bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin
Condition: Diabetes Mellitus; Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, One way, Two period Comparative study To Determine The effect of Morning
      Versus Evening administration of Empagliflozin 10mg on Its Pharmacokinetics And
      Pharmacodynamics in Healthy Adults
    

Detailed description: 
      Sixteen(16) healthy subjects will receive a single oral dose of Empagliflozin at the
      evening(Period I) and after a seven days washout period, the same 16 subjects will receive a
      single oral dose of Empagliflozin at the morning(Period II).

      In both Periods(I and II), blood samples will be collected from each volunteer ethylene
      diamine tetra-acetic acid(KEDTA) containing tubes prior to drug administration then samples
      will be obtained at 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48
      hours(h) after drug administration.

      These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.

      Urine samples will be collected over the first 24h after oral administration of the drug with
      sampling being at the following intervals: 0 to 4h, 4 to 8h, 8-12h, 12 to 24hr.
    

Intervention name(s): Empagliflozin 10 MG Oral Tablet [Jardiance]
Intervention type(s): Drug
Intervention description(s): Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus
Other intervention name(s): Jardiance (Boehringer Ingelheim and Eli Lilly)
Intervention MeSH terms: Empagliflozin
Intervention model: Single Group Assignment
Intervention model description: A single group of 16 subjects will receive a single oral dose of Empagliflozin 10 MG Oral Tablet [Jardiance] at the morning(Period I) and the same group will receive the same dose of the same drug at the evening(Period II) after a seven days washout period
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes; Empagliflozin; Circadian rythm
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
Condition: Oxidative Stress; Inflammation; Blood Pressure; Vasoconstriction; Coagulation; Pulmonary Function
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study aims to evaluate whether dietary supplementation with fish oil can protect against
      the cardiopulmonary alterations linked to air pollution
    

Detailed description: 
      The investigators conduct a randomized controlled trial among 70 healthy college students in
      Shanghai, China. These students fulfilling the recruitment criteria will be randomly divided
      into two parallel groups to receive either fish oil [marine-derived n-3 polyunsaturated fatty
      acids (PUFA)] or sunflower seed oil. Participants in fish oil group receive 2.5 g/day (two
      1.25-g capsules daily) in divided doses. The sunflower seed oil capsules are identical. All
      interventions started at 7:30 a.m.to avoid issues related to diurnal variation. Health
      endpoints, including blood pressure, fractional exhaled nitric oxide and pulmonary function
      were evaluated and biological samples such as morning urine, fast blood, saliva sample,buccal
      cells and skin tape stripping will be collected at week 1 before supplemenatation, and week
      8, week 10, week 12 as well as week 14 during the supplementation phase.The investigators
      measure personal real-time exposure to PM2.5 and personal temperature and relative humidity.
    

Intervention name(s): Fish oil supplementation; Sunflower seed oil supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].; Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomly assigned to two parallel groups at enrollment using a random-number table. And the investigators randomly assign the two groups in a double-blind fashion receive either ﬁsh oil or sunflower seed oil for 4 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Biomarker; Fish oil; Oxidative stress; Air pollution; Cardiopulmonary system
Comparison of Intranasal Oxytocin Effects Using Co-administration With a Vasoconstrictor
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin
      administration by using treatment with or without prior intranasal administration of a
      vasoconstrictor to reduce peripheral increases in peptide concentrations. Primary outcomes of
      the randomized placebo-controlled double-blind experiment are blood oxytocin concentration
      and oxytocin-associated responses in central and peripheral systems.

      Intranasal application of the neuropeptide oxytocin has been reported to produce a number of
      neural, physiological and behavior effects which may be of potential therapeutic relevance,
      but it is unclear the extent to which they are mediated directly via the peptide entering the
      brain or indirectly as a result of increased peripheral concentrations. In the current
      placebo-controlled, double blind experiment on healthy adult male subjects the investigators
      will measure the effects of a single dose of intranasal oxytocin (24IU) on brain activity
      (using electroencephaolography - EEG) as well as on cardiac (heart-rate and heart-rate
      variablility) and gastric (electrogastrogram - EGG) activity and physiological arousal (skin
      conductance response - SCR). The pattern of functional effects observed will be compared with
      subjects receiving intranasal pretreatment with a vasoconstrictor prior to oxytocin in order
      to reduce the amount of oxytocin entering the peripheral circulation. The investigators
      hypothesize that prior administration of the vasoconstrictor will greatly reduce blood
      oxytocin concentrations following intranasal oxytocin treatment. Where neural/physiological
      effects are also affected, this will indicate an indirectly mediated action of intranasally
      administered oxytocin whereas if they are not this will indicate a directly mediated action.
    


Intervention name(s): vasoconstrictor and oxytocin treatment; vasoconstrictor's placebo and oxytocin treatment; vasoconstrictor and oxytocin's placebo treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intransal administration of vasoconstrictor and oxytocin; intransal administration of vasoconstrictor's placebo and oxytocin; intransal administration of vasoconstrictor and oxytocin's placebo
Intervention MeSH terms: Vasoconstrictor Agents; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: vasoconstrictor; oxytocin; EEG; peripheral nervous system response
The Effect Of Plyometric Training On Balance And Proprioception In Different Branches Athletes
Condition: Athlete Foot
MeSH terms: Tinea Pedis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of plyometric training on balance and
      proprioception in athletes in different branches.

      54 athletes participated in the study. Two groups were included as 27 athletics and 27 karate
      groups. Plyometric training was applied to the athletes participating in our study, 2 days a
      week for 6 weeks, after 20 minutes of warming up and stretching movements before each
      training. Sociodemographic characteristics of the athletes were recorded. Dynamic balance Y
      balance test and static balance Stroke balance test; sense of proprioception was evaluated
      with Angle reproduction test.
    


Intervention name(s): The effect of plyometric training on balance and proprioception in athletes in different branches
Intervention type(s): Other
Intervention description(s): Investigating the effect of plyometric training on balance and proprioception in athletes in different branches
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Plyometrics; Balance; Proprioception
Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
Condition: Gastric Bypass; Parathyroid Hormone
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of
      parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess
      changes, if any, in measures of self-assessed well-being attributable to paricalcitol after
      RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and
      other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients
      after RYGB
    


Intervention name(s): Paricalcitol; Cholecalciferol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 microgram by mouth daily for 6 weeks; 5000 IU (international units) by mouth daily for 6 weeks; Inactive substance, one capsule daily for 6 weeks
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTH; Gastric bypass surgery; vitamin D; paricalcitol
Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
Condition: Parathyroid Disease
MeSH terms: Adenoma; Parathyroid Neoplasms; Parathyroid Diseases
Study type: Interventional

Summary: 
      Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a
      small growth called an adenoma in the parathyroid glands) is an increasingly significant
      medical and public health condition.

      Surgery is the only effective management for primary hyperparathyroidism. However; it is
      sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often
      fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative
      parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even
      greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of
      tumors.

      SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing
      the tumor. This, however, is a challenge because the parathyroid glands usually are located
      close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and
      parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the
      parathyroid but not in the thyroid.

      A more sensitive and specific radiotracer/tracking agent would markedly improve the
      investigators ability to identify parathyroid tumors preoperatively, and thus offer more
      patients a minimally invasive parathyroidectomy.

      anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in detecting
      a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown uptake in
      parathyroid cells greater than thyroid cells. Therefore, the investigators think that this
      radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.

      The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates uptake
      within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will
      undergo PET-CT using anti-3-[18F]FACBC in addition to the standard 99mTc sestamibi scanning
      and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced
      CT scanning. Since all these patients undergo surgery routinely, the investigators will then
      compare findings at surgery to those of the anti-3-[18F]FACBC PET-CT to determine if this
      radiotracer is worthy of further study in a more comprehensive experiment.
    


Intervention name(s): FACBC
Intervention type(s): Drug
Intervention description(s): Drug is give intravenously over 2 minutes at time of scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients
      using insulin glargine which can provide the highest control rate of glycated hemoglobin
      (HbA1c) < 7%.

      Secondary Objectives:

      The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients
      achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage
      of patients achieving the FPG target without hypoglycemia. The percentage of patients
      achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10
      mmol/L).
    

Detailed description: 
      The study duration for each patient will be 27 weeks.
    

Intervention name(s): INSULIN GLARGINE
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous
Other intervention name(s): HOE901
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
Condition: Hepatitis B; Cirrhosis; Awaiting Organ Transplant
MeSH terms: Hepatitis B; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical trial is to compare the response rate obtained with two
      different vaccination schemes against HBV in cirrhotic patients. These patients must be
      candidates for liver transplantation, who have failed seroconversion (anti-HBs < 10 IU/ml)
      after three intramuscular doses of 40 µg.
    


Intervention name(s): HBV vaccine; HBV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Patients receive a second cycle of vaccination; Patients receive vaccination according to the guidelines.
Other intervention name(s): HBVAXPRO 40µg HBV vaccine; HBVAXPRO 40µg HBV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Turmeric and Turmeric-containing Tablets and Sebum Production
Condition: Skin Inflammation
MeSH terms: Dermatitis; Inflammation
Study type: Interventional

Summary: 
      A noticeably increasing number of patients are asking for naturally based extracts and
      ingredients as supplementary dermatologic remedies. Patients are seeking natural and
      cost-effective skin care alternatives in place of prescription medications and procedures.
      This study will isolate the effects of oral turmeric and assess a combination tablet that
      includes turmeric on sebum production in healthy subjects.
    

Detailed description: 
      Turmeric (Curcuma longa) is a spice that has been shown to exhibit anti-inflammatory,
      antimicrobial, antioxidant, anti-neoplastic properties, and even potential to improve mental
      illnesses. In western herbalism, Turmeric is primarily used as an anti-inflammatory agent. In
      India, turmeric is used in Ayurvedic medicine for the treatment of acne. It has been used
      both internally and externally.

      Curcumin is a phytochemical derived from turmeric and believed to be one of the key active
      components of turmeric. Curcumin is reported to have activity as an antibacterial and
      anti-inflammatory agent and has been used as a paste for skin eruptions and infections.
      Previous basic science work by Dr. Raja Sivamani's lab has shown that both turmeric and
      curcumin inhibit lipid synthesis in human sebocytes, the cells responsible for the production
      of sebum

      The goal of this study is to evaluate how ingestion of turmeric and tablets that have a
      combination of herbs including turmeric may modulate sebum production.
    

Intervention name(s): Turmeric; Turmeric-containing combination tablet; Placebo tablets
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Turmeric extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
the Evaluation of the Efficacy of TCI66207 on the Skin.
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea
      live-face bacteria on the skin.
    


Intervention name(s): TCI66207 Essence; Placebo Essence
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.; Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
Condition: Oxidative Stress; Quality of Life; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this clinical trial are to evaluate the effectiveness of an iridoid
      enriched beverage containing noni and cornelian juices and olive leaf extract on advanced
      glycation end product levels.
    


Intervention name(s): iridoid enriched mixed fruit beverage
Intervention type(s): Dietary Supplement
Intervention description(s): Mixed fruit beverage consisting of noni (Morinda citrifolia) juice, Cornelian cherry (Cornus mas & Cornus officinalis) puree and juice, olive (Olea europea) leaf extract, and other fruit juices and natural flavors
Other intervention name(s): TruAge Max
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Morinda citrifolia; noni; advanced glycation end products; oxidative stress; quality of life; metabolic syndrome; safety
Complicated Grief Among Children After a Death From Cancer or Another Cause: A Longitudinal and Prospective Study (CAPS)
Condition: Grief
Study type: Interventional

Summary: 
      The purpose of this study is to identify risk factors of Complicated Grief (CG) among
      children and adolescents who lost a parent to cancer or from an other cause.
    

Detailed description: 
      Although the intensity of the grief and life disruption usually subsides in the months
      following the loss of a loved one, approximately 7% of bereaved individuals will continue to
      experience persistent and intense grief-related symptoms associated with marked distress and
      functional impairment years after the death.

      While several studies aimed to evaluate risk factors of CG among adults, little is known
      regarding CG among children and adolescents. Therefore, prospective research directly
      examining the impact of bereavement on post-loss psychiatric symptoms, including CG,
      post-traumatic-stress disorder (PTSD), depression, attentional and behavioral avoidance among
      children are needed. Improving our understanding of CG risk factors among children will help
      direct healthcare professionals' clinical attention toward screening and care of this
      underserved population.

      Furthermore, identifying mechanisms explaining why cancer bereaved children may be at greater
      risk for persistent psychological distress and CG will inform the development of preventive,
      early intervention and treatment strategies.

      Participants will be recruited to the Child and Adolescent grief counseling of the College
      Hospital of Toulouse as well as with the Team Regional Resource Pediatric Palliative Care
      "Enfant-Do". At 3, 6 and 12 months post-loss, children and their parent will be invited to
      complete questionnaires assessing peritraumatic dissociative experiences, peritraumatic
      distress, security attachment, symptoms of CG, symptoms of PTSD and attentional avoidance.
    

Intervention name(s): Scales, questionnaires and inventory
Intervention type(s): Behavioral
Intervention description(s): Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss
Other intervention name(s): Inventory
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Complicated Grief; Risk Factors; Cancer; Children
A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with schizophrenia.
    


Intervention name(s): SM-13496 40mg; SM-13496 80mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily orally; once daily orally; once daily orally
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment