bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      One purpose of this study is to evaluate the effectiveness and safety in long term treatment
      for patients who completed preceding phase I/II study. The other purpose is to evaluate the
      effectiveness and safety of patients who are re-treated with this drug in recommended dose.
    

Detailed description: 
      Multiple myeloma is a kind of malignant disease in the organ which produce blood cells such
      as bone marrow. It has poor prognosis, especially in patients who are relapsed repeatedly.
      Effective treatment is strongly expected in such relapsed patients in Japan. This is a open
      label multiple center study to evaluate the effectiveness and safety of bortezomib. This
      study is an extension or re-treatment study for patients who were administered with
      bortezomib in preceding Phase I/II study. For extension treatment, the same dose of the
      previous study will be administered into a vein as a bolus twice weekly followed by a 10-day
      rest (3-week cycle). For re-treatment, a recommended dose determined in Phase I/II study will
      be administered in 3-week cycle.
    

Intervention name(s): bortezomib
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; Proteasome inhibitor; Ubiquitin; Boronic acids; Bortezomib
ROSA Oligomineral Water for Oral Hydration in 6-Month-Old Healthy Infants
Condition: Hydration
Study type: Interventional

Summary: 
      The present study evaluates the safety of ROSA oligomineral water in 6-to-12-month old
      healthy children.
    

Detailed description: 
      Our study is designed as an open-label case-control interventional study that evaluates the
      safety of 28-day hydration with ROSA water in healthy infants aged 6-12 months. The
      participants are apparently healthy children breastfed or formula fed; minimal sample size (n
      = 52) was calculated according to 0.8 power to detect a significant difference in the
      prevalence of diarrhea (G*Power 3.1). Final group of participants will consist of sixty-five
      healthy male and female infants (we presume that 20% of participants will drop-out throughout
      the study). The stopping rules for participants include a refuse to participate in this
      research at any time and significant change of health status. All participants will be
      allocated in an open-label manner to two randomly assigned ad libitum hydration regimens:
      first group will receive ROSA water for daily hydration, and second (control) group will
      receive other water of personal choice (including tap water). All testing including parental
      diary of infant general status (e.g. daily amount of water consumed, number of stools per
      day, nutritional habits) and clinician-reported outcomes (e.g. body weight, clinical
      evaluation of hydration will be conducted at pre-administration (baseline) and at follow-up
      (after 28 days of administration). The study is entirely voluntary and the participants are
      free to stop participating at any time.
    

Intervention name(s): ROSA Water; Control water
Intervention type(s): Other; Other
Intervention description(s): Ad libitum hydration with ROSA oligomineral water; Ad libitum hydration with other waters
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants will be allocated in an open-label manner to two randomly assigned ad libitum hydration regimens: first group will receive ROSA water for daily hydration, and second (control) group will receive other water of personal choice (including tap water)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Infants; Water; Safety
An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter trial conducted in Pharmacy retail centers
    


Intervention name(s): tamsulosin
Intervention type(s): Drug
Intervention description(s): 0.4 mg
Intervention MeSH terms: Tamsulosin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Walking to School Supports
Condition: Health Behavior
Study type: Interventional

Summary: 
      This pilot study will test the feasibility and acceptability of an enhanced individual-level
      intervention delivered to 4th-6th graders to increase rates of walking to/from school. Up to
      8 youth who do not already walk to school will be enrolled into the intervention. The
      theoretically-based intervention content will be delivered over 6 weeks through family-based
      telephone coaching sessions, ongoing short message service (SMS) text messaging, and
      activities and content on the study website.
    


Intervention name(s): Support for walking to school
Intervention type(s): Behavioral
Intervention description(s): 5 modules that address psychosocial skills, with ongoing text messaging.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone
      vaccine (2006-2007 formulation).
    


Intervention name(s): Influenza Virus Vaccine, Fluzone®; Influenza Virus Vaccine, Fluzone®
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular; 0.25 mL, Intramuscular
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fluzone®; Influenza; Influenza virus infection; Influenza vaccine
Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX®
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to
      compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection
      (LY01005) and ZOLADEX® in patients with breast cancer.
    

Detailed description: 
      This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial
      using non-inferior design. A total of 188 patients with breast cancer who are suitable for
      endocrine therapy will be enrolled into the screening period from D-28 to D-1 before
      administration. Eligible subjects will be randomized in a 1:1 ratio to receive LY01005 3.6 mg
      intramuscularly or ZOLADEX ® 3.6 mg subcutaneously once every 28 days for three doses until
      intolerable toxicity, disease progression requiring other anti-tumor treatments, withdrawal
      of consent, loss to follow-up, death or the end of the whole study, and stratified according
      to history of chemotherapy (yes vs. no) and age (<45 vs. ≥45 years old). And all subjects
      will be also treated with tamoxifen orally twice per day (10 mg/tablet, 1 tablet/time). Blood
      samples will be collected at the specified time points of the study to detect serum E2, LH
      and FSH. Safety evaluation (including vital signs, physical examination, laboratory tests, 12
      ECG, adverse events, etc.) will be conducted as required in the protocol. Additional blood
      samples will be collected from 12 subjects (PK subgroup) who are randomized to LY01005 group
      to assess the PK and PD characteristics of LY01005 in patients with breast cancer.
    

Intervention name(s): LY01005; ZOLADEX® 3.6 mg
Intervention type(s): Drug; Drug
Intervention description(s): LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period.; ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period.
Other intervention name(s): Goserelin Acetate Sustained-Release Microspheres for Injection; Goserelin Acetate Implant 3.6 mg
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; LY01005; Efficacy; Safety
Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
Condition: Pain; Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This
      prospective clinical trial was conducted aiming to determine whether the addition of an
      autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and
      decrease pain scores.

      Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue
      dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF
      or not by a flip of a coin during the screening visit. Patients were instructed to complete a
      pain study form. The palatal donor area were evaluated for complete wound healing records.
      These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks
      postoperatively.
    

Detailed description: 
      Background: Despite a relatively painful surgical procedure, free gingival graft (FGG) is
      still commonly used to increase keratinized tissue dimensions. This prospective clinical
      trial was conducted aiming to determine whether the addition of an autologous platelet-rich
      fibrin (PRF) after harvesting a FGG would improve soft tissue healing of donor sites and
      subsequently decrease pain scores.

      Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue
      dimensions in the mandibular incisors area. Enrolled patients received periodontal
      examination, oral hygiene instructions and full-mouth debridement followed by standardized
      FGG of similar dimensions. Donor sites were assigned randomly to receive PRF or not by a flip
      of a coin during the screening visit. Patients were instructed to complete a pain study form
      to analyze pain scores including VAS, NRS-101, VRS-4 as well as three anxiety scales at base
      line. The palatal donor area were evaluated for complete wound healing based on the degree of
      color match, tissue texture, and contour of the surgical area compared to preoperative
      records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks
      postoperatively.
    

Intervention name(s): Platelet Rich Fibrin
Intervention type(s): Device
Intervention description(s): Native growth factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Exercise Intervention on the Community's Older Adults
Condition: Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Osteoporosis is a serious global health problem, second only to cardiovascular disease.
      Osteoporosis is the most common metabolic bone disease in the elderly population,
      characterized by loss of bone mineral density (BMD) and continuous destruction of bone
      microstructure, especially in postmenopausal women. It gives rise to bone fragility and
      fracture risk. Moreover, as people grow older, falls frequently occur with high severity, and
      nearly 35% to 45% of persons aged 65 or older fall at least once a year. Osteoporotic
      fractures increase mortality, morbidity, chronic pain, and the cost of social care and it
      decreases the quality of life. Here, investigators plan to perform different exercise
      interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older
      adults to evaluate whether exercise intervention could improve the bone mineral density,
      physical fitness, muscle strength or quality of life.
    


Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): circuit exercise, aerobic dance and Tai Chi exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Cardiovascular Diseases; Microbial Colonization; Aging
MeSH terms: Communicable Diseases; Infections; Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Study type: Observational

Summary: 
      Chronic kidney disease (CKD) is associated with an increased cardiovascular mortality. In
      particular children with early-onset CKD have a lifelong increased risk to suffer from
      cardiovascular disease (CVD). Therefore, children with CKD deserve our attention. The immune
      system in children with CKD is disturbed, exhibiting pro-inflammatory features. Therefore, we
      aim to learn more about the characteristics of the immune system in early-onset CKD. In this
      project PBMC of pediatric CKD patients and age-matched healthy controls will be analysed and
      compared using CITE-Seq as a multimodal scRNAseq phenotyping method. All patients will be
      clinically characterized to integrate cardiovascular and immunological data.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): There will be no intervention in the separate goups, as this is an observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only patients treated at the Department of Pediatric Nephrology in Berlin (Charité),
        Hamburg (UKE) and Leipzig (KfH) will be recruited for this study.
      
Biospecimen description: 
      Fecal and blood samples will be collected at a single timepoint at study enrollment.
Mindful Meditation for Epidural Catheter Placement
Condition: Anxiety; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated
      with these procedures, a method to decrease this anxiety could benefit millions of laboring
      women each year. Mindfulness practice has been used by many groups to decrease anxiety during
      pregnancy with optimistic results. However, there has been no major study evaluating the role
      of mindfulness interventions on anxiety associated with neuraxial placement. The purpose of
      our study is to address this gap in knowledge.
    

Detailed description: 
      The primary objective of this study is to evaluate the effects of a brief mindful meditation
      intervention on anxiety and satisfaction regarding epidural catheter placement for laboring
      parturients.The investigators hypothesize that a brief mindful meditation intervention,
      consisting of a 10 minute auditory instructional practice, implemented before epidural
      catheter placement will:

        1. Decrease anxiety

        2. Increase satisfaction

      compared to a neutral 10 minute auditory recording control, in participants undergoing labor
      epidural catheter placement.

      The secondary objective of this study is to evaluate whether anesthesia providers experience
      a difference in satisfaction with labor epidural catheter placement in participants who
      listen to a brief mindful meditation intervention prior to epidural catheter placement. The
      investigators hypothesize that anesthesia providers placing labor epidural catheters in
      patients who listen to a brief mindful meditation intervention prior to labor epidural
      catheter placement will:

      1. Experience an increase in satisfaction with labor epidural catheter placement.
    

Intervention name(s): 10 minute mindful meditation recording
Intervention type(s): Other
Intervention description(s): 10 minute mindful meditation recording
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation and Autonomic Response in Healthy Subjects
Condition: Pain
Study type: Interventional

Summary: 
      This randomized, crossover sham controlled trial with sham intended to study the effect of
      electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle
      in healthy subjects aims to access the effect o electrical stimulation of accessory spinal
      nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.

      Participants will be assessed through measure changes in cortical activation, local muscular
      peripheral perfusion and autonomic responses before and after intervention and
      intervention-sham, and crossed after a period of wash-out.

      The design aims to contribute to assessment of one electroacupuncture's techniques by
      measuring some of the physiological effects caused by peripheral stimulation.
    

Detailed description: 
      In recent years, there are growing evidence that many diseases such as chronic pain and
      psychiatric disorders can be managed with non-pharmacological techniques. The possibility of
      inducing central neuroplastic responses through transcranial magnetic stimulation (TMS) and
      transcranial direct current stimulation (tDCS) has been widely studied, as well as peripheral
      stimulation techniques such electroacupuncture (EA) and intramuscular stimulation (IMS).
      However, there are few studies on physiological mechanisms, indications and limitations of
      each technique.

      Thus, this randomized, crossover sham controlled trial, where sham intended to study the
      effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with
      acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of
      accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in
      healthy subjects.

      Participants will be assessed through measure changes in cortical activation, local muscular
      peripheral perfusion and autonomic responses before and after intervention and
      intervention-sham, and crossed after a period of wash-out.

      The design aims to contribute to assessment of one electroacupuncture's techniques by
      measuring some of the physiological effects caused by peripheral stimulation.
    

Intervention name(s): Electrical Stimulation
Intervention type(s): Procedure
Intervention description(s): A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;
Other intervention name(s): electroacupuncture
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pain mechanisms; Cortical activation; fNIRS; Accessory spinal nerve; Autonomic response; Muscular perfusion
4 Weeks Treatment of Type II Diabetic Patients With BI 44847
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 44847 in male and female patients with type 2 diabetes following oral administration of
      repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days.

      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI
      44847 after multiple dosing, including assessment of steady state.
    


Intervention name(s): BI 44847; placebo for BI 44847
Intervention type(s): Drug; Drug
Primary purpose: Treatment
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the percentage of subjects who reach the
      target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal
      hypoglycemia during treatment with insulin glargine or NPH human insulin.
    


Intervention name(s): insulin glargine; NPH human insulin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin naive
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who
      have failed at least 1 DMARD.
    


Intervention name(s): placebo; PH-797804; PH-797804; PH-797804; PH-797804
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, once daily (QD) for 12 weeks; Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks; Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks; Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks; Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; Rheumatoid
Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin
Condition: Skin Health
Study type: Interventional

Summary: 
      Participants will be supplemented BFKE for a period of 8-weeks to improve skin health. The
      objective of the study is to evaluate the 'Transepidermal Water Loss (TEWL)' that
      characterizes the skin barrier function of stratum corneum. Additional parameters include,
      evaluation of skin moisture content, wrinkling, elasticity, sagging, radiance and also on
      inflammatory biomarkers.
    


Intervention name(s): Blue fenugreek kale extract; Placebo
Intervention type(s): Other; Other
Intervention description(s): One capsule to be taken orally before breakfast and one capsule after lunch, with water.; One capsule to be taken orally before breakfast and one capsule after lunch, with water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other