bioihbjkbjnl/mcl2 huggingface dataset:
"Opinion of Doctors,Nurses and Key Informants About Independent Nurse Midwifery Practitioner in Northern India
Condition: Opinion
Study type: Observational

Summary: 
      "A Study to assess the Opinion of Doctors, Nurses and Key informants regarding Independent
      Nurse Midwifery Practitioner at selected Hospitals and Colleges of nursing in Haryana."
    

Detailed description: 
      Abstact Introduction: Despite improvement in coverage of institutional deliveries and skilled
      birth attendants, India has missed its Millennium Development Goal to reduce maternal
      mortality rate. In order to increase access to primary care services, the Independent Nurse
      Practitioner (INP) is one of the best solutions.

      Objectives: The objectives of the study were to assess the opinion of doctors, nurses and key
      informants regarding Independent Nurse Midwifery Practitioner (INMP) and to determine the
      association of opinion score of doctors, nurses and key informants with their selected
      demographic variables.

      Material and Methods: A Quantitative Non Experimental Research Approach and Descriptive
      Survey Design was adopted. A total of 400 subjects (120 doctors, 120 nurses and 160 key
      informants) were selected using purposive sampling technique from selected hospitals and
      nursing colleges of Ambala, Panchkula and Yamunanagar districts of Haryana. The tool used for
      the study consisted of structured performa regarding sample characteristics and likert scale.
      Research tool was submitted to 11 experts from various departments for validity. Reliability
      was calculated by Cronbach's alpha and it was 0.75 for likert scale. Data Collection was done
      from December 2016 to February 2017. The obtained data was analyzed and interpreted in terms
      of objectives and research hypothesis. Descriptive and inferential statistics were used to
      analyze the data.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Doctors, nurses and key informants in selected hospitals and colleges of Panchkula, Ambala
        and Yamunanagar districts of Haryana and available during data collection.
      
Keywords: Opinion,; Doctors,; Nurses,; Key informants,; Independent Nurse Midwifery Practitioner
Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Condition: Prostatic Neoplasms; Urinary Incontinence; Erectile Dysfunction
MeSH terms: Prostatic Neoplasms; Urinary Incontinence; Erectile Dysfunction
Study type: Interventional

Summary: 
      Urinary incontinence and impotence are typical disturbances after radical prostatectomy.
      Although, several surgical methods are developed to decrease these disturbances, 8% and 50%
      of the patients suffer from permanent urinary incontinence and impotence, respectively.

      Previously two studies have shown that endopelvic fascia preservation may decrease
      postoperative incontinence and impotence rates. Unfortunately these studies are retrospective
      decreasing their reliability.

      The present study is prospective and randomized clinical trial. The investigators are going
      to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional
      and oncological results are followed up to 1 year after surgery.
    

Detailed description: 
      180 patients going to radical prostatectomy as treatment of prostate cancer will be
      randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the
      operation, in the other arm the fascia are opened.

      After the operation urinary continence and erection function are compared between the study
      arms. Additionally the investigators will study oncological outcomes.
    

Intervention name(s): Preservation (endopelvic fascia); Opening (endopelvic fascia)
Intervention type(s): Procedure; Procedure
Intervention description(s): Robotic assisted radical prostatectomy with preserving of endopelvic fascia; Robotic assisted radical prostatectomy with opening of endopelvic fascia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pegs for Osteofixation of Proximal Humeral Fractures
Condition: Implant Complication; Proximal Humeral Fracture; Avascular Necrosis of Humerus
MeSH terms: Necrosis; Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Observational

Summary: 
      Patients treated operative for Proximal humeral fractures with angular stable device (Philos
      plate or ALPS-PHP)
    

Detailed description: 
      From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the
      period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007
      fracture classification were selected according to age and gender to be compared with
      patients operated with a Philos plate within the same fracture group, age and gender to be
      matched for adverse events:

        1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the
           glenohumeral joint (primary outcome) and

        2. Avascular head necrosis / sinking / need of re-surgery

        3. Clinical PROMS
    

Intervention name(s): Open reduction internal fixation (ORIF) with an angular stable plate
Intervention type(s): Device
Intervention description(s): Operative treatment of proximal humeral fracture
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to hospital with an acute PHF for surgical treatment
      
Keywords: Humeral head; Screw penetration; Peg penetration; Avascular necrosis
Combined PENG and LFCN Block for Total Hip Arthroplasty
Condition: Anesthesia, Conduction; Pain, Postoperative; Arthroplasty, Replacement, Hip
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      A clinical trial investigating the effect of a combined locoregional anesthesia technique on
      the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be
      used in combination with a LFCN block. The results will be compared to a control group that
      is solely treated with intravenous analgesia. This technique aims to provide improved pain
      scores after surgery without interference of revalidation.
    


Intervention name(s): PENG + LFCN block; Ropivacaine injection
Intervention type(s): Procedure; Drug
Intervention description(s): Regional anesthesia technique; Local anesthetic used for peripheral nerve block.
Other intervention name(s): pericapsular nerve group block; lateral femoral cutaneous nerve block; ropivacaine 0.375%
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: regional anesthesia; postoperative pain; total hip arthroplasty; pericapsular nerve group block
A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment
Condition: Chronic HBV Infection
MeSH terms: Infections; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B
      subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28
      Days treatment with EDP-514.
    

Detailed description: 
      The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in
      viremic chronic CHB-infected subjects not currently on treatment.

      Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or
      placebo.
    

Intervention name(s): EDP-514; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Placebo to match EDP-514
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Ascending Dose; hepatitis B virus; HBV
Pre-operative One-on-One Physical Therapy Education Improves Postoperative Function and Patient Satisfaction After Total Joint Arthroplasty
Condition: Arthroplasty
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical
      therapy protocol on postoperative (1) discharge disposition, (2) pain, function and stiffness
      and (3) patient satisfaction.
    


Intervention name(s): Preoperative Physical Therapy Session; Group Preoperative Education Session (per the standard of care)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This was a one-on-one preoperative physical therapy session on preoperative education. These patients were also given access to a surgery specific web-based microsite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Clinical Verification of Peptide Biomarkers for Human Aging
Condition: Aging
Study type: Observational

Summary: 
      Aging in human physically refers to a multidimensional process that all the changes were
      accumulated in a person over time. These aging changes are responsible for the progressive
      increases in the chance of disease and death associated with them. So far, there are several
      theories have been developed to understand the aging process, such as cross-linking, which is
      led by Maillard Reactions. Maillard Reaction is a complex series of reactions between
      reducing sugar/aldehydes and amino groups on proteins. Under physiological conditions,
      aldehydes are products of various exogenous and endogenous amines catalyzed by
      semicarbazide-sensitive amine oxidase (SSAO), a family of heterogeneous enzyme. It was
      reported that SSAO shows a significant higher catalytic activity, producing more aldehydes in
      age-related diseases. However, SSAO is not a perfect candidate to be monitored for evaluating
      aging, because it is widely distributed in tissues, which are not readily accessible
      sample-sources for clinical applications. In this work, the investigators have found 6
      biomarker candidates by developing a standard-free, label-free MS-based proteomics method
      based on standard protein (human serum albumin, the highest abundance protein in human
      plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates
      by clinical plasma samples to see if there is significant quantitative difference among
      people with different ages.
    

Detailed description: 
      The procedure of clinical study was:

        1. to get plasma samples from hospital;

        2. digestion of plasma protein-mixture by trypsin in lab;

        3. run mass spectrometry and monitor the amount of target HSA-peptides.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        university hospital, plasma samples of physical examination, faculties and staff of a
        certain university
      
Keywords: formaldehyde; Maillard Reaction; cross-linkage; human aging
Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition,
      daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid
      deposition in the brain. Participants will be randomly assigned to receive insulin aspart or
      placebo during a 12-week treatment period.
    

Detailed description: 
      A growing body of evidence suggests that insulin plays a role in normal memory processes and
      that insulin abnormalities may contribute to cognitive and brain changes associated with
      Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is
      transported within a few minutes into the brain, but does not affect blood sugar or insulin
      levels.

      This trial will consist of a randomized double-blind, placebo-controlled parallel group trial
      in which 30 participants with AD or mild cognitive impairment (MCI) receive twice daily
      intranasal administrations of insulin aspart (20 IU) or placebo (saline), two times per day
      for 12 weeks. All participants will appoint a "support person" to answer a collateral
      questionnaire and supervise the administration of the study drug. All participants and study
      partners will undergo the intensive, structured training program in the self-management of
      intranasal insulin administration. Cognitive testing and blood collection will occur at
      baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period.
      Participants will also receive a lumbar puncture to measure AD biomarkers in the subject's
      cerebral spinal fluid.
    

Intervention name(s): Insulin aspart; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.; Participants will administer placebo two times per day with an intranasal delivery device.
Other intervention name(s): NovoLog Fast-Acting Insulin Aspart; Saline
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dysport® Adult Upper Limb Spasticity Extension Study
Condition: Nervous System Disorders
MeSH terms: Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to assess the long term safety of Dysport® in
      hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over
      repeated treatment cycles.
    

Detailed description: 
      This was a phase III, multicentre, prospective, open label, repeat treatment cycles,
      extension to the double study Y-52-52120-145 (Study 145) . The study included both rollover
      subjects from Study 145 and de novo subjects. The primary study objective was to assess the
      long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke
      or traumatic brain injury over repeated treatment cycles. The secondary study objective was
      to assess the long term efficacy of repeated treatment with Dysport®.
    

Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Intervention description(s): Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection.
Each vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Access the Pharmacokinetics of HMS5552 in Renal Impaired Subjects and Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in
      single dose in renal impaired subjects and matched healthy adult subjects.
    

Detailed description: 
      This is an open-label and paralleled study with single oral dose of HMS5552 given to renal
      impaired subjects and body index matched healthy volunteers.

      The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in
      renal impaired subjects and (gender, age and BMI) matched healthy adult subjects.

      The secondary objective is to characterize the safety profiles of HMS5552 in single dose in
      renal impaired subjects.

      The subjects include ESRD subjects without dialysis (P1 group), severe (P2 group), moderate
      (P3 group), mild (P4 group), and healthy subjects (H Group) matched with renal impairment
      subjects in gender, age and BMI. The number of subjects in each group was 6-8.

      The study is divided into two parts:

        -  Part 1: ESRD subjects without dialysis and matched healthy subjects (P1 and H groups; n
           = 8 for each group);

        -  Part 2: subjects with severe, moderate and mild renal impairment (P2, P3 and P4 groups;
           n = 6-8 in each group).

      The study initiates from Part 1. The data will be evaluated at the end of Part 1 as the
      medium term. Compared with the matched healthy subjects, if the mean AUC of HMS5552 (either
      AUClast or AUCinf) increased by ≥ 100% in ESRD subjects without dialysis, which means Part 2
      will need to be conducted. The process of Part 2 is the same as that of Part 1
    

Intervention name(s): HMS5552
Intervention type(s): Drug
Intervention description(s): single dose of HMS5552 25mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the
      tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor
      cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may
      kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving thalidomide together with
      procarbazine works in treating patients with recurrent or progressive malignant glioma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with recurrent or progressive malignant glioma
           treated with thalidomide and procarbazine.

      Secondary

        -  Determine the progression-free survival of patients treated with this regimen.

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the quality of life of patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on
      days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline and then before every odd course.

      Patients are followed every 2 months.

      PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study.
    

Intervention name(s): procarbazine hydrochloride; thalidomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Thalidomide; Procarbazine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult glioblastoma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      In children with mild apnea combined therapy with an inhaled nasal steroid and a medication
      that decreased nasal congestion (montelukast) was shown to be effective. We are testing to
      see if this combination works in adults with mild apnea as well.
    

Detailed description: 
      40 adults with mild OSA (< 5 apneas/hypopneas per hour of sleep) will receive either a
      combination of two medicines that decrease nasal congestion-montelukast and nasal
      budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study
      will be done to determine the differences, if any, in the frequency of sleep disordered
      breathing in the two groups.
    

Intervention name(s): budesonide and montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks; sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Intervention MeSH terms: Budesonide; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: OSA; Medical treatment
Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model
Condition: Anesthesiology Trainee
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of simulation based practice on
      anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an
      anesthetized porcine model.

      The residents filled out a questionnaire before and after the training session. The
      questionnaires consisted of knowledge including ultrasound anatomy and block technique,
      comfort, confidence, and axiety levels for the TAP block.
    


Intervention name(s): Simulation-Based Education
Intervention type(s): Other
Intervention description(s): Participating residents receive lectures on TAP block and the use of ultrasound devices from an expert before training, and then receive simulation-based training for an hour from the anesthesiologist's staff. The residents performed three ultrasound guided TAP blocks using an anesthetized porcine model during the training session.
The residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in abdomen ultrasound and TAP block. Subjective comfort levels with ultrasound machine and block device functionality, patient positioning, proper block technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other