bioihbjkbjnl/mcl2 huggingface dataset:
Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118
Condition: Drug Induced Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics
      of NKTR-118
    

Detailed description: 
      A Randomized, 2-Part, Crossover, Single Center Study to Evaluate Effect of Quinidine on the
      Pharmacokinetics of NKTR-118 and the Concomitant Effect of Quinidine and NKTR-118 on
      Morphine-induced Miosis
    

Intervention name(s): Nektar 118; Quinidine; Quinidine placebo; Morphine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral 25 mg tablet; Oral 200 mg tablet; Oral Tablet; 10 mg/ml, intravenously
Intervention MeSH terms: Quinidine; Quinidine gluconate; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy male and female volunteers; Drug-drug interaction; Pharmacokinetics; NKTR-118
Effect of Commute Traffic on Vascular Function
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators will assess the vascular effects of riding in a car in heavily trafficked
      roadways, and whether filtering the car's air reduces those effects.
    

Detailed description: 
      In this double-blind, crossover trial, randomized to order, recruited participants will be
      screened and then will accompany the study team on three typical commutes on separate days
      with sufficient washout (i.e., three weeks) between drives. One day this will occur with an
      effective filter system in the vehicle and the other two days without effective filtration;
      ineffective filtration is the most typical actual vehicle condition. Subjects will be unaware
      of the filtration conditions of the commute on that day. Each subject's experimental sessions
      will occur at the same time of day and will be separated by at least 21 days. The two
      sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in
      duration and will encompass routes on heavily traveled roadways in the Seattle area. Before
      subjects begin the commute trials, they will go through the consent process and a series of
      screening tests. The study investigators will assess a series of measures regarding vascular
      function before and after each drive.
    

Intervention name(s): Filtered Air
Intervention type(s): Other
Intervention description(s): The vehicle is fitted with a (High-Efficiency Particulate Absorbing, HEPA) filter device incorporating a charcoal filter, as well as an augmented cabin filter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: air pollution; traffic; vascular function; gasoline exhaust; diesel exhaust
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
Condition: Restless Legs Syndrome; Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed
      dose conversion recommendations for RLS subjects converting from ropinirole immediate release
      to ropinirole controlled-release for RLS.
    


Intervention name(s): Ropinirole IR 1 mg; Ropinirole IR 2 mg; Ropinirole IR 1 mg Placebo; Ropinirole IR 2 mg Placebo; Ropinirole CR 2 mg; Ropinirole CR 3 mg; Ropinirole CR 2 mg Placebo; Ropinirole CR 3 mg Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance.; Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance.; Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg.; Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.; Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance.; Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance.; Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg.; Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg.
Other intervention name(s): ropinirole controlled-release for RLS
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: RLS; Ropinirole; Restless Legs Syndrome
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a
      targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and
      deliver radiation directly to the center of the tumor mass while minimizing effects on normal
      tissues. Cotara® thus literally destroys the tumor "from the inside out". This may be an
      effective treatment for glioblastoma multiforme, a malignant type of brain cancer.
    

Detailed description: 
      To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B
      MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first
      relapse.

      To estimate overall survival, progression free survival and proportion of patients alive at
      six months after treatment.
    

Intervention name(s): 131I-chTNT-1/B MAb (Cotara)
Intervention type(s): Drug
Intervention description(s): Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.
Other intervention name(s): Cotara®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma multiforme; GBM; brain cancer; Cotara; radioactive isotope; monoclonal antibody; Glioblastoma multiforme at first relapse
Bioavailability of Curcumin Capsules in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, open-label, randomized, two-period, crossover study design of
      pharmacokinetics and bioavailability in healthy adult male and female subjects under fasting
      conditions.
    

Detailed description: 
      Upgraded curcumin capsules(CuminUP60®) is made from curcumin with a natural extraction
      content of 95% and excipients through physical process microprocessing, with a curcumin
      content of more than 60%. CuminUP60® capsules are 400 mg/ capsules and ordinary curcumin
      capsules are 400 mg/ capsules. The main purpose of this study is to evaluate the
      bioavailability by comparing the pharmacokinetics of CuminUP60® capsule with that of curcumin
      capsule before the prescription improvement.

      12 cases are planned to be enrolled.According to the random table, each subject will be
      randomly assigned to one of two groups (group 1: A/B, group 2: B/A). The cleaning period
      between the two doses is 7 days. Subjects were given the test preparation (A) or the control
      preparation (B) on the first day of the first cycle of the trial, and were temporarily
      allowed to leave the phase I clinical research center after 72 hours of blood sample
      collection and vital signs examination after the completion of the medication. After a 7-day
      wash period, on the 8th day of the second cycle, the subject will be cross-administered with
      the control formulation (B) or the test formulation (A), all procedures are the same as in
      the first cycle.

      On the 11th day (the second cycle), subjects will undergo physical examination, ECG
      examination, assessment of vital signs (blood pressure, pulse, body temperature), laboratory
      examinations (blood biochemistry, blood routine, urine routine, detailed examination items
      are shown in the appendix 1) Female subjects must undergo a blood pregnancy test and then be
      allowed to leave the research center.
    

Intervention name(s): CuminUP60®; Curcumin capsules
Intervention type(s): Drug; Drug
Intervention description(s): 4 capsules, 400 mg / capsule; 4 capsules, 400 mg / capsule
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be given test preparation (A) or control preparation (B) on the first day of the first cycle. After a 7-day washout period, on the 8th day of the second cycle, subjects will be cross-administered with the control preparation (B) or test preparation (A)
Masking: None (Open Label)
Primary purpose: Prevention
The Role of Expectations in the Development of Intrusive Memories
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      In the experimental study, the well-established trauma film paradigm will be used to
      investigate the impact of expectations on the development of intrusive memories as a hallmark
      symptom of PTSD.
    

Detailed description: 
      The study aims to examine the influence of different expectations on the development of
      intrusive memories by using a well-established experimental paradigm - the trauma film
      paradigm. In healthy volunteers, intrusion-like symptoms are to be induced with an analogue
      stressor, i.e., aversive film clip footage (trauma film). After viewing this so-called trauma
      film, the expectations of intrusions during the following week are manipulated by assigning
      participants randomly to three different groups. In the first group, negative expectations
      are induced (experimental group 1), the second group is exposed to positive expectations
      (experimental group 2) and a third group does not face any kind of manipulation of their
      expectations (control group). Participants are asked to report occurring intrusions in a
      diary during the following week and are invited to a subsequent cued laboratory inquiry at
      follow-up.
    

Intervention name(s): Positive Expectation Manipulation; Negative Expectation Manipulation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase positive expectations.; Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase negative expectations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of three arms in parallel for the duration of the study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer
Condition: Breast Cancer; Estrogen Receptor Positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of exemestane on the pharmacokinetics
      (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in
      patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer.
      Additionally, this study will evaluate the safety and tolerability of entinostat in
      combination with exemestane, and assess the effectiveness of entinostat in combination with
      exemestane in terms of best overall response and overall survival.
    

Detailed description: 
      SNDX-275-0130 is a Phase 1, two-cohort, open-label, drug-drug interaction study of entinostat
      and exemestane. All patients will be enrolled into one of two cohorts to receive either
      entinostat monotherapy followed by entinostat plus exemestane (Cohort 1), or exemestane
      monotherapy followed by exemestane plus entinostat (Cohort 2).

      The cohorts will enroll sequentially, meaning that Cohort 1 will enroll prior to Cohort 2.
      Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Cohort 2 will evaluate
      entinostat's effect on the PK of exemestane. In both Cohorts, each treatment cycle will be 28
      days. Patients will participate in only one cohort.

      All patients will be assessed at Screening and at specified times during the conduct of the
      study using standard clinical and laboratory assessment. Patients will also be assessed for
      tumor response per standard of care after the Screening Period. Response to treatment will be
      assessed by computerized tomography (CT), magnetic resonance imaging (MRI) and bone scans as
      appropriate. Patients will continue receiving their appropriate cycles of study treatment
      until tumor progression or adverse events (AEs) occur which necessitate discontinuing therapy
      as determined by the Investigator.
    

Intervention name(s): entinostat; exemestane
Intervention type(s): Drug; Drug
Intervention description(s): An orally available histone deacetylases inhibitor (HDAC); Aromatase inhibitor
Other intervention name(s): SNDX-275; MS-275; Aromasin; FCE-24304
Intervention MeSH terms: Exemestane; Entinostat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Neoplasms; Breast Diseases; Exemestane; Protein Kinase Inhibitors; Aromatase Inhibitors; entinostat; Cancer of the Breast; Metastatic Breast Cancer; Hormone Receptor Positive Breast Cancer; Estrogen Receptor; ER+ Breast Cancer; Breast Tumor
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Condition: Rectal Tumors
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The aim of this pilot study is to investigate effectiveness, tolerability and safety of an
      oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low
      anterior resection.
    


Intervention name(s): PreOP Booster (food for special medical purposes)
Intervention type(s): Dietary Supplement
Intervention description(s): 3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Enteral nutritional regimen prior to surgery
Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
Condition: Influenza
MeSH terms: Influenza, Human; Rubella
Study type: Interventional
Phase: Phase 2

Summary: 
      - The primary objective of the study was to determine if intranasally administered influenza
      virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered
      combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children
      interferes with the immune responses.
    

Detailed description: 
      -  The primary objective of the study was to determine if intranasally administered
           influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T), when
           administered concomitantly with a subcutaneously administered combination live,
           attenuated mumps, measles, and rubella (MMR) virus vaccine to children aged 11 to less
           than 24 months, interferes with the immune responses to the measles, mumps, and rubella
           components of the MMR vaccine.

        -  To compare the efficacy over one season against culture-confirmed influenza-illness
           caused by community-acquired subtypes antigenically similar to those contained in the
           vaccine, in children who are aged at least 11 months and less than 24 months at
           enrollment, between those who receive two doses of CAIV-T and those who receive placebo,
           each with concomitant administration of a combination live, attenuated MMR vaccine
           administered prior to the anticipated commencement of the influenza season.
    

Intervention name(s): CAIV-T
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of the application of a citric acid +
      tetracycline gel solution during 90 or 180 seconds compared to no conditioning in the
      outcomes of treatment of Miller's class I or II recession defects by subepithelial connective
      tissue graft.
    

Detailed description: 
      Adult patients showing Miller's class I or II recession defects requiring root coverage were
      recruited to participate in the study. All patients were submitted to non surgical
      periodontal therapy consisting of scaling and root planing, prophylaxis, and oral hygiene
      instruction in order to reduce/eliminate gingival inflammation. After that, patients were
      randomly allocated to three different treatment groups based on root conditioning: G0- no
      conditioning; G90- root conditioning for 90 seconds; G180- root conditioning for 180 seconds.
      Allocation was defined by a software. Root coverage was performed by subepithelial connective
      tissue graft (SCTG) in all treated sites by the same operator, who performed the indicated
      root treatment. Periodontal parameters were investigated at baseline and at 1, 3, 6 and 12
      months post-operatively by a blinded trained expertise different from operator and included:
      pocket depth, recession height, clinical attachment level, width of keratinized gingiva,
      sulcular bleeding index and plaque index. Hypersensitivity at recession sites was also
      investigated at baseline and at 7 days, 14 days, 1, 3, 6 and 12 months after treatment
      according to visual analogic scale (VAS).
    

Intervention name(s): Root conditioning with citric acid+tetracycline solution
Intervention type(s): Other
Intervention description(s): Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft
Intervention MeSH terms: Tetracycline; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingival recession; soft tissue; root biomodification; root coverage; citric acid; tetracycline
Comparing Outcomes of Elbow Extension Tendon Transfers
Condition: Cervical Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      Active elbow extension has significant functional benefits for individuals with tetraplegia.
      The proposed work will provide information to assess how effectively people are using their
      elbow extension tendon transfers, and whether one surgery works more effectively than the
      other. This study will provide recommendations to clinicians about the possibility of
      improving function after surgery using rehab techniques.
    

Detailed description: 
      Voluntary control of elbow extension significantly improves functional abilities for
      individuals with tetraplegia. As a result, surgical reconstruction of elbow extension via
      tendon transfer is considered a fundamental intervention that benefits the patient, even if
      other tendon transfers aimed at improving hand function are never performed. Presently, there
      are two common tendon transfer surgeries used to restore elbow extension following spinal
      cord injury. These are the posterior deltoid to triceps transfer and the biceps to triceps
      transfer. Both surgeries significantly improve voluntary elbow extension, although there is
      variability in the amount of control that is restored among patients. This study will
      directly compare the performance of the posterior deltoid transfer to the biceps transfer
      with regard to: voluntary elbow extension strength, the ability to activate the transfer, and
      neural factors associated with voluntary and involuntary control of individual muscles. These
      comparisons will be made in functionally relevant postures and will provide fundamental
      information that will improve clinical understanding of the capacity of each of these two
      procedures to restore elbow extension.

      The fundamental hypothesis of this proposal is that an inability to maximally activate the
      transferred posterior deltoid and the transferred biceps significantly limits the elbow
      extension moment that can be produced.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Three groups of subjects will be recruited to participate in the experiments: individuals
        that have had the posterior deltoid to triceps tendon transfer, individuals that have the
        biceps to triceps tendon transfer, and individuals with SCI between C5-C7 who have not had
        tendon transfers. Nominally, we plan to recruit 15 subjects from each group.
      
Keywords: tendon transfer; elbow