bioihbjkbjnl/mcl2 huggingface dataset:
MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study
Condition: Insulin Resistance; Metabolic Syndrome X; Dyslipidemia; Hypertension; Overweight
MeSH terms: Microvascular Angina; Overweight; Metabolic Syndrome; Insulin Resistance; Dyslipidemias; Syndrome
Study type: Interventional

Summary: 
      Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands
      ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is
      expected to increasing. Prevention is therefore warranted. In this respect the amount and
      type of fat in the diet deserves attention. Recently, an intervention study reported that a
      diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin
      sensitivity in healthy subjects. However, additional beneficial effects can be expected from
      the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by
      mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a
      typical Mediterranean diet will even have more pronounced effects. Study objectives: To
      investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on
      markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary
      intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After
      a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets
      for a period of 8 weeks. Measurements of serum insulin concentration and other parameters
      will be carried out at weeks 2 and 10. Expected results: Our study will provide information
      on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean
      type of diet on the metabolic syndrome.
    


Intervention name(s): Isocaloric diet high in MUFA or Mediterranean diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: MUFA; Mediterranean diet; Insulin resistance; metabolic syndrome X
Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The current study examined the effectiveness of a behaviorally-based group intervention for
      overweight children and their families. The target intervention was compared to an enhanced
      standard of care treatment. The impact of both treatment programs on numerous outcomes was
      explored.
    

Detailed description: 
      The primary objective of the present investigation was to determine the effectiveness of an
      empirically supported intervention for pediatric overweight in two outpatient clinical
      settings. A number of previous randomized clinical trials have demonstrated the efficacy of
      behaviorally-based group interventions for overweight children and their families. As called
      for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was
      designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to
      examine the effects of the intervention on children's quality of life (QOL). Because the
      clinical impact of empirically supported interventions is mitigated by economic and consumer
      variables, a secondary aim of the proposed investigation was to examine (1) the
      cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the
      consumer satisfaction with the proposed intervention. Finally, an additional exploratory aim
      was to examine predictors of adherence to treatment for the intervention.
    

Intervention name(s): Positively Fit; Brief Family Intervention (Primarily education)
Intervention type(s): Behavioral; Other
Intervention description(s): 12-week group intervention for children with obesity and their parents/caregivers; 3 hours of contact with registered dietician for education and nutritional counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Behavioral treatment; Family involvement
Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair
Condition: Disorder of Rotator Cuff
Study type: Interventional

Summary: 
      Primary objective of this study is to prospectively compare and evaluate efficacy as well as
      note side effects of the interscalene block and combined suprascapular and axillary nerve
      block for ambulatory arthroscopic rotator cuff repair.
    

Detailed description: 
      Patients having elective arthroscopic rotator cuff repair will be randomized to one of the
      two groups.

      Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator
      aided) followed by a general anesthesia.

      Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided
      and nerve stimulator aided) followed by a general anesthesia.

      Performance time, quality and efficacy as well as any side-effects of the blocks will be
      evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning,
      opioid usage and patient satisfaction.

      Primary hypothesis:

      • Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as
      compared to interscalene block for arthroscopic rotator cuff repair.

      Secondary hypothesis

      • Interscalene block is associated with more side effects and complications as compared to
      suprascapular nerve block and axillary nerve block.
    

Intervention name(s): interscalene block; Suprascapular and Axillary nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.; This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: interscalene; suprascapular; axillary
A Study To Assess The Effect Of Linezolid On QTc Interval
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG
      readings) which could predispose patients to ventricular arrhythmias. This study is conducted
      to satisfy this requirement.
    


Intervention name(s): Placebo; Linezolid 900 mg; Linezolid 1200 mg; Placebo; Linezolid 600 mg; Linezolid 1200 mg; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous, Placebo control for blinding, Normal Saline, Single dose; Intravenous, 900 mg linezolid, single dose; Intravenous, 1200 mg linezolid, single dose; Intravenous, Placebo control for blinding, Normal Saline, Single dose; Intravenous, 600 mg linezolid, single dose; Intravenous, 1200 mg linezolid, single dose; Oral, 400 mg moxifloxacin, single dose
Other intervention name(s): Zyvox; Zyvox; Zyvox; Zyvox; Avelox
Intervention MeSH terms: Moxifloxacin; Linezolid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Linezolid, QTc interval, pharmacokinetics, therapeutic dose, supra-therapeutic dose
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the impact of itraconzaole on the
      pharmacokinetics of Dorzagliatin.
    


Intervention name(s): Dorzagliatin
Intervention type(s): Drug
Intervention description(s): GKA for T2DM currently under clinical development
Other intervention name(s): HMS5552
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10
      mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured
      at the Wilson, NC facility in the fasted state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (Totowa) (oxycodone HCl); Reformulated OXY (Wilson) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.; Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid; Healthy volunteers
Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery
Condition: Hypoxemia; Recruitment
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The risk of respiratory failure after cardiac surgery is high, and it may result in many
      complications. The maneuver of alveolar recruitment may improve the oxygen transport in the
      human organism. The investigators compare three different types of alveolar recruitment in
      patient after cardiac surgery, to reveal which one is better.
    

Detailed description: 
      The study compares three different approaches to alveolar recruitment maneuvers in the
      immediate postoperative period after off-pump coronary bypass grafting.
    

Intervention name(s): Alveolar recruitment
Intervention type(s): Procedure
Intervention description(s): Four approaches:
CPAP 40 cm H2O
Peak pressure 40 cm H2O
PEEP 15 cm H2O for 300 sec
no intervention (controls)
Other intervention name(s): CPAP40; PEAK40; PEEP15; CONTROLS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Recruitment; Coronary artery bypass grafting; Postoperative period
The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety
      between HIP2001 and HGP2001 in healthy volunteers.
    


Intervention name(s): HIP2001; HGP2001
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval
Condition: Female Urogenital Diseases
MeSH terms: Urogenital Diseases; Female Urogenital Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine what is the best time interval between GnRH agonist
      (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes
      (MII) collected in IVF cycles.
    

Detailed description: 
      Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for
      several decades. When GnRH antagonist protocols were introduced, it became possible to
      trigger final oocyte maturation and ovulation with a single bolus of a GnRH agonist (GnRHa)
      as an alternative to hCG. The use of GnRHa to trigger final oocyte maturation has potential
      advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes
      retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.

      From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the
      timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG
      triggering (34-36 h). However, differences exist regarding the duration and profile of the
      GnRHa induced surge of gonadotrophins when compared with that of hCG. Even more, differences
      in the intra-follicular mechanisms involved in ovulation have been described after GnRHa and
      hCG trigger.

      No previous randomized controlled trials have been reported to evaluate the optimal interval
      of time between ovulation induction by GnRHa and oocyte collection.

      The present study compares the ovarian response and the IVF outcomes after induction by
      triptorelin 0.2 mg at four different time intervals:

      Group 1: OPU 24 hours after GnRHa administration. Group 2: OPU 30 hours after GnRHa
      administration. Group 3: OPU 40 hours after GnRHa administration. Group 4: control group: OPU
      36 hours after GnRHa administration.
    

Intervention name(s): Decapeptyl® diario; Decapeptyl® daily
Intervention type(s): Drug; Drug
Intervention description(s): Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.; Decapeptyl® daily OPU 36 hrs after GnRH administration
Other intervention name(s): Decapeptyl® daily; GnRHa; Decapeptyl® diario; GnRHa
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ovulation induction,oocyte maturation timing and collection
Shifting and Distribution of Foot Pressure Among Obese Subjects
Condition: Obesity
Study type: Interventional

Summary: 
      Background: The foot is considered a sensitive structure of musculoskeletal system that bears
      significant loads of the body weight during walking. So, the evaluation of the body weights
      on planter pressure distribution during walking among adult obese subjects is very critical
      for foot dysfunctions.The aims:To evaluate the planter pressure distribution in normal ,over
      weight and obese adult during dynamic situation. Subjects and Methods: A one-hundred fifty
      normal adult (male and female) subjects will be recruited in this study. They will be divided
      into Group-I: includes 50 normal subjects Group-II: includes 50 of over weight
      subjects.group-III 50 obese adult subjects The all three groups will be detected according to
      the individual BMI. The details of the study will be explained to each participant and a
      consent form was signed by each subject.Each participant should be free from any
      musculoskeletal or locomotors disorders Conclusion: Results of this study can help physical
      therapists to understand the foot pressure distribution map for normal , over weight and
      obese and non-obese subjects to detect any foot abnormalities and detect any causes of foot
      dysfunctions.
    

Detailed description: 
      A one hundred fifty volunteers (male and female), age from 20 to 40 years old subjects will
      be recruited in this study. Demographic data of all participating subjects like age, weight,
      height, feet size, and body mass index (BMI) will be assessed. All participants will be
      assigned to three groups per measurement of individual BMI: Group-I: includes 50 normal
      subjects (18.5 -24.9 BMI); Group-II: includes50 overweight subjects (25.0 -29.9 BMI);
      Group-III: includes 50 obese subjects (30.0 and Above BMI) (Nuttall, 2015). The procedure and
      purpose of the study will be explained in details for all participants. A consent form will
      be signed by each participant. Human research already approved by Institutional review board
      of Imam Abdulrahman Bin Faisal University(University of dammam previously ).IRB.2017- 03-065.
    

Intervention name(s): Emed foot device
Intervention type(s): Device
Intervention description(s): foot pressure will be measure by using emed foot pressure system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Foot pressure, Obese, and normal Subjects
Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients
Condition: Pseudotumor Cerebri
MeSH terms: Intracranial Hypertension; Pseudotumor Cerebri; Hypertension
Study type: Interventional

Summary: 
      Idiopathic intracranial hypertensionis a type of increased intracranial pressure. Diagnosis
      is made by lumbar puncture, which is an invasive technique. The relationship between ICP and
      optic nerve sheath diameters (ONSD) were examined in our study. Thus, it was investigated
      whether the optic nerve sheath diameter could be used in the diagnosis of IIH. In the present
      study, it was found that ONSD measurement by optic USG significantly reflects increased ICP
      and decreasing pressure via LP is rapidly reflects to ONSD measurement. And it is suggested
      that ONSD measurements by optic USG, a non-invasive method, can be used in the diagnosis and
      follow-up of IIH patients.
    

Detailed description: 
      Backgrounds: Idiopathic intracranial hypertension (IIH); symptoms include headaches, blurred
      vision and papilledema which may lead to permanent visual loss. Definitive diagnosis of IIH
      usually requires the measurement of intracranial pressure (ICP) via lumbar puncture (LP)
      which is an invasive technique. In our study, the relationship between ICP and optic nerve
      sheath diameters (ONSD) were examined. Thus it was investigated whether optic nerve
      ultrasonography (USG) is a useful tool instead of LP for the diagnosis of IIH.

      Methods: A total of 25 patients who applied to the neurology clinics of Ankara Numune
      Training and Research Hospital between May 2014 and December 2015 and were diagnosed with IIH
      were included in the study. The control group consisted of 22 individuals who applied with
      other complaints than headaches. ONSD was measured from both eyes before and after the LP.
      After pre-LP measurements were taken, opening and closing CSF (cerebrospinal fluid) pressure
      was measured. In the control group, ONSD was measured with optic USG.
    

Intervention name(s): Optic ultrasonography; Lumbar puncture
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who applied to the neurology clinics and were diagnosed with IIH were included in the study. The control group consisted of 22 individuals who applied with other complaints than headaches. ONSD was measured from both eyes before and after the LP. After pre-LP measurements were taken, opening and closing cerebrospinal fluid pressure was measured. In the control group, ONSD was measured with optic USG.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Idiopathic intracranial hypertension; Optic nerve sheath diameter measurement; Increased intracranial pressure; Lumbar puncture
Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) Access Project for Youth Aged 13-24
Condition: Unsafe Sex; IV Drug Usage
Study type: Observational

Summary: 
      This study will evaluate the implementation of a PrEP program for youth aged 13-24 in
      Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the
      barriers for youth who are trying to initiate and continue taking PrEP will be examined.
    

Detailed description: 
      This observational study will describe the barriers encountered and the benefits found as
      youth engage in a PrEP program, the Phoenix PrEP Access Project and as they participate in
      PrEP provided through standard medical care. This study does not investigate the safety,
      efficacy or other medical benefits of PrEP, but looks at the issues surrounding youth who are
      trying to access PrEP.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Youth aged 13 through 24 in the Phoenix area who are high risk for HIV infections because
        of unsafe sex practices and or IV drug use and have been offered PrEP as part of their
        standard medical care.
Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?
Condition: Postpartum Endometritis
MeSH terms: Endometritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Cesarean delivery rates are increasing in Turkey and a major component of this increase is
      cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a
      national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of
      endomyometritis and wound infection, remains a leading cause of postoperative complications.
      Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and
      obstetric variables. Infection following cesarean delivery results in not only increased
      hospital stay but also increases the cost of care. Strategies to minimize postoperative
      infectious and other morbidities have included modifications of surgical technique, changing
      of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and
      altering the uterine position during repair of the uterine incision. Despite these
      interventions, endometritis is still major problem after cesarean delivery.

      Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing
      an important role. The microbes endogenous to the vagina change throughout the course of
      pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the
      vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand,
      reaching below the infant's head or presenting part, is in direct contact with the vagina.
      Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95%
      confidence interval [CI] 58%, 100%) of cesareans that follow labor. In these cases, vaginal
      flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision.
      Vaginal preparation has been shown to decrease the quantitative load of vaginal
      microorganisms as well as to remove certain species of bacteria.
    


Intervention name(s): povidone- iodine solution.; placebo
Intervention type(s): Drug; Drug
Intervention description(s): %10 Polivinilpirolidon iyot (Polividon- iyot; NO İNTERVENTİON
Other intervention name(s): BATTICON Solüsyon. Adeka; NO İNTERVENTİON
Intervention MeSH terms: Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention