bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation
      of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib
      given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body,
      in participants who completed study M19-130. This study will assess the change in disease
      symptoms.

      ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus
      Erythematosus (SLE). This study is "double-blinded", which means that neither the trial
      participants nor the study doctors will know who will be given which study drug. Study
      doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a
      different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260
      participants will be enrolled in the study in approximately 100 sites worldwide.

      Participants will receive the following for up to 56 weeks:

      Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once
      daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in
      M19-130 will continue to receive the same treatment in this study. Participants who were
      receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms
      in this study.

      Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and
      Upadacitinib Dose B

      There may be higher burden for participants in this trial compared to their standard of care.
      Participants will attend monthly visits during the course of the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,
      checking for side effects and completing questionnaires.
    


Intervention name(s): Elsubrutinib; Placebo for Elsubrutinib; Upadacitinib; Placebo for Upadacitinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral; Capsule; Oral; Capsule; Oral; Tablet; Oral; Tablet
Other intervention name(s): ABBV-105; ABT-494; RINVOQ
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; ABBV-599; ABBV-105; ABT-494; Elsubrutinib; Upadacitinib
Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia
Condition: ACUTE LEUKEMIA
MeSH terms: Leukemia; Acute Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Clinical trial phase I and II, single-center, historical control, to evaluate the
      effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia
      patients with poor prognosis and haploidentical unmanipulated transplant
    

Detailed description: 
      This clinical trial wants to study the safety, effectiveness and efficacy of NK cells
      incubated infusion (CD56 +, CD3) incubated ex vivo with IL-15 infusion in patients with high
      risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with
      post-transplant cyclophosphamide administration.
    

Intervention name(s): Donor IL-15 stimulated NK cells infusion
Intervention type(s): Biological
Intervention description(s): DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling
Condition: Hyperthermia; Weather; Heat; Heat Stress; Heat Syncope; Aging
MeSH terms: Syncope; Hyperthermia; Sprains and Strains; Heat Stress Disorders
Study type: Interventional

Summary: 
      The incidence and severity of hot weather and extreme heat events (heat waves) is increasing.
      As such, there is an urgent need to develop heat-alleviation strategies that can provide
      targeted protection for older adults who are at an elevated risk for heat-induced illnesses
      or death due to impaired body temperature and cardiovascular regulation. While
      air-conditioning provides the most effective protection from extreme heat, it is inaccessible
      for many individuals and cannot be used during power outages (e.g., heat-related rolling
      blackouts). Immersion of the lower limbs in cold water and/or the application of cold towels
      to the neck have been recommended as simple and sustainable alternatives to air-conditioning.
      However, empirical data to support the efficacy of these interventions for mitigating
      physiological strain and discomfort in older adults is lacking. To address this knowledge
      gap, this randomized crossover trial will evaluate the effect of lower limb immersion with
      and without application of cold towels to the neck on body core temperature, cardiovascular
      strain and autonomic function, dehydration, and thermal comfort in adults aged 65-85 years
      exposed to simulated heat wave conditions (38°C, 35% relative humidity) for 6 hours.
    


Intervention name(s): No cooling (control); Lower limb immersion; Lower limb immersion + neck cooling
Intervention type(s): Other; Other; Other
Intervention description(s): Participants are exposed to 38°C, 35% relative humidity for 6 hours without cooling interventions (control condition). Drinking water is available ad libitum.; Participants are exposed to 38°C, 35% relative humidity for 6 hours. For the last 40 min of each hour, participants lower limbs are immersed in cool water (~20°C) up to the level of mid calf. Drinking water is available ad libitum.; Participants are exposed to 38°C, 35% relative humidity for 6 hours. For the last 40 min of each hour, participants lower limbs are immersed in cool water (~20°C) up to the level of mid calf. During limb immersion, a towel soaked in cool water (~20°C) is placed around the participants neck. The towel is re-wet half way through the 40-min limb immersion. Drinking water is available ad libitum.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participant will complete 3 simulated extreme heat event exposures in random order: i) no cooling intervention (control); ii) lower limb water immersion; and iii) lower limb water immersion with application of cool wet towel to the neck.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Heat wave; Cooling intervention; Heat strain; Cardiovascular strain; Heat and health protection; Extreme heat events
Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)
Condition: Amphetamine-Related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators recently conducted a double-blind, randomized controlled trial (n=60) of
      limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an
      FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine,
      as determined by reduction in meth-positive urines. Sexual risk behaviors also declined
      significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use
      despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily
      doses were taken. All participants received weekly substance use counseling and monthly,
      brief clinician-delivered adherence counseling. The investigators propose expanding upon
      these results by lengthening the treatment period to 24 weeks, with adherence reminders added
      to the counseling, and determining if efficacy is sustained up to 12 weeks after drug
      discontinuation. The sample size for this 9-month study is 120.
    


Intervention name(s): Mirtazapine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Remeron
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; sexual behavior
momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology
Condition: Health Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to find out if information and support provided with a
      mobile-delivered (via iPad) momHealth Teen Pregnancy Program can promote healthy choices and
      behaviors during and after pregnancy.
    

Detailed description: 
      This is a RCT to pilot test an innovative multiple health behavior intervention to influence
      three areas of health for pregnant and parenting adolescents: breastfeeding, healthy
      eating/active living, and depression prevention. Intervention and control groups will be
      compared in the main outcomes of the study (see 4.2.c. and 4.3). Beginning in the last eight
      weeks of pregnancy and extending to one month after giving birth, we use mobile health
      technology (e.g., iPad minis) to deliver multi-media educational modules, text-messaging,
      virtual home visits with professionals using secure televideo, and real-time peer group
      support over televideo. At birth, five weeks, and three months after giving birth,
      effectiveness of the program outcomes will be assessed and compared to a usual care control
      group and include breastfeeding/infant-feeding practices; healthy eating and physical
      activity; and depressive symptoms. This is the first known study to address these multiple
      behaviors simultaneously with pregnant and parenting adolescent women.
    

Intervention name(s): momHealth; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mobile health program delivered via an iPad. Program delivers information and support related to breastfeeding education, Ten Steps of the Baby Friendly Hospital Initiative, healthy eating and active living topics, and depression prevention information.; Participants will receive standard health care via their prenatal provider, including routine prenatal education and postpartum support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using Urine Color as a Marker of Hydration Status
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The purpose of this study was to determine if rapid changes in hydration status could be
      determined by urine color expressed in CIE color space
    

Detailed description: 
      The study will examine if urine color expressed in CIE color space can reflect hydration
      status. Hydration staus will be rapidly altered via exercise in the heat.
    

Intervention name(s): dehydration and rehydration
Intervention type(s): Other
Intervention description(s): dehydration and rehydration
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: urine color was measured during dehydration and rehydration
Masking: None (Open Label)
Primary purpose: Basic Science
MR-Guided High Intensity Focused Ultrasound for Pain Management Of Osteoid Osteoma & Benign Bone Tumors in Children and Adults
Condition: Osteoid Osteoma; Benign Bone Tumor; Pain
MeSH terms: Bone Neoplasms; Osteoma; Osteoma, Osteoid
Study type: Interventional

Summary: 
      The Philips Sonalleve HIFU system is expected to be efficacious in reducing pain scores in
      patients with painful osteoid osteoma and other benign bone tumors, and in reducing their
      pain medication usage. No serious adverse effects are expected to result from this treatment.
    

Detailed description: 
      The objective of this study is to determine if MR-guided high-intensity focused ultrasound
      (MR-HIFU) is safe and effective technique for alleviating the pain associated with osteoid
      osteoma and other benign bone tumors in paediatric patients and adults(up to age 40 yrs).
      This technique meant to be an alternative to the standard-of-care, radiofrequency and
      laser-based percutaneous ablation. Safety of the technique will be assessed through
      evaluating non-targeted heating using MRI based temperature mapping. and inspecting patients
      post treatment for skin burns or other signs of serious adverse events. Efficacy of the
      technique will be assessed by evaluating/recording patients observed pain, quality of life,
      and pain medication usage both before and up to 6 months following treatment.
    

Intervention name(s): MR-Guided High Intensity Focused Ultrasound
Intervention type(s): Device
Intervention description(s): Target treatment of bone lesion using High Intensity Focused Ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Intensity Focused Ultrasound
Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy
Condition: Pain; Thoracotomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is
      contraindicated in certain patients. An alternative is continuous wound catheter analgesia.
      We will investigate whether ropivacaine, administered through a wound catheter placed by the
      surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult
      patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be
      randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75%
      ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or
      saline at the same scheme of administration. Patients will also benefit from
      patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min),
      paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary
      endpoints will be pain intensity on a visual analog scale at rest and on coughing and side
      effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the
      nurses and caring staff involved in this study will be blinded. Solutions of saline and
      ropivacaine will be prepared identically by the central pharmacy, without any possible
      identification of the product.
    


Intervention name(s): ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun); Placebo; ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.; In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.; The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The objective of this study is to determine the effectiveness of different training programs
      on outcomes in persons with spinal cord injury (SCI). We are interested to see which programs
      have the greatest impact.
    


Intervention name(s): Group 1 Training Program; Group 2 Training Program
Intervention type(s): Other; Other
Intervention description(s): Up to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).; Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Quality of life; Participation; Training
A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial
      to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients
      with advanced non-squamous non-small cell lung cancer who failed to second-line standard
      chemotherapy.
    

Detailed description: 
      Approximately 90 subjects will be randomized to Fruquintinib plus best supportive care or
      placebo plus best supportive care at a 2:1 ratio.

      Randomization will be stratified by EGFR (epidermal growth factor receptor) gene status:
      mutant vs. wild type vs. unknown.

      All subjects will receive Fruquintinib/placebo for consecutive 3 weeks, followed by one-week
      rest. A treatment cycle consists of 4 weeks. Tumor assessment will be performed every 4 weeks
      in the first 3 cycles, and every 8 weeks since the 4th cycle, until disease progression.
      Further treatment and survival follow-up after progression will be recorded.
    

Intervention name(s): Fruquintinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After checking eligibility criteria, subjects will be randomized into Fruquintinib plus best supportive care group (treatment group) or placebo plus best supportive care group (control group) in a ration of 2:1.; Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/1 week off
Other intervention name(s): HMPL-013; HMPL-013-placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Injectable Diclofenac for the Prevention of Post-operative Dental Pain
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in
      approximately 75 patients undergoing surgical removal of an impacted lower third molar.
    


Intervention name(s): Diclofenac sodium
Intervention type(s): Drug
Intervention description(s): One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other intervention name(s): Diclofenac HPBCD
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diclofenac, postsurgical pain, oral surgery
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients
      with Multiple Sclerosis
    

Detailed description: 
      Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS,
      inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are
      quite variable and may range from being mild to severe and from short to long lasting. People
      with MS may have a wide variety of symptoms ranging from mild to disabling. Some of
      thesymptoms of MS include visual disturbances such as double vision, weakness in arms or
      legs,difficulty with coordination, fatigue, changes in sensations such as numbness and
      tingling, or difficulties with concentration or memory.The drug being tested in this research
      study is an antibody called CNTO 1275. Antibodies are natural substances made by the body
      that stick to and react with other substances in the body that may cause diseases. The body
      makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been
      manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity
      of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than
      normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in
      animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals
      treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study
      is to better understand the safety and effectiveness of CNTO 1275 in people who have
      relapsing-remitting MS

      Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at
      Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks
      7 and 15.
    

Intervention name(s): CNTO 1275
Intervention type(s): Drug
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Multiple Sclerosis