bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386 ) in Adult Japanese Participants With Advanced Solid Tumors
Condition: Neoplasms, Advanced Solid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK)
      profile of trebananib (AMG 386) after intravenous administration in adult Japanese
      participants with advanced solid tumors.
    

Detailed description: 
      The drug being tested in this study is called trebananib (AMG 386). Trebananib (AMG 386) is
      being tested to treat people with advanced solid tumors.

      This study will look at the safety, tolerability and pharmacokinetic (PK) profile of
      trebananib and response to treatment.

      The study will enroll approximately 18 participants. Once enrolled, participants will be
      assigned sequentially into 1 of the 3 cohorts:

        -  Trebananib 3 milligram/kilogram (mg/kg),

        -  Trebananib 10 mg/kg,

        -  Trebananib 30 mg/kg.

      All participants will receive trebananib via 60 minute intravenous infusion. This study will
      be conducted in Japan. The overall time to participate in this study is 14 weeks or more.
      Participants will attend the end-of-treatment visit 28 days after the last dose of study
      drug.
    

Intervention name(s): Trebananib 3 mg/kg; Trebananib 10 mg/kg; Trebananib 30 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Trebananib (AMG 386) 3 mg/kg, intravenous infusion.; Trebananib (AMG 386) 10 mg/kg, intravenous infusion.; Trebananib (AMG 386) 30 mg/kg, intravenous infusion.
Intervention MeSH terms: Trebananib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to
      as insulin 965), its concentration in the blood and its effect on the blood sugar for the
      treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it
      is taken up in the blood, how long it stays there and how the blood sugar is lowered.
      Participants will either get the new insulin 965 or the already marketed insulin glargine
      U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections
      (one per day) of either insulin 965 or insulin glargine U100 under the skin of the left
      thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the
      study doctor. Participants can only be in the study if the study doctor thinks that there are
      no risks for their health. Women can only take part in the study if they can't have children.
    


Intervention name(s): NNC0268-0965; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days; One daily dose of 3.0 nmol/kg administered s.c. for 6 days
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 cohorts are planned. Each cohort will consist of 12 subjects, with 9 subjects being randomised to receive NNC0268-0965 and 3 subjects being randomised to insulin glargine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sodium Intake in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the
      differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were
      described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).

      However, the role of sodium intake in MS has not been investigated. In this study we
      investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological
      activity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 70 patients with relapsing-remitting MS according to McDonald criteria1 were
        recruited from the MS clinic at FLENI by attending neurologists. A second group of 52
        relapsing-remitting MS patients was recluted later.
      
Biospecimen description: 
      Blood, urine
    
Keywords: Multiple Sclerosis; Salt
A Study to Evaluate the Accuracy of a Breast Cancer Locator (BCL) in Patients With Palpable Cancers
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      In this study, the investigators will enroll women with palpable cancers to assess the
      accuracy of the Breast Cancer Locator (BCL) and the concomitant procedure as a vehicle to
      optimize and validate the approach in such surgical cases. This approach of adopting palpable
      cancer patients before initiating an evaluative trial of the BCL in non-palpable breast
      cancer cases ensures that the BCL does not substantially alter or modify the standard-of-care
      procedure.
    

Detailed description: 
      The investigators propose to test whether the Breast Cancer Locator (BCL) accurately defines
      the edges of the tumor. Twenty patients with palpable invasive breast cancer will undergo
      preoperative supine MRI, the creation of a BCL, and breast-conserving surgery using the BCL
      as an adjunct to palpation-guided tumor resection. Participants will also have the tumor
      position on their skin localized with the supine MR/optical scan/tracker method. The primary
      objective is to measure the distance from the center of the spots made by the BCL to the
      cancer edges.
    

Intervention name(s): Breast Cancer Locator (BCL)
Intervention type(s): Device
Intervention description(s): This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Conserving Surgery; Breast Imaging; Breast Diagnostics
Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a
      preemptive analgesia in patients undergoing lumbar spinal fusion.
    

Detailed description: 
      A prospective, double-blinded randomized control trial. Randomly allocated patient undergoing
      posterior lumbar spinal fusion into 3 groups (n=32) to receive Parecoxib, Ketorolac and
      Placebo around 30 minutes prior to incised skin. Efficacy was assessed by visual analog scale
      score (0-10), total opioid consumption, complication and bleeding also recorded.
    

Intervention name(s): Parecoxib; Ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): Parecoxib 40 mg intravenous; Ketorolac 30 mg intravenous
Other intervention name(s): Dynastat; Ketolac
Intervention MeSH terms: Ketorolac; Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: preemptive analgesia; lumbar fusion; Parecoxib; Ketorolac
The Efficacy and Tolerability of NP101 Patch in the Treatment of Acute Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was a randomized, parallel group, double-blind, placebo controlled design to
      compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch.
      The primary objective of this study was to assess the proportion of subjects who were
      headache pain free at two hours after patch activation.

      Key secondary objectives included:

        1. The proportion of subjects who were nausea free at two hours after patch activation.

        2. The proportion of subjects who were photophobia free at two hours after patch
           activation.

        3. The proportion of subjects who were phonophobia free at two hours after patch
           activation.
    

Detailed description: 
      Subjects stayed in the study until they had treated one migraine headache with a study patch
      or two months after randomization, whichever occurred first. During a migraine headache,
      subjects rated their baseline headache pain severity in a Migraine Study Diary using a
      4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only
      if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain
      severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and
      photophobia, as well as the location of their headache (unilateral or bilateral) and whether
      their headache increased with movement.
    

Intervention name(s): NP101 - Sumatriptan iontophoretic transdermal patch; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan iontophoretic transdermal patch; NP101 Placebo iontophoretic transdermal patch
Other intervention name(s): Sumatriptan; NP101 Placebo
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neurophysiological Evaluation of Training Effect on Cancer-Related Weakness
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Asthenia
Study type: Interventional

Summary: 
      Breast cancer patients often suffer from long-term physical symptoms of weakness. In this
      study, investigators propose to compare how two different low intensity physical exercise
      training programs can improve handgrip strength for breast cancer patients with symptoms of
      weakness. Using brain imaging, the study will also investigate changes in brain structure,
      and muscle activity associated with handgrip.
    

Detailed description: 
      Participants will be randomized to either a no treatment group or one of two low intensity
      6-week exercise training. Outcomes will be measured at baseline, post-intervention and 4
      weeks post intervention.
    

Intervention name(s): Low Intensity Exercise Training 1; Low Intensity Exercise Training 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will perform handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded); Subjects will perform a different handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fatigue; Breast cancer; Force; Motor imagery; Cancer Treatment
A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Condition: Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in
      participants with moderate to severe HS. The study will have a maximum duration of
      approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing
      Period and a 4 week Follow up Period.
    


Intervention name(s): PF-06650833; PF-06700841; PF-06826647; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400 mg QD; 45 mg QD; 400 mg QD; placebo
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The treatment period is a parallel design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder
Condition: Overactive Bladder; Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate blood levels of solifenacin succinate (the study
      drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If
      the bladder contracts strongly and without warning, the muscles surrounding the urethra
      (detrusor muscles) may not be able to keep urine from passing. This may happen as a
      consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
    


Intervention name(s): Solifenacin succinate suspension 5 mg
Intervention type(s): Drug
Intervention description(s): Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).
Other intervention name(s): YM905
Intervention MeSH terms: Solifenacin Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Solifenacin succinate suspension; Pharmacokinetics; Phase 1; Neurogenic Detrusor Overactivity
Comparision of FIBTEM and Blood-loss
Condition: Sternotomy; Bleeding Test
MeSH terms: Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      Correlation between FIBTEM and intraoperative blood loss
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with full sternotomy
      
Keywords: 5 minute bleeding test; swamb; fibtem; extem
Study of the Neural Basis of Analogical Reasoning
Condition: Frontotemporal Dementia; Progressive Supranuclear Palsy; Healthy Subjects
MeSH terms: Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Supranuclear Palsy, Progressive
Study type: Interventional

Summary: 
      Frontal patients are impaired in categorisation and analogical reasoning tasks, and different
      functional imaging studies from our group have shown the involvement of the prefrontal cortex
      in categorisation and analogy tasks. The aim of this project is to test our hypotheses about
      the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.
    


Intervention name(s): transcranial magnetic stimulation; MRI imaging; EEG recording; Neuropsychological examination
Intervention type(s): Device; Other; Other; Behavioral
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Intervention for Resistant Pregnant Smokers
Condition: Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases
Study type: Observational

Summary: 
      This 31-month supplement to Sustaining Women's Smoking Cessation Postpartum (Project PANDA)
      designed, implemented, and evaluated an intensified intervention for pregnant women who were
      unable to stop smoking with minimal assistance.
    

Detailed description: 
      DESIGN NARRATIVE:

      The substudy was a population-based experiment with White, Black, and Hispanic pregnant women
      whose continued smoking made them ineligible for randomization into the parent study. It was
      unique in focusing on heavier, more addicted pregnant smokers. PANDA research sites and
      protocols offered a special opportunity for a low cost test of a disseminable intervention
      which this project team was uniquely qualified to design and implement. The new intervention,
      One- to-One, used telephone counselors to assess the counselee's stage in the change process
      and give stage-appropriate messages, using established techniques of motivational
      interviewing. Between the two counselor calls spaced 10 days apart, counselees received
      personalized written feedback and suggestions. The primary aim, increasing quitting during
      pregnancy, was assessed by unobtrusive urine samples taken during prenatal visits in the
      ninth month and identified only by study group.

      A series of postpartum interviews with subsample cotinine validation was used to examine the
      second important aim, reduction of infant smoke exposure. A combination of messages, peer
      modeling, and support helped women sustain cessation after delivery and eliminate smoking
      around the baby. Project PANDA videotapes and newsletters already contained these messages
      and required only minimal supplementation to be used with the One-to-One experimental group,
      regardless of their success in quitting in pregnancy. As in Project PANDA, the assessments
      were separated from the experiment by enrolling subjects in a university-sponsored study of
      new mothers' health practices and baby care and by presenting the program as usual care by
      the health care site.
8-stage Model and Its Implications in National Pakistani Tennis Players
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of structured exercises for tennis
      serve performance by using 8-stage model.
    

Detailed description: 
      Tennis serve stroke is the most crucial component of tennis. 8-stage model like other
      training programs has proven to be effective in improving performance. This exercise program
      has yet not been implemented in Pakistani tennis players and remain to be tested in local
      population.

      This randomized controlled trial has been designed to assess the effectiveness of 8-stage
      model based exercise program in Pakistani national tennis players. The present study has
      hypothesized that there will be a significant difference between the effects of 8-stage model
      and conventional training program. There are two arms of intervention in this study:
      experimental and control group. Experimental group would follow the 8-stage model based
      exercise training program while control group would follow their conventional exercise
      training program. Outcome measurements (speed, flexibility, strength) has been carried out at
      baseline and after 12 weeks.
    

Intervention name(s): 8-stage model based exercise program; Conventional exercise program
Intervention type(s): Other; Other
Intervention description(s): The experimental group would follow exercises related to 8 phases of tennis serve, which would be based on 8-stage model. The participants would follow this program for three days per week for 12 weeks.; The control group would follow conventional exercise program advised by coaches. The participants of this group would also follow this program for three days per week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: 8-Stage Model; Flexibility; Strength; Tennis Serve
A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks
      in subjects with active ulcerative colitis.

      Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug
      over a total of 12 weeks, followed by an 8-week safety follow-up period.
    

Detailed description: 
      This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study in adult subjects with moderately to severely active UC. Randomization will be
      stratified by Mayo score.

      Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug
      over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration
      of the study will be 20 weeks, excluding the screening period.

      The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in
      subjects with active UC.

      The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with
      active UC on:

        -  Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of
           treatment.

        -  Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in
           subjects with active UC.

        -  Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC

        -  Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
    

Intervention name(s): PRV-300; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Treatment; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis