bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in
      combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate
      glycemic control on metformin monotherapy.
    


Intervention name(s): 75 mg LX4211; 200 mg LX4211; 400 mg LX4211; 200 mg LX4211; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive 75 mg LX4211 once daily; Subjects will receive 200 mg LX4211 once daily.; Subjects will receive 400 mg LX4211 once daily.; Subjects will receive 200 mg LX4211 twice daily.; Subjects will receive placebo once daily.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes mellitus
Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Condition: Nasal Obstruction
MeSH terms: Airway Obstruction; Nasal Obstruction
Study type: Interventional

Summary: 
      Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
    

Detailed description: 
      This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate
      the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when used to deliver
      radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed
      with nasal airway obstruction.
    

Intervention name(s): Vivaer Stylus
Intervention type(s): Device
Intervention description(s): Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
Other intervention name(s): Aerin Medical Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasal valve; Nasal airway obstruction
To Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With Sensitive Skin
Condition: Skin Care
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The objective of this clinical study is to assess the cutaneous and ocular local tolerance of
      two cosmetic facial cleansers in healthy female participants with sensitive skin under normal
      conditions of use.
    

Detailed description: 
      This is an assessor blind (dermatologist and ophthalmologist) clinical in use study to
      determine the local cutaneous and ocular tolerance of two cosmetic facial cleanser products
      when used as per the intended instructions for use in a population of healthy female
      participants with clinically assessed sensitive skin.
    

Intervention name(s): Micellar cleanser; Micellar foaming cleanser
Intervention type(s): Other; Other
Intervention description(s): Participants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser.; Participants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Mesenchymal Stem Cell Therapy for Bronchopulmonary Dysplasia in Preterm Babies
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      Bronchopulmonary Dysplasia (BPD) is the most frequent disease related to a premature birth,
      15-50% of very low birth newborns (<1500 gr.) will develop BPD. The prevalence of BPD is
      increasing due to the advances in neonatology, with a rise in the survival of smaller and
      more premature babies. The etiology of BPD is multifactorial, in which oxygen, maternal
      chorioamnionitis, insufficient pulmonary maturation etc. have an important role. These
      factors lead to a pathological development of the lung and pulmonary vessels, developing
      secondary Pulmonary Hypertension (PH). Nowadays there is no efficient treatment; this
      generates a important sanitary burden and a decrease in life quality. Multiple experimental
      models in mice have studied Mesenchymal Stem Cell (MSC) therapy as prevention of BPD, also
      recently some clinical trials have tried this therapy on premature newborns with promising
      results. Hypothesis: MSC therapy in patients at high risk of BPD prevents pulmonary lesions.
      Methods: The investigators have designed a clinical trial to evaluate the feasibility and
      security of MSC therapy in patients at high risk of developing BPD.
    


Intervention name(s): Mesenchymal Stem Cell (MSC) therapy
Intervention type(s): Biological
Intervention description(s): 3 doses of 5 million MSC will be administered
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bronchopulmonary dysplasia; pulmonary hypertension; stem cell therapy; mesenchymal stem cells; very low weight preterm babies
Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
Condition: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
MeSH terms: Neuromuscular Diseases
Study type: Interventional

Summary: 
      Critically ill patients frequently develop muscle weakness due to critical illness-related
      acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning
      from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased
      mortality rates. In addition, many patients continue to suffer from decreased exercise
      capacity and quality of life for months to years after the acute event.

      Besides controlling risk factors, no specific prevention or treatment exists. Recommendations
      advice to start early with active and passive exercise in critically ill patients (1). Having
      critically ill patients alert and engaged in progressive rehabilitation leading to
      mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to
      improved strength and physical function (2).

      This randomized controlled trial was designed to investigate whether a daily training session
      using a tilt table, started early in stable critically ill patients with an expected
      prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps
      force and functional autonomy at ICU and hospital discharge compared to a standard
      physiotherapy program.
    


Intervention name(s): the standard physiotherapy group; standing table group
Intervention type(s): Device; Device
Intervention description(s): Mobilization and rehabilitation program is progressively introduced after clinical stabilization; The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Muscle Weakness; Exercise therapy; Physiotherapy; Critical illness; Intensive care; Mechanical ventilation; Rehabilitation
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and
      Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry
      Eye Disease in a Dry Eye Chamber
    


Intervention name(s): Reproxalap Ophthalmic Solution (0.25%); Xiidra® (5% lifitegrast ophthalmic solution)
Intervention type(s): Drug; Drug
Intervention description(s): Reproxalap Ophthalmic Solution (0.25%) dosed once; Xiidra® (5% lifitegrast ophthalmic solution) dosed once
Intervention MeSH terms: Pharmaceutical Solutions; Lifitegrast; Ophthalmic Solutions
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Acute Mild Dehydration on Blood Pressure Control
Condition: Mild Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The goal of this project is determine how acute mild dehydration impacts blood pressure
      control at rest and during static exercise. This protocol will test healthy young and older
      adults in a normally hydrated and dehydrated condition.
    

Detailed description: 
      The purpose of this project is determine how acute mild dehydration impacts blood pressure
      control at rest and during static exercise. Additionally, we will determine whether or not
      the sympathetic nervous system has a role in mediating blood pressure control at rest and
      during static exercise. This protocol will test healthy young and older adults in a normally
      hydrated and dehydrated condition. This will allow for a within participant comparison.
      Additionally, we will later determine if age alters blood pressure control at rest or during
      static exercise.
    

Intervention name(s): Normal hydration; Dehydration
Intervention type(s): Other; Other
Intervention description(s): see description in 'arms'; see description in 'arms'
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Normal Hydration and Dehydration
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Dehydration
IQP-PO-101 for the Regulation of Bowel Movement Frequency
Condition: Constipation; Irregular Bowel Movement Frequency
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating
      the bowel movement frequency
    


Intervention name(s): IQP-PO-101
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gastric Bacterial Colonization of Preterm Neonates
Condition: Microbial Colonization; Preterm Birth
MeSH terms: Communicable Diseases; Infections; Premature Birth
Study type: Observational

Summary: 
      This prospective cohort study was conducted in the Christiana Care Health System Neonatal
      Intensive Care Unit. It occurred at two time periods: Time period 1 included infants admitted
      to the traditional, open bay NICU. Time period 2 included infants admitted to the new
      private, single family room NICU. There was a 3 month period between Time period 1 and Time
      period 2 to ensure that there was no patient overlap. Stool samples and environmental samples
      were collected at 1 and 4 weeks after birth in both time periods. The objective of this study
      was to establish the gastrointestinal microbiome of infants born at less than 32 weeks
      gestation admitted to the exiting open bay NICU and compare it to the gastrointestinal
      microbiome of infants born at less than 32 weeks admitted to the new private, single family
      room NICU.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): This was an observational study which involved collection of stool samples and environmental samples at 1 week and 4 weeks of life.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of infants born at less than 32 weeks born and admitted
        to the CCHS NICU. Infants in Time period 2 that were admitted to the traditional, open bay
        NICU will be excluded.
Analysis of Atropine and Propranolol Induced Changes
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn the effects of genetic make up on response to the drugs
      atropine and propranolol, to examine how changes in heart rate and blood pressure can be
      measured, and to test a new statistical analysis method.
    

Detailed description: 
      Healthy volunteers will be recruited and screened for eligibility. Participants will be
      placed into three possible groups based on genetic information obtained during screening.
      Rolling admissions will continue until at least 10 participants have been recruited for each
      genetic group. Participants will be randomly assigned to receive either the control
      (propranolol and saline) or combined drug (propranolol and atropine) treatment in a
      non-blinded fashion. The participant will return over one week later to receive the alternate
      treatment. Continuous heart rate/blood pressure data will be recorded until the end of the
      study period. Respiratory rate will be maintained at a fixed rate. Participants will undergo
      an orthostasis task, receive the drug or control infusions, and blood samples will then be
      obtained to determine drug concentrations at specific time intervals. Several relatively new
      mathematical techniques will be applied to the data.
    

Intervention name(s): Atropine; Propranolol; Normal Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus; One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline; One-time 0.25 ml/min infusion over 30 minutes
Other intervention name(s): NS
Intervention MeSH terms: Propranolol; Atropine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: heart rate variability; gene response
Investigation Of The Effect Of Proprioceptive Neuromuscular Fasilitation Tecniques in Scapular Dyskinesis
Condition: Scapular Dyskinesis
MeSH terms: Dyskinesias
Study type: Interventional

Summary: 
      Scapular dyskinesis is defined as the loss of strength around the scapular muscle, tightness
      of the pectoralis minor and disruption of scapular movements. Scapular patterns of
      proprioceptive neuromuscular fasilition (PNF) techniques are often preferred in the
      rehabilitation of scapular dyskinesis. The main principals of PNF applications are defined as
      the autogenous inhibition, reciprocal inhibition, stress relaxation and gate control
      theory.The aim of this study was to investigate the effect of scapular PNF patterns on
      muscular strength and pectoralis minor tightness among individuals with unilateral scapular
      dyskinesis.
    

Detailed description: 
      In order to standardize the measurements while evaluating individuals, the evaluation order
      will be as follows; The evaluation of minor pectoralis shortness, scapular dyskinesia by
      video analysis, scapular side shift test and then muscle strength evaluation will be done.
      The evaluation will be repeated before and 6 weeks after treatment and 12 weeks after
      treatment.

      Proprioceptive Neuromuscular Facilitation Application:

      Anterior elevation / posterior depression will be performed in the form of repetitive
      contractions using anterior depression / posterior elevation patterns. There will be 10
      repetitions, with a 2-minute rest break between each technique. The treatment will be
      continued twice a week for a total of 6 weeks. Perceived Effort Scale, which is graded
      between 0-10, will be used to determine the level of perceived resistance to individuals
      before each treatment. In order to ensure standardization, the perceived effort level will be
      set to 5-6 (moderate).
    

Intervention name(s): Exercise, proprioceptive neuromuscular fasilition (PNF) techniques
Intervention type(s): Other
Intervention description(s): PNF applications are defined as the autogenous inhibition, reciprocal inhibition, stress relaxation and gate control theory. Anterior elevation / posterior depression will be performed in the form of repetitive contractions using anterior depression / posterior elevation patterns. There will be 10 repetitions, with a 2-minute rest break between each technique. The treatment will continue twice a week for a total of 6 weeks.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scapular Dyskinesis
ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to provide information on the safety and tolerability of repeated oral
      doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study
      of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best
      address the study goals.
    


Intervention name(s): ACH04
Intervention type(s): Drug
Intervention description(s): The subjects will receive the study medication in each group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; tolerability; rising multiple doses; ACH04; adult; male
Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Distal radius fracture (DRF) is a common fracture of which the incidence appears to be
      increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's.

      In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment
      with plaster cast or brace for one-three weeks. Despite the advice in the guideline and
      despite several studies from the 90's showing that plaster cast treatment of a stable DRF for
      one week is safe, the usual length of plaster cast treatment for stable DRF is four-six
      weeks. In addition, recent studies have also shown that a long period of immobilization can
      lead to more post traumatic pain by increasing disuse and kinesiophobia.

      This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF
      is unnecessary.

      The aim of this feasibility study is to define whether one week of plaster cast treatment is
      possible and can lead to better functional results, with at least the same patient
      satisfaction and complications. In addition, this feasibility study will be used to define
      the sample size of the future RCT.
    


Intervention name(s): One week of plaster cast; Four-Five weeks of plaster cast
Intervention type(s): Procedure; Procedure
Intervention description(s): One week of plaster cast as treatment for a non-reduced distal radius fracture.; Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
Intervention MeSH terms: Calpastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distal radius fracture; Conservative treatment; Patient rated outcome (PRO)
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase IIIb study is to determine whether children who have not received a
      3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of
      age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity,
      safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be
      evaluated for four different age groups with different schedules:

      < 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age
      group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose
      vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no
      booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib
      vaccine.
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
    

Intervention name(s): Synflorix; Infanrix IPV/Hib
Intervention type(s): Biological; Biological
Intervention description(s): 1, 2, 3 or 4 Intramuscular injections, depending on age group; 4 intramuscular injections
Other intervention name(s): Pneumococcal conjugate vaccine GSK1024850A.; DTPa-IPV/Hib
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Booster vaccination; Catch-up vaccination; Pneumococcal vaccine; Immunogenicity; Safety; Pneumococcal disease
Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this randomized controlled trial is to compare partial pulpotomy treatments with
      Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed
      asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate
      root developments with Image J Software Program. The null hypothesis of this study is
      Biodentine® will promote healing with high success rates and induce root development more
      than CH and MTA.
    

Detailed description: 
      The purpose of this study was to evaluate clinical and radiographical success of three
      different materials in partial pulpotomy treatment. 50 patients with 54 asymptomatic,
      cariously exposed young permanent mandibular molar teeth were included to the study. The
      teeth were randomly divided into three main groups which were; calcium hydroxide, MTA and
      Biodentine® and finally restorated with stainless steel crowns. Pain, percussion sensitivity,
      palpation sensitivity of soft tissue around the tooth, root development, presence of lesion,
      integrity of lamina dura were evaluated clinically and radiographically during 12 months and
      recorded for each. Also, Image J Program with Turbo-Reg plug in was used for standardization
      of the radiographs and to determine the increase in root length.
    

Intervention name(s): Partial Pulpotomy; Pulp Capping Agents
Intervention type(s): Procedure; Drug
Intervention description(s): Partial removal of inflamed pulp tissue in cariously exposed teeth; Biocompatible materials
Other intervention name(s): Cvek Pulpotomy, Miniature Pulpotomy; Pulp Capping Materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biodentine; Cariously exposed pulp; MTA; Partial pulpotomy; Image J Software