bioihbjkbjnl/mcl2 huggingface dataset:
BIOAVAILABILITY OF GLI/METXR (4/850 mg)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      The purpose of this study is to evaluate the oral bioavailability of the combination
      Glimepiride/ extended release Metformin (GLI/METXR) (4/850mg) in healthy Mexican volunteers
      in fasting conditions.

      Methods: A prospective, longitudinal, open label, non randomized study, was performed, 24
      volunteers were administrated with a single oral dose of GLI/METXR (4/850 mg).
    

Detailed description: 
      Blood samples were collected over 30 hours. Plasma concentration of both drugs were measured
      by using high-performance liquid chromatography (HPLC). Plasma concentration-time curves were
      plotted for each volunteer, and pharmacokinetic parameters (PK) were calculated. the
      pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke, T1 /
      2 of glimepiride and metformin Adverse events were determined using clinical and laboratory
      test results, throughout the study. The statistical analysis will be descriptive for plasma
      concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t,
      AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin.
    

Intervention name(s): Glimepiride / Extended release Metformin (4/850 mg).
Intervention type(s): Drug
Intervention description(s): One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose, to all patient in fasting.
Other intervention name(s): GLIMETXR
Intervention MeSH terms: Metformin; Glimepiride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DM2; glimepiride; metformin extended release
Single Tooth Restoration in the Maxilla Using the Straumann® PURE® Ceramic Implant Monotype: One Year Follow up
Condition: Ceramic Implant
Study type: Interventional

Summary: 
      The main objective is to evaluate peri-implant hard and soft tissues's stability with the use
      of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.
    

Detailed description: 
      Nowadays, the material of choice for the manufacture of dental implants is titanium. However,
      if we consider the aesthetics, the use of metallic implants can lead to complications, namely
      metal translucency through the peri-implant mucosa or the presence of soft tissue recessions
      causing metal exposure. As an alternative to the use of titanium, we have zirconium, that is
      highly biocompatible and whose use in implantology has demonstrated a predictable
      osseointegration. In addition, some studies suggest a different histology that could help
      maintaining the stability of the peri-implant mucosa and, therefore, an improvement in
      long-term aesthetic results.

      The reason for designing this study is that there is not too much data about this type of
      implants, that can be, really, an alternative to those we know.

      To achieve those objectives a single-arm clinical trial is designed, using marginal bone loss
      as a primary response variable. It is estimated with the calculation of the sample size, we
      would need 30 patients to get relevant data.

      An experienced surgeon (M.V) will perform implant surgery. Later, experienced and calibrated
      examiners (R.E and E.RG) will collect the following clinical parameters at baseline, and at
      4, 8 and 12 months: gingival recession, papillary Jemt index, width and height of the
      keratinized gingiva, probing depth, plaque index and bleeding on probing.

      Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as
      unit of analysis the implant.
    

Intervention name(s): Straumann Pure Ceramic Implant
Intervention type(s): Device
Intervention description(s): The surgical technique begins with the lift of a vestibular mucoperiosteal flap respecting the papillae of the adjacent teeth. After the alveolar bone is exposed, the sequence of drilling and placement of the intra-bone fixation are carried out. In case of fenestrations or dehiscence, they are treated by xenograft and collagen-absorbable membrane. Once the implant is placed, a healing cap or provisional prosthesis is placed depending on the torque achieved. Finally, the flap is replaced and sutured.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zirconia implant; One-piece; Monoblock; Single tooth
PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine.
Condition: Covid19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of
      COVID-19 in a general population. This study is designed to evaluate the safety,
      tolerability, and immunogenicity of PTX-COVID19-B compared to Pfizer-BioNTech COVID-19
      vaccine in healthy seronegative adults aged 18 to 64.
    


Intervention name(s): PTX-COVID19-B; Pfizer-BioNTech COVID-19 vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Sterile solution for injection; Sterile solution for injection; 0.9% sodium chloride (normal saline) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Constraint-Induced Movement Therapy in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced
      Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT)
      delivered in a outpatient setting on upper limb motor recovery in stroke survivors.
    

Detailed description: 
      Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper
      limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are
      supposed to wear a mitt on the unaffected hand for 4 hours daily.

      Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb
      practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs
      at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected
      hand for 4 hours daily.
    

Intervention name(s): mCIMT; hCIMT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention is based on 3 main aspects:
intensive training of functional tasks with the affected arm (massed practice)
constraint of the un-affected hand through a mitt
shaping techniques designed to transfer gains to the real world activities
The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT.; This intervention is based on 3 main aspects:
intensive training of functional tasks with the affected arm (massed practice)
constraint of the un-affected hand through a mitt
shaping techniques designed to transfer gains to the real world activities
In this group, a comprehensive set of the material necessary to perform the training at home and a booklet containing an explanation of the exercises that can be done will be provided to subjects.
In addition, 2 hospital visits will be scheduled to instruct subjects and caregivers on the training and to update activities (1 visit at the beginning + 1 visit after 1 week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic
      differences of therapeutic effect of chloroquine and search the cause of these ethnic
      differences. For this purpose, chloroquine will be administered to four ethic groups of
      Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be
      measured. The result of this study will be helpful in finding more adequate dosing regimen of
      chloroquine in patients with malaria.
    


Intervention name(s): chloroquine phosphate 1000 mg
Intervention type(s): Drug
Intervention description(s): 1000 mg, 1day
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Mild Pulmonary Function Changes With Transfusion
Condition: Transfusion Reactions
MeSH terms: Transfusion Reaction
Study type: Observational

Summary: 
      The purpose of the study is to determine whether transfusion is associated with mild
      pulmonary changes.
    

Detailed description: 
      Transfusion-related acute lung injury (TRALI) is the leading cause of blood product related
      death. The precise mechanisms of TRALI are uncertain. We hypothesize that TRALI is a full
      spectrum of lung injury. One theory holds that the infusion of cytokines associated with the
      transfusion of stored blood combined with the trauma and stress of surgery produce lung
      injury. We propose to examine lung function following transfusion, and that stored blood (and
      by implication, cytokines) injures the lung. TRALI is a rare condition and we do not expect
      any of the patients that we observe will develop TRALI. We are merely observing their
      pulmonary function closely to see if there are any mild changes.

      Patients will be randomized into three groups based on whether or not they have pre-donated
      blood for the surgery. Once divided into these groups they are randomized to one of three
      groups with patients in the first group randomized to receive their stored (either autologous
      or allogeneic) "unwashed" blood first in the operating room using the standard cell salvage
      system. The second group will receive their stored (either autologous or allogeneic) "washed"
      blood first and the third group will receive blood from the cell salvage system first. Those
      who get the stored blood first will get the cell salvage blood as their second transfusion
      and those that get the cell salvage blood first will get stored "unwashed" blood as the
      second transfusion in the operating room. We will closely monitor pulmonary function and
      oxygenation, and try to observe whether there is early evidence of lung changes. If there is
      evidence of lung changes, then the blood is tested for cytokines and antibodies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is all adult spine surgery patients aged 16 to 75 who are scheduled
        for orthopedic spine surgery at UCSF who are expected to lose at least 1000 cc of blood
        during their surgery and who will receive both stored blood and cell-salvaged blood during
        their surgery.
      
Biospecimen description: 
      Biospecimens are retained for cytokine and inflammatory marker analyses.
    
Keywords: TRALI; Randomized Autologous Transfusion; Intra-Operative Testing of Pulmonary Function
The Effect of Minimalist Footwear on the Anthropometric and Biomechanical Parameters of the Lower Limb and Foot
Condition: Footwear
Study type: Interventional

Summary: 
      The study aims to determine whether 6months of wearing minimalist footwear causes changes in
      anthropometric parameters of the foot and the biomechanical parameters of the foot and lower
      limb.
    

Detailed description: 
      The minimalist footwear represents an alternative style of footwear wearing, which could
      allow the foot to move more naturally compared to the footwear wearing in conventional
      footwear. That footwear is characterized by no cushioning, wide toe box, zero foot drop, thin
      sole (1,5 - 8 mm), low weight, and high flexibility of footwear. This study aims to determine
      the effect of 6months of wearing minimalist footwear on the foot and lower limb's
      anthropometric and biomechanical parameters.

      The study is designed as a parallel interventional study. The sample size consists of 50
      healthy individuals divided into experimental and control groups by randomization. All
      participants undergo the initial examination and baseline and final measurement focused on
      the foot anthropometry and kinetics and kinematics of the foot and lower limb during walking.
      Besides, the experimental group undergoes a 6months intervention of wearing minimalist
      footwear, during which the participants will record their movement behavior by electronic
      diary.
    

Intervention name(s): minimalist footwear
Intervention type(s): Other
Intervention description(s): The intervention consists of wearing the minimalist footwear in recommended progression during the interventional period (6months). The intial load starts at 2,500 steps a day and will be gradually increased up according to the participant´s tolerance rate to the footwear wearing to fully use over the final period. Participants are instructed to report all issues and difficulties possibly connected to the intervention. There will be the opportunity to consult any issue connected with footwear or their wearing through the duration of the research.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: minimalist footwear; shoes; biomechanics; anthropometric parameters; foot; walking
Use of Social Media to Improve Medication Adherence in Adolescents and Young Adults With Systemic Lupus
Condition: Systemic Lupus
Study type: Interventional

Summary: 
      The goal of this study was to examine the effect of an online educational program with and
      without a social media experience.The primary goal of this study was to determine whether
      medication adherence would be improved by having adolescents and young adults with systemic
      lupus erythematosus participate in an online educational website, with or without a social
      media experience. The secondary goal was to determine whether secondary outcomes such as
      quality of life, stress, and self-efficacy improved in this model, and whether these changes
      were associated with improvements in medication management.
    

Detailed description: 
      Self-management skills, including medication management, are vital to the health of
      adolescents and young adults with systemic lupus erythematosus (SLE). Non-adherence with
      medications in patients with systemic lupus has been noted to be as poor as 40%. Success in
      disease control can be significantly impacted by such non-adherence. Poor medication
      compliance is associated with higher SLE disease activity scores and higher SLE disease
      activity in turn has been demonstrated to be significantly associated with a decline in
      quality of life. Much attention has been paid to how to improve self-management skills in
      adults, but less is known about how to target adolescents, an age group with a complex set of
      emotional and developmental needs.

      The goal of this study was to examine the effect of an online educational program with and
      without a social media experience.The primary goal of this study was to determine whether
      medication adherence would be improved by having adolescents and young adults with SLE
      participate in an online educational website, with or without a social media experience. The
      secondary goal was to determine whether secondary outcomes such as quality of life, stress,
      and self-efficacy improved in this model, and whether these changes were associated with
      improvements in medication management.
    

Intervention name(s): Social Media
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: systemic lupus; self-management; social media
A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the BA of 30 or 60 milligram (mg) dexlansoprazole
      capsule manufactured at TOB (Takeda GmbH Plant Oranienburg) to the corresponding 30 or 60 mg
      dexlansoprazole manufactured at TPC (Takeda Pharmaceutical Company Ltd.).
    

Detailed description: 
      The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
      tested in healthy participants to compare the BA of dexlansoprazole capsules manufactured by
      TOB relative to dexlansoprazole capsules manufactured by TPC, under fed conditions. The study
      consists of two parts: Part 1 participants will receive dexlansoprazole 30 mg capsules
      manufactured by TOB and TPC in a crossover fashion; Part 2 participants will receive
      dexlansoprazole 60 mg capsules manufactured by TOB and TPC in a crossover fashion.

      The study will enroll approximately 120 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to 1 of the 4 treatment sequences as following:

        -  Part 1: Dexlansoprazole 30 mg (TOB) + Dexlansoprazole 30 mg (TPC)

        -  Part 1: Dexlansoprazole 30 mg (TPC) + Dexlansoprazole 30 mg (TOB)

        -  Part 2: Dexlansoprazole 60 mg (TOB) + Dexlansoprazole 60 mg (TPC)

        -  Part 2: Dexlansoprazole 60 mg (TPC) + Dexlansoprazole 60 mg (TOB)

      All participants will be asked to take capsule of assigned dexlansoprazole on Day 1, 30
      minutes following the beginning of a high-fat/high calorie breakfast of each treatment
      period.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 86 days. Participants will be contacted by phone
      call approximately 10 days after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): 30 mg dexlansoprazole capsules manufactured at TOB; 30 mg dexlansoprazole capsules manufactured at TPC; 60 mg dexlansoprazole capsules manufactured at TOB; 60 mg dexlansoprazole capsules manufactured at TPC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexlansoprazole delayed-release capsules.; Dexlansoprazole delayed-release capsules.; Dexlansoprazole delayed-release capsules.; Dexlansoprazole delayed-release capsules.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the safety and efficacy of Salix Probiotic
      Blend, administered orally for 30 days, in participants with functional gastrointestinal (GI)
      disturbances.
    


Intervention name(s): Salix Probiotic Blend
Intervention type(s): Dietary Supplement
Intervention description(s): Oral capsule. The probiotic strains comprise the Salix Probiotic Blend include 3 strains of Bifidobacterium lactis (Bl-04®, Bi-07®, HN019) and 2 strains of lactobacillus (Lactobacillus acidophilus [NCFM]® and Lactobacillus paracasei [Lpc-37]®).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gastrointestinal Disorders, Functional
Coffee Consumption and Pregnancy
Condition: Coffee; Pregnancy
Study type: Interventional

Summary: 
      Coffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed
      during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood
      flow and amniotic fluid index (AFI) in the third trimester of pregnancy
    

Detailed description: 
      This cross-sectional study occurred in a tertiary center with volunteer pregnant women who
      agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios,
      AFI and fetal renal artery blood flow indices were evaluated before and after coffee
      consumption. Sixty three patients for the borderline oligohydramnios group (the study group)
      were included in this study. These patients were compared with 63 healthy pregnant women who
      had normal amniotic fluid volume (the control group)
    

Intervention name(s): coffee
Intervention type(s): Dietary Supplement
Intervention description(s): 2 g Nescafe Clasico contains approximately 65 mg caffeine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amniotic fluid index; caffeine; coffee; oligohydramnios