bioihbjkbjnl/mcl2 huggingface dataset:
Frozen Red Blood Cell Transfusions in Trauma Patients
Condition: Blood Loss; Anemia; Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients
      and evaluate for any differences between the age of the RBCs and how they were stored. The
      investigators will specifically look for the following differences between study groups:

        1. the transfused red blood cells' ability to delivery oxygen to the tissues

        2. differences in biochemical markers in subjects and units transfused, and

        3. how the subject's internal organs are working and if they develop any infections
    


Intervention name(s): RBC units
Intervention type(s): Biological
Intervention description(s): When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: frozen; red blood cells; transfusion; trauma
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is to evaluate the safety and efficacy of Gastric Banding for patients with body
      mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
    

Detailed description: 
      TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND®
      Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with
      co-morbidities

      CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA

      STUDY OBJECTIVES

        -  To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®)
           for patients with BMI between 30-40 kg/m2 with co-morbidities

        -  To determine long-term effects on patients' co-morbidities

      STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status,
      improvement of pre-operative co-morbidities, weight loss maintained, and quality of life
      evaluation

      DESIGN: Prospective single center study
    

Intervention name(s): LAP-BAND® Adjustable Gastric Band (LAGB®)
Intervention type(s): Device
Intervention description(s): Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity, 50 lbs overweight
A Study of JNJ-64251330 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate: systemic and local gut (rectum and sigmoid colon)
      exposure to JNJ-64251330, local tissue Pharmacodynamics (PD) using gut (rectum and sigmoid
      colon) biopsies (Part 1) and the effect of food on the rate and extent of absorption of
      JNJ-64251330 from oral tablet dosed with or without food (Part 2).
    


Intervention name(s): JNJ-64251330; Tofacitinib
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-64251330 tablet will be administered orally.; Tofacitinib tablets will be administered orally.
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique
Condition: Cervical Spine Myelopathy
MeSH terms: Spinal Cord Diseases; Bone Marrow Diseases
Study type: Interventional

Summary: 
      The goal of this clinical trial is to develop a motion recognition system based on video
      tracking technology and combine it with artificial intelligence technology to form a motion
      recognition and function evaluation system in in healthy people and patients with cervical
      spondylotic myelopathy. The main questions it aims to answer are:

        -  The development of this motion recognition system,

        -  In the scenario of hand motor dysfunction, the key parameters of hand movement in
           healthy people and patients with cervical spondylotic myelopathy were evaluated, and the
           hand motor function model was established to achieve an objective, highly sensitive,
           highly specific, repeatable and easy-to-use system in clinical hand motor function
           evaluation.

      Participants will recieved the evaluation of this system and mJOA before the surgery.

      If there is a comparison group: Researchers will compare the evaluation results of healthy
      people to see if this system could recognized the hand motor dysfunction of patients with
      cervical spondylotic myelopathy.
    


Intervention name(s): Motor Function Assessment System
Intervention type(s): Diagnostic Test
Intervention description(s): Participants were instructed to extend their fingers and subsequently clench their fists to the maximum possible range of motion, in order to complete the evaluation of Motor Function Assessment System.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cervical spine myelopathy; Hand motor funciton; Video tracking technology; Artificial intelligence
A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics
      and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects
      with kidney failure compared to the matched control subjects with normal renal function.
    

Detailed description: 
      This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics,
      pharmacodynamics and safety of a single dose of HSK7653 10 mg in subjects with mild,
      moderate, and severe renal impairment , subjects with kidney failure and the control subjects
      with normal renal function. This study consists of a screening period (Day -14 to Day -1), a
      baseline period (Day -1), a treatment period (Day 1 to Day 29), and a follow-up call on Day
      32.

      Subjects will be enrolled in the following groups:

      Glomerular filtration rate (GFR, unit mL/min/1.73m^2) will be calculated based on
      Modification of Diet in Renal Disease (MDRD) equation at screening, Multiply it by BSA, then
      divide by 1.73 to convert to absolute GFR (unit, mL/min) (group A1) mild renal impairment (60
      ≤ GFR< 90 mL/min); (group B1) moderate renal impairment (30 ≤ GFR<60 mL/min); (group C1)
      severe renal impairment (15 ≤ GFR< 30 mL/min); (group D1) kidney failure (<15 mL/min, not on
      hemodialysis); (group A2,B2,C2,D2) control subjects with normal renal function will be
      matched with subjects with renal impairment by weight, age, and sex (GFR≥90 mL/min).If
      subjects in group A2 can be matched with the subjects in groups A1 and B1 at the same time,
      the subjects in group B2 will not be enrolled, and so on.

      Approximately 64 subjects will be enrolled in total.
    

Intervention name(s): HSK7653 tablets
Intervention type(s): Drug
Intervention description(s): HSK7653, tablet, oral
Other intervention name(s): HSK7653
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Bilateral Ultrasonic Guided Sphenopalatine Ganglion Block in Maxilofacial Cancer Surgeries
Condition: Maxillofacial Tumors
MeSH terms: Ganglion Cysts
Study type: Interventional

Summary: 
      Patients will be randomly allocated according to computer - generated tables to one of two
      groups, group (A) ultrasonic guided sphenopalatine block using local anasthetic, group (B)
      ultrasonic guided sphenopalatine block using saline. Before induction anesthesia the
      following will be assessed, time needed to perform the technique, time till onset of the
      block, distribution of the block (Opthalmic, Maxillary, Mandibular) by needle brick.Intra and
      post- operatively the following will be assesse the quality of operative filed every 30 min
      intra-operatively using a pre- defined average category scale (ACS) (from 0 to 5), End tidal
      Sevo Flurane concentration will be recorded intra- operatively every 5 minutes, The total
      amount of Nitroglycerine used to achieve the target MAP and frequency of propranolol usage
      will be recorded,emergence time, postoperative VAS score and amount of meperdine used for
      rescue analgesia.
    


Intervention name(s): sphenopalatine block with local anesthetic; sphenopalatine block with saline
Intervention type(s): Other; Other
Intervention description(s): bilateral ultrasonic guided sphenopalatine ganglion block using local anesthetic after induction of general anesthesia in maxilofacial cancer surgeries; bilateral ultrasonic guided sphenopalatine ganglion block using saline after induction of general anesthesia in maxilofacial cancer surgeries
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study of Retinal Function Using Electroretinogram in Regular Alcohol Users
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Alcohol is a major public health problem and its neurotoxic effects are, among other things,
      responsible for altering the functioning of cerebral neurotransmission pathways.

      The retina is an anatomical and developmental extension of the central nervous system. It is
      composed of several layers of retinal neurons that share similar anatomical and functional
      properties with brain neurons. Retinal neurons are notably equipped with a complex system of
      neurotransmission constituted by the main neurotransmitters that are involved in the central
      effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of
      indirect investigation for abnormal central neurotransmission pathways following regular
      alcohol use. It is recognized to date as a good site for investigating central abnormalities
      in neuropsychiatric and addictive disorders.

      The objective of this project is to study the retinal function using electroretinogram (ERG)
      in regular alcohol users to isolate potential markers of cerebral neurotransmission
      abnormalities.
    


Intervention name(s): electroretinogram (flash, pattern and multifocal)
Intervention type(s): Other
Intervention description(s): we measured the waves a, b, oscillatory potentials, back ground noise and i for the flash ERG, the waves P50 and N95 for the pattern ERG and the P1, N1 and N2 for the multifocal ERG
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: mono centric study, in parallel groups, controlled, non-randomized and open
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: retina AND electroretinogram
Study of Capsule Endoscopy to Determine the Accuracy for Detection of Esophageal Varices
Condition: Esophageal Varices
MeSH terms: Esophageal and Gastric Varices; Varicose Veins
Study type: Observational

Summary: 
      Esophageal capsule endoscopy is sedation-less alternative to upper endoscopy for evaluating
      esophageal lesions and potentially other upper gastrointestinal lesions. The purpose of this
      study was to determine whether esophageal capsule endoscopy is convenient and accurate as
      upper endoscopy for detection of esophageal varices and related lesions.
    


Intervention name(s): Capsule endoscopy, Esophagogastroduodenoscopy
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cirrhotic patients
      
Keywords: Esophageal Capsule Endoscopy, Screening
Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      Allergic rhinitis (AR) is a common disease of nasal mucosa, affecting 10% to 40% of the
      population globally. Allergen specific immunotherapy (AIT) is the only etiological treatment
      available for AR.Traditionally, AIT is divided into subcutaneous immunotherapy (SCIT) and
      sublingual immunotherapy (SLIT). Artemisia annua is one of the most important allergen that
      is responsible for seasonal AR in China during July and October.

      The trial is a randomized, double-blind, placebo-controlled, multicentred, phase III trial.
      702 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized
      to the immunotherapy group and placebo group.
    


Intervention name(s): AIT drops; placebo drops
Intervention type(s): Drug; Drug
Intervention description(s): once a day; once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
Condition: Adenocarcinoma of Head of Pancreas
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on
      the endoscopic biliary stent. This technique has been shown to be preferable to a surgical
      shunt.

      Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized
      the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major
      way. This design will also be developed in patients with neoadjuvant tumor called
      "borderline" (the limit of the resectability).

      However, several conditions (protocol) are required to consider the implementation of this
      design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times
      the ULN.

      In addition, a randomized study showed that preoperative biliary stent treatment, despite a
      success rate of 94%, is associated with more complications than surgery fast (related gesture
      bladder).

      It would be interesting to analyze, prospectively, the fate of a series of patients with
      cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1
      and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.
    


Intervention name(s): Type WallFlex or Evolution biliary, stent system
Intervention type(s): Device
Intervention description(s): Laying of a stent biliary
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laying of the biliary stent
Low Fat Diet and Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate if following a specific low fat diet will improve
      the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression
      of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.
    

Detailed description: 
      This research project has significance for its potential to develop a new therapeutic
      approach to MS. Current treatments in MS include disease modifying therapies such as human
      recombinant interferon beta, glatiramer acetate and natalizumab. However, these are only
      partially effective, cannot be taken orally, have side-effects and are very expensive.
      Developing treatment that can be combined with current disease modifying agent remains an
      important goal for improving the care of people with MS.
    

Intervention name(s): Low fat study diet
Intervention type(s): Other
Intervention description(s): The low fat study diet is a very low-saturated-fat, plant food based diet. It will be approximately 10% fat, 14% protein and 76% carbohydrate.The diet is is starched based and also contains fresh or frozen fruits and vegetables and there is no animal meat used, including no use of fish. This diet is very low in saturated fats and enriched in unsaturated fats. Subjects do not take dietary supplements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Diet
A Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
Condition: Early Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effects of hepatic impairment on the
      pharmacokinetics (PK) of E2609 after a single dose administration.
    


Intervention name(s): E2609
Intervention type(s): Drug
Intervention description(s): Participants will receive a single 50-mg dose (1× 50-mg E2609 tablet).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Alzheimer's disease; E2609; Mild and Moderate Hepatic Impairment
Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers
Condition: Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will aim to prevent postpartum depression in pregnant teenagers through an
      interpersonal therapy-based program.
    

Detailed description: 
      Postpartum depression is believed to be one of the most common complications after pregnancy.
      This type of depression often occurs within the first year after the baby is born and is most
      likely caused by dramatic changes in hormone levels after pregnancy. Pregnant teenagers are
      even more at risk for experiencing complications throughout pregnancy and parenting
      difficulties after delivery. Minimal research has been done on preventive ways to reduce
      postpartum depression in teenagers. Therefore, this study will evaluate the effectiveness of
      an interpersonal therapy-based program at preventing postpartum depression in financially
      disadvantaged pregnant teenagers.

      Participants will first undergo a 15-minute interview about their background and emotions.
      Participants will undergo a second interview and then be randomly assigned to receive either
      interpersonal therapy-based treatment or standard care. Participants assigned to receive
      interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy
      and factors that may play a role in the development of postpartum depression in teenage
      mothers, such as poor social support, role transitions, and life stressors. Participants
      assigned to receive standard care will focus more on the health issues associated with
      pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks.
      Homework may be assigned to review topics discussed, and all participants will receive the
      book Baby Basics. Following treatment, participants will meet with researchers again when
      they are 34 to 36 weeks pregnant; in the hospital after the baby is born; and 6, 12, and 24
      weeks after the baby is born.
    

Intervention name(s): Interpersonal therapy-based treatment; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend weekly 1-hour sessions for 5 weeks.; Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks.
Other intervention name(s): REACH; Baby Basics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Adolescents; Depression, postpartum
TF-CBT for Adjudicated Youth in Residential Treatment
Condition: PTSD
Study type: Interventional

Summary: 
      Adjudicated youth often have traumatic stress responses but rarely receive treatment for
      these problems. This study is a randomized controlled trial to evaluate two alternative
      implementation strategies for providing an evidence-based trauma treatment, Trauma-Focused
      Cognitive Behavioral Therapy (TF-CBT), to therapist who treat adjudicated youth in 18
      residential treatment facilities (RTF) in New Hampshire, Vermont, and Connecticut: 1)
      web-based TF-CBT implementation strategy ("W"), consisting on only web-based training and
      consultation; versus 2) W plus live TF-CBT implementation strategy, consisting of W plus
      face-to face training and phone consultation with TF-CBT experts ("W+L").
    

Detailed description: 
      Therapists in each of 18 participating RTFprograms that serve adjudicated youth are
      randomized to receive either:

        1. W TF-CBT implementation strategy, provided via the free distance learning resources
           TF-CBTWeb, (www.musc/edu/tfcbt) and TF-CBTConsult (www.musc.edu/tfcbtconsult); or

        2. W+L implementation strategy, provided through W + 2 day TF-CBT training plus one year of
           twice monthly TF-CBT consultation calls with a TF-CBT expert trainer.

      All RTF staff receive one day training in trauma-informed care. All therapists in both
      conditions receive training in screening youth for trauma exposure and symptoms. Data are
      collected regarding primary outcomes of: 1) number of youth therapists in each condition
      screen for trauma symptoms, 2) number of youth consent to TF-CBT treatment; 3) number of
      youth complete TF-CBT, 4) TF-CBT fidelity during treatment. Secondary outcomes include
      1)changes in therapist knowledge and satisfaction regarding TF-CBT treatment and 2) youth
      outcomes including PTSD symptoms, depression and satisfaction with treatment.
    

Intervention name(s): TF-CBT
Intervention type(s): Behavioral
Intervention description(s): Web TF-CBT implementation or Web + Live TF-CBT implementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Implementation; TF-CBT; adjudicated youth; RTF; trauma