bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effects of the Two Alternative Sweeteners D-allulose and Erythritol on Metabolism
Condition: Physiological Satiation Mechanisms
Study type: Interventional

Summary: 
      The aim of this project is to investigate the effect of intragastric (ig) D-allulose on
      metabolic parameters in general and to investigate the effect of sweet taste receptor
      blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and
      appetite-related sensations to ig administration of erythritol and D-allulose.
    

Detailed description: 
      Erythritol (natural non-caloric sweetener) could be an ideal candidate substitute for sugar
      as it may reduce caloric intake without compensatory overeating or earlier return of hunger.
      Moreover, it may serve as a physiological tool to disentangle the effects of gastrointestinal
      (GI) sweet taste receptor stimulation, (an)orexigenic hormone secretion, and glucose
      metabolism/caloric content on food intake regulation in vivo in humans. However, its effects
      on appetite, satiation, and satiety have not been studied systematically. Moreover, the
      mechanisms underlying erythritol-induced anorexigenic GI hormone release have not been
      investigated so far.

      D-allulose is a sugar substitute with almost zero calories and is naturally occurring in
      small quantities. Apart from its use as sugar replacement, D-allulose seems to favorably
      affect glycemic control and metabolism as could be shown in animal trials and in a few human
      trials. However, to date the effects of D-allulose on GI hormone secretion, appetite-related
      sensations and glycemic control, are not or insufficiently studied in humans.

      The aim of this project is therefore to investigate the effect of intragastric (ig)
      D-allulose on metabolic parameters in general and to investigate the effect of sweet taste
      receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and
      appetite-related sensations to ig administration of erythritol and D-allulose.
    

Intervention name(s): Erythritol; Erythritol + lactisole; D-allulose; D-allulose + lactisole; Tap water; Tap water + lactisole
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50g erythritol dissolved in 300mL tap water; 50g erythritol + lactisole (450ppm) dissolved in 300mL tap water; 25g D-allulose dissolved in 300mL tap water; 25g D-allulose + lactisole (450ppm) dissolved in 300mL tap water; 300mL tap water; 300mL tap water + lactisole (450ppm)
Other intervention name(s): E968-Erythritol; E968-Erythritol
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Low Friction Bed Sheet
Condition: Spinal Cord Injury; Pressure Ulcer
MeSH terms: Spinal Cord Injuries; Pressure Ulcer
Study type: Interventional

Summary: 
      Introduction:

      It is known that people with spinal cord injury (SCI) bear a considerably increased risk of
      developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk
      factors. It was the aim of the study to examine the effects of a specially developed
      low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients
      with SCI.

      Method:

      Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be
      recruited. Each patient spends five consecutive nights on the new, respectively, conventional
      bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS)
      concerning well-being, odour, perspiration and wrinkling. In addition, the patients are
      examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin
      blood circulation in the parasacral region.
    


Intervention name(s): new bedsheet; conventional bedsheet
Intervention type(s): Device; Device
Intervention description(s): sleeping 5 nights on the new bedsheet; sleeping 5 nights on the conventional bedsheet
Other intervention name(s): specially developed low-friction hospital bed sheet; normal hospital bedsheet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      critical limb ischemia
    


Intervention name(s): Autologous Adipose Tissue derived MSCs Transplantation
Intervention type(s): Procedure
Intervention description(s): Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor
Condition: Hypoxia; Desaturation of Blood
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      To compare prototype pulse oximeter saturation measurements, during normal to low saturation,
      to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood
      samples from healthy human subjects.
    

Detailed description: 
      The study utilizes a single-site, physiology laboratory (Clinimark) for non-randomized,
      prospective, observational studies. The goal is to enroll a minimum of ten subjects. Subjects
      may be of any race, ranging in pigmentation from light to dark to meet the study design
      requirements.

      The general purpose of Invasive Controlled Desaturation Studies is to validate the SpO2 and
      pulse rate accuracy in comparison to reference-standard measurements of blood SaO2 by a
      CO-oximeter during low saturation conditions. This is achieved through paired observations of
      SpO2 and SaO2 values over the specified SpO2 accuracy range of 60 % to 100 % SaO22 of the
      prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired
      oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted
      steady-state saturation periods. Arterial blood samples are periodically taken from an
      indwelling arterial catheter for use in the comparison.

      Pulse rate accuracy will be evaluated during the same data collection period as SpO2. Pulse
      rate will be compared to reference ECG heart rate. In the unlikely event that the ECG monitor
      malfunctions, the Pulse rate reference may be taken using the average pulse rate value from
      the transfer standard pulse oximeters. This study is designed to support an FDA submission
      for pulse rate and saturation accuracy in a diverse subject population during low saturation
      conditions over a specified saturation range for the OxySoftN pulse oximetry system.
    

Intervention name(s): Non-Invasive Controlled Hypoxia
Intervention type(s): Device
Intervention description(s): Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.
Other intervention name(s): Desaturation; Blood Sampling
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population includes a minimum of ten healthy non-smoking (or has refrained from
        smoking for 2 days) competent adults 18-50 years of age. The subject selection will be an
        equitable distribution of males and females of any race with at least 2 darkly pigmented
        subjects or 15% of the subject pool, whichever is larger.
      
Keywords: Oxygen Saturation; Invasive Controlled Desaturation
Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq
Condition: Orotracheal Intubation
Study type: Interventional

Summary: 
      News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but
      they are still too restricted to situations (difficult intubation criteria ..). It wanted to
      focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during
      intubation while limiting mouth opening and cervical hyper extension, but also dental trauma
      and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time
      the apnea time. After a review of the literature, it has been proven that its use reduces
      haemodynamic changes during intubation. But these studies have been realized only in very
      particular patients (obese, heart failure) and with induction protocols that are not used
      routinely in our operating theaters.

      Reasons why it decided to carry out this study, on the one hand to find these results and
      especially to be able to extend them to the whole population.
    


Intervention name(s): orotracheal intubation by direct laryngoscopy; orotracheal intubation by indirect laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch; orotracheal intubation by indirect laryngoscopy by Airtraq
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Laryngoscopy direct; Laryngoscopy indirect by Airtraq; hemodynamic changes; side effects
Clinical Effect of Massage Chair on Older Adults
Condition: Older Adults
Study type: Interventional

Summary: 
      The use of massage chairs is becoming more popular in many countries. According to the
      previous reports, some manual massages have positive effects on the mood, pain, fatigue, and
      sleep quality. However, the clinical benefits of the massage chair have not been fully
      understood. In this trial, it is aimed to evaluate the clinical effectiveness of the 6-month
      regular use of massage chair twice a day. It is hypothesized that long-term regular use of
      massage chair has positive effects on the hormonal level related to the stress, inflammation,
      and aging, as well as physical, psychologic, and muscle quality.
    

Detailed description: 
      A total of enrolled 80 patients after randomization(1:1) in intervention(Massage chair)group
      and Control groups, will be provided

        -  Massage chair group

             -  lifestyle modification education + using massage chair twice per day during 24weeks

        -  control group: only lifestyle modification education

             1. Screening visit

                  -  collection demographic data, BMD, vital sign, Medication history

             2. Visit 1 (0-week)

                  1. Vital sign

                  2. Charlson comorbidity index

                  3. Laboratory test

                       -  WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol,
                          serotonin, DHEA-s, IGF-1, NK cell, Telomere length

                  4. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L

                  5. Physical& muscular assessment

                       -  SPPB, Grip strength, Muscle tone, Bioimpedance analysis

             3. Visit 2-6 (4,8,12,16 weeks) via Phone contact: assess compliance and adverse events

             4. visit 7 (24weeks)

                  1. Vital sign

                  2. Laboratory test

                       -  WBC diff count, Hb, creatinine, ALT, albumin, hsCRP, ESR cortisol,
                          serotonin, DHEA-s, IGF-1, NK cell, Telomere length

                  3. Questionnaire: K-MMSE, SGDS-K, BEPSI-K, EQ-5D-5L

                  4. Physical& muscular assessment

                       -  SPPB, Grip strength, Muscle tone, Bioimpedance analysis

                  5. Compliance

                  6. Adverse events
    

Intervention name(s): massage chair
Intervention type(s): Device
Intervention description(s): Patient should use massage chair, twice per day, for 30minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determinate the efficacy and safety of the 3-drug induction
      treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized
      autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide
      maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized
      mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony
      stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
    


Intervention name(s): Cyclophosphamide; Filgrastim
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclophosphamide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myeloma, stem cell mobilization, autologous stem cell transplantation; induction treatment, maintenance treatment
Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty
Condition: Dermatochalasis of Eyelid; Ocular Surface Disease; Meibomian Gland Dysfunction; Dry Eye; Brow Ptosis
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction; Cutis Laxa
Study type: Interventional

Summary: 
      This study aims to evaluate the short and long-term effects of skin-only and skin+muscle
      excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow
      position.
    

Detailed description: 
      The study was designed with the approval of the Ethics Committee on Human Research of Marmara
      University and was conducted following the tenets of the Declaration of Helsinki. Written
      informed consent was obtained from all patients who received information about the procedure
      and the postoperative course. The study included 48 eyes of 24 patients older than 18 who
      applied to Marmara University Oculoplastic and Orbital Surgery Unit due to dermatochalasis
      and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. The patients
      were divided into two groups, Group S (n=12) for skin excision only and Group M (n=12) for
      skin+muscle excision by the decision of the surgeon. In addition to all ophthalmological
      examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, Schirmer I
      test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared
      meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline
      and postoperative 1st week, 1st month and 1st-year follow-ups.
    

Intervention name(s): Upper Eyelid Blepharoplasty
Intervention type(s): Procedure
Intervention description(s): Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: blepharoplasty; skin; orbicularis oculi; corneal confocal microscopy; meibomian gland; dry eye; eyebrow
Efficacy Study of Acupoint Sticking in Summer to Treat Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases
      in Summer is effective in the treatment of chronic asthma.
    

Detailed description: 
      Asthma is a common chronic disease with an estimated 300 million worldwide. Treating Winter
      Diseases in Summer of traditional Chinese medicine treatment of asthma has a long history.
      But there are less related clinical trials. The purpose of this study is to assess whether
      Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of
      chronic asthma.

      After screening period, participants will undergo a physical examination, lung function,
      blood and induced sputum collection while being randomly assigned to one of the following 2
      groups for 6 weeks during summer dog days of treatment:

      Group A will receive acupoint sticking treatment of Chinese herbal medicine and magnetic
      stickers once every two days； Group B will receive acupoint sticking treatment of Chinese
      herbal medicine and sham magnetic stickers once every two days.

      Questionnaires to assess asthma control and quality of life will be completed. A physical
      examination, blood collection, and induced sputum collection will occur at selected visits.
    

Intervention name(s): Magnetic stickers; Sham magnetic stickers; Chinese herbal medicine
Intervention type(s): Device; Device; Drug
Intervention description(s): 36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.; 36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.; 72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
Other intervention name(s): Medical Magnet Points For Aching Pain; Blank Points For Aching Pain; Warm Yang Applicator Party
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 3

Summary: 
      The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of
      chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
    

Detailed description: 
      This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group
      study in patients with a diagnosis of chronic inflammatory demyelinating
      polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to
      study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of
      1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo.

      The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a
      Follow-up Period after discontinuation of study drug treatment. Patients who complete the
      study will have an option to enter an extension.
    

Intervention name(s): Fingolimod; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Fingolimod 0.5 mg capsules; Matching placebo capsules
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic inflammatory demyelinating polyradiculoneuropathy, CIDP, FTY720, fingolimod.
Ruxolitinib as add-on Therapy in Steroid-refractory Graft-vs-host Disease
Condition: Steroid Refractory GVHD
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Steroid-refractory graft-vs-host disease (SR-GVHD) is a major cause of mortality after
      allogeneic hematopoietic stem cell transplantation (HSCT). We sought to evaluate the effect
      and safety of ruxolitinib (RUX) add-on in the treatment of patients with SR-GVHD.
    

Detailed description: 
      Nowadays, second-line treatment for SR-GVHD differs between centers and depends on the
      physician's experience. The agents commonly used as second and further lines of therapy
      include anti-thymocyte globulin, mycophenolate mofetil, calcineurin inhibitor, or
      extracorporeal photopheresis. However, the response varied. This study highlighted that
      corticosteroid (CS) is not a panacea for treating GVHD, and some patients with remission
      still experience further relapse. Additionally, the identification of multiple infections
      adds complexity.

      Hope was supposed to come in 2019 after the Food and Drug Administration (FDA) approved RUX
      for the therapy of SR-GVHD in adult and pediatric patients > 12 years. RUX add-on should be
      withheld as the risks outweigh the benefits, especially for patients who developed
      scleroderma and bronchiolitis obliterans. RUX can be added on as needed for the treatment of
      GVHD, especially in patients receiving DLI as relapse therapy with the conversion from mixed
      chimerism to complete chimerism. Despite some studies showing the efficacy of RUX across
      affected organs, some other data bring the opposite results. Thus we conducted this study to
      reinforce the efficacy of RUX as an add-on therapy for SR-GVHD.
    

Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention description(s): A dosage of 5mg once daily will be applied as initiation. After one week use, dose escalation or de-escalation would depend on clinical response.
Other intervention name(s): Jakavi
Intervention model: Single Group Assignment
Intervention model description: Cases with steroid-refractory GVHD would be given an add-on therapy of age/weight adjusted dosage of Ruxolitinib
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute lymphoblastic leukemia; hematopoietic stem cell transplantation