bioihbjkbjnl/mcl2 huggingface dataset:
Continued Access Protocol
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This Continued Access Protocol has been written to allow ongoing treatment of subjects at
      selected investigational sites while the marketing application for the Arctic Front®
      Cryoablation System is under review. This study will also allow collection of additional
      safety data following modifications implemented into the Arctic Front® Catheter and
      Cryoablation System.
    

Detailed description: 
      1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter
           System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the
           continuous survival of subjects free from one or more primary safety outcome
           measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events
           (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or
           more Atrial Fibrillation Drugs (AFDs).

        2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation
           Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing
           the continuous survival of subjects with success in the primary effectiveness outcome
           measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial
           fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

        3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation
           Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter
           System used in the PS-023 STOP AF Pivotal Trial.
    

Intervention name(s): Arctic Front Cardiac Cryoablation System
Intervention type(s): Device
Intervention description(s): The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
Other intervention name(s): Arctic Front® Catheter Ref# 2AF232 & 2AF282; Manual Retraction Kit Ref# 20MRK; Freezor MAX Catheter Ref # 239F3 & 239F5; Console Ref # 106A2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers
Condition: Advanced Solid Cancers; Hematologic Cancers
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts.
      Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will
      enroll up to 48 patients with advanced solid tumors and hematological cancers. Part B will
      include monotherapy expansion cohorts in advanced solid and hematologic cancers to further
      examine SRF231 as monotherapy (100 patients total).
    

Detailed description: 
      This first-in-human study is designed to evaluate the safety and tolerability of SRF231 as a
      monotherapy via dose escalation (Part A), and to determine the dose(s) of SRF231 to be
      further examined in expansion cohorts as monotherapy. The preliminary clinical activity of
      SRF231 administered as monotherapy will be characterized, along with pharmacokinetics (PK)
      and pharmacodynamics. In Part B, the safety and tolerability of SRF231 as monotherapy will be
      evaluated in select patient cohorts of advanced cancers and evaluate clinical activity. The
      study also is designed to examine the effect of SRF231 monotherapy on peripheral blood immune
      cell subsets, peripheral blood gene expression, and serum biomarkers
    

Intervention name(s): SRF231
Intervention type(s): Drug
Intervention description(s): SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and lymphoma/CLL.
Part B will include 5 monotherapy expansion cohorts: in advance solid and hematologic cancers (100 patients total).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD47; SiRP α; tumor microenvironment; macrophage; solid tumor; Phase 1; safety; efficacy; hematologic malignancies; SRF231
Improving Care Coordination for Adolescents and Young Adults With Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of this research is to test an intervention designed to identify cancer needs and
      connect patients with services that address those needs. Participation in this research will
      involve completing 2 online surveys over the course of 1 month; each should take about 15
      minutes to complete.
    

Detailed description: 
      Adolescents and young Adults (AYA) Needs Assessment & Service Bridge (AYA NA-SB) includes a
      holistic Patient Reported Outcome Measures (PROM) assessing AYAs' physical, psychosocial and
      practical needs and a collection of referral pathways for connecting AYAs to services and
      resources based on the needs they report.

      To assess the implementation of AYA NA-SB, the study team will pilot AYA NA-SB in the North
      Carolina Cancer Hospital (NCCH)/ UNC Children's Hospital, with a primary focus on
      implementation outcomes (i.e., feasibility, acceptability, appropriateness, fidelity). To
      establish proof-of-concept for AYA NA-SB, the study team will use pilot data to generate
      preliminary evidence on the extent to which AYA NA-SB addresses AYAs' reported needs.
    

Intervention name(s): AYA NA-SB Questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaire identifying cancer needs so that providers can connect subjects with services that might address them.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: adolescents; care coordination; cancer care needs
Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock
Condition: Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Diabetes Insipidus; Shock
Study type: Observational

Summary: 
      Patients with severe infection can develop very low blood pressure. There are many mechanisms
      leading to this, and one of them appears to involve a hormone called vasopressin. In children
      as compared to adults, the mechanism and response to low blood pressure are different for
      reasons that are not clear. One possibility is the difference in the production and/or
      response to vasopressin. Vasopressin has become part of the treatment of children with low
      blood pressure in the setting of severe infection, when other treatment has failed, but its
      use is on the basis of animal and adult studies. The exact timing and dose is uncertain.

      In this research study, the patients will receive standard treatment for sepsis and septic
      shock, and the investigators will measure the blood levels of vasopressin and a related
      compound called copeptin (both are required to understand the mechanism of control involved).
      Blood will need to be taken from patients without any sepsis so as to be able to compare the
      values in health and in sickness. The patient groups the investigators have chosen for this
      are those children who will have blood taken anyway as part of their routine care. The aim of
      this study is to develop an understanding of the body's hormonal response (with respect to
      vasopressin) to severe infection in children. The long-term aim is to improve the care of
      critically ill children with severe infection by using the most appropriate dose of
      vasopressin at the most appropriate time.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between one day of age and sixteen years old.
      
Biospecimen description: 
      Blood samples
    
Keywords: Sepsis; Septic Shock; Vasopressin; Copeptin; Paediatrics
Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
Condition: Abdominal Pain; Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain; Somatoform Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to:

        1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a
           digital media player improves abdominal pain symptoms in children with functional
           gastrointestinal pain disorders managed in the primary care setting.

        2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a
           digital media player improves psychosocial distress in children affected by functional
           gastrointestinal pain disorders managed in the primary care setting.

      The possibility of treating functional gastrointestinal pain disorders using remotely
      delivered psychosocial therapies has the potential to treat many children affected by
      functional gastrointestinal pain disorders in a cost-effective manner. This study will
      provide insight into how well these patients in the primary care could benefit from such
      interventions.
    

Detailed description: 
      Children managed in primary care with a functional gastrointestinal pain disorder will be
      recruited and studied for this trial. After participants are deemed eligible, they will
      complete multiple questionnaires and then be randomly assigned (like a flip of a coin) to
      either guided imagery or deep breathing exercises delivered via a digital media player.
      Participants will be instructed to listen to the tracks at least 5 days per week for an 8
      week intervention period.

      At week 3 of the intervention period, the participant will complete another 2 week pain and
      stool diary.

      At week 7 of the intervention period, the participant will complete another 2 week pain and
      stool dairy. After this diary is completed, the participant will again complete multiple
      questionnaires for their final visit.
    

Intervention name(s): Apple iPod Shuffle
Intervention type(s): Device
Intervention description(s): One session at least 5 days a week for a total of 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Urinary Catheterization and Second Stage of Labor
Condition: Labor, Second Stage
Study type: Interventional

Summary: 
      -  Labor is divided into three stages: the first stage is from labor onset until full
           dilation, second stage is from full dilation until delivery of the baby, and the third
           stage from the delivery of the baby until the delivery of the placenta

        -  The mean duration of second stage in nulliparas as defined by the American college of
           obstetricians and gynecologists (ACOG) is 54 minutes

        -  Epidural anesthesia is a known cause for prolongation of the second stage of labor.
           Prolonged second stage in nullipara women with epidural is defined as more than 3 hours,
           and more than 2 hours in those without epidural.

        -  Although perinatal outcome is not compromised with a prolonged second stage , there is
           evidence that maternal morbidities such as perineal trauma, chorioamnionitis
           ,instrumental delivery and postpartum hemorrhage increase with prolonged second stage

        -  Another effect of epidural anesthesia during labor is urinary retention and a need for
           catheterization.

        -  Full bladder may behave as a tumor previa and interfere to fetal head descent in the
           birth canal, increasing by that the duration of the second stage.

        -  This study aims to investigate the effect of intermittent versus continuous
           catheterization on the duration of the second stage of labor
    


Intervention name(s): urinary catheterization
Intervention type(s): Other
Intervention description(s): nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.
Other intervention name(s): continuous versus intermittent catheterization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: duration of second stage; urinary catheterization; epidural anaesthesia
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
Condition: Safety Issues; Tolerance
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled, single ascending dose study in
      healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old
      male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly
      subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be
      included in the study at one dose level, once the safety and tolerability of AVLX-144 has
      been documented in younger subjects.
    


Intervention name(s): AVLX-144; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Placebo
Other intervention name(s): Test drug
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Intrauterine Injection of HCG on Clinical Pregnancy Outcome in Repeated Implantation Failure Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Repeated implantation failure（RIF） is a insurmountable bottleneck in assisted reproductive
      technology, many studies have considered that the cause of two-thirds of implantation failure
      is the decreased endometrial receptivity. After exclude some major local immune
      factors(NK,CD138 cells) and implantation window out of phase, There are still a part of
      patients infertile .Human chorionic gonadotropin (hCG) is an early pre-implantation signal
      molecule secreted by the embryo, it can promote endometrial proliferation, increase blood
      flow and promote embryonic adhesion and inhibit self-regulated apoptosis of trophoblast
      cells. Previous studies showed that: intrauterine injection of HCG before embryo transfer can
      improve clinical outcomes in IVF/Intracytoplasmic sperm injection(ICSI). But some studies
      found that the intrauterine injection of HCG can not significantly improve the success rate
      of blastocyst transfer, and the reason may be the intrauterine injection of HCG time is too
      late to significantly increase the implantation rate. Would ahead of intrauterine injection
      of HCG be more effective? Thus, the patients of repeated implantation frozen embryo cycle
      according to the random principle accepted two kinds of transplants ways: ①intrauterine
      injection of HCG before blastocyst transfer; ②blastocyst transfer. Try to understand whether
      intrauterine injection of HCG can significantly improve the clinical pregnancy rate of
      blastocyst transfer in repeated implantation failure patients.
    


Intervention name(s): HCG; culture medium
Intervention type(s): Drug; Other
Intervention description(s): we will use the catheter to pass through the cervix, and after that, the experiment Group will accept 40 μl 500 IU HCG injection into the uterine cavity 2 days before the blastocyst transfer.; The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia
Condition: Schizophrenia; Psychoses
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied
      in patients with first episode schizophrenia after one year neuroleptic maintenance
      treatment. Two groups of patients were followed over a period of 1 year: one further on under
      maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.
    

Detailed description: 
      In case of early signs of a relapse prodrome based early intervention with an antipsychotic
      drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in
      patients with first episode schizophrenia after one year neuroleptic maintenance treatment.
      Two groups of patients were followed over a period of 1 year: one further on under
      maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after
      stepwise drug discontinuation.
    

Intervention name(s): antipsychotics vs. Lorazepam (Drugs)
Intervention type(s): Drug
Intervention description(s): Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;
Intervention MeSH terms: Lorazepam; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; first episode; prodrome based early intervention; antipsychotics - benzodiazepine; maintenance treatment; drug discontinuation
Feasibility Study of an Integrated Sensor and Infusion Set
Condition: Diabetes Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to collect performance data on the integrated sensor and
      infusion set during 3 days of use and demonstrate performance adequacy of the Integrated
      sensor and infusion set with glucose sensing and insulin delivery functionalities. The
      hypothesis of this study is that having the infusion of insulin in close proximity to the
      sensor does not interfere with the sensor accuracy.
    

Detailed description: 
      Sensor clinical accuracy will be evaluated based on the following parameters: Mean ARD
      (absolute relative difference), median ARD, Clarke Grid Analysis. Meter BG values will be
      used as reference. Descriptive statistics will be used to assess non-inferiority of the
      Integrated sensor and infusion sets sensors compare to control Enlite sensors.

      Insulin delivery functionality will be evaluated based on BG profiles obtained during
      peri-prandial periods during which BG measurements will be performed at 15, 20, 30 min
      intervals according to a SMBG schedule. Post-prandial pharmacodynamic profiles will be
      analyzed to demonstrate the effect of insulin delivered using the Integrated sensor and
      infusion set. Specifically, rise in glucose levels followed by their fall will be used as an
      indication that insulin was delivered and absorbed. Post-prandial BG areas under the curve
      (AUC), Tmax (time to maximum rise of BG), and Cmax (maximum post-prandial BG) values will be
      calculated for each meal (breakfast, lunch, and dinner) consumed during both inpatient days
      and compared. Intra - and inter-subject mean values and standard deviations will be
      calculated. Paired and unpaired T-tests will be used to evaluate statistical significance.

      Longevity of device performance will be assessed by comparing the listed parameters obtained
      during two inpatient days.
    

Intervention name(s): Integrated sensor and infusion set.
Intervention type(s): Device
Intervention description(s): Change patients from current devices to the Integrated sensor and infusion set.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Lipid Encapsulation for Ileal Brake Activation
Condition: Appetite Regulation
Study type: Interventional

Summary: 
      This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack
      to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two
      treatments (active, and placebo) on two different days, following a randomized cross-over
      design.
    


Intervention name(s): Active yoghurt; Placebo yoghurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.; Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid
      leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of
      quizartinib has not yet been studied. This study is designed to estimate quizartinib
      bioavailability of quizartinib following oral and intravenous (IV) administration.
    

Detailed description: 
      Quizartinib bioavailability based on the dose-adjusted exposure of quizartinib following oral
      and IV administration will be assessed in healthy male subjects. The primary objective of
      this study is to determine the absolute oral bioavailability of quizartinib. Secondary
      objectives will include characterizing the plasma PK of quizartinib, radiolabeled
      quizartinib, and the major circulating metabolite after a single oral dose and IV
      administration. Safety and tolerability of quizartinib will also be assessed.
    

Intervention name(s): Quizartinib dihydrochloride; 14C-Quizartinib solution for infusion
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 60 mg quizartinib (2 x 30 mg tablets); 50 μg solution for infusion containing NMT 22.84 kBq 14C in 5 mL; administered once as a 15-minute infusion
Other intervention name(s): Quizartinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quizartinib; Healthy Subjects; Pharmacokinetics; Oral Bioavailability; Microtracer