bioihbjkbjnl/mcl2 huggingface dataset:
Guided Bone Regeneration With Particulate Versus Block Graft
Condition: Surgery
Study type: Observational

Summary: 
      The aim of present study was to compare two bone augmentation techniques (Guided Bone
      Regeneration, GBR, with autogenous block graft and GBR with particulate autograft plus
      xenograft) in terms of efficacy, complications, operational parameters (cost of the materials
      used, time for patient preparation, time for surgery, fatigue of the physician caused by
      surgery) tolerability by the patient and patient comfort.
    

Detailed description: 
      The aim of present study was to compare two bone augmentation techniques (Guided Bone
      Regeneration, GBR, with autogenous block graft and GBR with particulate autograft plus
      xenograft) in terms of efficacy, complications, operational parameters (cost of the materials
      used, time for patient preparation, time for surgery, fatigue of the physician caused by
      surgery) tolerability by the patient and patient comfort. 30 systemically healthy individuals
      with inadequate alveolar bone crest width who requested implant placement (15 Female and 15
      Male) participated in this study. After an initial examination, 15 patients were assigned to
      GBR with block graft (GBR-BG) and 15 were assigned to GBR particulate autograft plus
      xenograft (GBR-AX). Bone thickness was recorded before surgery and at a post-operative 6th
      month. Complications as Bleeding, Hematoma, Flap dehiscence, Infection, Numbness were
      evaluated. Patients were requested to record pain and swelling via visual analog scale (VAS)
      at 3rd, 7th and 14th days after surgery. The swelling was also recorded by an experienced
      clinician at 3rd, 7th and 14th days after surgery. Cost, time for patient preparation, time
      for surgery, fatigue of the physician caused by surgery were also determined.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients admitted to the clinic with a complaint of tooth loss and inadequate alveolar
        crest (crest width <4mm) and requested of dental implant placement were examined. Patients
        with any systemic disease , smoking or alchol habits and medications did not included into
        the study due to avoid any possible effects on our results
Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when
      taken by mouth. To evaluate its effect on blood coagulation.

      DS has been reported to have anti-HIV activity. However, it is not known how much of the drug
      is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
    

Detailed description: 
      DS has been reported to have anti-HIV activity. However, it is not known how much of the drug
      is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.

      On 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24
      hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each
      volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is
      withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the
      infusion. All urine is collected.
    

Intervention name(s): Dextran sulfate
Intervention type(s): Drug
Intervention MeSH terms: Dextrans
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reference Values; Infusions, Intravenous; Intestinal Absorption; Dextran Sulfate; Administration, Oral; Blood Coagulation
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional

Summary: 
      This study will evaluate the safety and efficacy of once daily administered 0.03%
      Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03%
      Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution
      concurrently in patients with open-angle glaucoma or ocular hypertension
    


Intervention name(s): 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution; 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
Intervention type(s): Drug; Drug
Intervention description(s): One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution; One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Other intervention name(s): Bottle 1: Ganfort®; Bottle 1: Lumigan®; Bottle 2: Timoptol®
Intervention MeSH terms: Timolol; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the
      pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of
      the combination of quizartinib and induction and consolidation chemotherapy.
    


Intervention name(s): Quizartinib; Cytarabine; Idarubicin; Daunorubicin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): [Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21.
[Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19.
[Consolidation period] Once-daily repeated oral administration Day 6 to Day 19.; [Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7.
[Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5.
[Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5.; Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2.; Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3.
[Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2.
Intervention MeSH terms: Cytarabine; Daunorubicin; Idarubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; phase 1; hematology; malignancy; newly diagnosed
Effect of Turmeric on Diabetic Nephropathy
Condition: Diabetic Nephropathy; Proteinuria
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether turmeric is effective in improvement of
      diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.
    

Detailed description: 
      Diabetic nephropathy is leading cause of ESRF that many therapy recommended for it. In this
      study, we investigate effect of turmeric on diabetic nephropathy, thus we selected diabetic
      nephropathy patients and divided them into 2 groups. One group received turmeric + ACE
      inhibitor + Angiotensin II receptor blocker (ARB) and the second group received only ACE
      inhibitor + ARB.
    

Intervention name(s): Turmeric extract; Angiotensin-converting enzyme (ACE) inhibitor + Angiotensin-II type 1 receptor (ATI) blocker
Intervention type(s): Drug; Drug
Intervention description(s): turmeric 500 mg TID for 45 days; maximum dosage as patient tolerated for 45 days
Other intervention name(s): turmeric; enalapril; losartan
Intervention MeSH terms: Losartan; Enalapril; Angiotensin II; Giapreza; Angiotensin-Converting Enzyme Inhibitors; Angiotensinogen; Turmeric extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; nephropathy; turmeric; serum IL8; serum TGFb; serumINF; urinary IL8; urine TGFb
Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This is a single-arm, phase IV, open-label, prospective, non interventional study in
      approximately 600 patients that will be followed for 6 months in order to evaluate the safety
      and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration
      period from their previous antipsychotic medication to quetiapine according to the approved
      SPC.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care
      
Keywords: Switching; Quetiapine; schizophrenia; unsuccessfully treated; antipsychotics
Plasma Profile of Exclusively Breastfed Infants
Condition: Breast Fed Infants
Study type: Observational

Summary: 
      To characterize nutrient levels in breastfeeding infants and their mothers.
    

Detailed description: 
      The objectives of this study are (1) to characterize plasma lutein levels in breastfed
      infants in an Asian population where lactating mothers have diets habitually high in lutein
      and (2) investigate how blood lutein levels in breastfed infants vary according to lutein
      content of the mothers' milk in such a population.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breastfeeding infants and their mothers
      
Biospecimen description: 
      Blood sample; Human Milk sample
BURCH Colposuspension or Transobturatuar Tape (TOT)
Condition: Incontinence
Study type: Observational

Summary: 
      Stress urinary incontinence surgery combined with hysterectomy can often be applied to
      patients in the same session. The aim of this study was to determine which urinary
      incontinence surgery would be a better option for patients who would have hysterectomy.

      The aim of this study was to retrospectively review the data of 69 patients between the ages
      of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery
      (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence
      (SUI). In addition to demographic data and preoperative examination findings, operative
      times, postoperative hemogram values, postvoiding residual amounts and complications were
      examined.

      In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and
      UDI-6 interrogations related to urinary incontinence.
    


Intervention name(s): BURCH Colposuspension; TOT
Intervention type(s): Procedure; Procedure
Intervention description(s): stress urinary incontinence surgery ( burch or tot)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 40-65 who ; tlh operation with benign reasons and planned, and
        concurrent stress describing urinary incontinence.
      
Keywords: hysterectomy; anti-incontinence surgery; Burch; Tot; stress incontinence
Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center
      study of AMP-110 in adult subjects with rheumatoid arthritis.
    


Intervention name(s): AMP-110; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 2, 5, or 10 mg/kg; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Arthritis; Joint diseases; Musculoskeletal diseases
Non-alcoholic Fatty Liver Disease in Women With Polycystic Ovary Syndrome
Condition: PCOS; NAFLD
MeSH terms: Polycystic Ovary Syndrome; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      This study was planned to examine the prevalence of vitamin D insufficiency, insulin
      resistance, non-alcoholic fatty liver disease (NAFLD), and their relationship with each other
      and the nutritional status of individuals with polycystic ovary syndrome (PCOS) in
      reproductive age, by evaluating anthropometric, biochemical, and ultrasonographic findings
      and food consumption frequency data.
    

Detailed description: 
      A total of 72 female individuals diagnosed with PCOS were included in the study. Nutritional
      status, physical activity levels, anthropometric measurements, and biochemical parameters of
      individuals were examined. A food consumption frequency questionnaire was applied to the
      individuals. According to the 2003 Rotterdam Consensus revision, PCOS is diagnosed when at
      least two of the following three conditions are present: Polycystic ovaries on
      ultrasonography, oligomenorrhoea, or anovulation; clinical and/or biochemical symptoms of
      hyperandrogenemia. Testing was done on insulin, lipid profiles, fasting plasma glucose, and
      liver function. Bioelectrical impedance analysis was used to determine body weight and
      composition. An abdominal ultrasound was used to diagnose NAFLD.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Nutritional status, physical activity levels, anthropometric measurements, and biochemical parameters of individuals were examined. A food consumption frequency questionnaire was administered.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The appropriate sample size was determined to be 65 using power analysis in accordance with
        the results of the prior studies, with a 90% confidence interval and a 0.05 type-I error.
        The Rotterdam Consensus, revised in 2003, defined polycystic ovary syndrome (PCOS) as the
        presence of at least two of the following three criteria: (i) oligomenorrhoea or
        anovulation; (ii) clinical and/or biochemical signs of hyperandrogenemia; and (iii)
        ultrasound-confirmed polycystic ovaries. 328 volunteer women who visited the clinic
        throughout the research period were chosen as participants after being screened for
        eligibility. This study included 72 women who were confirmed to be eligible and ranged in
        age from 18 to 40.
      
Biospecimen description: 
      Blood samples
    
Keywords: polycystic ovary syndrome; non-alcoholic fatty liver disease; obesity; insulin resistance
Stress and the Sympathetic Nervous System in Adults With Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      To test our hypotheses, we will enroll healthy adults having no history of mood disorders and
      adults with major depressive disorder (MDD) having a broad range of depressive symptom
      severity. After screening, subjects will meet with the research coordinator or an
      investigator for a discussion, with opportunity for questions, before applicable consent
      forms are obtained. Daily stress processes will be assessed using an ecological momentary
      assessment approach for 8 consecutive days. On the last day of the daily stress assessment,
      we will directly measure muscle sympathetic nerve activity, blood pressure, and heart rate
      during acute laboratory-based cognitive, emotional, and physiological interventions to induce
      a stress response. A venous blood sample will be taken for measurements of metabolic and
      renal health and systemic inflammation.

      Aim 1: To examine the effect of daily psychosocial stressor exposure on acute sympathetic
      stress reactivity in MDD. Two stressor exposure indicators will be calculated: stressor
      frequency (i.e., percentage of interview days during which at least one stressor occurred)
      and total stress (i.e., total number of stressors reported across all interview days) and
      will be related to the magnitude of responsiveness to the acute stress interventions. We
      hypothesize that the slope of this relation will be steeper in adults with MDD compared to
      healthy non-depressed adults.

      Aim 2: To determine the relation between negative affective reactivity to daily psychosocial
      stressor exposure and acute sympathetic stress reactivity in MDD. Negative affective
      reactivity will be calculated as the change in affect on days when stressors occurred
      compared to one's typical affect on non-stressor days and will be related to the magnitude of
      responsiveness to the acute stress interventions. We hypothesize that the slope of this
      relation will be steeper in adults with MDD compared to healthy non-depressed adults.
    


Intervention name(s): Acute Stressors
Intervention type(s): Other
Intervention description(s): Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Nafamostat on Postreperfusion Syndrome (PRS)
Condition: Liver Transplantation; Postreperfusion Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study intends to see the effect of nafamostat on the attenuation of postreperfusion
      syndrome (PRS) that frequently occurs during liver transplantation.
    


Intervention name(s): Nafamostat; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.2 mg/kg as bolus 1 minute before reperfusion; 10 ml of normal saline
Intervention MeSH terms: Nafamostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The main objective of this study is to investigate the correlation between the rate of motor
      decline and blood levels of Vitamin D total. Secondary objectives are to investigate the
      relationship between blood levels of vitamin D and total disease duration of ALS, forced
      vital capacity, weight loss, age of onset and the start site of ALS.
    

Detailed description: 
      Amyotrophic lateral sclerosis is one of the most serious neurodegenerative disease, leading
      to death in 3 years by progressive paralysis of 4 limbs, speech, swallowing and breathing,
      and due to a progressive death of central and peripheral neurons. The cause of the disease is
      unknown, but an immunologically factor is more precisely suspected in ALS. Since 2008, the
      work of Immunology have shown that vitamin D was a major regulator of immunity. It regulates
      particularly the function of dendritic cells and regulates the immune response in
      macrophages. A vitamin D deficiency will induce activation of microglia. In neurology,
      vitamin D deficiency is associated with a greater impairment in neuronal function. This
      deficit is associated with a faster alteration of the microvasculature, alteration known to
      increase neuronal suffering and to enhance the neurodegenerative processes. The investigators
      postulate that ALS patients have a more severe prognosis if their vitamin D levels at the
      time of diagnosis is lower. The main objective of this study is to investigate the
      correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary
      objectives are to investigate the relationship between blood levels of vitamin D and total
      disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site
      of ALS.
    

Intervention name(s): Blood test
Intervention type(s): Procedure
Intervention description(s): Blood test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Amyotrophic lateral sclerosis; Vitamin D; Blood Levels
Electrical Impedance Myography of Neck and Low Back Pain
Condition: Low Back Pain; Neck Pain
MeSH terms: Back Pain; Low Back Pain; Neck Pain
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to assess neck and low back pain using Electrical Impedance
      Myography (EIM) in order to develop an algorithm to aid primary care providers (PCPs) in the
      diagnosis of neck/back pain. Secondary goals include the refinement of EIM technology and
      associated software of ease-of-use and interpretation by PCPs and staff.
    


Intervention name(s): EIM Measurements
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Neck and Low Back Pain Subjects
      
Keywords: EIM