bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole
      depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in
      treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the
      protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of
      reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end
      which is passed down your throat into the esophagus, stomach, and duodenum) after treatment
      with rabeprazole and lansoprazole.
    

Detailed description: 
      This is a prospective (study following participants forward in time), open-label (all people
      know the identity of the intervention), multi-center (conducted in more than 1 center),
      randomized (study drug assigned by chance) study in participants with reflux esophagitis. The
      study will include 4 visits: Visit 1 (Screening period of up to 14 days), Visit 2 (Day 1),
      Visit 3 (Day 29+3), and Visit 4 (Day 56). After Screening, eligible participants will be
      analyzed on Visit 2 (Day 1) for symptoms during past week, At visit 3 (Day 29+3) participants
      will be randomly assigned to 1 of the 2 treatment groups: rabeprazole 20 milligram (mg) or
      lansoprazole 30 mg group. Participants will receive rabeprazole 20 mg tablet orally once
      daily for 28 to 56 days or lansoprazole 30 mg capsule orally once daily for 28 to 56 days. A
      post-study follow-up visit will be conducted only if participant will be affected by any
      serious adverse event within 30 days after the completion of study drug. Participants will
      primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 2 groups.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Rabeprazole; Lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days.; Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.
Intervention MeSH terms: Rabeprazole; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reflux esophagitis; Rabeprazole; Lansoprazole
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
Condition: Contraception; Liver Metabolism; Hemostasis Parameter
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed study will provide an assessment of the effect of this combination on endocrine
      function, metabolic control and hemostasis during 6 treatment cycles. This will be compared
      to the effects of two reference COCs.
    


Intervention name(s): 15 mg E4/3 mg DRSP; 30 mcg EE/150 mcg LNG; 20 mcg EE/3 mg DRSP
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.; 30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.; 20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
Other intervention name(s): 15 mg estetrol and 3 mg drospirenone; 30 mcg ethinylestradiol and 150 mcg levonorgestrel; 20 mcg ethinylestradiol and 3 mg drospirenone
Intervention MeSH terms: Drospirenone; Levonorgestrel; Ethinyl Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Estetrol (E4); Drospirenone (DRSP); Ethinylestradiol (EE); Levonorgestrel (LNG); Oral contraceptive; Prevention of pregnancy; Hemostasis; Metabolism
Papilla Suture Design Affects Papillary Postsurgical Dimensions
Condition: Periodontal Surgery; Oral Surgery
Study type: Interventional

Summary: 
      The current prospective, randomized, controlled clinical trial aimed at comparing the impact
      of papillae suture technique on interdental papilla dimensions after periodontal surgery
      using a novel 3D intraoral scanning technique.
    

Detailed description: 
      Scientific rationale for study: Choosing the appropriate suture design for periodontal
      surgery may affect post-surgery tissue dimension. This is a critical issue in periodontal
      surgery due to the grave impact papilla play on soft tissue esthetics.

      Principal findings: using the novel 3D scanning of the gingiva tissue show that simple
      interrupted suture negatively affect post-surgery papillary height and recession adjacent to
      the suture compared with vertical internal mattress suture.

      Practical implications: the study provide evidence that allows the clinician to better choose
      the suture design that will allow optimal healing of the papilla. Furthermore, the study
      presents a novel 3D scanning method to analyzed dimensional changes in the soft tissue.
    

Intervention name(s): papila suture technique
Intervention type(s): Procedure
Intervention description(s): simple interupted vs internal horoizontal matress suture
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: RCT parallel study
Masking: None (Open Label)
Primary purpose: Treatment
Ivermectin Versus Albendazole for Chronic Strongyloidiasis
Condition: Chronic Strongyloidiasis
MeSH terms: Strongyloidiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective controlled trial to compare the efficacy and safety of 7-day albendazole,
      single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic
      strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.
    


Intervention name(s): Ivermectin; ivermectin; Albendazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of 200 mcg/kg; two single dose of 200mcg/kg in 2 weeks; Albendazole 7 days
Other intervention name(s): stromectal; stromectal
Intervention MeSH terms: Ivermectin; Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: strongyloidiasis, ivermectin, albendazole
Endothelial Bleb Response With Toric Lenses
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      Evaluate the short-term corneal response of oxygen deprivation when using toric contact
      lenses. The response will be noted by endothelial bleb formation in both open eye and closed
      eye state.
    

Detailed description: 
      Interested subjects who meet the entry criteria for the study will be scheduled for four
      sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline
      measurements of visual acuity and corneal and conjunctival physiology will be recorded. An
      examination of the endothelium of the corneas will be conducted using the specular
      microscope, readings obtained at 5 locations on each cornea: one in the centre and one in
      each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from
      the limbal margin. The assigned lenses will be inserted according to a fixed-allocation
      randomization schedule, where each session follows an optimized 2- period simultaneous
      crossover design, which specifies lenses to be used in each of the four sessions. Lenses will
      be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at
      20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will
      be performed prior to subject clearance from the study.
    

Intervention name(s): alphafilcon A toric; lotrafilcon B toric; senofilcon A toric
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).; Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).; Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: toric; endothelial bleb
SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings
Condition: Movement Artifacts During SpO2 Measurements; Reduced Perfusion During SpO2 Measurements
Study type: Interventional

Summary: 
      The aim of this study is to characterize the noise in the SpO2 signal depending on different
      pulse oximeter averaging time settings.
    

Detailed description: 
      Noise in the SpO2 signal is most often caused by artifacts, such as movement artifacts,
      reduced perfusion, additional light and others. These artifacts can be partially removed from
      the SpO2 signal by different pulse oximeter settings, specifically the sensitivity mode and
      averaging time. It is known that when a longer averaging time is set, the measured signal
      contains fewer artifacts, on the other hand there is an increased risk of missing short
      desaturation. The aim of this work is to characterize the noise in the SpO2 signal depending
      on the set averaging time of the pulse oximeter based on experimental data from healthy
      volunteers.
    

Intervention name(s): Movement artifact - knocking; Movement artifact - tremor; Artifact - ambient light; Artifact - low perfusion; SpO2 measurement
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 60 seconds motion artifact simulation - knocking with sensors; 60 seconds motion artifact simulation - tremor with sensors; 60 seconds artifact simulation - ambient light using sensor opening; 60 seconds artifact simulation - reduced perfusion using a cuff; Two SpO2 measuring devices are active simultaneously on one hand during measurement.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants go through all study arms, in random order. Two pulse oximeters with different averaging time settings are active simultaneously during measurement on each participant and the measured signal is compared.
Masking: Single (Participant)
Primary purpose: Other
Keywords: pulse oximetry; SpO2; averaging time; motion artifacts
Safety and Efficacy Study Comparing ETS6103 With Amitriptyline in the Treatment of Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate that the antidepressant activity of ETS6103 is not inferior to amitriptyline
      in subjects who have an unsatisfactory response to / are resistant to treatment with SSRIs.
    


Intervention name(s): ETS6103 (low dose); ETS6103 (high dose); Amitriptyline
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Condition: Hepatic and Hepatobiliary Disorders
MeSH terms: Liver Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day
      for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.

      Secondary Objectives:

      To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms
      in acute and chronic liver diseases.

      To monitor compliance.
    

Detailed description: 
      The total study duration per patient will be 13 weeks that consists of 1-week pre-screening
      period and a 12-week treatment period.
    

Intervention name(s): Phosphatidylcholine
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:Paste Route of administration: Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Starter Kit Study in Insulin naïve Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The concept consists of an initial period (two weeks) of intensive data capture by use of
      continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second
      period (variable duration) of basal insulin titration guided by self monitored blood glucose.
      Data captured during the first period are used as input to an algorithm that estimates the
      optimal daily dose for the individual patient. The estimated optimal daily dose is used to
      guide the titration of the basal insulin during the second period. The goal is to safely and
      successfully achieve blood glucose targets. The concept is based on the use of basal insulin
      degludec (Tresiba, Novo Nordisk A/S).
    


Intervention name(s): Starter Kit Algorithm
Intervention type(s): Device
Intervention description(s): Long acting insulin titration to target
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Telemedicine Mindfulness-based Intervention for People With Multiple Sclerosis and Their Caregivers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of the project is to investigate the impact of a multiple sclerosis specific
      telemedicine mindfulness-based Intervention on the quality of life of people with multiple
      sclerosis and their caregivers.
    

Detailed description: 
      The mindfulness protocol will be modified according to multiple sclerosis clinical
      peculiarities and implemented with a multimedia web-based software.

      The project will be divided in two parts. During the first phase of the project, a standard
      mindfulness-based stress reduction protocol will be modified according to clinical
      peculiarities and specific needs of people with multiple sclerosis. In the meanwhile, a
      multimedia software with these teaching will be developed, so that the training could be
      available online, from home. The protocol and the software will be tested for ergonomics in a
      pilot, qualitative, study.

      In the second phase, a randomized clinical trial will be performed. One-hundred and twenty
      multiple sclerosis patients-caregivers couples will be randomly allocated in the experimental
      or to the control group. Subjects in the experimental group will attend the telemedicine
      mindfulness intervention, while controls will join a psycho-educational telemedicine program.
      At baseline, post-treatment and at a 6-month follow-up, participants will be assessed for
      quality of life, anxiety, depression, quality of sleep and mindfulness level. A subgroup of
      subjects will be assessed with actigraphs, for an objective evaluation of their sleep and
      physical activity. Experimental subjects will be assessed for participation and engagement to
      the treatment. Data will be analyzed with a complex longitudinal design, considering both
      within and between groups comparisons.

      The dissemination process will involve scientific publication on neurological and
      psychological journals, a book, scientific meeting presentations and communication to general
      media. If there will be a positive effect of the mindfulness software, it will be diffused to
      multiple sclerosis clinics and associations.
    

Intervention name(s): Telemedicine mindfulness-based intervention; Psycho-education intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Comparison of telemedicine mindfulness intervention with telemedicine psycho-education control group; Psycho-education control group, provided with a telemedicine approach. Subject in this group will use a similar software than the experimental intervention, with identical time efforts required. Software contents will be psycho-educative.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: caregivers
Study of Different Doses of a Novel Treatment for Onychomycosis
Condition: Distal, Subungual Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5%
      AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual
      onychomycosis of the great target toenail.
    

Detailed description: 
      The intent is for all subjects to complete a 180 day treatment period consisting of 90
      consecutive days of once daily treatment with their assigned study treatment followed by an
      additional 90 days of three times weekly dosing, even if the treated toenail(s) is evaluated
      as a "complete responder" prior to the end of treatment 180 day treatment period.

      At the end of the 180-Day treatment period, subjects who remain in the study will be
      classified as complete responders, partial responders, or non-responders. All complete or
      partial responders will continue to be followed for an additional 180 days until the last
      evaluation for inclusion in the final analysis.

      Periodic efficacy and local tolerance evaluations of the test medication will be performed of
      the target great toenail and all other treated toenails. KOH wet mounts and fungal cultures
      from the treatment-targeted great toenail will be performed on the same schedule.

      Subjects will also be queried for adverse events and evaluated for application site
      reactions. Clinical laboratory assessment for safety will be made at Screening, periodically
      throughout the study, and upon premature discontinuation from the study.
    

Intervention name(s): AN2690, 2.5%; AN2690, 5%; AN2690, 7.5%; AN2690 Solution Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once daily application for 90 days and 3 x weekly for 90 days; Once daily application for 90 days and 3 x weekly for 90 days; Once daily application for 90 days and 3 x weekly for 90 days; Once daily application for 90 days and 3x weekly for 90 days
Intervention MeSH terms: Tavaborole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail
Portion Size Effects on Body Weight:Free Living Setting
Condition: Portion Sizes
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The study purpose was to evaluate the effects of portion sizes on body weight and energy
      intake in a free-living setting. 223 healthy adults were recruited from an urban worksite and
      randomized to one of four groups for a six-month period. The groups were: 1) 400 kcal box
      lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. Participants were
      required to pick up a box lunch every week day for six months. Control participants did not
      receive a box lunch and were instructed to eat their usual lunch. Participants were weighed
      and dietary intake measured at baseline, one, three and six months. It was hypothesized that
      at six months, participants in the 1600 kcal box lunch would gain more weight and have higher
      energy intake than those in the other groups.
    


Intervention name(s): portion size kcal of box lunch
Intervention type(s): Other
Other intervention name(s): box lunches of different portion sizes were provided to participants each weekday for six months. Portion size conditions were 440 kcal, 800 kcal or 1600 kcal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration
Condition: Bone Void in the Maxillofacial Area
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II open label first in human single center clinical study, is to evaluate the safety
      and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose
      tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area
      approximately 6 month follow up after implantation in the following two clinical indications:

        1. Bone augmentation (e.g. sinus augmentation)

        2. Bone grafting after removal of cysts from jaws
    

Detailed description: 
      Primary endpoint: The implantation of BonoFill to the maxillary or mandible defect/void is
      safe under the following conditions: No chronic bone infection (Osteomyelitis); no
      significant changes in complete blood count (CBC) and in general health.

      Secondary endpoint: The implantation of BonoFill to the maxillary or mandible void is
      efficient under the following conditions: Following BonoFill implantation, the bone
      regeneration in the operated site was significantly accelerated. Also, the bone defects/voids
      were filled with a significant amount of bone tissue.
    

Intervention name(s): Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study
Intervention type(s): Procedure
Intervention description(s): Liposuction - will be performed on Visit 2, BonoFill will be based on subject's autologous Human Adipose Tissue Derived Cells (HATDCs).
BonoFill Transplantation will be performed on Visit 6. BonoFill will be administrated to the subject in a single session at one tested cell dose.
Other intervention name(s): BonoFill is an Biological, cell therapy Product that complies with the definition of Somatic Cell Therapies; BonoFill is an autologous Human Adipose Tissue Derived Cells (HATDCs) based product, combined with OraGraft® mineral particles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; efficacy; BonoFill; bone filler; autologous adipose tissue derived cells (HATDCs); Bone augmentation; sinus augmentation; Bone grafting after removal of cysts from jaws
A Phase I Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical
      study.
    


Intervention name(s): VC005 tablets; VC005 Tablets Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VC005 groups repeat administration for 4 weeks; VC005 placebo groups repeat administration for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment