bioihbjkbjnl/mcl2 huggingface dataset:
Deformation of the Diaphragm Zone of Apposition
Condition: Respiratory Physiology
Study type: Observational

Summary: 
      The assessment of the work of the respiratory muscles is a fundamental clinical data in
      intensive care, especially to guide the management of patients requiring ventilatory support.
      This data is difficult to access in current practice. The reference technique to estimate the
      work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and
      evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The
      ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the
      deformation of the respiratory muscles during the respiratory cycle.

      The investigators hypothesize that the analysis of the multidimensional deformation of the
      diaphragm at the level of the apposition zone can produce a robust and reproducible index,
      which is correlated with the work of breathing. The performance of this index will be
      compared to that of the thickening fraction of the diaphragm. On the other hand, the
      investigators will evaluate the feasibility of measuring the thickening of the accessory
      respiratory muscles (scalene and intercostal).
    

Detailed description: 
      Fifteen healthy subjects will be equipped with a double-balloon esophagogastric tube and
      subjected to increasing and gradual loading of the respiratory system by a negative-pressure
      inspiration device. The respiratory work will be recorded continuously by measuring the
      transdiaphragmatic pressure (reference technique).

      The recording of the deformation of the diaphragmatic apposition zone by speckle tracking
      technique will make it possible to define a multi-dimensional deformation index of this
      muscular portion.

      The reproducibility and the repeatability of this index will be evaluated then this index
      will be compared to the reference technique, as well as to the fraction of thickening. The
      deformation of the accessory muscles will also be evaluated in a second step.
    

Intervention name(s): diaphragm ultrasound
Intervention type(s): Other
Intervention description(s): respiratory loading
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The subjects and participants will be contacted individually by the investigators. The
        principles of the study will be explained and explained to the volunteer.
      
Keywords: diaphragm; ultrasound
Accu-Chek Combo in Young Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This is an open, prospective, descriptive study aiming to evaluate the change in treatment
      satisfaction of primary care givers of young children who use the Accu-Chek Combo System.
      Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System
      on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment
      Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a
      distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes
      related therapeutic information will be collected and data about the use of the device
      components will be downloaded from the Accu-Chek Combo System
    


Intervention name(s): Accu-Chek Combo System
Intervention type(s): Device
Intervention description(s): 12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes,
        Schneider Children's Medical Center, which is a tertiary hospital
      
Keywords: Insulin Pump Therapy; Type 1 Diabetes; Treatment Satisfaction
Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Systolic Murmurs; Wounds and Injuries; Neck Injuries
Study type: Observational

Summary: 
      A systolic blood pressure (SBP) lower than the heart rate (HR) could indicate a poor
      condition in trauma patients. In such scenarios, the reversed shock index (RSI) is <1, as
      calculated by the SBP divided by the HR. This study aimed to clarify whether RSI could be
      used to identify high-risk adult patients with isolated traumatic brain injury (TBI).
    


Intervention name(s): reversed shock index < 1; reversed shock index ≥ 1
Intervention type(s): Other; Other
Intervention description(s): Among patients with isolated TBI, those with an RSI < 1 had higher mortality; Among patients with isolated TBI, those with an RSI ≥ 1 had lower mortality
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and
        without severe injury to other regions (other AIS ≤ 1) were included. We excluded patients
        younger than 18 or older than 65 years of age. Patients were grouped and analyzed according
        to RSI (< 1 or ≥ 1).
      
Keywords: systolic blood pressure; reversed shock index; traumatic brain injury; mortality
A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study
      to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC
      administraion of CM326 at different doses in healthy subjects.

      40 healthy male subjects will be enrolled in the study. The drug will be administered by
      dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.
    


Intervention name(s): CM326; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a humanized monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extraperitoneal Versus Transperitoneal Cesarean Section
Condition: Cesarean, Extraperitoneal
Study type: Interventional

Summary: 
      The aim of the study is to compare post operative morbidity between extra peritoneal cesarian
      and trans peritoneal cesarean section.
    


Intervention name(s): Extraperitoneal Cesarean; Transperitoneal Cesarean
Intervention type(s): Procedure; Procedure
Intervention description(s): Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry; Pfannenstiel-Kerr technique for laparatomy and uterine entry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cesarean, extraperitoneal; Cesarean; Pain
Diabetes Prevention in Women With a Recent History of Gestational Diabetes (Focus Groups)
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      The objective of this research is to conduct focus groups in order to adapt the Diabetes
      Prevention Program (DPP) so that it may successfully target women diagnosed with gestational
      diabetes (GDM) who are at high risk for developing Type 2 diabetes in the post-partum period.
      As this research seeks to gather formative data for a future intervention, the focus groups
      will: 1) provide information to maximize participation in the future intervention and 2)
      inform the location, content and format of the intervention.

      We will be conducting focus groups and informant interviews to determine the DPP
      modifications necessary for adapting to the post-partum lifestyles of women with a recent
      history of GDM. Subjects will attend a 1 hour focus group or phone interview where they will
      be encouraged to respond to the facilitators' questions and to each other's comments on
      topics such as: gestational diabetes, healthy eating, exercise, and other type 2 diabetes
      prevention related activities. Working with a variety of health care providers, including
      endocrinologists, obstetricians and nurse-practitioners, we will identify and enroll up to 60
      women total who are either current GDM patients at BWH or have a recent history of GDM who
      have delivered at Brigham and Women's Hospital in the last 5 years.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Healthy women with a diagnosis of gestational diabetes during a pregnancy within the past 5
        years
Comparison of Transfers of Fresh and Thawed Embryos in Normal Responder Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This study tests the hypothesis that controlled ovarian stimulation impairs endometrial
      receptivity in normal responders.
    

Detailed description: 
      The purpose of this study is to determine if blastocyst transfers in cycles of post-thaw
      extended culture (PTEC) have different efficacy than transfers of fresh blastocysts in
      patients with expected normal response to ovarian stimulation.

      Multiple studies have found altered endometrial histology and gene expression following
      controlled ovarian stimulation.

      PTEC cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. Once
      thawed, the embryos are cultured to the blastocyst stage before transfer.

      In typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do
      not actually resume and continue development. PTEC ensures the transfer of embryos that
      resumed development and continued developing at least to the blastocyst stage (4-5 days
      post-thaw).

      The viability of a blastocyst in a PTEC cycle has been shown to be on par with that of a
      fresh blastocyst. Therefore, comparing outcomes of blastocyst transfers in PTEC cycles with
      that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian
      stimulation to be assessed.
    

Intervention name(s): Embryo cryopreservation; Fresh blastocyst transfer
Intervention type(s): Procedure; Procedure
Intervention description(s): Cohort cryopreserved as bipronuclear (2pn) oocytes, then thawed and cultured to the blastocyst stage before transfer to the uterus.; Fresh blastocyst transfer following cycle of controlled ovarian stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blastocyst transfer; endometrial receptivity; IVF; in vitro fertilization; embryo cryopreservation
Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion
Condition: Coordination and Balance Disturbances; Healthy
MeSH terms: Illusions
Study type: Interventional

Summary: 
      The purpose of this study is to examine the influence of extremity manipulation on
      individual's center of pressure after they adapt to an ankle based illusion.
    


Intervention name(s): chiropractic manual therapy
Intervention type(s): Other
Intervention description(s): high velocity low amplitude thrust into a human joint
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Radiation Therapy in Treating Patients With Metastases to the Lymph Nodes in the Neck From an Unknown Primary Tumor
Condition: Carcinoma of Unknown Primary
MeSH terms: Carcinoma; Neoplasms, Unknown Primary
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
      therapy in different ways may kill more tumor cells. It is not yet known which regimen of
      radiation therapy is more effective in treating patients who have metastases to the lymph
      nodes in the neck.

      PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in
      treating patients who have metastases to the lymph nodes in the neck from an unknown primary
      tumor.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the disease-free survival of patients with cervical lymph node metastases of
           squamous cell carcinoma from an unknown primary treated with selective irradiation vs
           extensive irradiation.

        -  Compare the overall survival of patients treated with these regimens.

        -  Compare the incidence of acute and late side effects in the head and neck region in
           patients treated with these regimens.

        -  Compare control of the neck and incidence of subsequent primary in the head and neck
           region in patients treated with these regimens.

        -  Compare quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to disease stage (N1-2a vs N2b-3), radiation technique (2D vs 3D conformal vs
      intensity-modulated), and participating center. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients undergo selective irradiation of the ipsilateral level of the neck once
           daily 5 days a week for 6 weeks.

        -  Arm II: Patients undergo extensive irradiation of the neck (nasopharyngeal,
           oropharyngeal, hypopharyngeal, and laryngeal mucosa and ipsilateral neck node areas on
           both sides of the neck) once daily 5 days a week for 6 weeks.

      In both arms, treatment continues in the absence of unacceptable toxicity or disease
      progression.

      Quality of life is assessed at baseline, at week 4, on the last day of therapy, and then
      every 3 months for 1 year.

      Patients are followed at day 30, every 3 months for 3 years, every 6 months for 2 years, and
      then annually thereafter.

      PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this
      study within 7 years.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: newly diagnosed carcinoma of unknown primary; squamous cell carcinoma of unknown primary
A Comparison of Short Interval vs. Routine Postpartum Visit on Contraceptive Initiation
Condition: Contraception
Study type: Interventional

Summary: 
      The current postpartum care model of a single visit 4-6 weeks after delivery does not
      optimally address contraceptive needs. By this visit, many women have resumed sexual
      activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In
      addition, many women with pregnancy-related Medicaid lose insurance coverage at this time,
      making it difficult to obtain long-acting reversible contraception (LARC) if desired.
      Therefore, an earlier postpartum visit may remove barriers to improve access to LARC thereby,
      reducing unintended and rapid repeat pregnancy. Our primary objective is to determine whether
      an additional 3-week postpartum visit, compared to usual postpartum care, will affect the
      initiation of LARC by 6 weeks postpartum.
    

Detailed description: 
      Our primary objective is to determine whether an additional 3-week postpartum visit, compared
      to usual postpartum care, will affect the initiation of LARC by 6 weeks postpartum. Our
      secondary outcomes include: 1) desired method of postpartum contraception; 2) continuation
      and satisfaction with contraception; and 3) incidence of rapid repeat and unintended
      pregnancy at 12 months. We will also measure attendance and satisfaction with 3- compared to
      6-week postpartum visits.We will perform a two-arm randomized controlled trial (RCT). Women
      will be randomized to routine postpartum follow-up compared to two postpartum visits; one at
      3 weeks and one at 6 weeks, with initiation of contraception at the 3-week visit as
      indicated. Women will be recruited from the postpartum service of Barnes-Jewish Hospital and
      all women will receive structured comprehensive counseling (adapted from the CHOICE Project
      Model) prior to discharge from the hospital. Postpartum visits will occur at our outpatient
      ambulatory clinic sites. Participants will complete in-person surveys at baseline and at each
      visit, and telephone surveys at 6- and 12-months postpartum. Planned recruitment will be 200
      women based on a 2-fold increase in LARC initiation in the intervention group compared to
      control group (40% vs. 20% initiation rate).
    

Intervention name(s): 3-week visit; usual care
Intervention type(s): Other; Other
Intervention description(s): The intervention will be an additional visit to the usual postpartum care provider at 3-weeks postpartum.; Participants in the usual care arm will receive no additional interventions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantification of UE Use and Effects of Feedback in the Home Setting
Condition: Stroke
Study type: Interventional

Summary: 
      The investigators are proposing a pilot study, the purpose of which is to use accelerometers
      to quantify UE use (1 and two hand use) in people post-stroke from which the investigators
      will develop use-based feedback to improve recovery in the home setting. The objectives of
      this pilot study are to:

      i.) determine the feasibility of using accelerometers to quantify amount of UE use in the
      home setting in individuals chronic post-stroke,

      ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger
      (non-paretic) UEs, and

      iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on
      unilateral and bilateral UE use.

      iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally
      in subjects post-chronic stroke pre and post feedback.
    


Intervention name(s): Accelerometer based feedback about paretic arm use
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids
Condition: Eosinophilic Esophagitis; Eosinophilic Gastrointestinal Disorders (EGIDs)
MeSH terms: Esophagitis; Eosinophilic Esophagitis; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this interventional study is to test and compare the effectiveness of two
      elimination diets-the 1-food elimination diet (1FED, milk only) and the 4-food elimination
      diet (4FED, milk, egg, wheat, and soy) for eosinophilic esophagitis (EoE). The study will
      also test the effectiveness of swallowed glucocorticoid therapy in some of the study
      participants for whom diet therapy was not effective.
    

Detailed description: 
      This study will consist of two phases, plus a screening period. During the screening period,
      subject eligibility for the study will be determined. During Phase 1, qualified participants
      will be randomly assigned to one of two elimination diet therapies--the 1FED or the 4FED.
      Participants will remain on the assigned dietary therapy for 12 weeks. At the end of 12 weeks
      of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine
      care) endoscopy will be evaluated to determine disease status. Participants whose EoE is in
      remission (i.e. <15 eos/hpf) will be done with the study.

      Participants whose EoE is still active (i.e. ≥15 eos/hpf) will continue into Phase 2 of the
      study. During Phase 2, participants who were on 1FED in Phase 1 will receive 4FED therapy for
      12 weeks, and participants who were on 4FED during Phase 1 will receive swallowed
      glucocorticoid therapy for 12 weeks. At the end of 12 weeks of therapy, esophageal biopsies
      from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated
      to determine disease status.
    

Intervention name(s): 1 Food Elimination Diet; 4 Food Elimination Diet; 4 Food Elimination Diet (post 1FED failure); Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): Participants eliminate milk from the diet for 12 weeks; Participants eliminate milk, egg, wheat, soy from the diet for 12 weeks; Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in Phase 2; Participants that fail to respond to 4FED in phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in Phase 2
Other intervention name(s): 1FED; 4FED
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of TAK-227 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to test the effects of food consumption with sponsor compound
      TAK-227 in healthy participants. The study will also measure side effects, and to check how
      much TAK-227 stays in the blood over time to work out the best dose.
    

Detailed description: 
      The drug being tested in this study is called TAK-227. This study will assess the effect of
      food on single-dose of TAK-227 in healthy participants.

      The study will enroll approximately 24 participants. A single dose of 50 milligram (mg)
      TAK-227 will be administered orally under one of 3 different feeding conditions.

        -  Fasting (Treatment A),

        -  Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and

        -  Fed following a high-fat or high-calorie meal after dosing (Treatment C)

      Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3
      feeding conditions.

        -  Sequence 1: (Treatment A + Treatment B + Treatment C)

        -  Sequence 2: (Treatment B + Treatment C + Treatment A)

        -  Sequence 3: (Treatment C + Treatment A + Treatment B)

        -  Sequence 4: (Treatment A + Treatment C + Treatment B)

        -  Sequence 5: (Treatment B + Treatment A + Treatment C)

        -  Sequence 6: (Treatment C + Treatment B + Treatment A)

      All participants will receive all 6 treatment regimens. This is a single-center trial.
      Participants will be followed up for up to 7 days after the last dose of study drug for a
      follow-up assessment. The overall time to participate in this study is approximately 40 days
      including screening period and follow-up period.
    

Intervention name(s): TAK-227
Intervention type(s): Drug
Intervention description(s): TAK-227 capsules.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy