bioihbjkbjnl/mcl2 huggingface dataset:
Patient Specific Instrumentation in TKR
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a randomised control trial to assess the benefits of using patient specific
      instrumentation in total knee replacement surgery. Patient specific instrumentation is an
      individualised system for total knee replacement surgery. The system has been marketed and is
      already in use in some centres. The type of implant used remains the same but the sizing of
      the components, and alignment of the implant is expected to improve. This study assesses any
      improvement in implant alignment in using the patient specific instrumentation, any improved
      intra-operative outcomes and any long term clinical outcome improvements for patients.
    

Detailed description: 
      This is a randomised control trial to assess the benefits of using patient specific
      instrumentation in total knee replacement surgery. Patient specific instrumentation is an
      individualised system for total knee replacement surgery. The system has been marketed and is
      already in use in some centres. The process is similar to traditional knee replacement
      surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of
      their knee, hip and ankle. From this data the dimensions and rotation of the knee can be
      accurately measured, and a custom made jig can be made specific to that patients anatomy. The
      jig is used intra-operatively to make accurate bone cuts according to this pre-operative
      plan, the type of implant used remains the same but the sizing of the components, and
      alignment of the implant is expected to improve. This study assesses any improvement in
      implant alignment in using the patient specific instrumentation, any improved intra-operative
      outcomes and any long term clinical outcome improvements for patients.
    

Intervention name(s): Zimmer Patient specific instruments; Standard instrumentation
Intervention type(s): Device; Device
Intervention description(s): A custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery.; Standard instrumentation will be used during total knee replacement surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous
      injection
    


Intervention name(s): Etanercept (Enbrel); HD203
Intervention type(s): Biological; Biological
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
Condition: Safety; Pharmacokinetics; Pharmacodynamics of AZD7594
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and
      biomarkers in blood when the drug is administered inhaled to healthy subjects
    

Detailed description: 
      A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study
      to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and
      Multiple Ascending Inhaled Doses of AZD7594 in Healthy Male Volunteers
    

Intervention name(s): AZD7594; Placebo to match
Intervention type(s): Drug; Drug
Intervention description(s): Suspension inhaled via Spira nebuliser; Matching placebo inhaled via Spira nebuliser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1,; healthy volunteers,; safety,; tolerability,; pharmacokinetics,; pharmacodynamics,; single ascending dose study,; multiple
A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes
Condition: Sexual Dysfunction; Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      A pilot study to determine the degree and effectiveness of the various modes of vSculpt, an
      over-the-counter "OTC" medical device, on enhanced genital blood flow and improvement in
      quality of life in menopausal women who suffer sexual dysfunction and stress incontinence
    

Detailed description: 
      The primary aim of this study is to determine the degree and effectiveness of the various
      modes of vSculpt on enhanced genital blood flow with menopausal women who experience sexual
      dysfunction and stress incontinence as measured by temperature change in the genitalia
      immediately after initial and final treatment and an improvement in quality of life after
      using the vSculpt device over the course of four weeks. The secondary aim is to compare the
      differences in genital blood flow and improvement in quality of life of vSculpt's various
      modes against Intone, another over-the-counter "OTC" medical device that utilizes a different
      technology to treat stress incontinence and improve sexual dysfunction.
    

Intervention name(s): vSculpt; InTone
Intervention type(s): Device; Device
Intervention description(s): A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.; A genital device using electric muscle stimulation to treat incontinence.
Other intervention name(s): ApexM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Computer-based Social Skills Training for Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate changes in subject performance on social
      skills assessments after engaging in a gaze-controlled video game that leverages ABA
      principles of learning, in comparison to an alternative game. The secondary objectives of
      this study are to evaluate changes in subject gaze patterns during social skills assessments
      after engaging in the video game, including in comparison to an alternative game and to
      evaluate possible correlations in changes in social skills assessments with changes in
      subject game play performance.
    


Intervention name(s): Lookware TM; Lookware TM Control Module
Intervention type(s): Device; Device
Intervention description(s): Lookware TM is a computer-based video game that requires the subject engage in social skills related exercises that include certain visual behaviors. These exercises combine techniques from applied behavior analysis (ABA) and use of gaze-contingent eye tracking technology during simulated social interactions with 3D animated characters to target certain social skills deficits in children with autism spectrum disorder (ASD). The game is delivered through a laptop computer, eye tracker, and game controller.; Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises. The game is delivered through a laptop computer, eye tracker, and game controller.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Litramine for Weight Loss
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Safety and Efficacy of Litramine in weight loss.
    


Intervention name(s): Litramine
Intervention type(s): Dietary Supplement
Other intervention name(s): IQP G-002AS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy
      (Hydros) and Hydros-TA Joint Therapy (Hydros-TA) for treatment of pain from osteoarthritis of
      the knee, in patients who have failed to respond adequately to conservative non-pharmacologic
      therapy and simple analgesics.
    

Detailed description: 
      The objective of the study is to evaluate Hydros and Hydros-TA treated subject for reduction
      of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC
      Osteoarthritis Index.

      The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered
      and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the
      areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain
      Subscale has been used extensively as an effectiveness endpoint in clinical trials of
      viscosupplements.
    

Intervention name(s): Hydros Joint Therapy; Hydros-TA Joint Therapy; Synvisc-One
Intervention type(s): Device; Device; Device
Intervention description(s): Single intra-articular injection.; Single intra-articular injection; Single intra-articular injection.
Other intervention name(s): Hydros; Hydros-TA; Hylan G-F 20
Intervention MeSH terms: Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; knee
The Efficacy of White Kidney Bean on Oral Glucose Tolerance Test
Condition: Diabetes; Sugar; Blood, High
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The goal of this randomized, double-blind, cross-over inverventional study is to evaluate the
      efficacy of white kidney bean on OGTT (oral glucose tolerance test). About 34 eligible
      participants will be randomized in two groups of the same size to take the assigned
      interventions at one study site in Shanghai, two visits will be required. The first group of
      participants will take Wonderlab product first and then placebo product after 72 hours of
      washout period, while the other group of of participants will take placebo product first and
      then Wonderlab product after 72 hours of washout period. For each visit, the finger blood
      will be sampled and the relevent data such as blood glucose will be captured based on OGTT
      procedures, and recorded into clinical data management system for statistical analysis.

      Researchers will compare the two groups to see if there is significant change of blood
      glucose by using products containing ingredient of white kidney beans.
    


Intervention name(s): Phase 1 Wonderlab Product; Phase 1 Placebo; Phase 2 Placebo; Phase 2 Wonderlab Product
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Chew two tablets of Wonderlab Product for phase 1 (day 1); Washout 72 hours and chew two tablets of placebo for phase 2 (day 4).; Chew two tablets of placebo for phase 1 (day 1); Washout 72 hours and chew two tablets of Wonderlab Product for phase 2 (day 4).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: White Kidney Bean; Oral Glucose Tolerance Test
SGLT2 Inhibitors in Patients With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to
      15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation
      disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other
      metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS.
      However, the clinical responses to metformin are limited and different. Sodium glucose
      co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes,
      with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is
      available on the efficacy of SGLT2 inhibitors in patients with PCOS.
    

Detailed description: 
      This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin
      in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single
      center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was
      conducted in the department of endocrinology, Shanghai Tenth People's Hospital between July
      2019 and April 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned
      to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12
      weeks. The primary outcome was changes in HOMA-IR after 12 weeks treatment. The secondary
      outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic
      parameters.
    

Intervention name(s): SGLT2 inhibitors; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet β-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet β-cell function, and reducing oxidative stress.; Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.
Other intervention name(s): Canagliflozin tablets or Glucophage
Intervention MeSH terms: Metformin; Canagliflozin; Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome (PCOS);; Insulin resistance (IR); Sodium-glucose co-transporter-2 inhibitors (SGLT-2i); Canagliflozin
Pharmacokinetics of Two Formulation of Pregabalin
Condition: Diabetic Peripheral Neuropathy; Fibromyalgia; Partial Seizure Disorder
MeSH terms: Fibromyalgia; Seizures; Peripheral Nervous System Diseases; Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 4

Summary: 
      A Randomized, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of
      Two Formulations of Pregabalin after Oral Administration in Healthy Volunteers under Fasting
      Conditions
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): pharmacokinetic study under fasting conditions
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
Clinical Evaluation of Fractional Bi-Polar RF for Symptoms of SUI and Vulvovaginal Atrophy
Condition: Stress Urinary Incontinence; Vulvovaginal Signs and Symptoms
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Atrophy
Study type: Interventional

Summary: 
      Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary
      Incontinence and Vulvovaginal Atrophy
    

Detailed description: 
      The objective of this trial is to evaluate the safety and efficacy of the MorpheusV
      Applicator for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy
    

Intervention name(s): MorpheusV Applicator
Intervention type(s): Device
Intervention description(s): 1 treatment with the MorpheusV Applicator
Intervention model: Single Group Assignment
Intervention model description: Eligible subjects will receive 1 treatment with the MorpheusV Applicator according to the study protocol.
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate in renal transplant recipients the potential drug intreaction between
      Sirolimus, Mycophenolt Mofetil and Fluvastatin

      All patient enrolled in this PKI-Study had no changes in the therapy before or because of the
      study. Only patients without changes more than 4 weeks before startin the study were included
    


Intervention name(s): sirolimus, mycophenolat mofetil, fluvastatin
Intervention type(s): Drug
Intervention MeSH terms: Sirolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluvastain; sirolimus; mycophenolat mofetil; renal transplantation
Measurement of Cerebral Blood Flow Using Transcranial Doppler Ultrasound in Children With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Sickle cell disease (SCD) affects haemoglobin - the molecule in blood cells which carries
      oxygen. It causes red blood cells to become abnormal crescent (or sickle)- shaped. Sickled
      red blood cells cannot travel through small blood vessels as easily as normal red blood cells
      which can lead to blockages. This means that oxygen may be prevented from getting to where it
      is needed. Individuals with sickle cell disease also suffer form abnormality in the lining of
      their blood vessels, which contributes to the damage.

      Damage and blockage can occur in the blood vessels in the brain and means that children with
      sickle cell disease have a significant risk of suffering from strokes. Research has shown
      that transcranial Doppler ultrasonography can be used in this setting to identify children at
      most risk of getting strokes.

      Ultrasound is therefore used in children with sickle cell disease to measure the blood flow
      in the vessels in the brain. This research has formed the basis of the National Health
      Service (NHS) Standard of Care for Sickle Cell Disease in the United Kingdom (UK) which uses
      transcranial Doppler ultrasonography at once a year to screen children with sickle cell
      disease aged 2 to 16.

      Ultrasound is used because it is portable, does not uses ionising radiation such as x-rays,
      is non-invasive and gives good results. However, the results are dependent on the operator.
      This means that the screening service is provided by centres of excellence with experienced
      scanning staff visiting clinics in smaller hospitals with portable machines. There is a lack
      of research comparing the use of portable machines to laboratory-based machines. This is
      important because screening can identify children at high risk of stroke and may be used by
      clinical staff to make a decision about the care of the child.
    

Detailed description: 
      Please see above
    

Intervention name(s): Ultrasound scan
Intervention type(s): Other
Intervention description(s): Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of a Nursing Intervention in First-time Mothers
Condition: Mothers; First Birth
Study type: Interventional

Summary: 
      Experimental study will determine the efficacy of nursing intervention named Maternal support
      to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory
      design will be used. It is a mixed design with approach quantitative and qualitative in order
      to obtain a better approach of the phenomen. The approach quantitative will be randomized
      controlled clinical trial. The qualitative analysis of the content will be done according to
      Bardin.
    

Detailed description: 
      Taking into account the scientific literature related to studies in first-time mothers with
      healthy newborns, it can be concluded that the limited success of interventions that have
      been made suggests that the main areas of becoming a mother have not been addressed, either
      as part of the content or process of the interventions. This study will be conducted in 24
      months. The sample size calculated will be 74 first-time mothers in total, which are
      allocated in two groups, intervention and control. Each group with 37 mothers.
    

Intervention name(s): Maternal support to become mother; Control Group: usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): "AMACOM-PRI": Apoyo Materno para Convertirse en Madre - Primerizas. Maternal support to become first-time mothers is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of.
Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
Four Educational sessions and support sessions for maternal empowerment in each home visit.
Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum.; This intervention is usual care, which consists of:
care of the mother and her newborn during the puerperium
Teaching about breastfeeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The assigment of the mothers to each group will be like that: The allocation will be generated in the Epidat 4.1 program. This will be done by blocks in groups of equal size, randomized 1: 1, control and intervention group. The generation will be given by an statistician who will not perform the intervention, nor the initial or final evaluations.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nursing Care; Mothers; Research; Support