bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Talus Fractures: a Retrospective Study
Condition: Talus Fracture
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      The main purpose of this retrospective case series study was to evaluate long-term
      radiographic and clinical outcomes of a consecutive series of patients with diagnosis of
      isolated, displaced, closed talar neck or body fractures treated by open reduction and
      internal fixation. Secondly, it was aimed to verify the influence of the location of talar
      fractures on the outcomes, the prognostic value of the Hawkins sign, whether operative delays
      promote avascular necrosis (AVN) and if the fractures require emergent surgical management.
    

Detailed description: 
      From January 2007 to December 2012, 31 patients underwent ORIF by screws at our institution.
      On the basis of Inokuchi criteria, the injuries were divided between neck and body fractures,
      which were classified according to Hawkins and Sneppen, respectively. The patients included
      were divided into two groups in relation to fracture location and complexity. Radiographic
      assessment focused on reduction quality, bone healing, Hawkins sign and osteoarthritis
      development. For clinical evaluation, clinical-functional scores (AOFAS Ankle-Hindfoot Score;
      MFS; FFI-17; SF-36) and VAS were determined, and statistical analysis was performed.
    

Intervention name(s): open reduction and internal fixation (ORIF).
Intervention type(s): Procedure
Intervention description(s): Depending on the fracture location, a single anteromedial or anterolateral approach was carried out. The fracture site was cleaned to make it visible, allowing anatomical reduction. Subsequently, fixation of provisional fragments was achieved using temporary Kirschner wires under radiographic guidance. Having obtained satisfactory reduction as seen with the radiographic intensifier, definitive fixation of the main bone fragments was carried out using two or more 3.5 mm titanium cannulated screws or 4.0 mm lag screws, placed anteriorly to posteriorly. Fractures complicated by severe comminution necessitated 3.5 mm cortical screws in order to avoid shortening, translation or angulation of the fragments.
Other intervention name(s): ORIF
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        There were 19 men (1 bilateral case for a total of 20 fractures, 71.4%) and 8 women
        (29.6%). Overall, mean age at the time of injury was 38.3 years old (range 18-81)
      
Keywords: talar fractures; talar neck fractures;; talar body fractures;; talus;; ORIF;; screw fixation.
A Study to Assess the Effect of Multiple Doses of Gemfribozil on a Single Dose of ASP3652, and to Assess the Effects of Multiple Doses of ASP3652 on a Single Dose of Repaglinide in the Body of Healthy Subjects
Condition: Drug-Drug Interaction (DDI); Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a
      two-part study to investigate the drug-drug potential of ASP3652.

      Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of
      ASP3652.

      Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of
      repaglinide.

      Subjects participating in one part of the study may not participate in the other part.
    

Detailed description: 
      Part 1:

      On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid
      (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On
      Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered
      one hour after the morning dose of gemfibrozil.

      Part 2:

      On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days,
      bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the
      5th day of ASP3652 administration), a single dose of repaglinide is administered one hour
      after the morning dose of ASP3652.
    

Intervention name(s): ASP3652; Gemfibrozil; Repaglinide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Intervention MeSH terms: Repaglinide; Gemfibrozil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; ASP3652; Gemfibrozil; Repaglinide; Pharmacokinetics
Effects of Yoga Exercise on Participates With Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational

Summary: 
      This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep
      quality in humans. We selected adult participates with chronic tinnitus (>6 months). All
      participates performed Yoga exercise once per week at outpatient department under the
      guidance of a professional teacher, and performed once daily by themselves at home for 12
      weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were
      measured before the start of this study, at the end of this study, and 1 month after the end
      of this study.
    

Detailed description: 
      Tinnitus is the auditory phantom sensation in the absence of external sound stimulation.
      Tinnitus that persisted more than six months without improvement can be called chronic
      tinnitus. One report proposed the neurophysiological model of tinnitus. In addition, tinnitus
      patients suffered from insomnia, irritability, anxiety and/or depression.

      Current management of tinnitus is a drug-based treatment and/or nutritional supplementation.
      Music therapy, hearing aid therapy, and tinnitus retraining therapy (TRT), were also applied
      for patients with tinnitus. Even though, success rates of various tinnitus treatments were
      still unsatisfactory till now.

      This study aimed to investigate the effectiveness of Yoga on the tinnitus handicap and sleep
      quality in humans. We selected adult participates with chronic tinnitus (>6 months). All
      participates performed Yoga exercise once per week at outpatient department under the
      guidance of a professional teacher, and performed once daily by themselves at home for 12
      weeks. Questionnaires of Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index were
      measured before the start of this study, at the end of this study, and 1 month after the end
      of this study.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): Yoga stretch warm-up exercise for 15 minutes.
Five kinds of yoga correction method for 30 minutes (abdominal breathing, throat breathing, wind box breathing, nasal alternating breathing, buzzing breathing).
Great rest for 15 minutes
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Tinnitus participates.
      
Keywords: Yoga; Tinnitus; Sleep
A Phase IV Study of Huazhi Rougan Granule
Condition: A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional
Phase: Phase 4

Summary: 
      A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the
      efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty
      liver (damp-heat obstruction syndrome: Shi-Re-Zhong-Zu Zheng)
    


Intervention name(s): Huazhi Rougan Granule Placebo granule
Intervention type(s): Drug
Intervention description(s): Experimental: Huazhi Rougan granule Placebo Comparator: Placebo granule Placebo Comparator: Placebo granule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers in this study want to learn how the study drug BAY1817080 interacts with another
      drug called rosuvastatin (brand name: Crestor) and affects the way the body absorbs,
      distributes and excretes rosuvastatin in healthy adult male and female participants
      (drug-drug interaction study). The study drug BAY1817080 is a new drug under development with
      a goal to suppress pain and chronic cough. It works by binding to and blocking proteins
      related to pain in the body. Rosuvastatin is an approved and marketed drug to lower high
      levels of "bad" cholesterol (a waxy, fat-like substance found in blood). Both drugs interact
      with the same proteins (molecules) in the human body, and as a result, the study drug may
      affect the way rosuvastatin is taken up and used by the body when applied together.

      Participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4
      weeks. Each participant will receive rosuvastatin tablets twice with at least 11 days in
      between and the study drug tablets twice daily for 14 days. Blood samples will be taken from
      the participants to measure the blood levels of rosuvastatin.
    

Detailed description: 
      The primary objective of the study is to investigate the influence of multiple doses of
      BAY1817080 on the pharmacokinetics of rosuvastatin given concomitantly. Secondary objective
      is to investigate the safety of BAY1817080.
    

Intervention name(s): Rosuvastatin; Rosuvastatin + BAY1817080
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).; A single dose of 5 mg rosuvastatin tablets is administered on Day 8 of Period 2 (total length = 15 days). BAY1817080 is administered as tablets twice daily on Days 1 to 14 of Period 2.
Other intervention name(s): Crestor®; P2X3 receptor antagonist;; Crestor®
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: P2X3 receptor antagonist; Rosuvastatin; Organic Anion Transporting Polypeptide 1B1 (OATP1B1); Organic Anion Transporting Polypeptide 1B3 (OATP1B3); Breast Cancer Resistance Protein (BCRP); Pain; Chronic cough; Cholesterol
Efficacy of Low Dose Levothyroxine During Pregnancy
Condition: Euthyroid Females
Study type: Interventional
Phase: Phase 3

Summary: 
      the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5
      mU/L in the first trimester on pregnancy outcome
    

Detailed description: 
      the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and
      compare it with others receiving placebo
    

Intervention name(s): levothyroxin
Intervention type(s): Drug
Intervention description(s): 90 female received levothroxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long Acting Insulin Glargine Titration Web Tool (LTHome) vs Enhanced Usual Therapy of Glargine Titration
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Evaluating patients with type 2 diabetes either starting once daily basal insulin or
      requiring increased basal titrations in order to compare the LTHome web based tool with the
      usual standard of practice for insulin glargine dosing adjustment.
    

Detailed description: 
      INNOVATE is a 12 week, parallel, open-label, randomized, multi-center study evaluating use,
      safety and effectiveness of a web based tool (LTHome) vs. enhanced usual therapy (EUT) of
      glargine titration in T2DM patients.

      The primary objective of this study is to compare the effectiveness LTHome versus EUT of
      glargine titration in people with T2DM patients on basal insulin not meeting local targets or
      patients requiring basal initiation. Success will be measured by the percentage of subjects
      reaching Canadian Diabetes Association (CDA) guideline targets.

      The efficacy objective is to demonstrate that the percentage (%) of subjects to reach FPG
      target by titration of insulin glargine using the LTHome tool with dose adjustment advice is
      not inferior to the % of subjects to reach FPG target using Enhanced Usual Therapy glargine
      titration during study participation (LTHome vs. EUT treatments).

      The secondary objectives of this study are to assess safety, effectiveness, satisfaction and
      adherence of LTHome use versus Enhanced Usual Therapy glargine titration.
    

Intervention name(s): Long-acting insulin glargine titration web tool (LTHome); Diabetes Education
Intervention type(s): Other; Other
Intervention description(s): The LTHome study arm will receive insulin glargine titration instructions from the LTHome web-based tool; Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.
Intervention MeSH terms: Insulin Glargine; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; T2DM
Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, non-randomised study to assess the mass balance
      recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-orvepitant in
      healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single
      dose of 30 mg [14C] orvepitant containing not more than (NMT) 3.7 megabecquerel (MBq) [14C],
      administered as an oral solution in the fasted state. Subjects will be admitted in the
      evening on the day prior to [14C]-orvepitant administration and will be dosed in the morning
      following an overnight fast. It is planned that subjects will remain resident in the clinical
      unit until 168 hours post-dose (Day 8) when they will be discharged from the clinical unit.
      Through the resident period samples (blood, urine, faeces) will be collected and analysed for
      mass balance, total radioactivity, orvepitant levels. Metabolite profiling and ID will also
      be performed.
    


Intervention name(s): [14C]-orvepitant
Intervention type(s): Drug
Intervention description(s): Oral solution of [14C]-orvepitant
Other intervention name(s): orvepitant
Intervention model: Single Group Assignment
Intervention model description: Open label, single dose
Masking: None (Open Label)
Primary purpose: Other
Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department
Condition: Behavior, Child; Anxiety
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if a virtual reality (VR) distraction game played
      prior to procedural sedation for long bone fracture reduction will improve post-discharge
      negative behavior changes following discharge from the pediatric Emergency Department (ED).
    

Detailed description: 
      This randomized control trial will investigate the use of a virtual reality (VR) distraction
      game prior to IV ketamine procedural sedation for long bone fracture reduction. Prior studies
      have demonstrated that children undergoing anesthesia or procedural sedation can have
      lingering negative behavioral changes lasting several weeks after discharge home. Children
      who are anxious have higher rates of developing negative behavior changes. Opiate pain
      control and pre-operative instructional workshops have demonstrated efficacy in decreasing
      negative behavior outcomes. There is some evidence that distraction techniques, such as VR,
      can alleviate pre-procedural anxiety and pain during procedures. To our knowledge, evaluating
      the use of a non-pharmacologic, virtual reality intervention and its effects on reducing
      post-discharge negative behavior changes following discharge from the Emergency Department
      has not been evaluated.
    

Intervention name(s): Virtual Reality Game
Intervention type(s): Other
Intervention description(s): The virtual reality headset, device, and software, created by Stanford's Childhood Anxiety Reduction through Innovation and Technology (CHARIOT)program/Weightless Studio, LLC will be utilized in this study. Children in the VR intervention group will be allowed to select a distraction-based game to play with active VR content featuring interactive avatars and interactive experiences tailored to the pediatric population that allow players to do things such as control penguins sliding down a mountain while collecting pebbles for points, control puppies running in space to collect treats to the rhythm of music, and control an asteroid miner exploring an asteroid belt and collecting points based on color of asteroids collected. The game will last a minimum of 5 minutes in duration, provided participant tolerance. The participant may play longer if desired prior to receiving procedural sedation and the total length of activity played will be documented.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Virtual Reality; Procedural Sedation; Modified Yale Preoperative Anxiety Scale; Post-Hospitalization Behavior Questionnaire; Pediatric; Emergency Department; Ketamine
Biosimilarity Study of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA).
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparative randomized, single dose, parallel, triple-blinded study in infertile females to
      evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin (HCG) after
      Parenteral administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO
      PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter
      Pharmaceutical Solutions for Organon, USA)
    

Detailed description: 
      In this study, the biosimilarity of Human chorionic gonadotropin (HCG) from Epifasi IM
      Injection (EIPICO Pharma Egypt) and Pregnyl IM Injection (Baxter Pharmaceutical Solutions for
      Organon, USA) after a single IM dose administration of each to healthy adult will be
      investigated to determining the study variables: Ovarian Ultrasonic counting mature grafian
      follicles, Number of retrieved oocytes and their grades.
    

Intervention name(s): Epifasi: Human chorionic gonadotrophin; Pregnyl: Human chorionic gonadotrophin
Intervention type(s): Drug; Drug
Intervention description(s): IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin; IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
Other intervention name(s): Epifasi; Pregnyl
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Adjunctive Metformin Therapy in Double Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The significance of this project is to investigate the effects of adjunctive metformin
      therapy in children and adolescents with double diabetes. Double diabetes describes a
      clinical state where an individual possesses features of both type 1 and type 2 diabetes.
      There is a paucity of data on the role of adjunctive metformin therapy in children and
      adolescents with double diabetes. To help fill this knowledge gap, the investigators propose
      a randomized, double-blind, placebo-controlled trial of metformin in double diabetes.
      Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in
      patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or
      metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated
      autoantibodies. This will help determine the safety profile, and efficacy of adjunctive
      metformin therapy in these subjects.
    

Detailed description: 
      In this 12-month clinical trial, a 3-month run-in period will precede the interventional
      phase of the study. All patients will be placed on treat-to-target insulin regimen alone
      during the run-in phase. At the end of the 3-month run-in period, all participants will
      continue on treat-to-target insulin regimen, and will then be randomized to either of the 2
      arms of the study: an experimental arm, consisting of treat-to-target insulin regimen plus
      metformin, and a control arm consisting of treat-to-target insulin regimen plus placebo. Both
      the physicians and patients will be blinded to the oral agents being administered to
      patients.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 1000 mg once daily by mouth for 9 months; 2 capsules once daily by mouth for 9 months
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Double Diabetes; Type 1 diabetes; Type 2 diabetes; Obesity; Acanthosis nigricans; Diabetes associated autoantibodies