bioihbjkbjnl/mcl2 huggingface dataset:
Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on
      renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent
      magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were
      included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without
      diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1
      intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and
      after lipo-PGE1 administration to acquire bilateral renal cortical R2*(CR2*) and medullary
      R2* (MR2*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including
      24 hours urinary protein and serum creatinine were collected. the investigators want to prove
      Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.
    

Detailed description: 
      R2* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks,
      Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo
      time. The R2* map was windowed from 0 to 60 s-1.

      Regions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper,
      middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane
      based on the anatomical images. Three ROIs were placed in the medulla and cortex,
      respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding
      a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral
      cortex and medulla. To prevent significant bias from measurement variability, each sample was
      measured independently by three professional radiologists with more than 5 years of
      experience who were blinded to the clinical results. Thereafter, assuming the tests were
      coincident, the results were the averaged.
    

Intervention name(s): Lipo-PGE1
Intervention type(s): Drug
Intervention description(s): all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
Other intervention name(s): alprostadil
Intervention MeSH terms: Alprostadil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish if BMS-986202 is safe and effective at treating
      autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical
      studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first
      time this drug is given to humans.
    


Intervention name(s): BMS-986202; Placebo; Interferon alpha-2a recombinant; Famotidine; Ustekinumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Ustekinumab; Famotidine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Poor Ovarian Responders Undergoing IVF Using Luteal Ovarian Stimulation Versus Follicular Ovarian Stimulation
Condition: Fertilization in Vitro
Study type: Interventional

Summary: 
      The investigators attempted to compare the clinical outcomes and cumulus genes expression in
      poor ovarian responders undergoing luteal ovarian stimulation or follicular ovarian
      stimulation in in vitro fertilization cycles.
    

Detailed description: 
      Multiple follicular wave theory proposed by Baerwald et al. implied that follicle recruitment
      may occur in the luteal phase of menstrual cycle. Therefore, luteal phase ovarian stimulation
      (LPOS) was considered as a potential feasible stimulation method during in vitro
      fertilization (IVF) cycle. In the beginning, in order to avoid delaying cancer treatment,
      LPOS was applied for fertility preservation of cancer patients, showing no difference in
      numbers of oocyte retrieved, mature oocytes and fertilization rate between luteal or
      follicular phase stimulation. In the recent, LPOS was used for infertility women, suggesting
      that LPOS owned quite good IVF outcomes. In previous studies, premature luteinizing hormone
      (LH) surge, a major reason worsening ovarian quality in poor ovarian responders (PORs), was
      seldom found in LPOS. High progesterone in luteal phase may aid in suppressing premature LH
      surge. An updated research claimed that numbers of oocyte retrieved, mature oocytes and
      fertilized oocytes in LPOS significantly increased when compared to follicular ovarian
      stimulation. Therefore, the investigators presumed that LPOS was a more effective method than
      follicular stimulation in PORs.
    

Intervention name(s): luteal ovarian stimulation; follicular ovarian stimulation
Intervention type(s): Other; Other
Intervention description(s): In the in vitro fertilization cycle, controlled ovarian stimulation was started since the luteal phase.; In the in vitro fertilization cycle, controlled ovarian stimulation was started since the follicular phase.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: In vitro fertilization; Poor ovarian responder; Luteal ovarian stimulation; Antagonist protocol; Cumulus cells
Establishment of a Prognosis Prediction Model and Scoring Criteria of Pulmonary Contusion Caused by Severe Thoracic Trauma
Condition: Pulmonary Contusion , Chest Trauma , Prediction Model
MeSH terms: Wounds and Injuries; Thoracic Injuries; Contusions
Study type: Observational

Summary: 
      Pulmonary contusion caused by severe thoracic trauma is a complex disease. Some patients may
      be secondary to severe complications such as pulmonary infection or even acute respiratory
      distress syndrome. At present, there have been no reports on related studies based on Chinese
      population. In this study, 800 patients with pulmonary contusion will be retrospectively
      investigated to determine the risk factors and independent risk factors of their poor
      prognosis, and to construct a prognosis prediction model and scoring criteria.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 800 cases of patients were hospitalized from 2014 to 2019.All patients were
        Chinese.
      
Keywords: pulmonary contusion; severe chest trauma; prediction model
Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Glycemic variability will be assessed using continuous glucose monitor(CGM) in type 2
      diabetic patients who receive dulaglutide 1.5 mg/qw injection for 4 weeks.
    

Detailed description: 
      Glycemic fluctuation is a major problem in glucose control in diabetic patients. It is
      interesting to know that whether weekly GLP-1RA can improve glycemic variability in diabetic
      patients. The present study aims to assess the effect of dulaglutide on glycemic variability
      using continuous glucose monitor(CGM) (Libra, Abbott) in type 2 diabetic patients with 4
      weeks.
    

Intervention name(s): Dulaglutide 1.5 MG/ML
Intervention type(s): Drug
Intervention description(s): Dulaglutide 1.5Mg qw sc injection for 4 weeks
Intervention MeSH terms: Dulaglutide
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetes come to the clinic who want to use dulaglutide and never used dulaglutide
        before
Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens
Condition: Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the vaccination protocol is to induce specific immune responses against
      melanoma associated antigens by intradermal injections of mRNA coding for the corresponding
      antigen.
    

Detailed description: 
      vaccination protocol to induce clinically specific immune responses against melanoma
      associated antigens by intradermal injections of mRNA coding for the corresponding antigens.
      Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100
      and Tyrosinase. The other half of patients is treated with an individualized selection of
      mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is
      used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in
      stage III/IV melanoma patients.
    

Intervention name(s): mRNA coding for melanoma associated antigens; GM-CSF
Intervention type(s): Biological; Drug
Intervention description(s): mRNA vaccine s.c. applied weekly; Given s.c. as adjuvant drug one day after vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaccination; mRNA
A Comparison of Cognitive and Dynamic Therapy for Depression in Community Settings
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The goal of this study is to compare supportive-expressive therapy, a type of psychodynamic
      psychotherapy, with cognitive therapy for the treatment of depression in community mental
      health consumers.

      Hypothesized mediators of treatment will also be examined.
    

Detailed description: 
      The goal of this study is to conduct a randomized, comparative, non-inferiority clinical
      trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy
      (supportive-expressive psychodynamic therapy) is not inferior to cognitive therapy when
      implemented in community mental health settings for the treatment of major depressive
      disorder (MDD). The specific aims are (1) to conduct a randomized non-inferiority trial to
      compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with
      MDD and (2) to assess the comparative effectiveness of supportive-expressive psychodynamic
      therapy and cognitive therapy on secondary measures of symptoms, patient functioning, and
      quality of life.

      Patient mediators of outcome will also be examined through an additional grant awarded to
      Paul Crits-Christoph, Ph.D. This grant was funded by the National Institutes of Mental Health
      - RO1MH092363-01. This grant is entitled:"The mechanisms of cognitive and dynamic therapy in
      community settings."

      Recruitment will occur solely through community mental health clinics in and around
      Philadelphia.
    

Intervention name(s): Cognitive Therapy; Supportive-Expressive Psychodynamic Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 sessions of cognitive therapy administered weekly by a community mental health therapist; 16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist
Other intervention name(s): Cognitive Behavioral Therapy; CBT; Psychodynamic Psychotherapy; Short Term Dynamic Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; community mental health; treatment; psychotherapy; mediators
Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to investigate the bioequivalence of the test and reference products
      when administered as single oral doses in two consecutive study periods, under fasting
      conditions.
    

Detailed description: 
      A single 300 mg dose of the test (T) and of the reference (R) products will be administered
      to the study subjects in two consecutive periods, according to a randomised 2-sequence
      cross-over design. A wash-out interval of at least 10 days will elapse between the two
      administrations. The two investigational products will be administered with 240 mL of still
      mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.

      To investigate the bioequivalence of the test and reference products when administered as
      single oral doses in two consecutive study periods, under fasting conditions.
    

Intervention name(s): Trazodone HCl - new polymer; Trazodone HCl - Contramid®
Intervention type(s): Drug; Drug
Intervention description(s): A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.; A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.
Other intervention name(s): Trittico®
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is single dose, open-label, randomised, two-period, two-sequence, cross-over, bioavailability and bioequivalence study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioavailability; Cross over; trazodone hydrochloride (HCl) (new polymer); Trittico®, 300 mg trazodone HCl; Bioequivalence; prolonged-release tablets; Contramid®,
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria
Condition: EPP; XLP
MeSH terms: Protoporphyria, Erythropoietic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to investigate the efficacy of MT-7117 on time to
      onset and severity of first prodromal symptoms (burning, tingling, or stinging) associated
      with sunlight exposure in subjects with EPP or XLP aged 12-75.
    


Intervention name(s): Placebo; MT-7117 Low Dose; MT-7117 High Dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; MT-7117 Low Dose; MT-7117 High Dose
Other intervention name(s): Dersimelagon; Dersimelagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim:

      The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on
      vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type
      2 diabetes.

      Methods:

      A prospective study will be performed in 20 uncontrolled patients previously treated with
      dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8
      mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to
      the alternative treatment for an additional 4-month period on similar dosage schedule.

        -  The following variables were assessed before (basal values) and after 4 months of each
           treatment period:

             1. Hormonal and metabolic determinations: fasting plasma glucose, insulin,
                catecholamine, lipid profile and HbA1 levels.

             2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity,
                platelet aggregation, fibrinogen and plasminogen levels.

             3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at
                the end of each treatment period, a 12-hour metabolic profile including
                measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at
                fasting and every 2 hours (7:00 am to 7:00 pm)will be done
    

Detailed description: 
      Measurements were be made at fasting
    

Intervention name(s): Metformin; Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): 750 to 2500 mg/day, two times a day during 4 months; 1 to 8 mg/day , two times a dya, during 4 months.
Other intervention name(s): glifage; Amaryl
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; metformin; glimepiride; glucose control; vascular reactivity; Adverse Reaction to Other Drugs and Medicines
The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin
Condition: Transthyretin Familial Amyloid Polyneuropathy
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
    


Intervention name(s): tafamidis
Intervention type(s): Drug
Intervention description(s): tafamidis meglumine 20 mg QD
Other intervention name(s): tafamidis meglumine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Heart rate variability (HRV) is used to noninvasively assess the activity of the autonomic
      nervous system, in particular, its parts help to evaluate the cardiac sympathetic and
      parasympathetic activities. Increasing HRV may contribute to improving autonomic nervous
      system dysfunctions. In traditional medicine, acupuncture in the region of the vagus nerve
      distribution in the ear could increase parasympathetic activity and cause changes in HRV.
      Zero point located on the vagus nerve distribution is scientifically proven to enhance
      parasympathetic activity, however, the number of studies examining the effect of auricular
      acupressure at zero point on HRV is limited while this method is highly effective and
      convenient. In our study, we want to survey heart rate variability during auricular
      acupressure at Zero point on the left ear in healthy volunteers.
    

Detailed description: 
      Participants and Methods: A randomized controlled trial is conducted by comparing the changes
      in HRV and elements of HRV during the auricular acupressure process at zero point on the left
      ear in healthy volunteers. A total of 114 participants were randomly assigned to 2 groups by
      computer GraphPad software and the allocation was 1:1. Participants in the experimental group
      received auricular acupressure at the left zero point, while the control group received
      placebo auricular acupressure by removing the ear seed but keeping the sticker attached in
      the left zero point. The primary outcome was the change in heart rate variability during
      auricular acupressure at zero point on the left ear. This trial will be performed as
      randomized, controlled, and single- blinded.
    

Intervention name(s): Auricular acupressure
Intervention type(s): Procedure
Intervention description(s): We conducted auricular acupressure at zero acupoints on the left ear with Vaccaria ear seed (Group A) or removed seed (Group B) in 20 minutes, with 2 times of auricular acupressure. The stimulation was performed for 30 seconds each time, with two pressure movements per second, resulting in a total of 60 pressure movements per stimulation.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: A single-blinded pilot study
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Auricular Acupressure; Zero point
Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte
      donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS
      Secondary Objectives

      Estimate the effects of a quinagolide dose-titration regimen compared to placebo in
      peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory
      parameters of haemoconcentration
    


Intervention name(s): Quinagolide
Intervention type(s): Drug
Intervention description(s): • Quinagolide 200 μg/day (dose titration from 50 μg/day to 100 μg/day to 200 μg/day), oral. Quinagolida tablets, 50 mcg.
placebo, oral.
Intervention MeSH terms: Quinagolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation
      on heart rate variability and QTc interval.
    


Intervention name(s): 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min
Intervention type(s): Drug
Intervention description(s): ECG monitoring for evaluation of QTc interval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: dexmedetomidine; heart rate variability; QTc interval
The Prevalence of Obesity For Schizophrenia Inpatients in Taiwan
Condition: Schizophrenia; Obesity
MeSH terms: Obesity; Schizophrenia
Study type: Observational

Summary: 
      This study is the first hospital-based, cross-sectional study to discuss the prevalence of
      obesity among 710 inpatients with schizophrenia.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        710 adult schizophrenia patients living in the chronic ward in Tsau-Tun psychiatric center
        during the first week in March 2010
      
Keywords: Schizophrenia; inpatient; obesity; prevalence