bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the long-term safety and tolerability of
      BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple
      sclerosis (MS) who previously participated in the registrational and extension studies
      conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT)
      and NCT00649792 (MS-F204EXT).
    


Intervention name(s): BIIB041 (Fampridine-SR)
Intervention type(s): Drug
Intervention description(s): 10 mg twice a day (BID) sustained-release (SR) tablets by mouth for up to 27 months (in addition to treatment in previous studies) or until the product is commercially available, whichever comes first. Doses of study treatment must be spaced at least 12 hours apart.
Other intervention name(s): Dalfampridine; Fampridine-ER; Ampyra; Fampyra; Fampridine-PR
Intervention MeSH terms: 4-Aminopyridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ramipril in Pediatric Patients on Hemodialysis
Condition: Hemodialysis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular
      hemodilaysis
    

Detailed description: 
      Evaluate the effect of Ramipril on blood pressure, heart rate, Endothelial dysfunction and
      inflammatory markers in pediatric patients on regular hemodilaysis and the correlation of
      response with ACE I/D polymorphisms.
    

Intervention name(s): Ramipril; placebo
Intervention type(s): Drug; Drug
Intervention description(s): angiotensin-converting enzyme inhibitor; same odor, color and size as the drug but without the active ingredient
Other intervention name(s): Tritace
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: angiotensin-convertting enzyme inhibitor; ramipril
Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma
Condition: Localized Osteosarcoma; Metastatic Osteosarcoma; Osteoblastic Osteosarcoma; Recurrent Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Observational

Summary: 
      This research study is studying biomarkers in predicting response to chemotherapy in samples
      from young patients with osteosarcoma. Studying samples of tumor tissue from patients with
      cancer in the laboratory may help doctors learn more about changes that occur in DNA and
      identify biomarkers related to cancer. It may also help doctors predict how patients will
      respond to treatment.
    

Detailed description: 
      Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective:
      Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study
      Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample

      PRIMARY OBJECTIVES:

      I. Determine whether methylation status predicts response to neoadjuvant chemotherapy in
      samples from children and young adults with osteosarcoma.

      OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs
      poor).

      DNA and RNA extracted from biopsy samples are analyzed for methylation changes and
      transcription changes by ligation-mediated PCR and mass-array genotyping.
    

Intervention name(s): laboratory biomarker analysis
Intervention type(s): Other
Intervention description(s): Correlative studies
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Diagnosed with high-grade osteoblastic osteosarcoma.
Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study
Condition: Colorectal Cancer; Inflammatory Bowel Diseases; Microbiota; Anastomotic Leak
MeSH terms: Colorectal Neoplasms; Inflammatory Bowel Diseases; Anastomotic Leak
Study type: Observational

Summary: 
      The study is based on the hypothesis that patients with postoperative anastomotic leakage
      have a different bacterial profile contributing to poor tissue healing, and that patients
      operated for colon cancer presumably have a different preoperative microbiota than healthy
      patients. This different composition is probably induced by the high heme level in the light
      intestinal tract that tumor spoliation generates.

      The objective of the study is to evaluate the feasibility of a larger study to evaluate the
      difference between microbiota composition of patients with and without colorectal cancer,
      with inflammatory bowel disease and those with and without anastomotic leakage
      postoperatively of a colonic resection.

      Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5
      with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5
      with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.

      The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make
      up the microbiota of each patient.
    

Detailed description: 
      No more details required.
    

Intervention name(s): Fecal sample collection for analysis
Intervention type(s): Other
Intervention description(s): Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering MiSeq reads into operational taxonomic units (OTUs); Iron and heme measurements in the samples.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants included in groups 1,3 and 4 will be recruited at the outpatient clinic of the
        CHUM digestive surgery department, during the visit for evaluation prior surgery.

        Participants included in group 2 will be recruited during the post surgery period, during
        their hospitalization in the department of digestive surgery of the CHUM.
      
Biospecimen description: 
      For participants included in groups 1, 3 and 4, stool samples will be collected prior to
      surgery. For participants included in group 1 only, a stool sample will also be collected
      after surgery.

      For patients included in group 2, a sample of the digestive content (stool) will be collected
      during surgery.
A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883
      in Healthy Adults.

      This study is seeking participants who are:

        -  male and female aged 18 to 65 years old,

        -  overtly healthy. This can be determined my medical evaluation, medical history, lab
           tests etc.

      This study will consist of 2 parts, Period 1 and Period 2.

      Period 1: participants will take PF-07817883 one time by mouth at the study clinic.

      Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will
      also take daily itraconazole by mouth for 7 days.

      Participants will stay at the study clinic for 2 weeks in total. The study doctors will
      collect blood and urine samples from everyone. The study doctors will check participants'
      reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35
      days from the last dose of PF-07817883.

      Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some
      medicines, it affects the actual level of these medicines in the body. This study will
      compare blood levels of PF-07817883 given with and without Itraconazole. This will help
      decide safety and right amount for PF-07817883 when given with metabolism inhibitors.
    

Detailed description: 
      This is a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of
      itraconazole, a strong CYP3A4 inhibitor, on the plasma PK of PF-07817883 in healthy adults.
      The study will consist of 2 treatments: a single oral dose of PF-07817883 alone and a single
      oral dose of PF-07817883 in combination with multiple oral doses of itraconazole. The PK and
      safety will be assessed and compared for single dose of PF-07817883 in period 1 and period 2.
    

Intervention name(s): PF-07817883; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose (period 1) or co-administered with itraconazole (period 2); Interacting drug which will be given for 7 days in period 2
Other intervention name(s): Sporanox®
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19
Non-Specific Chronic Back Pain; Insight From Spatial Aspects of Lumbar Spinal Muscle Activation
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      There is evidence for altered muscle activity patterns in individuals with non-specific
      chronic back pain (NSCBP). It is unknown why these alterations in activation pattern occur
      and how they may be linked to pain experience and to the development of CNSBP. The main
      objective of this study is to investigate the spatial aspects of muscle activation in
      relation to fatigue/endurance and CNSBP. A novel approach, utilizing a new multi-channel
      surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental
      mechanisms related to motor control and fatigue/endurance. In this project data from healthy
      persons and from patients with NSCBP will be collected and analyzed. NSCBP patients will be
      compared to healthy persons. To minimize heterogeneity between groups the subject's age range
      will be from 30 - 50 years. The investigators main hypothesis is that motor control
      mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals,
      explaining the reduced tolerance for static postures. There has been little investigation of
      the lumbar musculature with MCsEMG recordings. The lumbar musculature has a complex
      organization; many, relatively small muscles, in a restricted area. Utilizing two HDsEMG
      grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate motor
      control mechanisms in this region, and further the investigators understanding of
      neuromuscular adaptations related to NSCBP. The project may demonstrate changes that will
      lead us to new insight and new strategies for the treatment of back pain.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Chronic non-spesific low back pain and healthy control subjects
Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
Condition: Kidney Transplant Recipients
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is specifically designed to determine whether the initiation of Myfortic 2 weeks
      prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy
      in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to
      Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction
      starting at the time of transplant in kidney transplant recipients.
    


Intervention name(s): mycophenolic acid
Intervention type(s): Drug
Intervention description(s): Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant.
Other intervention name(s): Myfortic
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology
Condition: Loneliness; Depression; Anxiety; Alcohol Abuse; Drug Abuse
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Observational

Summary: 
      This study seeks to gather data and insight on epidemiologic trends of loneliness and other
      behaviors in the wake of the CDC recommended "social distancing" during the COVID-19
      pandemic. The objective of this study is to use a cross-sectional survey to assess the impact
      of COVID-19's associated recommendations (social distancing, self-isolation, and
      self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety,
      substance abuse) on young adults (18-35 years old).
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new
      and old formulations after oral dose under fasted condition on healthy Chinese subjects.

      The secondary objective is to evaluate the safety after famitinib malate capsules oral dose
      on healthy Chinese subjects.
    


Intervention name(s): Famitinib malate
Intervention type(s): Drug
Intervention description(s): TR group:
The first period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h.
RT group:
The first period，the subjects will be administrated with Famitinib malate in old formulation, then conduct blood collection within 192h; 14 days washout；The second period，the subjects will be administrated with Famitinib malate in new formulation, then conduct blood collection within 192h.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Treatment group TR Intervention: Drug: famitinib malate, new formulation; Intervention: Drug: famitinib malate, old formulation.
Treatment group RT Intervention: Drug: famitinib malate, old formulation; Intervention: Drug: famitinib malate, new formulation.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence; Old formulation; New formulation
Meal Enjoyment and Tolerance: Sex Differences
Condition: Healthy
Study type: Interventional

Summary: 
      Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10
      men and 10 women) will be instructed to eat a standard dinner the day before, to consume a
      standard breakfast at home after overnight fast, and to report to the laboratory, where the
      test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet,
      isolated room with participants sitting on a chair. Participants will ingest a probe meal up
      to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5
      min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive
      well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20
      min after ingestion at 10 min intervals.
    


Intervention name(s): probe meal
Intervention type(s): Other
Intervention description(s): The probe meal will be served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: meal ingestion; meal tolerance; postprandial responses; hedonic sensations; homeostatic sensations
A Study Comparing Two Treatments for Child With Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      First, can exposure therapy for childhood anxiety begin earlier in the course of treatment
      than current treatment manuals suggest?

      Second, is treating childhood anxiety with exposure therapy more effective and efficient than
      treating childhood anxiety with relaxation training + cognitive restructuring?
    

Detailed description: 
      Anxiety disorders are among the most common psychiatric disorders in children and typically
      produce significant disruption in family, social, and academic functioning (Merikangas &
      Avenevoli, 2002). Fortunately, treatments for childhood anxiety have been manualized and
      found to be efficacious (Walkup, et al., 2008). These treatments most often incorporate
      aspects of cognitive-restructuring, relaxation training, and exposure to anxiety-producing
      stimuli. Unfortunately, many practitioners opt to utilize mainly cognitive and relaxation
      techniques at the expense of exposure techniques (Freiheit, Vye, Swan, & Cady, 2004).
      However, it remains unclear which of these components is most effective in reducing anxiety
      symptoms or the extent to which they act in concert; thus, the relative effectiveness of
      treatment for childhood anxiety when leaving-out a treatment component is unknown. The
      current study aims to compare the relative effectiveness of exposure therapy for childhood
      anxiety to cognitive restructuring and relaxation techniques. Sixty children and adolescents
      seeking treatment for anxiety in an outpatient pediatric anxiety clinic will be randomized to
      receive either six sessions of parent assisted exposure therapy or six sessions of individual
      cognitive restructuring and relaxation training. Comprehensive assessments will be completed
      by trained clinicians at pre-treatment and again at post-treatment to measure reductions in
      anxiety and related symptoms as well as improvements in daily functioning. We anticipate that
      children treated with exposure therapy will demonstrate significantly greater improvement
      over the six sessions than children treated with cognitive-restructuring and relaxation
      training, and will require fewer additional treatment sessions. Support of this hypthothesis
      would clarify the active ingredients in manualized treatment for childhood anxiety disorders
      and would potentially lead to quicker, more efficient treatment.
    

Intervention name(s): Experimental treatment; Traditional Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): six sessions of child anxiety treatment; six sessions of treatment consistent with current practice
Other intervention name(s): CBT; Cognitive behavioral therapy; CBT; Cognitive behavioral therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: child; anxiety; CBT
Phase I Study of VLX-1005 in Healthy Subjects
Condition: Safety and Tolerability in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The principal objective of this study is to describe the safety of and tolerability to single
      and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration.

      Other exploratory objectives are:

      To evaluate the pharmacokinetics and pharmacodynamics of VLX-1005 following IV
      administration.
    


Intervention name(s): VLX-1005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VLX-1005 infusion; Placebo infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)
Condition: Hereditary Thrombotic Thrombocytopenic Purpura (TTP)
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1, prospective, uncontrolled, open-label, multicenter,
      dose-escalation study is to evaluate the safety, including immunogenicity, and
      pharmacokinetics of BAX930 (rADAMTS13) in a total of 14 evaluable subjects diagnosed with
      severe hereditary thrombotic thrombocytopenic purpura (TTP) (plasma ADAMTS13 activity <6%)
      who are assigned to one of three dose cohorts.
    


Intervention name(s): Recombinant ADAMTS13
Intervention type(s): Drug
Intervention description(s): rADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) is a lyophilized formulation for intravenous injection. The lyophilized rADAMTS13 is reconstituted with sterile water for injection.
Subjects will receive an intravenous injection with rADAMTS13 at a dose of either 5 U/kg bodyweight (Cohort 1), or 20 U/kg bodyweight (Cohort 2), or 40 U/kg bodyweight (Cohort 3).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of
      DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately
      controlled on metformin
    


Intervention name(s): DWP16001
Intervention type(s): Drug
Intervention description(s): DWP16001 Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment