bioihbjkbjnl/mcl2 huggingface dataset:
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Condition: Peanut Allergy; Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will perform a double blind, placebo controlled clinical trial with Xolair
      (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut
      allergy. The investigators will determine if pretreatment with anti-IgE mAb
      (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer
      desensitization.
    

Detailed description: 
      36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at
      4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University
      and Lurie Children's Hospital.

      Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization.
      Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization,
      receiving their final dose of Xolair one week after reaching the highest tolerated dose of
      peanut.
    

Intervention name(s): Omalizumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Xolair; omalizumab; peanut; oral desensitization
Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
Condition: Scar Formation
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess whether intradermal injections of GBT009
      along full thickness incisions following surgery results in an improvement in scar
      appearance.
    


Intervention name(s): GBT009; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal Injection following surgery; Intradermal Injection following surgery
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GBT009; incisional scar; breast reconstruction
Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the safety and feasibility of autologous
      mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for
      individuals with declining performance of their single right ventricle systemic pumps. This
      procedure has the potential to foster a new strategy for congenital heart patients. This is
      an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to
      document 1) related serious adverse events and 2) monitor changes in cardiac structure and
      function.
    

Detailed description: 
      This study is an open label Phase I trial to determine the safety and feasibility of bone
      marrow-derived mononuclear cells delivered into the coronary circulation of subjects with
      Fontan circulation and right ventricular dysfunction. Subjects will be screened at outpatient
      clinic visits at Mayo Clinic and interested qualified subjects will be consented and offered
      participation in this trial. Once informed consent has been obtained; preoperative values
      will be established and a selection committee will review subjects within three days prior to
      planned procedure to confirm inclusion and exclusion criteria. This will require a non-study
      cardiologist to review the clinical case and confirm the baseline cardiac function with
      evidence of disease progression with right ventricle dysfunction. However, individuals with
      decreased cardiac function requiring inotropic support and immediate listing for cardiac
      transplantation will NOT be included such that the risk of this research procedure may not be
      acceptable. Following cell-based product delivery, subjects will be followed for 6-months
      according to a pre-determined schedule that includes imaging studies along with
      questionnaires, electrophysiology and laboratory studies. Subjects will be contacted for an
      additional 18-months for surveillance by phone.
    

Intervention name(s): Autologous Bone Marrow-derived Mononuclear Cells
Intervention type(s): Biological
Other intervention name(s): MNC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Single right ventricular failure
A First-In-Human Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single and multiple
      oral doses of JNJ-64417184 administered to healthy participants and the antiviral effect of
      multiple oral doses of JNJ-64417184 compared to placebo in participants infected through
      inoculation with respiratory syncytial virus (RSV)-A Memphis 37b (Part 4).
    


Intervention name(s): JNJ-64417184; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.; Participants will receive matching placebo to JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Recombinant Grass Pollen Allergen Cocktail in the Treatment of Allergic Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to assess efficacy and safety of a recombinant grass Pollen allergen
      cocktail in allergic rhinoconjunctivitis
    


Intervention name(s): Recombinant grass pollen
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergy; Grass pollen; Recombinant
Mindfulness Meditation for Cognition and Mood
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this pilot study is to collect feasibility and acceptability of an internet
      mindfulness meditation intervention for older adults and to collect preliminary data on mood
      and cognition changes from before to after the intervention. Up to 32 older adults will be
      randomized to receive a mindfulness meditation intervention or a time and attention control,
      both delivered over the internet (16 completers). Participants will have a one-hour session
      weekly for six weeks with daily home practice between sessions. Participants will complete
      the sessions online with a study iPad. Their home practice will also be installed on the
      study iPad as well as an objective adherence monitoring program that the investigators
      developed to track actual home practice between sessions. The feasibility and acceptability
      measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood
      questionnaires and cognitive tasks will be measured before and after the intervention period
      and data used to conduct power analyses and sample size estimation for a larger clinical
      trial.
    


Intervention name(s): Mindfulness Meditation; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A standardized and structured program based on Mindfulness Based Cognitive Therapy and Mindfulness Based Stress Reduction and has been piloted in our laboratory.Each session included 1) discussion on stress, relaxation, meditation, and mind-body interaction, 2) instruction and practice in formal and informal MM, and 3) enquiry about problem-solving techniques regarding success and difficulty in practicing mindfulness. Formal meditation instruction included a mindful Body Scan and Sitting Meditation (awareness of breath, body sensations, cognitive and emotional processes). Informal practice of mindful daily activities (e.g., washing dishes) was also taught to generalize mindfulness beyond the formal meditations. A 3-minute meditation was offered as a quick coping strategy, and it could be practiced with or without a guided recording.; The Education control was matched for session time and home practice. The internet sessions included a general health video and questions about the material. For home practice, the participants listened to podcasts about the same topic. The session topics were 1) Healthy Eating, 2) Healthy Exercise, 3) Healthy Sleep, 4) Healthy Brain, 5) Healthy Mood, and 6) Community Involvement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: meditation; education; stress, psychological; aged
Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP
Condition: Healthy
Study type: Observational

Summary: 
      Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the
      prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the
      two methods on preventing PEP are controversial. We hypothesized that some group of patients
      with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP)
      compared with indomethacin alone (IN).
    


Intervention name(s): Pancreatic duct stenting
Intervention type(s): Device
Intervention description(s): A stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent ERCP and received administration of rectal indomethacin.
      
Keywords: Indomethacin; Double-guidewire technique; Adverse events; PEP; PD stenting
Parent Perceptions of Weight Status: Impact of a Pilot Intervention
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This pilot study is a randomized controlled trial with an embedded cross sectional study
      exploring parental perceptions of their weight status and how it affects their perceptions of
      their child's weight status. This study uses an educational intervention in which parents are
      informed of their actual weight status and how it affects their child's health. We will study
      the effect of this intervention on the parent's perceptions of and level of concern for their
      own and their child's weight status.
    

Detailed description: 
      Pediatric obesity has tripled in the past 20 years. Obesity prevention early in life is
      important and parental participation is essential. Parents must recognize overweight in their
      child so health providers may engage them in a dialogue to change their child's diet and
      physical activity patterns, yet a large proportion of parents do not recognize that their
      child is overweight. Parents' misperception of their overweight child's weight status
      presents a barrier to treating obesity.

      This pilot study is a randomized controlled trial with an embedded cross sectional study
      exploring parental perceptions of their weight status and how it affects their perceptions of
      their child's weight status. This study uses an educational intervention in which parents are
      informed of their actual weight status and how it affects their child's health. We will study
      the effect of this intervention on the parent's perceptions of and level of concern for their
      own and their child's weight status.

      Our goal is to develop a primary care intervention that will enhance parental perceptions of
      overweight and motivation to make changes for their family. Pilot data collected here will
      support an R21 Exploratory/Developmental Clinical Research Grant in Obesity or a Centers for
      Disease Control (CDC) or Robert Wood Johnson Foundation (RWJ) grant submission.
    

Intervention name(s): Education Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention is a short educational handout regarding BMI and the effect of parental weight status on children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Obesity; Weight perceptions
The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS
Condition: Breif Description: Patients' Quality of Life of
Study type: Interventional

Summary: 
      Quality of life (QOL) is a significant importance for people living with HIV/AIDS by
      modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia,
      interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for
      quality of life. The objective of the study was to assess the effects of interpersonal
      psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital,
      southwest Ethiopia, 2022.
    


Intervention name(s): Interpersonal Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Intervention Group were took interpersonal psychotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment for Word Retrieval Impairments in Aphasia
Condition: Stroke
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      In this study the investigators are examining the effectiveness of two different speech
      therapy protocols for word retrieval impairments experienced by individuals with
      stroke-induced aphasia. One treatment involves errorless naming treatment and the other
      employs verbal plus gestural facilitation of word retrieval. Participants will receive one of
      the two treatments over several months. Before and after treatment the investigators will
      administer several tests and conversational samples to examine changes associated with the
      treatments. The investigators hypothesize that, whereas both treatments will lead to
      improvements in words rehearsed in therapy, communication outcomes in conversation will be
      broader for the verbal plus gestural protocol.
    

Detailed description: 
      In this study the investigators are examining the effectiveness of two different speech
      therapy protocols for word retrieval impairments experienced by individuals with
      stroke-induced aphasia. One treatment involves errorless naming treatment and the other
      employs verbal plus gestural facilitation of word retrieval. Participants will receive one of
      the two treatments over several months. Before and after treatment the investigators will
      administer several tests and conversational samples to examine changes associated with the
      treatments. The investigators hypothesize that, whereas both treatments will lead to
      improvements in words rehearsed in therapy, communication outcomes in conversation will be
      broader for the verbal plus gestural protocol.
    

Intervention name(s): Word Retrieval Treatments for Aphasia
Intervention type(s): Behavioral
Intervention description(s): Speech therapy sessions take place 4 times per week for up to 90 minutes per session. Following a phase of baseline pre-testing, two phases of speech therapy will take place lasting up to 20 sessions per phase. Post-testing will take place immediately upon completion of the treatment phases and again at 1 month post study completion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: aphasia; anomia; speech therapy; rehabilitation
Healthy Creations: Community Based Lifestyle Intervention Validation
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      There remain important barriers to the translation of the programs like the Diabetes
      Prevention Program to public health. There is a lack of established lifestyle intervention
      programs as they are resource and time intensive, exceeding both the resources and the
      training of most primary care providers. A solution may be the implementation of lifestyle
      intervention programs in the community setting that are unrelated to primary medical care. A
      community based program at a public facility may extend the reach of lifestyle intervention
      to those unable to obtain these services from an established medical facility. Community
      lifestyle intervention to modify dietary, physical activity, and behavioral factors may be a
      promising strategy for weight management and the reduction of risk for metabolic disease. In
      this validation study we will assess pre and post intervention to identify whether measurable
      changes can be detected in body weight, body composition, markers of metabolic disease and
      quality of life after participation in the "Healthy Creations", a community based lifestyle
      intervention program presented by Center Court Fitness Center of the Grand Forks Park
      District and Altru Health System.
    


Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention group will attend an 8-week group intervention discussing "Healthy Creations" lifestyle changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
NBI for Identifying Resection Margin Status in Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      As the proportion of early gastric cancer has been steadily increased in Korea, so has
      function-preserving surgery. The function preserving surgery is characterized by the
      minimized extent of gastrectomy, so this implies that bilateral margins are getting shorter
      than those of standard gastrectomies.

      Currently, there is only one way to identify resection margin status in gastric cancer,
      'frozen biopsy'. However, it is labor-intensive and time-consuming procedure. In addition,
      the results rely on the pathologist's expertise, thereby it showed limitation of its
      accuracy; high false negative rate of signet ring cell carcinoma was reported in a previous
      study.

      Recently, many studies on magnifying endoscopy with narrow band imaging(NBI) demonstrated
      that this emerging technique is useful to identify the gastric tumor margin more clearly in
      vivo, compared with conventional indigocarmine chromoendoscopy. So it was hypothesized that
      NBI may allow reliable delineation of tumor and identification of resection margin status in
      the specimen after gastrectomy for gastric cancer.
    

Detailed description: 
      1. Tumor delineation and identification of resection margin:

           After specimen delivery from the abdomen, frozen biopsy is performed before checking
           tumor margin. After inspection with NBI, the tumor margin is marked with
           electrocauterization. The tumor size and the lengths of both resection margins are
           evaluated using a ruler.

        2. Pathologic examination:

      The specimen is sliced as 4mm interval paralleled to the markings. Tumor size, the status of
      both resection margins, and microvessel density are evaluated under the 200 magnified view.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient who is diagnosed as early staged gastric cancer preoperatively
      
Keywords: Stomach neoplasm; Endoscopy; Narrow band imaging
A Research Study for Patients With Overactive Bladder
Condition: Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether injections of botulinum toxin Type A into
      the bladder are safe and effective in treating overactive bladder.
    


Intervention name(s): botulinum toxin Type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): botulinum toxin Type A injected into detrusor on Day 1; Placebo (normal saline) injected into detrusor on Day 1
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Condition: Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The purpose of this study is to compare computer aided design/computer aided manufacturing
      (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and
      also to decide whether they are necessary in treatment of painful flexible flatfoot.
    


Intervention name(s): CAD/CAM Insole; Semi-custom Insole; Control
Intervention type(s): Device; Device; Other
Intervention description(s): A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.; Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.; 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: orthotic insoles; pain; quality of life; athletic performance