bioihbjkbjnl/mcl2 huggingface dataset:
Single Portable Pulse-dose-conserving Device vs. Combined Use of Stationary and Portable.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Introduction: Portable oxygen devices simplify and facilitate patient therapy. This study was
      designed to compare oxygen saturation and patient satisfaction with a portable oxygen
      concentrator or with a combined system consisting of a fixed device with continuous flow
      oxygen dispensation and a portable device with pulse dispensation for ambulation.

      Methods: This cross-over trial assessed 25 patients with COPD (92% men; mean age 72.2 ± 7.4
      years; mean FEV 34.14 ± 12.51%) at four hospitals in Madrid. All patients had previously used
      the combined system, consisting of a fixed oxygenation system and a portable system for
      ambulation, with 16 (64%) using stationary and portable concentrators and 9 (36%) using a
      stationary reservoir and portable liquid oxygen bag. Oxygenation settings at rest and while
      walking were determined at baseline. Patients were maintained on the previous combined system
      for one week and then switched to the portable oxygen concentrator for one week. Mean SpO2
      over 24 hours was calculated by the software in the oximeter, and compliance was monitored
    


Intervention name(s): Inogen; Combination system of a portable and a stationary device.
Intervention type(s): Device; Device
Intervention description(s): single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours; Combination system of a portable and a stationary device (reservoir of liquid oxygen "Liberator 30, Caire" and a liquid Stroller oxygen pack "Caire" for patients using previously liquid oxygen, or a VisionAire5 "Airsep" stationary concentrator and an Inogen One G2 portable "Inogen" concentrator for patients using previously concentrators)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD, portable concentrator, oxygen sources
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to examine the effect of daridorexant on the way the body absorbs, distributes, and
      gets rid of dabigatran and rosuvastatin in healthy male subjects
    


Intervention name(s): Dabigatran etexilate; Rosuvastatin; Daridorexant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On Day 1 (Treatment A1) and on Day 9 (Treatment C1) a single oral dose of 75 mg dabigatran etexilate will be administered under fasted conditions.; On Day 3 (Treatment A2) and on Day 11 (Treatment C2) a single oral dose of 10 mg rosuvastatin will be administered under fasted conditions.; On Day 7 and Day 8 (Treatment B), on Day 9 and Day 10 (Treatment C1), and on Day 11 through 14 (Treatment C2) subjects will receive 50 mg daridorexant o.d. under fasted conditions.
Intervention MeSH terms: Dabigatran; Rosuvastatin Calcium
Intervention model: Sequential Assignment
Intervention model description: Three-period, fixed-sequence design
Masking: None (Open Label)
Primary purpose: Other
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12
      healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics
      (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will
      be evaluated after a single oral dose of ceftibuten/VNRX-7145.
    


Intervention name(s): VNRX-7145; Ceftibuten
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Intervention MeSH terms: Ceftibuten
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial
Condition: Intrauterine Growth Restriction
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 4

Summary: 
      Will follow up umblical artery Doppler indices for pregnancies with iugr taking placebo and
      oral isosorbide mononitrate to study its efficacy on the intrauterine growth restricted
      fetuses
    

Detailed description: 
      Patients meeting these criteria are to be randomized into one of the following two groups:

        -  Group A (n=23): The Isosorbide Mononitrate group: will receive (IMDUR®, 30 mg, tablet,
           AstraZeneca, Egypt) (Isosorbide-5-mononitrate Biphasic) twice daily for 4-6 weeks
           (according to xPharm: The Comprehensive Pharmacology Reference, 2007, Pages 1-4).

        -  Group B (n=23): The placebo group will receive (Osteocare®, tab, VITABIOTICS, Egypt)
           twice daily for 4-6 weeks Justification: Using PASS 11 program for sample size
           calculation, setting power at 80% and alpha error at 0.05 and according to "Trapani et
           al., 2015", the expected change in UTA-PI in isosorbide mononitrate group=21% compared
           to no change in placebo group. Sample size of 23 women per group will be needed to
           detect difference between two groups.

      The study is to be double-blinded, where neither the researcher, nor the participants will
      know what type of medication each participant will receive, as a nurse will give each patient
      a closed envelope containing 21 tablets of one of the above two medications in a randomized
      fashion.
    

Intervention name(s): Isosorbid mononitrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Imdur tablets were given twice daily for 4 weeks; Placebo tablets were given twice daily for 4 weeks
Other intervention name(s): Isosorbide -5- mononitrate biphasic; Imdur
Intervention MeSH terms: Isosorbide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Blepharospasm Patient Survey for Patients With Blepharospasm
Condition: Blepharospasm
MeSH terms: Blepharospasm
Study type: Observational

Summary: 
      The purpose of this survey is to collect detailed information on patients treated for
      blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including
      how often they are treated with botulinum toxin, how long their treatment lasts, how
      satisfied they are with their treatment, and if there is any improvement in their symptoms
      with the treatment.
    

Detailed description: 
      This study is open to males and females > 18 years and < 81 years with a clinical diagnosis
      of blepharospasm.
    

Intervention name(s): No intervention- only one time survey
Intervention type(s): Other
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or
        onabotulinumtoxinA treatment.
Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP)
      therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps
      and continuous glucose monitoring systems in Germany.
    

Detailed description: 
      The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump
      (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin
      pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the
      aim is of this registry is to support:

        -  obtain reimbursement for SAP therapy in Germany

        -  building a platform (advisory committee) for discussion of SAP data.

        -  looking for deficits with implementation of glucose sensor data in diabetes therapy
           management and development of "follow-up education" materials.

      This is a national multi-center, post-market non-interventional prospective study with CE
      marked and commercially available devices and consumables.

      The study will be conducted from March 2012 to April 2013 in Germany. The duration of
      individual patient participation is 3 to 6 months.

      Health outcomes will be measured in approximately 75 patients between 6-65 years old
      diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The
      patients are under treatment of Paradigm VEO® without any additional insulin injections and
      use continuous glucose monitoring, or patients that are not using continuous glucose
      monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit
      inquiring the status data (including upload of device data in CareLink software, Hemoglobin
      A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is
      optimized based on individual continuous glucose monitoring (CGM) data during a second visit
      one month later and then a last visit like the first visit in which the status will be
      determined.

      Parameters of glycemic control will be measured, such as the frequency of hypoglycemia
      (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit
      1) and after the visit 2 when an adjustment of the therapy has been discussed with the
      patient based on the collected CGM results between the two first visits.
    

Intervention name(s): sensor augmented pump (SAP)
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diabetes mellitus, type 1
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Exercise therapy is effective in improving pain experience and disability in patients with
      non-specific low back pain (NSLBP) and movement/postural control impairments. However,
      patients often find traditional exercises monotonous and discontinue their execution.
      Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but
      evidence is currently lacking on their effects on movement/postural control. In a pilot
      randomised controlled trial (RCT) on a population of patients with NSLBP and movement control
      impairment, treatment with physiotherapy and home exercise supported by AF is compared to
      traditional physiotherapy and home exercise treatment without AF (control group). The primary
      outcomes are defined as lumbar movement control and postural control, measured using an
      inertial measurement system.
    


Intervention name(s): Augmented Feedback; Control Group
Intervention type(s): Device; Other
Intervention description(s): An inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle. The corresponding software includes therapeutic games. Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises. The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises. The intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.; Conventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled pilot trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain
Accelerometry at the Neck: Comparison With m. Adductor Pollicis Stimulation
Condition: Feasibility of Measurement of a Neuromuscular Block at the m. Trapezius
Study type: Interventional

Summary: 
      Accelerometric Assessment of neuromuscular block during anaesthesia is routinely performed at
      the M. adductor pollicis. However, many operations require positioning of the patients with
      arms attached to the body. In these situations, the anaesthesiologist has no access to the
      m.adductor pollicis.

      In this study, a new position of accelerometry at the neck is evaluated: Stimulation of the
      n. accessorius with accelerometry of the m. trapezius.
    


Intervention name(s): accelerometry m. trapezius and m. adductor pollicis
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: accelerometry; neuromuscular block; m. trapezius
A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to
      placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a
      randomised, double blind, placebo controlled, two way crossover evaluation. There will be a
      screening period of up to three weeks and a washout period of at least one week between the
      two treatment periods. There will be a follow up one to three weeks after the last dose of
      study drug.
    


Intervention name(s): OC000459; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OC000459 200mg bid for 8 days; Placebo bid for 8 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis; CRTH2
A Study of LY2216684 in Major Depressive Disorder in Patients Taking Selective Serotonin Reuptake Inhibitors
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of LY2216684 on heart rate and blood
      pressure in research participants with MDD who are being treated with an SSRI (selective
      serotonin reuptake inhibitors). Information about any side effects that may occur will also
      be collected. The duration of participation in this study is approximately 24 days not
      including the screening visit. This study requires 1 clinic confinement of 17 days/16 nights
      and 1 Follow-up Outpatient Visit. A screening visit is required within 30 days prior to the
      start of the study. In both periods 1 and 2, the study involves 4 single daily doses of 18 mg
      LY2216684 or placebo taken as 2 tablets by mouth. In period 3, the study involves four single
      daily doses of 36 mg LY2216684 or placebo taken as 4 tablets by mouth.
    


Intervention name(s): LY2216684; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Partial Removal and Total Removal of the Corneal Epithelium on Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which surgical method makes less corneal haze
    

Detailed description: 
      Keratoconus is an asymmetric, bilateral, progressive non-inflammatory ectasia of the cornea.
      The investigators evaluate whether partial removal versus total removal of the corneal
      epithelium can lead to less corneal haze and better visual outcomes.
    

Intervention name(s): collagen cross-linking procedure (total removal); collagen cross-linking procedure (partial removal)
Intervention type(s): Procedure; Procedure
Intervention description(s): patients underwent Corneal collagen cross-linking procedure with totally corneal epithelium removing. Total removal was performed by mechanical debridement of the corneal epithelium over the central 9 mm.; patients underwent Corneal collagen cross-linking procedure with partially corneal epithelium removing. Partial removal was performed by removing a 3-mm width ring and leaving the central 3 mm of the cornea intact.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keratoconus; remove; cornea; visual acuity
Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess the immunogenicity, reactogenicity and safety following
      vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been
      vaccinated with one dose of PandemrixTM at the age of 10-17 years.
    


Intervention name(s): FluarixTM; HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Intervention type(s): Biological; Biological
Intervention description(s): One Intramuscular injection; Two Intramuscular injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Pandemrix; H1N1; Fluarix
Comparison of Two Daily Disposable Soft Contact Lenses
Condition: Astigmatism Bilateral
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this study was to investigate the short-term clinical performance and subjective
      acceptance of the two study lenses.
    

Detailed description: 
      This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled
      by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week
      in random order. Lenses were worn on a daily wear, daily disposable basis.
    

Intervention name(s): midafilcon A; somofilcon A
Intervention type(s): Device; Device
Intervention description(s): midafilcon A 1 day daily disposable contact lens; somofilcon A 1 day daily disposable contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly
Condition: Elderly Exercise
Study type: Interventional

Summary: 
      The number of elderly has been increasing in recent decades. Current studies focused on the
      risk factors of poor physical performance, poor daily activity performance, and even
      disability in the elderly. We planned to evaluate the physical performance of elderly
      dwelling in the community and designed a multimodal exercise program which can improve
      physical performance, prevent disability and promote quality of life.
    


Intervention name(s): multimodal exercise program
Intervention type(s): Other
Intervention description(s): warm-up, strengthening exercise, aerobic exercise, cool-down
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group: receive multimodal exercise program for half year control group: participate community activity
Masking: None (Open Label)
Primary purpose: Treatment
Effects of 5-Aminolevulinic Acid on Glucose Metabolism
Condition: Type 2 Diabetes on Medication
Study type: Interventional

Summary: 
      This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2
      diabetes on medication.
    


Intervention name(s): Placebo; 5-aminolevulinic acid phosphate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Physical Activity on Cardiovascular Risk and Quality of Life
Condition: Cardiovascular Diseases; Quality of Life
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Community intervention trial, randomized, to promote regular PA and social and cultural
      support activities for 9 months in older-adult primary care users and assess their effects on
      cardiovascular risk factors and health-related quality of life.
    

Detailed description: 
      A structured program to promote Physical , according to the recommended guidelines and
      supervised by healthcare personnel should be deployed to assess their short, medium and
      long-term effects on CVD risk and Qulity of life. The aim of this study was to evaluate the
      effectiveness of a program to promote Physical, social and cultural activities for 9 months
      on cardiovascular risk factors and quality of life among older-adults,
    

Intervention name(s): Physical, social and cultural activities
Intervention type(s): Behavioral
Intervention description(s): This intervention included two 60-min aerobic exercise sessions per week. Each session was supervised by a physical activity specialist and walking and stretching exercises were performed after programmed exercise sessions. PHC nurses were prepared to advise patients about the health benefits of PA and used different strategies to encourage the adherence of participants to the program. In addition, social and cultural support activities were included in this intervention program. These activities were performed once a month and they included: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Condition: Bipolar I Disorder; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center open-label study to be conducted in the United States in subjects
      with bipolar I disorder or schizophrenia.
    


Intervention name(s): Iloperidone
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Other intervention name(s): FANAPT®; VYV-683
Intervention MeSH terms: Iloperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment