bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Skin Quality Improvement
Condition: Skin Quality
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to comprehensively investigate and objectively demonstrate the
      effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more
      specifically evenness of skin tone, reduction of pore size and improvement in the appearance
      of preexisting skin scars.
    

Detailed description: 
      The purpose of this study is to comprehensively investigate and objectively demonstrate the
      effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more
      specifically evenness of skin tone, reduction of pore size and improvement in the appearance
      of preexisting skin scars. The ability of hyperdilute Botox® Cosmetic to improve overall skin
      quality is likely optimized when it is injected uniformly in hyper-diluted small aliquots in
      order to "saturate" the dermis. We propose to prepare Botox® Cosmetic in a manner that is
      approximately 4 times more dilute compared to the typical Botox® Cosmetic preparation. A 4x4
      centimeter area located in the mid-cheek adjacent to the nose will be injected with
      hyperdilute Botox® Cosmetic. Botox® Cosmetic is not FDA-approved for this use. A maximum of
      15 subjects will participate in this study, all of whom will receive injections of Botox®
      Cosmetic during the course of this study.

      This study is a randomized, placebo-controlled, and double-masked study. This means neither
      the study doctor nor participant know the experimental agent (e.g., 0.9% saline solution and
      hyperdiluted Botox® Cosmetic) injected on each side of the patients' faces. The study will
      last for a total of 75 days. Evaluation of the study is based on the analysis of photographic
      images obtained during the study.
    

Intervention name(s): Hyper-Diluted Botox; Topical anesthesia; 0.9% saline solution
Intervention type(s): Drug; Drug; Other
Intervention description(s): 0.1ml of hyper-diluted Botox® Cosmetic will be administered in the superficial dermis using a 1ml luer lock syringe coupled with a 33g ½" needle; Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes; 0.1ml of 0.9% saline solution will be administered to the side of the face
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a longitudinal study in which patients will be initially treated with hyper-diluted Botox Cosmetic in the superficial dermis or they will be treated 0.9% saline. Then, on day 30 of the study patients initially treated with hyper diluted Botox Cosmetic will be treated with saline and patients initially treated with saline will be treated with hyper-diluted botox.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metformin for the Treatment of Endometrial Hyperplasia
Condition: Endometrial Hyperplasia; Endometrial Hyperplasia Without Atypia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to see if metformin will be effective in making endometrial
      hyperplasia without atypia better by returning the tissue to a normal state.
    

Detailed description: 
      This is a multi-institutional pilot clinical trial designed to estimate the response rate and
      safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH)
      without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines
      Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin
      will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum
      of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat
      endometrial biopsy to assess for regression or persistence of EH.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): 850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).
Other intervention name(s): Fortamet; Glucophage; Glumetza; Riomet
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometrial hyperplasia; Uterus; Pilot; Metformin
Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for
      SARS-CoV-2 infected patients.
    

Detailed description: 
      Given no specific antiviral therapies for COVID-19 approved yet and Danoprevir sodium tablet,
      an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open,
      controlled trial will evaluate the efficacy and safety of Danoprevir sodium tablet in
      hospitalized patients infected with SARS-CoV-2.
    

Intervention name(s): Danoprevir+Ritonavir
Intervention type(s): Drug
Intervention description(s): Danoprevir 100mg , one tablet each time , twice per day, up to 10 days. Ritonavir 100mg, one tablet each time , twice per day, up to 10 days.
Other intervention name(s): Ganovo
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
Condition: Cognitive Impairment Associated With Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this randomized, double-blind, placebo-controlled cross-over study is
      to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC)
      and participants with mild-to-moderate schizophrenia (SZ) to determine if the mean
      inter-trial coherence (ITC) magnitude derived from the 40 Hz-ASSR is lower in SZ than in HC
      at baseline.
    

Detailed description: 
      This is a 2-part study. Part 1 is a 2-period study in which participants receive 21 mg
      nicotine patches or placebo patches, each with placebo capsules, in Period 1 and Period 2
      under a cross-over design. In Part 2 (Period 3), participants are randomized to receive
      either MK-4334 250 mg capsule or placebo capsule, each with placebo patches.
    

Intervention name(s): Nicotine patch; MK-4334; Placebo patch; Placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Nicotine 21 mg transdermal nicotine patch.; MK-4334 250 mg capsule taken by mouth.; Placebo patch.; Placebo capsule taken by mouth.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Comparison the Intubation of a Left Sided Double Lumen Tube and Uniblocker
Condition: Therapeutic Procedural Complication
Study type: Interventional

Summary: 
      One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical
      visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the
      commonly used device for OLV.The objective of our study was to comparison the safety and
      effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under
      the guidence of chest computed tomography (CT) image.
    

Detailed description: 
      One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical
      visualization by collapsing the lung. The double-lumen tube (DLT) and Bronchial blockers
      (BBs) are the commonly used device for OLV.The objective of this study is to comparison the
      safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the
      Uniblocker under the guidence of chest computed tomography (CT) image(the operator count the
      number of CT slices (slice thickness is 5mm) from vocal cord slice to carina slice to
      calculate the distance between vocal cord and carina) then measure a distance on the DLT or
      Uniblocker from the upper edge of the cuff to the mouth side and made a marker on the DLT or
      Uniblocker.During the intubation the operator insert the DLT or Uniblocker into the trachea
      via video laryngoscope, after passing the glottis the DLT or Uniblocker are advanced toward
      the left main-stem bronchus, once the anesthesiologist see the marker on the DLT or the
      Uniblocker just above the vocal cord stop the insertion.
    

Intervention name(s): Uniblocker; Left-sided Double-lumen Tube
Intervention type(s): Device; Device
Intervention description(s): The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery.; the double-lumen tube (DLT) is the most commonly used device for OLV
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Neurotrophic Factors and Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Study intended to determine if there are baseline differences in serum neurosteroid levels
      and neurotrophic factor (BDNF) levels in healthy controls vs unmedicated depressed subjects,
      and whether the levels of these change with antidepressant treatment. Study also intended to
      determine if baseline neurosteroid/ BDNF levels, and the change in these levels with
      =treatment, are correlated with clinical antidepressant response to escitalopram (Lexapro).
    

Detailed description: 
      The study was approved by the UCSF Committee on Human Research, and all participants gave
      informed consent. The depressed subjects began treatment with placebo for one week, followed
      by escitalopram for eight weeks (10 mg per day x 4 weeks, followed by 20 mg per day x 4
      weeks, as tolerated) in a double-blind, fixed-order, within-subject cross-over manner. The
      depressed subjects and the psychiatric rater were unaware of the study design and the
      sequence and duration of treatments. Depressed and control subjects underwent venipuncture to
      obtain blood for assays. The controls underwent venipuncture once, and the depressed subjects
      had venipuncture just prior to beginning active escitalopram treatment and again after 8
      weeks of escitalopram treatment. Blood was also collected at Weeks 4 and 8 of treatment in
      the depressed subjects for assay of citalopram and citalopram metabolites, to gauge
      medication compliance. Finally, depression severity and global clinical change were assessed
      in the depressed subjects at Baseline and at the end of Week 8 of escitalopram treatment.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SSRI antidepressant
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Depression; BDNF; neurotrophic factor; neurosetroid; allopregnanolone
High-Dose Melphalan Followed by Peripheral Stem Cell Transplant in Treating Patients With Amyloidosis
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma
      cells, either by killing the cells or by stopping them from dividing. Having a peripheral
      stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows
      higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing
      the number of plasma cells, the disease may progress more slowly.

      PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with
      peripheral stem cell transplant works in treating patients with primary amyloidosis or
      amyloidosis associated with multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Assess overall and progression-free survival following high-dose melphalan and
           autologous peripheral blood stem cell transplantation in patients with primary
           amyloidosis.

        -  Evaluate the toxic effects associated with this treatment regimen.

        -  Evaluate the function of involved organs, especially the heart, lungs, and nervous
           system, before and after treatment with this regimen.

      OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte colony-stimulating
      factor (G-CSF) for 5 days and then collected by leukapheresis. Patients receive high-dose
      melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC transplantation.
      G-CSF is given from 1 day after transplantation until the neutrophil count is greater than
      1,500 for 3 consecutive days.

      Patients are followed at 100 days and 1 year post-transplant.

      PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10
      years.
    

Intervention name(s): filgrastim; melphalan; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Procedure; Procedure
Intervention MeSH terms: Melphalan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; primary systemic amyloidosis
Growth and Safety Study of an Infant Formula for Healthy Term Infants
Condition: Infant Development
Study type: Interventional

Summary: 
      A goal of infant formula development is to mimic human milk (HM) both in nutrient composition
      as well as physiologic outcomes. investigators have developed an infant formula for term
      infants that more closely resembles the composition of human milk. The purpose of this study
      is to demonstrate that this formulation meets nutritional requirements and supports age
      appropriate growth of healthy term infants.
    

Detailed description: 
      This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF)
      infants. FF infants will be randomized to receive either a experimental infant formula,
      formulated for healthy term infants (BBN) or a commercially available infant formula for
      healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks;
      infant growth, serum markers for inflammation and tolerance to the formulas will be assessed
      throughout the study.
    

Intervention name(s): BBN; Brand
Intervention type(s): Other; Other
Intervention description(s): BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.; Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Other intervention name(s): BBN-001; Enfamil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Understanding and Improving Diabetes Care for Ethnic Minorities
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study, we are testing the effectiveness of an intervention known as "Coached Care" to
      improve health outcomes and quality of care of patients being treated for type 2 diabetes,
      particularly patients in underserved populations. The intervention involves training members
      of minority communities who have diabetes to be "coaches", teaching minority patients the
      skills needed to participate effectively in care during office visits, as they present for
      those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing
      participation skills before and between their routine office visits.
    


Intervention name(s): Coached Care; Standard Diabetes Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Coached Care pairs patients with linguistically and ethnically matched peer "coaches", who themselves have diabetes, and have been trained to meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. Using a decision tree algorithm, they help patients identify relevant questions about symptoms, barriers to self-management and treatment options to discuss with doctor. They encourage mutual decision-making about tailoring the patient's medication regimen, diet and physical activities and work with the patients to overcome barriers to communication with their doctor. After the medical visit, the coach and patient review any treatment decisions and goals for self-care.; Patients randomized to the control group will receive 20 minutes of standardized diabetes education delivered by staff research assistants. Education materials have been adapted from materials developed by the American Diabetes Association. The content of these materials includes information about the causes and complications of diabetes, as well as ways to reduce complication risks. Patients in the control arm will receive 20 minutes of standardized diabetes education before each visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Healthcare Disparities
Effect of Hot Water Immersion on Heart Rate Variability and Glucose
Condition: Glucose Tolerance; HRV
Study type: Interventional

Summary: 
      Heat therapy has been shown to reduce risk of various diseases, including heart disease,
      alzheimers, and pneumonia, as well as all-cause mortality . A previous study found heating a
      single hand lowers postprandial blood glucose levels with a magnitude similar to certain
      exercise interventions such as 40 minutes of slow walking We propose that heating both feet
      and heating both legs up to the calves will result in similar glucose reductions in a dose
      response manner.Overview To determine the effect of heating both feet to the ankles and
      heating both legs to the calves on postprandial blood glucose
    


Intervention name(s): Feet heating; Calf heating
Intervention type(s): Procedure; Procedure
Intervention description(s): Feet placed in hot water; Feet to calves placed in hot water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Influence of Neuromuscular Reversal on Neurological Physical Exam Time in Lumbar Neurosurgical Cases.
Condition: Neurological Complication
Study type: Observational

Summary: 
      Neurological physical exam is a very important outcome that should be evaluated as soon as
      possible after every lumbar procedures. The aim of this study was to evaluate the
      neurological physical examination time after lumbar procedures.
    

Detailed description: 
      Neurological physical exam is a very important outcome that should be evaluated as soon as
      possible after every lumbar procedures. By that early postoperative neurological
      complications can be revealed and early interventions planned. The aim of this study was to
      evaluate the neurological physical examination time after lumbar procedures. Two routinely
      used different reversal agents (neostigmine or sugammadex) were compared according reversal
      times and muscle strength on PACU admission.
    

Intervention name(s): Neurological physical exam
Intervention type(s): Diagnostic Test
Intervention description(s): Neurological physical exam is performed in all patients at the OR table, immediately after the operation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All lumbar surgeries performed during the study period were enrolled in the study.
Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      In this project, the investigators aim to compare the safety, efficacy, and predictability
      outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an
      effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may
      lead to preservation of endothelial cells compared to conventional CE IOL.
    

Detailed description: 
      This study will only include patients who are eligible to undergo cataract surgery. All
      patients will receive treatment that is FDA approved for cataract surgery. Because all study
      participants will have been scheduled for elective cataract extraction regardless of their
      participation in this study, there will be little or no additional surgical risk associated
      with participation. A total of 720 patients are expected to be enrolled in the study during a
      period of 2 years. The investigators will recruit patients with bilateral operable cataracts.
      One eye will undergo cataract surgery using conventional cataract extraction technique
      including phacoemulsification whereas the second eye will undergo FLACS. No significant
      increased risk to the patient is expected in either arm of the study compared to routine
      cataract surgery. The patients will be examined as per previous post-operative cataract
      surgery guidelines on POD1, POW1, POM1, POM3, POM6, POY1 and POY2. The only treatment
      difference will take place at the time of the cataract surgery. Post-operatively, endothelial
      cell count will be obtained by the no-touch technology of specular microscopy at baseline as
      well as three months after surgery. If the study ends prematurely, the investigators do not
      anticipate any significant change in the care of the patient.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who present to our center with visually significant cataract and who may benefit
        from cataract surgery
      
Keywords: Cataract, femtosecond laser, FLACS