioavailability tablet vs. solution and food effect at 50mg dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; PK
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated
      Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels
      at 24th week from baseline, when compared to placebo group(no diabetic medication given). The
      secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting
      blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study
      assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American
      Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with
      placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures,
      body weight and compare with the respective placebo groups.This study also assess the change
      from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of
      EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).
    

Detailed description: 
      EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as
      sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the
      blood by increasing the amount of urine produced. Hence the blood glucose levels are
      significantly decreased and the efficacy of EGT001442 can be established by assessing the
      three months average blood glucose levels (HbA1c). Due to the increased urinary output, the
      effect of EGT001442 on blood pressure levels are also assessed.
    

Intervention name(s): EGT0001442; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Bexagliflozin
Intervention MeSH terms: Bexagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
    


Intervention name(s): MEDI4920 3 mg; MEDI4920 10 mg; MEDI4920 30 mg; MEDI4920 100 mg; MEDI4920 300 mg; MEDI4920 1000 mg; MEDI4920 3000 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Other
Intervention description(s): Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.; Participants received single IV dose of MEDI4920 10 mg infused on Day 1.; Participants received single IV dose of MEDI4920 30 mg infused on Day 1.; Participants received single IV dose of MEDI4920 100 mg infused on Day 1.; Participants received single IV dose of MEDI4920 300 mg infused on Day 1.; Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.; Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.; Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Male; Healthy Female of non child bearing potential
Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
Condition: Parkinson Disease; Neuropathic Pain; Pain
MeSH terms: Parkinson Disease; Neuralgia
Study type: Interventional

Summary: 
      Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in
      chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient
      basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the
      brain and by targeting particular areas in the brain it can be used to help modulate the
      perception of pain.

      The study intends to use this technique to treat such a disabling symptom in patients who
      suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in ten
      patients who are suffering from pain and have PD. These patients would initially require an
      MRI scan which allows us to map the brain and target the correct brain areas for the delivery
      of the stimulation. The stimulation would be performed over ten sessions and the patients
      would be assessed by a clinician using well recognized clinical tools.

      It is anticipated that there will be a meaningful improvement in pain. It is also anticipated
      that TMS is a safe technique to use in patients with PD. The study will be used to help plan
      a future study that compares TMS with sham technique to prove whether TMS could be an option
      in the treatment of such a disabling condition.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Evaluating Safety, Tolerability and Immune Response of AG-707
Condition: Genital Herpes
MeSH terms: Herpes Genitalis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts
      of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility
      will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80
      µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the
      protocol.
    

Detailed description: 
      Primary Objective:

      Determine the overall safety profile of three different dose levels of AG-707 vaccination
      (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21
      alone in HSV-2 seropositive adults.

      Secondary Objective:

      Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of
      80, 240, and 400 µg as compared to placebo and QS-21 alone.
    

Intervention name(s): AG-707
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Genital Herpes; HSV-2 Seropositive; Vaccine
Minirin Versus Oxybutynin for Nocturnal Enuresis in Children
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      Nocturnal enuresis is among the most common disorders in children. The aim of current study
      was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal
      enuresis in children in Bandar Abbas in 2014.
    

Detailed description: 
      Nocturnal enuresis is among the most common disorders in children. Several pharmacological
      and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching
      the best pharmacological treatment for this disorder are continuing. The aim of current study
      was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal
      enuresis in children in Bandar Abbas in 2014.
    

Intervention name(s): Minirin; Oxybutynin
Intervention type(s): Drug; Drug
Intervention description(s): Minirin 5 to 10 mg daily for 6 months; Oxybutynin 5 to 10 mg daily for 6 months
Other intervention name(s): Desmopressin acetate; Ditropan
Intervention MeSH terms: Deamino Arginine Vasopressin; Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Minirin; Oxybutynin; Nocturnal enuresis
Drug Interaction With Metformin
Condition: Healthy Male and Female Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the effect of metformin on dapagliflozin exposure
      and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally,
      the safety and tolerability of dapagliflozin will be assessed in the presence and absence of
      metformin in healthy volunteers
    


Intervention name(s): Dapagliflozin; Metformin; Dapagliflozin + Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 20 mg, once daily single dose; Tablets, Oral, 1000 mg, once daily, single dose; Tablets, Oral, once daily, single dose
Dapagliflozin: 20 mg
Metformin: 1000 mg
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Diabetes,NOS
Reactogenicity, Safety and Immunogenicity of a LAIV H7N9 Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre phase I, double-blind placebo-controlled study to assess
      reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9)
      influenza vaccine in healthy male and female adults, 18 through 49 years of age .
    


Intervention name(s): H7N9 live influenza vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): H7N9 live influenza vaccine; Lyophilized purified allantoic fluid of chicken embryos with stabilizers
Other intervention name(s): LAIV H7N9
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza vaccine pandemic
Vitamin Deficiencies and Suppletion in Morbid Obesity
Condition: Vitamin B12 Deficiency
MeSH terms: Obesity, Morbid; Vitamin B 12 Deficiency; Avitaminosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the most effective treatment for patients who
      underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.
    

Detailed description: 
      Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is
      to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent
      a Roux-en-Y gastric bypass.

      Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.
    

Intervention name(s): Hydroxocobalamin; FitForMe vitamin B12
Intervention type(s): Drug; Drug
Intervention description(s): patients are treated for 6 months with hydroxocobalamin. Patients will be treated with once a dose of 2000ug, after that treatment will be continued with a dose of 1000ug per 2 months. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.; patients are treated for 6 months with a daily dose of 1000ug vitamin B12 tablets. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
Condition: Rotavirus Infections; Intestinal Bacteria Flora Disturbance; Reaction - Vaccine Nos; Tetanus; Streptococcal Pneumonia
MeSH terms: Rotavirus Infections; Pneumonia, Pneumococcal
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus
      vaccine immune responses in healthy adult volunteers.
    

Detailed description: 
      This study will alter the intestinal microbiota in healthy adults using antibiotics and
      subsequently measure immune reactions to the rotavirus vaccine (Rotarix), the tetanus vaccine
      and the pneumococcal vaccine (Pneumo23).
    

Intervention name(s): Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine
Intervention type(s): Biological
Intervention description(s): All subjects will be given an oral dose of the rotavirus vaccine, RotarixTM, and intramuscular injections of the Tetanus vaccine and Pneumococcal vaccine, Pneumo 23.
Other intervention name(s): RotarixTM, Pneumo 23
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
Condition: Immune System Diseases; Autoimmune Diseases; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases; Connective Tissue Disease
MeSH terms: Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
    


Intervention name(s): CDP7657; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Ascending single doses of CDP7657; Placebo: 0.9% sodium chloride aqueous solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Lupus; SLE
Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
Condition: Amyloid-beta
MeSH terms: Sleep Deprivation; Amyloidosis
Study type: Interventional

Summary: 
      The purpose of this study is to change the concentration of amyloid-beta in human
      cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.
    

Detailed description: 
      The purpose of this research study is to investigate whether or not increasing or decreasing
      duration of sleep over one night will change the concentration of amyloid-beta in cerebral
      spinal fluid (CSF).
    

Intervention name(s): Sodium Oxybate; Sleep deprivation
Intervention type(s): Drug; Behavioral
Intervention description(s): Sodium oxybate h.s.; 36hr sleep deprivation
Other intervention name(s): Xyrem
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different
      formulations of indacaterol, one administered via the Concept1 device and one administered
      via the Simoon device. The study aimed to determine whether the novel formulation (Simoon)
      had a similar profile to that of the established formulation (Concept1).
    

Detailed description: 
      This study was double-blind with regards to the Concept1, where placebo for the
      lactose-blended indacaterol was available. However, with regards to the Simoon, neither the
      subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere
      formulation. Hence, the overall designation of the study was partially-blind.
    

Intervention name(s): Indacaterol 150 μg via the Concept1 dry-powder inhaler; Indacaterol 60 μg via the Simoon dry-powder inhaler; Indacaterol 120 μg via the Simoon dry-powder inhaler; Placebo to indacaterol via the Concept1 dry-powder inhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.; Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.; Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.; Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; QAB149; indacaterol; pulmonary function
A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Condition: Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy and safety of traditional Chinese medicine in patients with
      Sjogren's syndrome.
    

Detailed description: 
      This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients
      fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible
      subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or
      placebo for 12 weeks. The treatment group will receive a combination formula with traditional
      Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary
      endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary
      endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain
      scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological
      markers. Thirty patients will be enrolled in the first year. After interim analysis at the
      end of first year, sample size will be recalculated base on the interim analysis results.
    

Intervention name(s): TCM (Gan-Lu-Yin)GLY; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks; TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
Other intervention name(s): Gan-Lu-Yin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Sjögren's syndrome; Traditional Chinese Medicine; Herbs; Clinical trial; Gan-Lu-Yin; Jia-wei-Xiao-yao-San; Ye-Jiao-Teng; Suan-Zao-Ren