bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic
      response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.
    


Intervention name(s): QAU145; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic fibrosis, QAU145, nasal potential difference
Chromium and Insulin Action
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis
      of the study was to evaluate the effect of supplementing the diet of individuals with Type 2
      diabetes with chromium picolinate and assessing the effect on blood glucose levels and
      insulin sensitivity
    

Detailed description: 
      The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes
      consists of lifestyle modification combined with pharmacologic intervention. However,
      alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are
      extensively practiced by a large number of patients and are frequently undertaken without
      first informing the medical provider. Unfortunately, considerable controversy exists
      regarding use of dietary supplements in subjects with diabetes because efficacy data for many
      of the supplements consists of only uncontrolled studies and anecdotal reports. As such,
      there is a paucity of data in humans in regard to the effect of most commercially available
      supplements to improve metabolic abnormalities.

      One supplement that has attracted considerable clinical interest is chromium (Cr). However,
      routine use of Cr in subjects with diabetes is not currently recommended. In part, the
      controversy surrounding Cr supplementation stems from the lack of definitive randomized
      trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies
      reported, the use of differing doses and formulation , and the study of heterogeneous study
      populations (4). As such, conflicting data has been reported that has contributed greatly to
      the confusion among healthcare providers concerning Cr supplementation. In order to provide a
      comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded,
      placebo-controlled trial in subjects with Type 2 diabetes, and over a 10 month period of
      observation, used established techniques to assess changes in insulin sensitivity, body
      composition and glycemic control.
    

Intervention name(s): Chromium Picolinate
Intervention type(s): Drug
Intervention MeSH terms: Chromium; Picolinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: insulin; glucose; body weight; chromium
Exogenous Ketones and Glucose Tolerance
Condition: Ketones; Dietary Supplements
Study type: Interventional
Phase: Phase 1

Summary: 
      The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous
      carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous
      beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering
      potential but this has not been adequately studied. The purpose of this study is to determine
      whether supplementing with an acute dose of ketone monoester can improve the glycemic
      response to an oral glucose tolerance test in individuals with impaired fasting glucose.
    


Intervention name(s): Ketone monoester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.; Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in
      which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+")
      on improving quality of life (QoL), screening practices and treatment follow-up compliance
      among breast HL survivors. In usual PN, participants will receive information brochures on
      breast cancer survivorship and have a minimum of 1 contact with the patient navigator.
    

Detailed description: 
      This RCT involves a 2 (group) by 2 (time) repeated measures design with experimental
      condition (specialized PN+cancer survivorship program over 6 months versus PN only (control
      condition) as the between-groups factor, and time-point (baseline pre-randomization and
      post-PN at 6 months follow-up) as the within-groups factor. This RCT involves 2 patient
      navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy
      of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening
      practices and treatment follow-up compliance among breast HL survivors. In usual PN,
      participants will receive information brochures on breast cancer survivorship and have a
      minimum of 1 contact with the patient navigator.
    

Intervention name(s): PN+; PN usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors; participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.
Condition: Locally Advanced or Metastatic EGFR Mutated NSCLC.
Study type: Observational

Summary: 
      This is a retrospective, non-interventional, multicenter, observational chart review study to
      explore the clinical benefits of retreatment with TKI in the real world.
    

Detailed description: 
      This study is designed to retrospectively review the medical and chemotherapy records of 300
      patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows:
      histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime
      after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated
      with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target
      population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical
      effect in re-administration of EGFR-TKI using retrospectively collected data from these
      eligible patients to provide valuable information.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated
        Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor
        Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy -
        SEQUENCE study
      
Keywords: Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor retrement.
A Study Of CP-690,550 In Stable Kidney Transplant Patients
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1 dose escalation study to evaluate the safety, tolerability and
      pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In
      Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of
      subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort
      in Stage 2.
    


Intervention name(s): Placebo; CP-690,550 5 mg BID; CP-690,550 15 mg BID; CP-690,550 30 mg BID
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo tables twice daily (BID) for 28 days; CP-690,550 5 mg BID for 28 days; CP-690,550 15 mg BID for 28 days; CP-690,550 30 mg BID for 28 days
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: CP-690,550; kidney transplant
Electrical Stimulation in Patients With Unipolar Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive
      Disorder. The primary objective is to assess the safety and tolerability of an implantable
      sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients
      with the diagnosis of unipolar MDD (Major Depressive Disorder).
    


Intervention name(s): Stimulation of the trigeminal nerve (active stimulation); Placebo stimulation of the trigeminal nerve (placebo)
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.; Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. Patients of the placebo group will be implanted with a lead in the V1 branch of the trigeminal nerve, but will not receive stimulation.
After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
Participants randomized to placebo stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks.
Other intervention name(s): Electrical Stimulation; Sham Eletrical Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Electrodes, Implanted; Electric Stimulation Therapy
Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy
Condition: Gynecologic Neoplasms; Abdominal Neoplasms
MeSH terms: Neoplasms; Genital Neoplasms, Female; Abdominal Neoplasms
Study type: Observational

Summary: 
      Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator
      based on heart-lung interaction to predict fluid responsiveness. Generally, patients are
      considered to be fluid-responsive when the PPV value larger than 11-13%. However, several
      previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To
      predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%),
      the investigators would evaluate the augmented PPV using augmented ventilation.
    


Intervention name(s): Augmented ventilation; Fluid loading
Intervention type(s): Other; Other
Intervention description(s): When the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration.; We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid
Other intervention name(s): Balanced crystalloid infusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients undergoing elective open laparotomy surgery.
Early Pregnancy Sample Collection Study
Condition: Pregnancy
Study type: Interventional

Summary: 
      Female volunteers, wishing to become pregnant will be offered the use of Clearblue ovulation
      prediction products to help identify their most fertile time and aid conception. Volunteers
      will provide SPD with a daily urine sample throughout the study period, which will be used
      for the development and validation of SPD products related to pregnancy and fertility.
    

Detailed description: 
      In order to develop and validate new and existing products SPD needs to maintain a sample
      bank of early pregnancy urine samples from the beginning of the cycle in which pregnancy is
      achieved, and throughout pregnancy.

      This generic study will be initiated to maintain the SPD sample bank, the study will run
      continuous to replenish the sample bank, as samples are used.

      To obtain these samples, volunteers wishing to become pregnant will be offered the use of a
      Clearblue ovulation prediction product to enable them to pinpoint their most fertile time and
      aid conception. Whilst on the study volunteers will be asked to collect daily urine samples
      and return them to SPD on a regular basis in addition to keeping a daily record of menstrual
      cycle details and test results. Women who become pregnant during the course of the study will
      be asked to continue collecting daily urine samples for a minimum of a further 4 weeks. Each
      volunteer will be on the study for a minimum of 1 and a maximum of 3 cycles. Volunteers will
      not be allowed to re-enter the study once they have completed without achieving pregnancy

      It is anticipated that any one of SPD's marketed ovulation prediction products may be used in
      this study to aid the conception rate, this may include, but not be limited to the Clearblue
      fertility monitor and Clearblue digital ovulation test.

      It is anticipated SPD will have to recruit approximately 600 volunteers to achieve each 100
      pregnancies and that approximately 500 volunteers will be participating at any one time. The
      study size may be increased or decreased to meet sample demands.
    

Intervention name(s): Ovulation predictions products
Intervention type(s): Other
Intervention description(s): Home diagnostics for ovulation prediction will be provided to study volunteers
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pregnancy
Deep Brain Stimulation for Treatment-Refractory Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the use of deep brain stimulation (DBS) to reduce symptom
      severity and enhance the quality of life for patients with treatment-refractory major
      depression.
    

Detailed description: 
      Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial
      number of patients fail to improve significantly even after years of conventional and
      experimental interventions. Bilateral deep brain stimulation (DBS) to the region of the
      anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a
      more effective treatment for patients with major depression. This study will determine the
      effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major
      depression.
    

Intervention name(s): Deep Brain Stimulation with Medtronic Activa Neurostimulator
Intervention type(s): Device
Intervention description(s): Deep brain stimulation (DBS) at 130 Hz
Other intervention name(s): Activa Neurostimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Treatment Refractory Major Depression
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
Condition: Intubation
Study type: Interventional

Summary: 
      The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to
      increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of
      gastric insufflation and insertion of a gastric tube. In the following randomized prospective
      double-blind trial, we test the hypothesis that the postoperative analgesic requirements is
      higher for the ProSeal laryngeal mask airway than the tracheal tube.
    


Intervention name(s): ProSeal LMA; ProSeal LMA, Tracheal Tube
Intervention type(s): Device; Device
Intervention description(s): ProSeal LMA vs Tracheal Tube; ProSeal LMA vs Tracheal Tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses
Condition: Myopia
MeSH terms: Seizures; Myopia
Study type: Interventional

Summary: 
      The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision
      performance of three monthly replacement sphere lenses.
    

Detailed description: 
      This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial
      comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study
      will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1
      hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a
      series of three short fitting comparisons.
    

Intervention name(s): Omafilcon A; Somofilcon A; Omafilcon A - Proclear (PC)
Intervention type(s): Device; Device; Device
Intervention description(s): contact lens; contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Posterior Cavities
Condition: Secondary Caries
Study type: Interventional

Summary: 
      The aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing
      bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in
      posterior cavities.
    


Intervention name(s): Surefil One; Cention N; Bulkfil resin composite
Intervention type(s): Other; Other; Other
Intervention description(s): Ion-releasing restoration; Ion-releasing restoration; resin composite (No ion-release)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Lateralization of the Inferior Alveolar Nerve After Repositioning of the Bone Window Versus Sticky Bone Augmentation
Condition: Posterior Atrophic Mandible; Inferior Alveolar Nerve; Nerve Lateralization
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Rehabilitation of edentulous posterior mandibular regions with severe ridge atrophy using
      implants is subject to anatomical, surgical, and biological difficulties. In many cases, the
      bone is severely atrophied that sufficiently long fixtures cannot be placed without
      encroaching on the inferior alveolar nerve (IAN). IANL is defined as the lateralization of
      inferior alveolar neurovascular bundle posterior to the mental foramen, with preservation of
      the incisive nerve; exposure and traction are used to deflect the IAN laterally while the
      implants are placed.
    

Detailed description: 
      This prospective randomized clinical trial will enroll 20 patients with posterior mandibular
      ridge atrophy. Ten of which will undergo computer guided nerve lateralization with subsequent
      implant placement and repositioning of the osteomotized bone window and ten patients will
      undergo computer guided nerve lateralization with subsequent implant placement and sticky
      bone grafting.
    

Intervention name(s): Guided inferior Alveolar Nerve lateralization
Intervention type(s): Procedure
Intervention description(s): Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique
Other intervention name(s): computer guided implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inferior Alveolar nerve lateralization; neurosensory disturbance; guided surgery; Posterior atrophic mandibular ridge