bioihbjkbjnl/mcl2 huggingface dataset:
The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis
Condition: Osteoarthritis, Knee; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Static imaging has been commonly and clinically accepted to assess the severity of medial
      knee osteoarthritis (KOA), especially the radiography. Gait analysis has been adopted to
      evaluate the kinematic characteristics of the knees in patients with KOA. Most of the current
      studies focus on the sagittal plane of the knee, but very few of them focus on the frontal or
      horizontal plane. With the different severity of medial KOA, anatomical structures of the
      knees will change and influence kinematics of the knees, such as osteophytes and deformity.
      At present, there has been no study focusing on the relations between the imaging assessment
      of the severity and quantitative kinematics of medial KOA. The aim of the study is to explore
      the relationship between the imaging assessment based on the Kellgren-Lawrence Scores and in
      vivo 3D knee kinematic characteristics in Chinese patients with medial KOA during walking
      using a new portal gait system.
    

Detailed description: 
      All patients are assessed according to the Kellgren-Lawrence Score.
    

Intervention name(s): Steps 1; Steps 2
Intervention type(s): Other; Other
Intervention description(s): Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.; Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese patients diagnosed with medial KOA andasymptomatic participants will be recruited.
        The asymptomatic participants（>35 years） have no history of knee pain, trauma, surgery, or
        obvious gait abnormalities.
      
Keywords: knee osteoarthritis; gait; Kellgren-Lawrence Scores
Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets(Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals
      & Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International
      GmbH, Germany) after a single oral dose administration of each to healthy adults under
      fasting conditions
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Prevaglip (linagliptin); Trajenta (linagliptin)
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 5 mg linagliptin; 1 tablet contains 5 mg linagliptin
Other intervention name(s): Prevaglip; Trajenta
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Cardiometabolic HIIT-RT Study
Condition: Metabolic Diseases; Overweight; Motor Activity
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional

Summary: 
      Several studies have shown relationship between exercise intensity and improvement
      cardiometabolic health such as body composition, endothelial function, blood pressure and
      blood lipids. It has been suggested that high intensity interval training and also strength
      or resistance training generate positive effects on metabolic risk factors, nevertheless the
      comparison between both types of training and their combination has not yet provided
      conclusive evidence. Also, it has been shown that dietary restriction has similar or more
      positive effects that exercise alone and the effect is greater when it is combined with
      exercise. For these reasons, it is necessary to clarify which type of training, in
      combination with a dietary restriction, is more effective to improve cardiometabolic health
    

Detailed description: 
      The investigators hypothesized that high intensity interval, resistance training or combined
      training would result in similar improvements in cardiometabolic health as compared to the
      usual clinical care in a cohort of sedentary overweight (age 30-50 years old).
    

Intervention name(s): High Intensity Interval; Resistance training; Plus: High Intensity Interval + Resistance Training; Usual clinical care
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Acute appendicitis is the most common surgical emergency in childhood. Despite access to
      current diagnostic modalities, diagnosis may be challenging since the child may have
      difficulty in articulating symptoms. Additionally there is a high frequency of atypical
      presentation and rapid progression. Delayed diagnosis in children is reported as being up to
      60%. Delayed diagnosis >48hr increases the perforation rate from 21% to 71%. Around 20% of
      children presenting with appendicitis have perforated by the time they come to surgery.

      Appendix perforation is associated with a prolonged hospital stay and increased cost. Once
      perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases
      from 2 to 6 days and hospitalisation costs are estimated at US $33,348.

      Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been
      suggested that only 35% of surgical referrals with possible appendicitis actually need
      surgery thus impacting on resource use.

      A reliable test, especially if painless, would be very useful. If positive the child could
      undergo early appendicectomy in expectation of a reduction in the perforation rate (and,
      therefore, reduction in hospital stay). If negative the child could be discharged home
      safely. No adequate biomarker has been identified.

      Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC
      analysis is already used commercially to identify disease processes in animals and crops.
      Although VOC has been previously used to detect human diseases, it has never been used to
      look for changes in the composition of breath in appendicitis.

      The investigators hypothesise that the composition of VOC's in children with appendicitis
      will differ from those without. The investigators anticipate these differences will be of
      diagnostic and prognostic value in clinical practice. The feasibility of collecting breath
      samples from children with possible appendicitis to allow VOC testing has not been examined.
    


Intervention name(s): Blowing into the mouthpiece
Intervention type(s): Diagnostic Test
Intervention description(s): Blowing into the mouthpiece of diagnostic device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: paediatric
Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores
Condition: Skin Lesion
Study type: Interventional

Summary: 
      Facial pores are visible topographic features of the skin that reflect openings of
      pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many
      patients desire treatment for this condition, which can be an early sign of skin aging.
      Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and
      topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and
      Q-switched Nd-YAG, can potentially be used in treatment of wide pores.

      This study aims at the assessment and comparison of therapy with short pulsed and Q-switched
      Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial
      pores.
    

Detailed description: 
      topical carbon cream will be applied to one side of the face in patients with wide facial
      pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched
      ND-YAG laser.

      fractional CO2 laser will be performed to the other half of the face. the patients will
      receive 2 treatment sessions
    

Intervention name(s): short pulse and Q-switched ND-YAG laser with topical carbon; fractional CO2 laser
Intervention type(s): Device; Device
Intervention description(s): application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face; single pass of fractional CO2 laser on the other side of the face
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Myofascial Release With Isometric Exercises Versus Scapular Stabilization Exercise on Neck Pain in Text Neck
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effects of myofascial release combined with
      isometrics and with scapular stabilization on neck pain, disability and ROM in young adults
      with text neck syndrome
    

Detailed description: 
      Neck pain NP (pain in cervical region) has been a major issue these days related to the
      increased use of smartphones. A posture that has been developed by growing use of technology
      is a posture called the Text Neck, which has become an epidemic to the world. The text neck
      is a posture in which a person keeps their head down (forward head posture) to look at their
      device for long periods of time. There are many medications and techniques used in management
      of neck pain. Myofascial release has been proved to be efficacious for pain in the neck. This
      study is unique in that it examines the effect of myofascial therapy along with isometric
      exercises or scapular stabilization exercises on neck pain, disability, movements and daily
      life activities.
    

Intervention name(s): Myofascial release with isometric exercises; Myofascial release with scapular stabilization exercise
Intervention type(s): Other; Other
Intervention description(s): Patients in group A will receive 40 minutes of combined therapy treatment session including myofascial release of muscles with trigger point release and 5 isometric exercises of neck at alternative 3 days/week for 4 weeks.; Patients in group B will get 40 minutes of myofascial therapy same as the first group combined with scapular stabilization exercise in 5 different positions and this treatment session will be at alternative 3 days/week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: text neck syndrome; pain and disability; isometrics; scapular stabilization; myofascial release
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
Condition: Depression; Depressive Disorder; Depressive Symptoms; Depressive Disorder, Major; Depressive Episode; Depression Severe
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to
      evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in
      patients with Major Depressive Disorder (MDD).
    


Intervention name(s): TNX-601 ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 pill orally once daily for 6 weeks.; Patients will take 1 pill orally once daily for 6 weeks.
Other intervention name(s): Tianeptine
Intervention MeSH terms: Tianeptine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and
      symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with
      active rheumatoid arthritis who currently have an inadequate response to DMARD therapy.
      Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks,
      in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    


Intervention name(s): tocilizumab [RoActemra/Actemra]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8mg/kg iv every 4 weeks for 24 weeks; iv every 4 weeks for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sleep Apnea and Vascular Function
Condition: OSA
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development
      of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but
      given the association between OSA and obesity, adipose-derived hormones (adipokines) are
      likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown
      to be associated with deleterious effects on vascular function resulting in impaired
      endothelial function. This proposal is directed at investigating the molecular mechanisms of
      endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction
      associated with OSA is a result of molecular alterations within endothelial cells. As a part
      of these studies we will look at NO signaling pathways in adipose tissue and microvessels
      from normal and OSA subjects.
    


Intervention name(s): Sleep Study
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions
Condition: Bioavailability, Therapeutical Indication Not Studied
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study will be performed to investigate and to compare the in-vivo performance of
      the two investigational products Gen-nifedipine extended release, (previously referred to as
      Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as
      Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic
      parameters after oral single dose administrations in the fasted and fed state.
    

Detailed description: 
      In the past, several attempts have been made to develop nifedipine formulations with
      pharmacokinetic characteristics similar to the unique characteristics of nifedipine GITS. A
      new extended release nifedipine tablet based on an osmotically active system for once a day
      administration has been registered under the trade name Gen-nifedipine extended release,
      (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) in Canada.

      According to the product monograph of Gen-nifedipine extended release, (previously referred
      to as Gen-Nifedipine XL), this tablet consists of a semipermeable membrane surrounding an
      osmotically active drug core. After contact with water from the GI tract osmotic pressure in
      the core increases, releasing the active drug at a controlled rate through an orifice in the
      tablet membrane. The functional principle of this nifedipine tablet seems to be quite similar
      to the one of the GITS system.

      However, especially in case of modified release formulations, various factors can affect the
      absorption and the systemic availability of the drug. Two important factors are i) the drug
      release rate from the dosage form and ii) the gastrointestinal transit rate, which in turn
      has an influence on the site of absorption. Especially food intake and the caloric content of
      a meal can affect drug transit time, luminal dissolution and drug permeability. Thus, the
      prandial state may have a significant impact on the in vivo behaviour of such formulations as
      a whole and particularly on the drug bioavailability.

      For GITS formulations, such as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS, earlier
      studies have demonstrated that no significant influence of concomitant food-intake occurs.
    

Intervention name(s): Nifedipine (Gen-nifedipine extended release, previously referred to as Gen-Nifedipine XL); Nifedipine (Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS)
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg nifedipine; 60 mg nifedipine
Other intervention name(s): Nifedipine 60 mg, GITS
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy; Bioavailability; Nifedipine
Comparing Ticagrelor Versus Clopidogrel on Microcirculation
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes,
      a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing
      ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary
      syndrome patients on ASA background, have demonstrated superiority of ticagrelor over
      clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the
      mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine
      mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation.
      Several experimental and clinical studies support the hypothesis that adenosine could reduce
      cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor
      enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there
      are no available data on coronary circulation effects after chronic treatment of ticagrelor
      in patients with ACS who have altered resting coronary blood flow dynamics due to advanced
      coronary artery disease.
    

Detailed description: 
      This study is a prospective, randomized, open-label, active controlled study with two
      parallel study groups.

      For inclusion in the study subjects should fulfill the following criteria:

        1. Provision of informed consent prior to any study specific procedures

        2. Female or male aged 20-85 years

        3. All patients with ACS scheduled for PCI will be eligible, assuming their ability to
           understand the character and individual consequences of participation as well as giving
           written informed consent.

        4. Be able to understand and comply with the requirements of the study, as judged by the
           investigator.

      To investigate the effects of ticagrelor on coronary microcirculation, IMR will be measured
      twice, 6 months apart in the same lesion, compared with clopidogrel.

      The IMR is defined as simultaneously measured distal coronary pressure divided by the inverse
      of the thermodilution-derived hyperaemic mean transit time (Tmn), or more simply, distal
      coronary pressure multiplied by the Tmn.
    

Intervention name(s): Ticagrelor; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): 90mg, twice a day; 75mg, once a day
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trauma Informed Prevention for Substance Use and Risky Sex
Condition: Substance Use; HIV/AIDS
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the usefulness of the TIPS iPad app in the
      treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy
      (TF-CBT).
    

Detailed description: 
      The primary goal of this study is to conduct a feasibility test of the delivery of the TIPS
      app during implementation of TF-CBT in comparison to TF-CBT as it is usually administered, as
      well as feasibility of methods that would be utilized in a larger scale evaluation of the
      toolkit. Clients will be randomly assigned to one of the two conditions, TF-CBT plus the TIPS
      app or TF-CBT as usual. Study duration is six months and includes four total assessments,
      which will be completed by hand. These assessments will occur over the 12-16 weeks of TF-CBT
      that clients would receive whether they choose to participate in the study or not.
      Participation in this study may broaden your child's treatment to target prevention of risk
      behaviors, but that cannot be guaranteed.
    

Intervention name(s): TIPS app; Trauma Focused-Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Psycho-educational electronic application; Effective form of trauma therapy for adolescents
Other intervention name(s): TF-CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Traumatic stress; substance use prevention; HIV prevention; adolescents