bioihbjkbjnl/mcl2 huggingface dataset:
Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of paclitaxel and GEM 231 in treating
      patients who have recurrent or refractory solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and maximum tolerated dose of GEM 231 and paclitaxel in
      patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor
      activity of this regimen in these patients.

      OUTLINE: This is a dose escalation study of GEM 231. Patients receive paclitaxel IV over 3
      hours on day 1, immediately followed by GEM 231 over 2 hours on days 1, 4, 8, 11, 15, and 18.
      Treatment continues every 3 weeks in the absence of disease progression or unacceptable
      toxicity. Cohorts of 3-6 patients are treated with one of two doses of paclitaxel and
      escalating doses of GEM 231 until the maximum tolerated dose (MTD) is determined. The MTD is
      defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity.
      Patients are followed monthly for 3 months.

      PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the
      maximum tolerated dose is reached.
    

Intervention name(s): GEM 231; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD),
      Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a
      fed state. Safety will be assessed by periodic measurement of vital signs, physical
      examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events
      (AE).
    

Detailed description: 
      This is a randomized, double-blind study of PIPE-791 or placebo given as single and multiple
      escalating doses in normal healthy subjects. The study will be conducted in three parts: Part
      1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total
      duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling
      approximately 32 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD
      cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-791,
      enrolling approximately 8 subjects for a duration of 6 weeks.
    

Intervention name(s): PIPE-791; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single and multiple ascending oral doses of PIPE-791 tablets.; Single and multiple ascending oral doses of matching placebo tablets.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; PIPE-791; Health volunteers
Collaborative Care for Infants at Risk
Condition: Child Abuse; Primary Health Care; Child Welfare
Study type: Interventional

Summary: 
      This study evaluates the feasibility, acceptability, and impact of a collaborative care
      practice for infants investigated by state Child Protective Services (CPS) for suspected
      maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of
      life, as well as the frequent contact of infants with health care providers in the first year
      of life, the investigators will conduct a RCT to measure the impact of a collaborative
      practice model linking CPS caseworkers with primary health care providers during an
      investigation for suspected infant maltreatment. With this trial, the investigators will ask
      (3a) Can a collaborative practice model improve parent-reported infant health-related quality
      of life 6 months following child welfare involvement for suspected infant maltreatment? and
      (3b) Does a collaborative practice model impact repeat child welfare involvement for
      suspected child maltreatment over 6 months?
    


Intervention name(s): Collaborative Care
Intervention type(s): Other
Intervention description(s): CPS caseworkers will explain collaborative care to parents, ask parents to allow communication with an infant's primary care provider, and have willing parents sign a release allowing communication with the infant's provider during the investigation. Caseworkers will make at least two attempts to contact identified providers with parental consent. In the first week, caseworkers will contact the provider, identify the infant, and summarize the child maltreatment concerns. The caseworker will ask whether the provider recognizes any additional strengths or vulnerabilities for the infant. Prior to case closure, caseworkers will provide a summary of investigation findings, disposition, and service referrals including placement changes, safety planning, family preservation, and community resources, with a summary letter delivered to the provider after case closure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one
      month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months
      of age
    

Detailed description: 
      Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals'
      10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar
      + DTPa-HBV-IPV/Hib
    

Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Lifestyle Interventions for Overweight Adults With Mental Illness
Condition: Mental Health Disorder
MeSH terms: Overweight; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine the lifestyle intervention on life quality and mental
      health among overweight adults with severe mental illness in Shenzhen, China. A total of 210
      overweight adults with severe mental illness will be randomly allocated to intervention group
      and control group. Participants in the intervention groups will receive a 10-month lifestyle
      intervention while the control group will be waitlisted. A group of investigators will
      measure the anthropocentric indicators, blood pressure, lifestyle, life quality, and mental
      health for all participants.
    

Detailed description: 
      Previous studies suggest that overweight is an important risk factor for life quality and
      mental health among patients with severe mental illness. Findings on Chinese adults regarding
      this issue are limited. Thus, we aim to assess the lifestyle intervention on life quality and
      mental health among overweight adults with severe mental illness in Shenzhen, China.

      A total of 210 overweight adults with severe mental illness will be randomly allocated to two
      groups. Participants in the intervention groups will receive a 10-month lifestyle
      intervention while the control group will be waitlisted.

      In the intervention group, participants will receive lifestyle education delivered by trained
      staffs from Wuhan university. The main objective of the lifestyle education is to raise
      participants' awareness regarding the health complications related to obesity and
      subsequently to promote weight loss through behavioural modifications. Participants will be
      advised to reduce energy intake by having three main meals and avoiding snacks; limiting
      intake of sugary food and beverages as well as fried and fatty foods; increasing intake of
      fruits and vegetables, etc. They will be asked to increase physical activity, aiming for a
      minimum 150 min of moderate-intensity exercise per week and/or 10,000 steps per day.

      Outcome measurement include height, weight, blood pressure, dietary habits, sleep, physical
      activity, life quality, and mental health that will be measured by a group of trained
      investigator for all participants.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Nutrition and physical activity education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement
Condition: Drainage
Study type: Interventional

Summary: 
      Surgical skin complications can be costly and could contribute to extended in-patient stay
      following total joint replacement or even the need for re-admission. If efficacy in reducing
      the incidence of post-operative wound drainage and, in turn, surgical wound complications can
      be demonstrated, it may also reduce the length of hospital stay and the need for revision
      surgery or readmission. The aim of this research is to investigate the incidence of
      post-operative wound drainage following elective total joint arthroplasty using two surgical
      skin preparation protocols.
    


Intervention name(s): Duraprep Surgical Solution
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.
Condition: Aging
Study type: Interventional

Summary: 
      Healthy older adults with self-reported cognitive difficulties who receive strategy training
      will demonstrate greater performance benefits on measures of real-world activities, relative
      to those receiving a control intervention, immediately post treatment and at follow-up.
    


Intervention name(s): Real world strategy approach; Psychosocial Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.; The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
Other intervention name(s): Adopted Cognitive Orientation to Occupational Performance (CO-OP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Age-related changes
B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer
Condition: HER2-positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability characteristics of B003 in HER2-positive patients with
      recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the
      maximum tolerated dose (MTD) is explored.
    


Intervention name(s): Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.
Intervention type(s): Biological
Intervention description(s): Usage: Intravenous infusion; Dose escalation stage: doses 0.6, 1.2, 2.4, 3.6, 4.8 mg / kg, 1-6subjects each. Dose expansion stage: 20 subjects are enrolled and take the recommended dose based on the result of dose escalation stage.
Infusion time：90 minutes(90min-106min suggested) for the first time; if no infusion reaction happens, the follow-up time is adjusted to at least30 minutes(30min-40min suggested).Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is the 21st day of the first treatment cycle.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Intervention model description: The study is divided into the dose escalation group and the dose expansion group. Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is from day 1 to day 21 of the first treatment cycle.
Dose expansion stage: treatment cycle is administered every 21days and could be administered continuously until the disease progresses or is intolerable.DLT is not accessed during this stage.
Blind method: open Test range: Domestic test
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLT; MTD; Safety; tolerability; HER2-positive; Recombinant Humanized Anti-HER2 Monoclonal Antibody
A Study of Single and Multiple Doses of ALXN1210 in Healthy, Adult Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety and tolerability of single and multiple doses (400 and 800
      milligrams [mg]) of ALXN1210 following intravenous administration to healthy Japanese
      participants.
    

Detailed description: 
      A total of 3 cohorts were enrolled sequentially. Participants received different doses per
      Cohorts: Cohort 1, 400 mg single dose; Cohort 2, 800 mg single dose; and Cohort 3, 800 mg
      every 4 weeks for a total of 5 doses. The Safety Review Committee (SRC) conducted a review of
      the available clinical and safety data after the last participants in the 400 mg cohort
      (Cohort 1) completed Day 15 to determine if dose escalation to the single dose 800 mg (Cohort
      2) could proceed. The SRC then conducted a review of all available clinical and safety data
      after the last participants in Cohort 2 completed Day 15 to determine if dosing of Cohort 3
      could begin. A 120-day (Cohort 1) or 140-day (Cohort 2) Follow-up Period was performed for
      safety, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity assessments.
      Participants in Cohort 3, however, had a 185-day Follow-up Period for safety, PK, PD, and
      immunogenicity assessments after the fifth dose of study drug.
    

Intervention name(s): ALXN1210
Intervention type(s): Drug
Intervention description(s): Participants received a single dose (400 mg or 800 mg) and multiple doses (800 mg) of ALXN1210.
Other intervention name(s): Ultomiris; Ravulizumab
Intervention MeSH terms: Ravulizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALXN1210; Pharmacokinetics; Pharmacodynamics; Safety; Immunogenicity
An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral
      System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder
      (ADHD).
    

Detailed description: 
      This is an open-label (all people involved know the identity of the intervention), single
      arm, multicenter (when more than one hospital or medical school team work on a medical
      research study), prospective study (study following participants forward in time) to evaluate
      the efficacy and safety of OROS methylphenidate in participants with ADHD (behavior disorder
      originating in childhood in which the essential features are signs of developmentally
      inappropriate inattention, impulsivity, and hyperactivity). The study duration will be of 12
      weeks per participant, which is divided into 2 parts Screening (within 14 days before study
      commences on Day -1) and treatment (8 weeks and will include titration period [from the
      initiation of the study treatment to determination of the individual's maintenance dose] and
      maintenance period [at least 4 weeks after determination of maintenance dose]). Participants
      will receive initial dose depending on their body weight. OROS methylphenidate hydrochloride
      (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for
      participants below 30 kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose
      will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum
      maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be
      decreased by 9 mg depending on tolerability. Efficacy will be evaluated by Korean Version,
      ADHD Rating Scale (K-ARS) total score and Clinical Global Impression)-Severity / Impression
      rating scale CGI-S/I. Participants safety will be monitored throughout the trial.
    

Intervention name(s): Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride
Intervention type(s): Drug
Intervention description(s): OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate Hydrochloride
Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to determine whether reduction of serum calcium concentration by
      cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary
      objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV),
      2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.
    


Intervention name(s): Cinacalcet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days; One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Cognitive Multisensory on Upper Extremity in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      PURPOSE:

      To investigate the effect of cognitive multisensory rehabilitation program on upper extremity
      function in stroke patients.

      BACKGROUND: Cognitive Multisensory Rehabilitation (CMR) is a promising therapy for upper limb
      recovery in stroke, as the CMR considered an effective therapy for motor recovery for adults
      with stroke
    

Detailed description: 
      Thirty patients with stroke The patients will randomly be divided into two equal groups; the
      control group which received the selected exercise program and the study group received the
      same exercise training program in addition to cognitive multisensory rehabilitation program,
      three times per week for 2 months. The evaluation methods Action research arm test (ARAT),
      Fugl-Myer Assessment upper extremity (FMA-UE), manual function test and Motor Evaluation
      Scale for Upper Extremity
    

Intervention name(s): cognitive multisensory rehabilitation; the selected exercise program
Intervention type(s): Other; Other
Intervention description(s): sensorimotor rehabilitation approach, in which the patient is asked to solve sensory discrimination exercises with closed eyes or to solve multisensory discrimination exercises, e.g., by comparing feeling shapes with seeing shapes.; Upper Extremity Range of motion (ROM) exercises Passive Prolonged Stretching and positioning Weight-bearing exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the control group which received the selected exercise program and the study group received the same exercise training program in addition to cognitive multisensory rehabilitation program
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine for Depression: An MRI Study
Condition: Depression; Anxious Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Ketamine has been shown to decrease symptoms of anxious depression quickly. This decrease has
      been shown to last for up to one month. MRI technology will be used before and after ketamine
      for patients with depression to examine the extent to which certain brain areas predict
      ketamine's antidepressant effects.
    

Detailed description: 
      Ketamine's antidepressant effects were measured with Hamilton Depression Rating Scale (HDRS).
      MRI data will also be analyzed to examine the extent to which certain brain areas predict
      ketamine's antidepressant effects.
    

Intervention name(s): Ketamine; Magnetic Resonance Imaging (MRI)
Intervention type(s): Drug; Other
Intervention description(s): Ketamine 0.5mg/kg over 40 minutes IV; MRI technology will be used before and after ketamine for patients with depression
Other intervention name(s): Ketamine Hydrochloride
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ketamine; Depression; Anxious Depression; MRI