bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
Condition: Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in
      the treatment of long (≥80 mm) femoropopliteal artery lesions.

      Study design :

        -  Prospective, randomized, multi-center study

        -  A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who
           meet all inclusion and exclusion criteria will be included.

        -  Patients will be randomized in a two by two factorial manner according to the strategy
           of stenting (long versus short stenting) and the additional use of cilostazol. Each
           randomization of the enrolled subjects will be done 1:1.

        -  Patients will be followed clinically for 1 year after the procedure.

        -  Angiographic or CT follow-up will be performed at 1 year.
    


Intervention name(s): Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long; short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.; Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look into how a base dose of insulin peglispro and insulin glargine will
      affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.
    


Intervention name(s): Insulin Peglispro; Insulin Lispro; Insulin Glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring
Condition: Technology
Study type: Observational

Summary: 
      Evaluation of a novel smartphone application designed to estimate blood pressure
      (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical
      signals on patient's finger treated in the emergency department against the reference method
      (the oscillometric brachial cuff )
    

Detailed description: 
      The purpose of the study is to compare the blood pressure values measured by a novel
      smartphone application ( camera of the smartphone will be obstructed by the patient's right
      index) and the values measured by reference method used (the oscillometric brachial cuff).

      All patients admitted to the emergency department at Erasme Hospital Brussels, Belgium during
      5 consecutive weeks will be recruited and their pressure will be measured with both
      mesurement methods. (novel smartphone application versus upper arm cuff oscillometry).

      The OptiBP Application is a mobile application installed on a smartphone which is a
      non-invasive data-logger intended to acquire physiological data from patients. By applying
      the patient's finger on a smartphone's camera, a movie is generated and transformed into
      values of diastolic, mean and systolic blood pressure (+ heart rate), as well as patient's
      heart rate.

      After having compared that the blood pressure in both arms are similar ( maximum of 10 mmHg
      of blood pressure difference between both arms), three measures will be taken (spaced by one
      minute) with both methods after a period of 3 minutes of rest (supine position).

      The patient's blood pressure will be measured in parallel with the mobile application and
      with the reference equipment (the oscillometric brachial cuff).

      Then, the values obtained by the two methods will be compared to confirm the reliability of
      the data obtained with the novel mobile application.

      The goal is therefore to compare blood pressure values as obtained by the analysis of the
      data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by
      the oscillometric brachial cuff
    

Intervention name(s): novel mobile phone application for blood pressure monitoring.
Intervention type(s): Device
Intervention description(s): Comparative blood pressure measurement with the smartphone application and the non-invasive reference method (upper arm cuff).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the Emergency department at Erasme hospital during one month (October
        7 th until November 7 th 2019)
A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This was a US-based, observational cross-sectional study with primary data collection via
      questionnaires directly administered to patients with MS receiving KESIMPTA and care partners
      of patients with MS (formal or informal)receiving KESIMPTA.
    

Detailed description: 
      The study aimed to enroll ninety-four (94) patients/care partners. The time period for
      enrollment was dependent on the uptake of KESIMPTA in the real-world.

      Data collected for the study was obtained directly from the patient/care partner within the
      web-based database: De-identified data was stored on a secure server and transferred for
      analysis. Responses from the patient and care partner surveys were pooled for analysis of
      study endpoints.
    

Intervention name(s): Kesimpta
Intervention type(s): Other
Intervention description(s): There was no treatment allocation. Patients administered Kesimpta by prescription that started before inclusion of the patient into the study were enrolled.
Other intervention name(s): ofatumumab
Intervention MeSH terms: Ofatumumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        To ensure a representative sample of patients with MS, the patient study population will
        include patients who are new to the use of injectable treatments for MS, as well as those
        with use of other injectable MS treatments prior to initiation of KESIMPTA using the
        Sensoready® pen.

        Patients care partner (formal or informal) may also be eligible for study participation.
      
Keywords: Multiple Sclerosis; MS; NIS; KESIMPTA; ofatumumab
Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device
Condition: COPD
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the systemic availability to CHF 6001 after a single
      dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose
      capsule inhaler Aerolizer®.

      CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary
      disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an
      inhaler device. Previous studies were conducted using a single-dose capsule inhaler
      (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device
      will be used.
    

Detailed description: 
      This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in
      1 single european site. The main scope of the study is to compare the systemic availability
      to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir
      NEXThaler® device or the single-dose capsule Aerolizer® device.
    

Intervention name(s): CHF 6001 dry powder for inhalation via NEXThaler®; CHF 6001 DPI capsules for inhalation via Aerolizer
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: systemic availability , pharmacokinetics, COPD
The Effects of Low- and High-intensity Resistance Exercise on Force-velocity Characteristics in Older Adults
Condition: Effects of Strength Training in Older Adults
Study type: Interventional

Summary: 
      The purpose of this study is to compare the impact of high- and low-intensity resistance
      exercise on force-velocity characteristics, muscle mass and inflammatory processes in older
      adults. As all training protocols are designed to end with maximal effort, effects are
      expected to be similar between groups.
    


Intervention name(s): Strength training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Effect of 12 Weeks of Resistive Exercises Versus Aerobic Exercises in Overweight Hypertensive Postmenopausal Women
Condition: Exercise
Study type: Interventional

Summary: 
      Sixty postmenopausal women participated in this study from gynecological outpatient clinic,
      at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to
      be hypertensive in their early postmenopausal period .Their blood pressure ranged between
      140/90mmHg to 170/105mmHg, their ages ranged from 50 to 60 years and their body mass index
      ranged from 30:35 kg/m2.
    

Detailed description: 
      The participants were divided randomly according to closed envelop into three equal groups in
      number: Group A (RE) consisted of twenty women who participated in the resistive exercise
      program. Group B (AE) group: consisted of twenty women who participated in an aerobic
      exercise program. All patients in both groups (A & B) participated in the exercises three
      times per week for twelve weeks and every session lasted for 45 min and continues their
      antihypertensive medication
    

Intervention name(s): resistive exercise; aerobic exercise in form of treadmill walking
Intervention type(s): Device; Device
Intervention description(s): resistive exercise by elastic band for 12 weeks; aerobic exercise in form of treadmill walking for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: resistive exercises; aerobic; Menopause; hypertension
Outcomes of Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequelea in Children With Spina Bifida
Condition: Stem Cell Infusion
MeSH terms: Spinal Dysraphism
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to evaluate the safety and efficacy of autologous bone marrow
      mononuclear cell infusion in the management of neurological sequelae in children with spina
      bifida
    

Detailed description: 
      The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow
      mononuclear cells in 11 patients with spina bifida at Vinmec Research Institute of Stem Cell
      and Gene Technology in Hanoi, Vietnam from 2016 to 2020
    

Intervention name(s): Autologous bone marrow mononuclear cell transplantation
Intervention type(s): Combination Product
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spina bifida; mononuclear cell; neurologic sequelea
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate
      in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in
      patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
    


Intervention name(s): Lumateperone (ITI-007); Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)
Condition: Diabetes Mellitus, Type 2; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes
      Mellitus and Metabolic Syndrome.

      This is an early phase trial and some specific protocol information is in progress and not
      publicly available at this time. (Full information is available to trial participants).
    


Intervention name(s): MK0916
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Human Perception on Medical Extended Reality Devices
Condition: Healthy
Study type: Interventional

Summary: 
      The proposed research will collect participant's responses that respond to questions about
      visibility of certain signals on an immersive mixed reality environment. These responses will
      be used to assess Head Mounted Display (HMD) quality and task performance. Other collected
      data may be included such as response time and eye movements.

      Responses will be collected via an FDA application designed to work with a wide range of HMDs
      and able to display both 2D simple scenes and 3D complete scenes. This application allows a
      human observer to look at a signal (sinusoidal, disk, sphere, etc.) on a synthetic noisy
      background or a realistic 3D scene both in virtual reality and augmented reality immersive
      environments. The application will also provide instructions and a response interface for the
      observer to respond to questions related to the visibility and to gather task performance
      measurements.

      Participants will not be asked to complete tasks that require specific training or skills.
      Any adult human with normal or corrected-to-normal vision that can wear an HMD is eligible to
      participate in this experiment.

      Data collected will not include identifiable information. FDA will perform participant
      enrollment and data collection, ensuring management of PII in accordance with federal rule.
      Participants will be recruited at will and in person, using promotional materials only
      containing language within this document. Participants will sign the attached consent form
      either electronically or by hard copy.
    


Intervention name(s): Visual stimuli
Intervention type(s): Behavioral
Intervention description(s): Stimuli will be shown to participants and they will be asked to perform a visual task.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep
Condition: Dental Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study was to evaluate over eighteen months the clinical bonding failure and
      survival rates of the conventional bonding technique using the Transbond XT (3M Unitek,
      Monrovia, California, USA) and the RMGIC Fuji Ortho LC (GC Corporation, Tokyo, Japan)
      prepared with the V-prep. Therefore, one operator using the straight-wire technique bonded
      two hundred metallic brackets to upper and lower premolars of twenty-five patients requiring
      an orthodontic treatment. The randomized trial was a single-blind design in a split-mouth
      comparison. Each patient was randomly allocated one of the two bonding systems for each
      premolar on each side of the mouth. The bonding and rebonding techniques were standardized
      throughout the trial and bond failure was recorded each month for a period of eighteen
      months.
    


Intervention name(s): v-prep combined with RMGIC for bracket bonding; Conventional bracket bonding technique
Intervention type(s): Combination Product; Combination Product
Intervention description(s): prepare the tooth surface with the V-prep, then bond a bracket with the RMGIC; prepare the tooth with acid-etch, then bond a bracket using resin composite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: resin-modified glass ionomer; surface preparation; orthodontic bracket
The Effectiveness of Using Bougie or Cooled Nasogastric Tube to Facilitate Nasotracheal Intubation
Condition: Intubation Complication
Study type: Interventional

Summary: 
      either uses a bougie or nasogastric tube to assist the nasotracheal tube passing the nasal
      cavity, nasopharynx, oropharynx and advanced into the trachea
    

Detailed description: 
      In oro-maxillo-facial surgery, it is a common practice for patients receiving general
      anesthesia with nasotracheal intubation to widen the surgical field and to ease undergoing
      surgery. However, a nasotracheal tube blindly passing through the nasal cavity may easily
      result in nasal cavity and oropharynx damages. In addition, the advancement of the tube from
      oropharynx into trachea may assist by either using magic forceps or cuff inflation technique.

      The aim of the study is to investigate either use a bougie or nasogastric tube to assist the
      nasotracheal tube passing the nasal cavity, nasopharynx, oropharynx, and advanced into the
      trachea.

      Patients were randomized into three groups by using either bougie or nasogastric tube to
      facilitate nasotracheal tube sliding through into trachea from assigned nostril and compared
      with the control group with a conventional technique.

      Hemodynamic changes in each time interval, each time taken of tube going through the nasal
      cavity, tube advanced from oropharynx into trachea were recorded. The incidence of using
      Magill Forceps to accurately place tube tip into trachea, intubation related side effects and
      complications were recorded at postoperative time stages.
    

Intervention name(s): bougie; Nasogastric(NG) tube
Intervention type(s): Device; Device
Intervention description(s): The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.; The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: bougie or nasogastric tube
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: bougie, nasotracheal tube; Endotracheal Tube intubation General Anesthesia (ETGA)
Inpatient Alcohol Detox & Psychotherapy
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The aim of the study is to evaluate effectiveness of inpatient detoxification and
      psycho-therapeutic support, measured in terms of readiness to change and abstinence
      maintenance. The study participants will be the patients admitted for alcohol use disorder
      (age: 18 years above) at a tertiary level hospital in Kathmandu. Baseline assessments on
      readiness to change will be done during admission, and compared prior to and after discharge.
      Percentage of participants maintaining abstinence in 3 months after discharge will be another
      outcome to be analysed.
    


Intervention name(s): Detoxification & psychotherapeutic support
Intervention type(s): Behavioral
Intervention MeSH terms: Psychotropic Drugs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension
Condition: Oxygen Saturation
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Controlled hypotension is a preferred method for reducing surgical bleeding during
      septoplasty operations however, the level of hypotension and bradycardia should not disrupt
      cerebral oxygenation. On this account, the investigators aim to investigate the effects of
      different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation
      during controlled hypotension using near infrared spectroscopy.
    


Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane %2-3 for general anesthesia maintenance; Desflurane %6-8 for general anesthesia maintenance
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients
Condition: Median Nerve Entrapment
MeSH terms: Arthritis; Arthritis, Rheumatoid; Carpal Tunnel Syndrome; Nerve Compression Syndromes; Median Neuropathy
Study type: Observational [Patient Registry]

Summary: 
      In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made
      based on clinical findings and physical examinations. Then, the cross-sectional areas of the
      participants' median nerves from different levels were measured. Meidolateral and
      anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening
      ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated.
      The obtained data were compared between RA with CTS, RA without CTS and healthy control.
    


Intervention name(s): Ultarsound
Intervention type(s): Diagnostic Test
Intervention description(s): Median nerve evaluation of participants with ultrasound
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        RA patients identified according to the 2010 American College of Rheumatology/Europan Leage
        Against Rheumatism classification criteria healthy controls (HC) with no history of
        rheumatic diseases and CTS.
      
Keywords: Rheumatoid arthritis; Ultrasound; Carpal Tunnel Syndrome