bioihbjkbjnl/mcl2 huggingface dataset:
Retinal Ganglion Cell Layer in Patients With Intracerebral Processes
Condition: Ganglion Cells
MeSH terms: Ganglion Cysts; Synovial Cyst
Study type: Observational

Summary: 
      Transsynaptic degeneration of the retinogeniculate pathways is well documented to occur in
      nonhuman primates when the cerebral lesion occurs even during adulthood. In case of humans,
      retrograde transsynaptic degeneration of the retinogeniculate pathways has been shown to
      occur following prenatal or perinatal lesions, but its occurrence after cerebral lesions in
      adults is considerable rare. It is, however, well established that retrograde transsynaptic
      degeneration affects other neural systems in humans even when the injury occurs during
      adulthood. Some histopathological evidence points to the possibility of transsynaptic
      degeneration of the retinogeniculate pathway in humans even when the lesion occurs in adults,
      but the clinical significance is unknown.'

      Purpose:

      To measure the retinal ganglion cell layer (GCL) in patients with visual field defects due to
      intracerebral processes. To correlate GCL with the localization and type of intracerebral
      lesion.

      To compare the GCL with the retinal nerve fibre layer (RNFL) to investigate, which of the 2
      parameters is more sensitive to show retinal layer abnormalities.

      To correlate GCL with visual field defects and electrophysiological parameters.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with intracerebral lesions
Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections
Condition: Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam
      (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000
      mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose
      adjustments for subjects with mild renal impairment are not necessary and subjects with more
      severe degrees of renal failure are excluded.
    


Intervention name(s): CXA-101/ tazobactam and metronidazole; meropenem plus saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion; meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
Intervention MeSH terms: Metronidazole; Meropenem; Tazobactam; Ceftolozane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Observational

Summary: 
      The purpose of this study is to investigate areas of the brain responsible for
      self-regulation in adult women who have never had an eating disorder with women who have
      bulimia nervosa. More specifically, investigators are interested in changes in brain
      activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and
      regulating emotions. Data collection will rely on a technology called functional magnetic
      resonance imaging (fMRI).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.
      
Keywords: Bulimia Nervosa; Bulimia; fMRI; Emotion Regulation; Response Inhibition
The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
Condition: Visceral Pain, Postoperative
MeSH terms: Pain, Postoperative; Visceral Pain
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effectiveness of erector spinae plane block
      on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus
      sheath block may provide sufficient somatic pain block, investigators aimed to investigate
      whether erector spinae block is effective in visceral pain block.

      After induction of general anesthesia, group of patient is decided randomly. In Group R,
      rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group
      RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine
      70ml before the operation.

      NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12,
      18, and 24 hours after arrival at the recovery room were collected
    


Intervention name(s): Ultrasound guided Rectus sheath block; Ultrasound erector spinae plane block
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus; Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: laparoscopic cholecystectomy; erector spinae plane block; visceral pain
Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
Condition: Neurogenic Bladder; Spinal Cord Injuries; Quality of Life; Incontinence
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries
Study type: Observational

Summary: 
      The investigators goal is to create a better understanding of patient reported outcomes for
      bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter
      (IDC) and bladder surgery.
    

Detailed description: 
      Our study is a longitudinal observational study between bladder management strategies,
      comparing outcomes measured by patient reported questionnaires.
    

Intervention name(s): Clean Intermittent Catheterization; Indwelling Catheter; Surgery; Voiding
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Clean intermittent self catheterization is a standard of care.; Indwelling catheterization is a standard of care.; Bladder surgery is a standard of care.; Voiding spontaneously is a standard of care.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with neurogenic bladder with urinary issues and currently being managed by
        one/ any of various bladder management treatments (clean intermittent catheterization,
        indwelling catheter, voiding or bladder surgery).
      
Keywords: Urinary Bladder; Neurogenic; Quality of Life; Spinal cord injury; incontinence; Bladder
Continuum™ Metal Bearing System in Total Hip Arthroplasty
Condition: Avascular Necrosis; Osteoarthritis; Inflammatory Arthritis; Post-traumatic; Arthrosis; Total Hip Arthroplasty
MeSH terms: Arthritis; Osteoarthritis; Necrosis
Study type: Observational

Summary: 
      The study is a multi-center, prospective, non-controlled, consecutive cohort post market
      surveillance study. The objective of this study is to obtain survival and outcome data on the
      Continuum Metal Bearing System in primary total hip arthroplasty.
    

Detailed description: 
      The subject of this clinical investigation is the Continuum Metal Bearing THA System in
      primary total hip arthroplasty. This system consists of a cementless modular Trabecular
      Metal™ (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul
      femoral head. The characteristics of this THA system may allow for reduction in wear and
      osteolysis as compared to other approved and marketed THA systems and thus increase the
      expected implant life.

      In total, 3 centers will be involved. This number of clinical sites will permit assessment of
      the consistency among a multitude of investigators. A total number of 100 subjects will be
      included in the study. It is anticipated that each clinical site will enroll 10 to 45
      eligible study subjects, who have provided written informed consent.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be comprised of max. 100 males and females who require primary
        total hip arthroplasty. Subjects will be enrolled at 3 investigative centers. Subjects must
        be geographically accessible throughout the study and be willing and able to attend
        required follow-up appointments. Candidates who express interest in study participation
        will be offered informed consent, and eligibility will be determined based upon the
        inclusion/exclusion criteria.
      
Keywords: Total hip arthroplasty; Medical Device; Post Market Surveillance Study; Performance; Safety
Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice
Condition: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Crohn´s Disease; Ulcerative Colitis; Plaque Psoriasis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Crohn Disease; Colitis; Colitis, Ulcerative; Psoriasis; Ulcer
Study type: Observational

Summary: 
      The purpose of this non-interventional, multicenter, post-marketing observational study
      (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing
      spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC)
      patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or
      combination therapy with methotrexate (in participants with RA) and to investigate whether
      there were correlations between such beliefs and adherence to maintenance treatment.
    

Detailed description: 
      Adalimumab was prescribed in the usual manner in accordance with the terms of the local
      marketing authorization with regards to dose, population and indication. The assignment of a
      participant to an adalimumab-containing regimen was decided in advance and was to be current
      practice. The prescribing of adalimumab was clearly separated from the decision to include
      the participant in the study. Participants were observed for a maximum of 12 months, with a
      total of 5 study visits (Screening = Visit 1).
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab administered by subcutaneous injection, via pre-filled syringe or autoinjector pen
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants currently being managed in a specialist rheumatology practice or respective
        hospital department
      
Keywords: Arthritis; Morbus Crohn; Adherence; Spondylitis; Ulcerative colitis; Monoclonals; Rheumatoid; Antibodies; Ankylosing; Plaque psoriasis; Psoriatic; Crohn´s disease; Antirheumatic Agents
Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine
      succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and
      the effects of the drug will also be evaluated.
    


Intervention name(s): desvenlafaxine succinate SR; Placebo
Intervention type(s): Drug; Other
Intervention description(s): desvenlafaxine succinate SR
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes
Condition: Diabete Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It is essential to manage the disease to prevent and reduce complications and mortality in
      patients with diabetes. Adequate information and options should be provided to patients by
      healthcare providers so that patients can make informed choices. Patient education is a
      patient empowerment process designed to enable patients to be responsible for their health.
      With this study, it is considered essential to educate diabetic patients according to the
      theory of planned behavior and to develop self-efficacy by contributing to patient
      empowerment in this way.
    


Intervention name(s): Application of The Theory of Planned Behaviour for Diabetes
Intervention type(s): Behavioral
Intervention description(s): In the study, diabetes education consisting of a total of 4 sessions structured according to the Planned Behavior Theory will be applied to the intervention group, and a standard diabetes education consisting of a single session containing information about diabetes on the website of the Ministry of Health will be applied to the control group. The training will be given face-to-face in groups of 10-15 people. After the training, the participants will be monitored for 3 months. To increase patient empowerment and self-efficacy, the intervention group will be followed up by phone calls every 15 days to increase motivation and answer questions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Diabetes; Theory Of Planned Behavior; Patient Empowerment; Self-Efficacy
NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to investigate the mechanism of action of a new
      investigational medication (drug), NNC 90-1170, which is being developed for the treatment of
      type 2 diabetes (adult onset type of diabetes.

      NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is
      important for controlling insulin levels. Insulin, another hormone, is also important for
      controlling blood glucose levels, which are higher than normal in people who have type 2
      diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to
      cause insulin to be released from the pancreas in response to increasing blood glucose
      concentrations. These results will be compared to that of a group of healthy volunteers of
      similar age and body weight who do not have diabetes. Also, various other hormones and
      substances that are known to control blood sugar will be measured in blood samples that will
      be drawn.

      One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study,
      and the effects of this dose will be compared to a placebo (inactive substance that looks
      like the active drug). This is a crossover study, which means that subjects will be treated
      both with NNC 90-1170 and with placebo. The order in which subjects will receive the
      treatments will be determined by chance (randomly).

      The study will be conducted as a so-called "double-blind" study, meaning that neither
      subjects nor study doctors will know the order in which subjects will be given each treatment
      until the study is over.

      The study will include approximately 15 healthy volunteers and 15 volunteers with type 2
      diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in
      the United States.
    


Intervention name(s): NNC 90-1170
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: glucagon-like peptide 1
The Role of Parents in Adolescent Weight Loss
Condition: Adolescent Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether a novel model of including parents in
      adolescent weight control results in greater decrease in adolescent z-BMI compared to an
      intervention with minimal parent involvement.
    


Intervention name(s): Behavioral Weight Control with Enhanced Parent Involvement; Behavioral Weight Control with Minimal Parent Involvement
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy
Condition: Insulin Pump Therapy in Treating Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      The recent study suggested that oxidative stress resulting from increased production of
      reactive oxygen species (ROS) plays a crucial role in the development of diabetic
      complications. The researches aim to monitor the level of oxidative stress of patient in
      different stage of diabetic nephropathy before and after insulin pump therapy.
    

Detailed description: 
      Worldwidely, about 30% of Type 1 Diabetes Mellitus (T1DM) and 20%-50% of T2DM patients
      suffered diabetic nephropathy (DN). Oxidative stress resulting from increased production of
      reactive oxygen species (ROS) plays a crucial role in the development of diabetic
      complications. Insulin pump therapy is better than subcutaneous injection in terms of the
      drug safety and effectiveness. The researches aim to monitor the level of oxidative stress of
      patient in different stage of diabetic nephropathy before and after insulin pump therapy.
    

Intervention name(s): Insulin pump
Intervention type(s): Device
Intervention description(s): Blood glucose management device
Other intervention name(s): Diabetes insulin pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Normal group (NC) and Type 2 diabetic (DM) group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic nephropathy; Insulin pump intensive therapy
A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC)
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and SERETIDE DISKUS® 250/50 mcg inhalation
      powder/GSK (reference-R) in healthy volunteers under fasting conditions with charcoal
      blockade. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and
      TR), single dose, laboratory-blinded.
    

Intervention name(s): Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals; SERETIDE DISKUS® 250/50 inhalation powder/GSK; Activated Charcoal suspension
Intervention type(s): Drug; Drug; Other
Intervention description(s): 2 inhalations in one study period; 2 inhalations in one study period; oral suspension before and after inhalation of study Investigational Products
Other intervention name(s): Test; Reference
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; SERETIDE; charcoal blockade
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
Condition: Interstitial Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety,
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when
      administered to healthy volunteers (HVs). The study in HVs will be a randomized, double
      blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD)
      (Part B) study.
    


Intervention name(s): AD-214; Placebo
Intervention type(s): Biological; Other
Intervention description(s): AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment