bioihbjkbjnl/mcl2 huggingface dataset:
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000
      cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being
      done to better understand how to treat MCL.
    


Intervention name(s): R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.
Intervention type(s): Other
Intervention description(s): INDUCTION: R-CHOP-14 CHEMOTHERAPY: 4 cycles every 2 weeks ± 1 day All patients in the study in both phases will undergo induction and consolidation with R-CHOP 14R-HIDAC, followed by RIT/HDT/ASCR. Patients will undergo restaging scans 12 to 14 days following completion of R-CHOP 14, with CT, and FDG-PET. Patients demonstrating at least a PR may proceed to consolidation with R-HIDAC. CONSOLIDATION: R- HIDAC CHEMOTHERAPY: 2 cycles every 3 weeks ± 2 days After R-HIDAC, restaging will occur 17-21 days post cycle 2 with CT scan (or FDG-PET, if this was positive following R-CHOP-14). Radioimmunotherapy Dosimetric dose is given approximately 4-5 weeks after completing cycle 2 of R-HIDAC. This is to be preferred 1 week post restaging scans 17-21 days post cycle 2 of RHIDAC, and up to 2 weeks post-scans will be acceptable only if required by 131 I Tositumomab availability.
Other intervention name(s): HIGH DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RESCUE (ASCR)Patients admitted to the hospital for high dose chemotherapy. The anticipated length of; stay is 3-4 weeks. 14 days ± 1 day following the administration of the therapeutic dose of Iodine 131 I; Tositumomab, patients will be admitted for high-dose chemotherapy. BEAM; will be administered
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYCLOPHOSPHAMIDE (CYTOXAN); CYTARABINE (ARA-C); DOXORUBICIN/ADRIAMYCIN; PREDNISONE; RITUXIMAB; TOSITUMOMAB (BEXXAR); Iodine; VINCRISTIN; Lymphoma; Chemo-Radioimmunotherapy; Autologous Transplantation; Untreated; 11-095
Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas
Condition: Antibiotic Resistant Bacteria
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomised, open labelled study design is selected in order to determine the emergence and
      persistence of antibiotic resistant bacteria in humans and on the composition of the
      indigenous microbiotas at various body sites. These will involve the administration to
      volunteers of minocycline and amoxicillin- a control group will receive a placebo.
      Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse
      events, vital signs, will be evaluated. The objectives of metagenomic analysis are:

        -  To identify the in vivo molecular mechanisms responsible for antibiotic resistance and
           its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome
           analysis.

        -  To determine the impact of the use of antimicrobial agents on the oral resistome

        -  To determine the impact of the use of antimicrobial agents on the faecal resistome

        -  To determine the ecological impact of the use of antimicrobial agents on the relative
           abundance of phylotypes of the indigenous oral microbiota

        -  To determine the ecological impact of the use of antimicrobial agents on the relative
           abundance of phylotypes of the indigenous faecal microbiotas
    


Intervention name(s): 3 doses of amoxicillin daily for 7 days; 2 doses of minocycline daily for five days; 2 doses of placebo daily for five days
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Amoxicillin; Minocycline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: The impact of a number of different types of antibiotics; The emergence and persistence of antibiotic resistance
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment
Condition: Avoidant / Restrictive Food Intake Disorder
MeSH terms: Avoidant Restrictive Food Intake Disorder
Study type: Interventional

Summary: 
      Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5,
      no specialized intervention has yet been empirically studied. This randomized controlled
      crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention,
      Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients
      ages 5-12 years old.
    

Detailed description: 
      Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN)
      diagnosed with ARFID and their families will be recruited will be recruited through Stanford
      University, pediatricians, mental health experts, clinics treating EDs, and local parents'
      groups. Those eligible for the program will be invited to read and sign informed consent
      forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID
      program either immediately after their screening or 3 months after assessment (i.e., to a
      usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.

      There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3
      months into treatment, and EOT. There will be 4 major assessment time points for those in
      Usual Care: Baseline, transition to treatment (3 months after the usual care period is
      complete), 3 months into treatment, and EOT. Both the child and the parent will complete
      measures at these time points. In addition, patients and parents will participate in ongoing
      qualitative assessments before treatment (BL), throughout treatment (every other session),
      and at EOT.
    

Intervention name(s): Family Based Treatment
Intervention type(s): Behavioral
Other intervention name(s): FBT-ARFID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Oxytocin in Children and Adolescents With Autistic Disorder
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators propose to conduct this pilot study to evaluate oxytocin as a supplemental
      treatment for improving social difficulties in individuals with autism.
    

Detailed description: 
      The proposed pilot study is an essential first step toward rigorously evaluating oxytocin
      treatment of individuals with autism. The biologic actions of oxytocin on social cognition
      and prosocial behaviors and the clinical, genetic and epigenetic evidence for involvement of
      the oxytocin system in the pathophysiology of some cases of autism strongly suggest that
      supplemental oxytocin therapy could significantly improve the social disabilities involved in
      autism. Many people feel that these social difficulties are the most characteristic and
      central feature of autism. Overall, this study aims to determine the tolerability,
      accessibility, and feasibility of an oxytocin pilot study.

      This study will consent up to 30 subjects in order to randomize up to 25 subjects into a
      2-month (8 weeks) randomized double-blind, placebo-controlled initial treatment period, a
      subsequent 2-month (8 weeks) period in which all participants receive oxytocin, and up to
      three post-treatment visits that occur at week 28 (±2 weeks),an interim visit anytime between
      week 16 and week 76 only for those patients who plan to start oxytocin on their own outside
      of study treatment and who will experience a lag time between week 16 (end of open label
      treatment) and when outside oxytocin treatment will begin, and some time before week 76. The
      investigators hope that this study will help to inform future study designs in determining
      whether a short term or long term treatment trial is necessary to observe significant
      effects. This will also help to develop systematic preliminary safety measures.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 International units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU.; Placebo Nasal Spray
Other intervention name(s): Syntocinon® Nasal Spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy
Condition: Lumbosacral Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      Purposes of the study

      To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and
      Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.
    

Detailed description: 
      Participants will receive Multimodal Physical Therapy program consisting of electrophysical
      agents, manual therapy interventions, and core stability exercises. Patients will receive the
      intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
    

Intervention name(s): Multimodal Physical Therapy
Intervention type(s): Other
Intervention description(s): Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises
Other intervention name(s): Physical Therapy; Physiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbosacral Radiculopathy; Lumbar disc herniation
A-MAV™ Anterior Motion Segment Replacement
Condition: Spinal Diseases
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to collect safety and effectiveness data concerning the
      A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with
      lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary
      clinical endpoint.
    

Detailed description: 
      For this clinical trial, there is only one treatment group- patients receiving the A-MAV™
      Anterior Motion Segment Replacement via an anterior surgical approach in the lumbar region of
      the spine from L4-S1.
    

Intervention name(s): A-MAV™ disc
Intervention type(s): Device
Intervention description(s): The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.
Other intervention name(s): A-MAV™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbar Degenerative Disc Disease at One Level from L4-S1
BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect
Condition: Clinical Trials, Phase I as Topic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-man study that will investigate the safety, tolerability and
      pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled,
      randomized, single center design. In addition the influence of food on the pharmacokinetics
      of BAY1902607 and the bioavailability between different pharmaceutical formulations will be
      investigated
    


Intervention name(s): BAY1902607; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food); Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Compartmental Biology of HIV in the Male Genital Tract
Condition: Human Immunodeficiency Virus; Virus Shedding
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      Male participants taking tenofovir-emtricitabine (TDF/FTC) will provide semen and blood
      samples which will be analyzed to better understand the pharmacology of antiretroviral
      therapy in the male genital tract.
    

Detailed description: 
      8 HIV positive men taking TDF/FTC and 8 HIV negative men taking TDF/FTC as pre-exposure
      prophylaxis will provide multiple semen and blood samples during a 48-hour inpatient visit. 8
      HIV positive men taking TAF (tenofovir alafenamide) will provide multiple semen and blood
      samples during a 48-hour inpatient visit.

      Participants will take part in the study for approximately two months. After the screening
      visit, there is one 2 day overnight visit for intensive PK/PD
      (pharmacokinetic/pharmacodynamic) sampling. The investigators will study drug concentrations
      and intracellular endogenous nucleotide concentrations (dATP and dCTP) in seminal plasma and
      (where appropriate) seminal cells.

      Samples will be analyzed through the use of novel laboratory methods to determine the seminal
      plasma and seminal cell concentrations of tenofovir and emtricitabine. New technologies will
      be used to better understand compartmental and intracellular antiretroviral pharmacology of
      nucleoside/tide reverse transcriptase inhibitors. Pharmacokinetic modeling will be used to
      estimate the primary outcomes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV positive and HIV negative men taking TDF/FTC once daily, HIV positive men taking
        TAF/FTC once daily
      
Biospecimen description: 
      Blood and semen samples
    
Keywords: HIV; tenofovir-emtricitabine; antiretroviral therapy; Prevention; tenofovir alafenamide
A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study will evaluate whether the use of an electronic diabetes tracker by both patients
      and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with
      technology and health data privacy issues. As part of the study, the investigators will be
      able to test whether practices that use computers perform any better than practices using
      paper. The investigators also will be developing the first Canadian computerized chart
      summary for each patient that can be communicated securely in emergencies (the Emergency
      Health Record) and read by all current electronic systems.
    


Intervention name(s): Electronic disease management decision support
Intervention type(s): Other
Intervention description(s): A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)
Other intervention name(s): Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes; Computerized clinical decision support; shared care; patient self-monitoring; quality of care; complex interventions; composite outcomes
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-human study is to evaluate the safety, tolerability, and
      pharmacokinetics (PK) of HS-10374 in healthy subjects.
    


Intervention name(s): HS-10374 tablets; HS-10374-matched placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple dosing of HS-10374 orally in a fasting state; Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Esophageal Atresia: Metaplasia, Barrett
Condition: Gastroesophageal Reflux; Esophagus, Barrett
MeSH terms: Barrett Esophagus; Gastroesophageal Reflux; Esophageal Atresia
Study type: Observational

Summary: 
      The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE
      is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting
      the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux
      disease. Because gastroesophageal reflux disease plays a major role in the development of BE
      by causing repeated mucosal damage, development of BE is a concern even in children and young
      adults in this specific population. The aim of this study is to assess the prevalence of BE
      (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had
      been treated for EA in early infancy. All eligible patients received upper gastrointestinal
      endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological
      suspicion of metaplasia was confirmed centrally.
    


Intervention name(s): esophageal biopsies
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All esophageal atresia patients treated in 20 centers that participated in the
        French-speaking Group of Gastroenterology, Hepatology, and Nutrition and/or were members of
        the esophageal atresia national registry
      
Keywords: gastroesophageal reflux; barrett esophagus
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women
Condition: Infertility; Stress
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The general hypothesis of the research is that stress decreases fertility and that Cognitive
      Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize
      that stress has a detrimental effect on DNA integrity and that stress reduction will reduce
      DNA damage in the cell.
    


Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): The intervention (CBT) will focus on teaching specific skills which are adapted for women undergoing fertility related problems. Through the sessions the participants will learn relaxation techniques such as breathing, progressive relaxation, and guided imagery. Furthermore, suggestions for making healthier choices for coping and for releasing tension will be reviewed and discussed, with an emphasis on making healthy lifestyle changes with balance and perspective rather than in a punishing or depriving way. Each session will consist of: 20 minutes of stress-reduction behavioral relaxation, 40 minutes of cognitive restructuring and 30 minutes personal tailoring of the behavioral homework between each session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic
      bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy
      volunteers.
    

Detailed description: 
      Glucagon has been shown to be effective in the treatment of hypoglycemia, low blood sugar
      levels, in patients with diabetes. It primarily functions as a counter-regulatory hormone by
      opposing the actions of insulin to maintain blood glucose levels. A major problem for
      diabetic patients with hypoglycemia is the development of defective counter regulatory
      responses including reduced or absent glucagon responses to hypoglycemia. Mayne Glucagon for
      Injection has been developed as an alternative to currently marketed products.

      Administration of exogenous glucagon i.e., not produced in the body, has been shown to be
      effective in the treatment of low blood sugar in patients with diabetes. Mayne has developed
      a product, Glucagon for Injection, which is an alternative to currently marketed products.
      The only difference is the source of the active ingredient. The formulation, routes of
      administration, dosage regimen and indications of Mayne Glucagon for Injection are identical
      to those currently registered for the marketed product.

      A total of 28 healthy volunteers will be recruited into this study at one investigational
      site.
    

Intervention name(s): Glucagen; Mayne Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): 0.2 mg or 1 mg Glucagen single injection; 0.2 mg or 1 mg Mayne Glucagon
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment