bioihbjkbjnl/mcl2 huggingface dataset:
Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor
      analgesia. The DPE technique is a modification of the combined spinal epidural (CSE)
      technique, where a dural perforation is created from a spinal needle but intrathecal
      medication administration is withheld. The DPE technique has been shown to improve caudal
      spread of analgesia compared with epidural technique without the side effects observed with
      the CSE technique.
    

Detailed description: 
      Investigators designed this prospective interventional study to determine if morbid obesity
      would influence DPE technique regarding labor analgesia onset and block characteristics.
    

Intervention name(s): Dural puncture epidural
Intervention type(s): Other
Intervention description(s): Parturients, between 18 and 45 years of age, with cervical dilation less than 5 cm were consented to receive a DPE technique, with a single dural puncture with a 26-gauge spinal needle. After successful placement of the epidural catheter and puncturing the dura; 20 mL of bupivacaine 0.25% was administered through the epidural catheter and a patient-controlled epidural infusion of bupivacaine was initiated.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Morbid Obesity; Labor Pain
Irritable Bowel Syndrome and Food Sensitivity
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      The primary objective of the clinical trial portion of this study is to assess whether an
      individualized dietary plan based on a commercial food sensitivity assay provides specific
      benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).
    

Detailed description: 
      This is a parallel group, randomized control trial, powered to assess changes in validated
      outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive
      dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments
      will occur at baseline, 4-weeks, and 8-weeks post-baseline.
    

Intervention name(s): Personalized Dietary Advice
Intervention type(s): Other
Intervention description(s): Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; IBS; Diet; Food sensitivity
Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a
      naturally occurring chemical in your body) has efficacy in reducing the methamphetamine
      craving of the subjects with methamphetamine dependence craving and helping them maintain the
      abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic
      marker for neuronal viability) level of participants to determine if brain deficits induced
      by methamphetamine may recover by taking CDP-choline.
    


Intervention name(s): CDP-choline; Placebo (fructose)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The subjects will be given 1g citicoline twice daily for a total of 8 weeks.; The Subjects will be given 2 tablets of placebo twice daily for 8 weeks. They will be taking the same quantity as the CDP-choline group.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism
Condition: Type 2 Diabetes; Prediabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It has previously been shown in healthy overweight subjects, that table water including a
      defined amount of amino acids and chromium can decrease the postprandial glucose and insulin
      response. In this study, the effect of this table water on glucose excursions after a test
      meal containing a defined amount of available carbohydrates, protein and fat will be studied
      in patients with early type 2 diabetes or prediabetes according to guidelines that are
      treated with dietary measures or metformin only. The study will be conducted in a cross -over
      design, double blinded and placebo controlled including 20 participants. The primary endpoint
      of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180
      minutes after ingestion of the meal.
    


Intervention name(s): Amino Acid and chromium-picolinate containing drink; Placebo Drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.; Placebo drink ist taken with a test meal to study efects on glucose and insulin response.
Intervention MeSH terms: Chromium; Picolinic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Model-based Iterative Reconstruction (MB-IR VEOTM) in Ultra Low-dose Abdominal CT Versus Adaptative Statistical Iterative Reconstruction (ASIR): A Prospective Study for Acute Renal Colic
Condition: Model-based Iterative Reconstruction (MB-IR VEOTM)
MeSH terms: Renal Colic
Study type: Interventional

Summary: 
      The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR
      VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal
      colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).
    

Detailed description: 
      Renal colic is a common recurrent pathology in young patients, multi explored by imaging such
      as CT and abdominal radiography.

      Abdominal MDCT(MultiDetector Computed Tomography) without injection is the gold standard in
      diagnosis of acute flank pain suspect of renal colic due to high sensitivity (96%) and
      excellent specificity (100%).

      The increased use of medical imaging examinations using ionizing radiation (+57 % between
      2002 and 2007) makes it essential to optimize protocols, including CT-scans which represents
      10.1 % of procedures and 58 % of the collective effective dose.

      Model-based iterative reconstruction (MB-IR VEOTM) (GE Healthcare, Milwaukee, WI) can use a
      low dose acquisition, reducing the effective dose delivered to the patient almost 80%
      comparing a standard CT with the last algorithm: adaptative statistical iterative
      reconstruction (ASIR).

      MB-IR VEOTM shows great potential for substantially reducing radiation doses at routine
      abdominal CT. ASIR is limited in this regard owing to reduced image quality and diagnostic
      capability. Further investigation is needed to determine the optimal dose level for
      MBIR(Model Base Iterative Reconstruction) that maintains adequate diagnostic performance. In
      general, objective and subjective image quality measurements do not necessarily correlate
      with diagnostic performance at ultralow-dose CT.

      Objective:

      Prospective clinical study, equivalence between two CT protocols for the diagnosis of acute
      renal colic.

      Show that a low dose acquisition with model based iterative reconstruction (MB-IR VeoTM) is
      as good as a standard CT with adaptative statistical iterative reconstruction (ASIR) in the
      diagnosis acute renal colic
    

Intervention name(s): Model-based iterative reconstruction (MB-IR VEOTM) on CT Discovery 750HD (GE Healthcare, Milwaukee, WI)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Model-based iterative reconstruction MB-IR; VEOTM; Ultra low-dose; Abdominal CT; Dose reduction; Adaptative statistical iterative reconstruction ASIR; Acute renal colic
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
Condition: Overweight; Obesity; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Dietary protein is a key element of most effective weight loss regimens. This study will
      investigate the effects of consuming soy protein on body composition and cardiometabolic
      health within the context of an effective weight loss and maintenance program called the
      Colorado Diet.
    

Detailed description: 
      This is a randomized study comparing the efficacy of inducing weight loss of two treatment
      arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study
      arms and instructed to follow the Colorado Diet by participating in weekly State of Slim
      group classes. Subjects will be followed in the study for one year. The Colorado Diet
      consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16).
      The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study
      visit and body composition will be determined using DXA. Blood lipid and lipoprotein
      concentrations, health & wellness questionnaires, and fitness measures will also be assessed
      throughout the study.
    

Intervention name(s): Colorado Diet with soy protein foods.; Colorado Diet with monetary payments
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Phase 1 (week 1-2): Participants will be given soy protein powder and asked to consume 3 protein shakes per day.
Phase 2 (week 3-8): Participants will be given both protein powder and soy patties designed to be similar to other phase 2 acceptable foods and will be asked to consume 2 soy protein shakes and 1 soy patty per day.
Phase 3 (week 9-16): Participants will be given protein powder, soy patties, and protein bars designed to be similar to other phase 3 acceptable foods and will be asked to consume 1 soy protein shake, 1 soy patty and 1 soy protein bar per day.
Maintenance Phase (month 5-12): Participants will continue to receive study food products (protein powder, patties and protein bars); Phase 1 (week 1-2): Participants will be given monetary stipend and asked to consume 3 non-soy protein shakes per day.
Phase 2 (week 3-8): Participants will be given monetary stipends and asked to consume 2 non-soy protein shakes per day.
Phase 3 (week 9-16): Participants will be given monetary stipend and asked to consume 1 non-soy protein shake and 1 non-soy protein bar per day.
Maintenance Phase (month 5-12): Participants will continue to receive monetary stipend.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Soy; Obesity; Weight Loss; Muscle; Cardiovascular Disease; Colorado Diet
Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the proposed phase I trial is to evaluate the safety and
      tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123
      and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and
      have shown to be safe and well tolerated, this is the first time the combination regimen is
      being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The
      secondary objective of the trial is to evaluate the effect of S. mansoni infection on the
      immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen.
      Successful vaccination against most viruses requires efficient Th1 response. There is
      evidence that helminth infections skew the host immune system of human and animals to
      T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that
      helminth infected populations may not generate the desired immune responses to vaccines
      designed to drive Th1-type and cytotoxic T-cell responses.

      Furthermore, the influence of helminth infections on the development of protective antibody
      responses remains unclear. Limited data in animal models suggests that worm infections
      reduced efficacy of vaccines.

      The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a
      vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine
      (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine
      trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune
      responses to HIV vaccines.
    


Intervention name(s): DNA; AIDSVAX B/E
Intervention type(s): Biological; Biological
Intervention description(s): DNA co-administered with protein at month 0, 1 and 6; Protein co-administered with DNA at month 0,1 and 6
Other intervention name(s): DNA-HIV-PT123
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV/AIDS vaccine; helminth infection; Impact of co-infection
The HEALS Project - Health Education and Active Living for Surviving Seniors
Condition: Cancer Survivorship; Safety and Efficacy; Quality of Life
Study type: Interventional
Phase: Phase 2

Summary: 
      Persons over age 65 years constitute a large and growing population of cancer survivors.
      Available data indicate that both short- and long-term female breast cancer survivors report
      more limitations related to strength and mobility than women with cancers of other sites and
      women without a personal history of cancer. Further, better mental health among breast cancer
      survivors has been shown to protect against physical decline and overall quality of life. The
      combination of mental and physical interventions may result in substantial improvements in
      quality of life. Tai Chi Chih (TCC), a form of mind-body exercise, is one such intervention.
      TCC may be particularly suited toward elderly breast cancer survivors with impaired physical
      and/or mental functioning, yet despite its increasing popularity and benefits in healthy and
      diseased populations, its benefits have never been scientifically evaluated in this
      population. The overarching goal of this study is to conduct preparatory work regarding the
      effects of TCC on quality of life and physical function that will underpin future definitive
      trials of TCC in elderly cancer survivors. As part of this 12-week trial, participants will
      be randomized to a TCC or a health education control group (HEC). Establishment of meaningful
      interventions that facilitate a more positive cancer survival experience in old age is an
      important issue; there are substantial public health and clinical benefits should a TC
      intervention be successful in this patient population.
    


Intervention name(s): Tai Chi Chih; Health Education Classes
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.; The Health Education classes serve as an attention control group, are led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: tai chi; elderly cancer survivor; mind body intervention
Study of Obese Subjects Previously Implanted With the EndoBarrier Gastrointestinal Liner
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the GI Endobarrier Liner can be
      reimplanted.
    

Detailed description: 
      Patients with obesity are at significantly greater risk of developing significant co-morbid
      complications, and are associated with an increased risk in all-cause mortality. The GI
      Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It
      is a minimally invasive endoscopic procedure, which may allow patients to recover faster with
      less morbidity and mortality. This study is investigating whether the the GI Endobarrier
      Liner can be reimplanted.
    

Intervention name(s): Endobarrier Liner
Intervention type(s): Device
Intervention description(s): Medical device placed endoscopically in the duodenum
Other intervention name(s): GI Sleeve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this project is to determine the effect of lower back injections on select
      biomechanical outcomes, walking patterns, lower back flexibility and balance.
    

Detailed description: 
      The purpose of this project is to determine the effect of lumbar injections on select
      biomechanics parameters; walking pattern, lumbar flexibility and balance. The surveys will
      help assess the patient's sense of functional ability and feeling of wellness compared with
      low back pain scores. The long terms goals of this project will be to elucidate the mechanism
      of action of injections and to improve identification of patients that are likely to benefit
      from injection therapy
    

Intervention name(s): Observation of biomechanical effects post injection
Intervention type(s): Other
Intervention description(s): Observation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients receiving a lumbar epidural steroid injection for lumbar spine stenosis
      
Keywords: low back pain; lumbar; injection; lumbar pain
Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the amount of tooth movement achieved over time
      between subjects undergoing aligner treatment using a pulsation device known as AcceleDent®
      Aura with those not using the device.
    

Detailed description: 
      There are many variables that can affect the rate of tooth movement. Preliminary data showed
      that the rate of tooth movement may be affected by variables such as age, sex, as well as
      alveolar bone levels, tooth root length and alveolar bone quality. The purpose of this study
      is to examine the amount of tooth movement achieved over time between subjects undergoing
      aligner treatment using a pulsation device known as AcceleDent® Aura with those not using the
      device.

      A preliminary validation pilot study will be done to calibrate all staff on study procedures.
      The pilot will consist of 3 subjects using the active AcceleDent® Aura device and 3 using the
      sham control AcceleDent® Aura device for 4 weeks. Study staff will be calibrated for all
      study procedures.

      The primary study will be a prospective, single-center, randomized crossover clinical trial
      comparing two groups of subjects with 40 participants. Subjects will be randomized to groups
      that will receive aligner treatment while using either an active AcceleDent® Aura device or a
      sham control AcceleDent® Aura device for the first 6 weeks of the study. After 6 weeks,
      groups will cross-over and switch devices, and tooth movement will be followed for another 6
      weeks. Patients will be blinded as to which device they are using. Amount of tooth movement
      per week, pain perception, and change in gingival crevicular fluid biomarkers will be
      outcomes assessed. Device safety evaluation to be performed will include adverse events and
      clinical examination findings including pulp vitality testing and periodontal probe results.
    

Intervention name(s): AcceleDent Aura; Sham Device
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Orthodontic; Orthodontic Treatment; Accelerated Tooth Movement; Malocclusion; Device; AcceleDent Aura; Clear Aligners
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
Condition: Ventilator Lung; Newborn; Hemodynamic Instability; Echocardiography
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional

Summary: 
      The aim of the present work is to study the cardio-respiratory effects of non-invasive
      ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of
      respiratory distress in moderate and late preterm infants as regard:

      I. Primary outcomes:

        -  Duration of the non- invasive respiratory support.

        -  Need of invasive ventilation in the first 72 hours.

        -  Short-term complications such as air leak syndromes, pulmonary hemorrhage,
           intraventricular hemorrhage, and nasal trauma.

      II. Secondary outcomes:

        -  Need for surfactant administration.

        -  Days on invasive mechanical ventilation.

        -  Days on supplemental oxygen.

        -  Duration of hospital stay.

        -  Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.
    


Intervention name(s): NHFOV; NCPAP
Intervention type(s): Device; Device
Intervention description(s): The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.; The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Premature infants; Echocardiography