bioihbjkbjnl/mcl2 huggingface dataset:
Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in
      postmenopausal women with osteopenia or osteoporosis.
    


Intervention name(s): ONO-5334; ONO-5334; ONO-5334; ONO-5334; ONO-5334
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo - 24/mos.; 100mg QD /24 months; 50mg BID /24 mos.; 300mg QD /24 mos.; Alendronate 70mg once weekly / 24 mos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-5334; osteoporosis; osteopenia
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of
      MK8245.
    

Detailed description: 
      Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients
      with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences
      (AEs), to permit continued clinical investigation.
    

Intervention name(s): MK8245; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.; MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal Fluid
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Because AVI-4020 Injection was found to cross the blood-brain barrier, and because AVI-4126
      (RESTEN-NG) has potential medical benefit to people with a variety of diseases, including
      cancers, this study is being performed to find out if AVI-4126 also crosses the blood-brain
      barrier. If it does, then additional investigations could be performed, such as in people
      with certain types of cancer.
    


Intervention name(s): AVI-4126 Injection (RESTEN-NG®)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692
      vs D serine.
    


Intervention name(s): CTP-692; D-Serine
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions
Condition: Intrauterine Adhesions; Chronic Endometritis
MeSH terms: Endometritis; Recurrence; Tissue Adhesions
Study type: Observational

Summary: 
      This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe
      intrauterine adhesions and compare recurrence of adhesion in women with and without CE.
    

Detailed description: 
      Chronic endometritis (CE) is a persistent in endometrium that is characterized by the
      presence of plasma cells. Recently, there has been increasing interest in the role of CE in
      recurrent pregnancy loss (RPL). One of the most common uterine abnormalities for RPL is
      Intrauterine adhesion (IUA).Intrauterine adhesion, also known as Asherman's syndrome, is the
      partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most
      intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility,
      and intrauterine growth restriction, which seriously affect their reproductive health.It is
      well established that the formation of IUA likely involves hypoxia, reduced
      neovascularization, and altered expression of adhesion-associated cytokines, but the exact
      mechanisms are not well understood. Although excessive curettage is considered the primary
      cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors,
      such as postabortal sepsis, puerperal sepsis and infections. It is therefore possible to
      hypothesize that Intrauterine adhesion may be related to chronic endometritis. To the best of
      researchers knowledge,there have been no reports investigating this relationship. The aim of
      this study was to clarify the hypothesis by evaluating the prevalence of chronic endometritis
      (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women
      with and without chronic endometritis (CE).
    

Intervention name(s): Chronic endometritis
Intervention type(s): Other
Intervention description(s): with or without Chronic endometritis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 125 patients who received hysteroscopy in the Department of Obstetrics and
        Gynecology of the First Affiliated Hospital of Sun Yat-sen University and were diagnosed
        with moderate to severe Intrauterine adhesion according to the criteria of American
        Fertility Society (AFS) were recruited into present study.
      
Biospecimen description: 
      endometrium
    
Keywords: intrauterine adhesions; Chronic endometritis; infections; Hysteroscopy
Paraspinal Muscle Remodeling
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      Lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar
      spine with a prevalence of 2 to 3% in the adult population. Unilateral lumbar disc herniation
      is characterized by compression or irritation of the lumbar nerve roots or dural sac by
      either protrusion, extrusion or sequestration of the nucleus pulposus, mostly in the
      posterolateral region. Compression or irritation of the lumbar nerve roots and dural sac can
      induce unilateral sensory and motor symptoms. Therefore, it is the principal cause of lumbar
      spinal surgery.

      Different imaging studies have investigated asymmetry of the paraspinal muscles in patient
      with unilateral low back pain due to lumbar discus herniation. Both animal and human studies
      indicate a reduction in total muscle cross-sectional area, increased fat infiltration and
      fibrosis within the lumbar multifidus at the affected side.

      Increased fat infiltration is clinically important because there is a correlation between the
      amount of intramuscular fat and lumbar muscle dysfunction. Not only fat infiltration
      correlates with lumbar dysfunction, also a lower multifidus cross-sectional area is
      associated with and predictive for low back pain. This indicates that there is an association
      between paraspinal muscle changes/ remodeling and muscle dysfunction that could lead to low
      back pain.

      The aim of this research is to quantify the decrease in muscle and muscle fibre size, the
      amount of fat infiltration, and the amount of fibrosis present within the multifidus muscle
      at the herniated side in relation to the unaffected side. The second aim is to investigate
      the possible role of different cell types in the process of muscle remodeling. The last aim
      of this study is to correlate these muscular changes with long-term functional outcomes such
      as pain, fear and disability. This information can possibly contribute to the etiology of
      paraspinal muscle changes, and provide a handgrip to future research.
    


Intervention name(s): Multifidus muscle biopsy during minimally invasive back surgery
Intervention type(s): Procedure
Intervention description(s): Bilateral biopsy of the multifidus muscle in patient with a unilateral disc hernia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lumbar disc herniation; hernia
Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of HLA-A*2402 restricted epitope peptides
      CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.
    

Detailed description: 
      CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules
      especially in breast cancer using genome-wide expression profile analysis by cDNA microarray
      technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these
      molecules and identified that these peptides significantly induce the effective tumor
      specific CTL response in vitro and vivo. According to these findings, in this trial, we
      evaluate the safety, immunological and clinical response of these peptides. Patients will be
      vaccinated once a week until patients develop progressive disease or unacceptable toxicity.
      On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of
      each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
      Repeated cycles of vaccine will be administered until patients develop progressive disease or
      unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety
      and tolerability of these peptides vaccine. Also we evaluate the immunological and clinical
      response of this vaccine therapy.
    

Intervention name(s): CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1
Intervention type(s): Biological
Intervention description(s): CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: no number
Exploratory/Proof of Principle Microbiota Study
Condition: Fecal Microbiota
Study type: Interventional

Summary: 
      This clinical trial will evaluate the stool of infants fed one of two infant formulas, which
      contain different types of proteins, or breast milk to determine if different proteins have
      an effect on the type of bacteria that enters and lives in an infant's intestine early in
      life.
    

Detailed description: 
      This clinical trial will evaluate the stool of infants fed one of two infant formulas, which
      contain different types of proteins, or breast milk to determine if different proteins have
      an effect on the type of bacteria that enters and lives in an infant's intestine early in
      life.
    

Intervention name(s): Amino acid based infant formula; Extensively hydrolyzed casein infant formula; Mother's own breast milk
Intervention type(s): Other; Other; Other
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Interrupting Sitting Time During Postprandial State
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      The literature has shown that interrupting sitting time with frequent physical activities
      (e.g., cycling on a stationary bike for 3 minutes every 30 minutes of sitting) is effective
      for decreasing blood sugar levels. However, the optimal frequency and distribution of sitting
      interruption remains less clear. The purpose of this study is to compare the effects of two
      different protocols of sitting interruption (i.e., 3 minutes of cycling every 30 minutes
      versus 3 minutes of cycling every 15 minutes) on blood sugar levels.
    

Detailed description: 
      This study will involve two different physical activity conditions and a control condition.
      Each participant will undergo the three conditions in a random order. The first protocol
      involves 3 minutes of cycling on a stationary bike at moderate intensity every 30 minutes for
      6 hours, totaling 36 minutes of cycling exercise. The second protocol involves 3 minutes of
      cycling on a stationary bike at moderate intensity every 15 minutes for 3 hours to match the
      total exercise duration in the first protocol. Participants will remain seated for 3 hours to
      match to the total time spent in the lab. For the control condition, participants will remain
      seated. For each condition, participants will be provided with two meals, one before the
      protocol and another one in the middle of the protocol. The meals will be purchased from the
      cafeteria on campus based on the participant's own choice as long as carbohydrates account
      for 55-65% of total calories. Participants will eat identical meals across the three
      conditions.
    

Intervention name(s): 3-min Exercise Per 30 Min; 3-min Exercise Per 15 Min
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This protocol involves 3 minutes of cycling on a stationary bike at 50 revolutions per minute and 1 kilopond every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise.; This protocol involves 3 minutes of cycling on a stationary bike at 50 revolutions per minute and 1 kilopond every 15 minutes for 3 hours, totaling 36 minutes of cycling exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: three-by-three crossover design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess ALD403 in the prevention of migraine headache in
      frequent episodic migraineurs.
    


Intervention name(s): ALD403; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Eptinezumab-jjmr; Vyepti
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Creatine Supplementation and Cognitive and Physical Tests
Condition: Healthy; Creatine Supplementation
Study type: Interventional

Summary: 
      To assess whether brain creatine availability has an effect on cognition. To do so we will
      seek to increase brain creatine concentration via a creatine supplementation protocol.
    


Intervention name(s): Creatine; Calcium lactate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will have to supplement themselves with creatine for 7 days (20g/day).; Participants will have to supplement themselves with calcium lactate for 7 days (elemental calcium: 0.780g/day).
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
ELND005 in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the dose-related safety and efficacy of multiple
      oral dosages of ELND005 as treatment for Alzheimer's disease (AD).
    

Detailed description: 
      ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally
      administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein
      in the brains of AD patients.

      This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy
      study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate
      AD. Approximately 340 patients will be enrolled into the study at approximately 65 study
      sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's
      participation will last approximately 18 months.
    

Intervention name(s): Placebo Control; ELND005; ELND005; ELND005
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ELND005 matched placebo capsules for oral administration, bid for 78 weeks; ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks; ELND005 capsules for oral administration at a dose of 250 mg bid for 78 weeks; ELND005 capsules for oral administration at a dose of 1000 mg bid for 78 weeks
Other intervention name(s): scyllo-inositol; scyllo-inositol; scyllo-inositol
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Induction Related BK Viremia in Renal Transplant Patients
Condition: Disease Due to BK Polyomavirus; Transplantation Infection; Disorder Related to Transplantation
MeSH terms: Viremia
Study type: Observational

Summary: 
      The increase immunosuppression in our transplant population has led to an unacceptable rate
      of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by
      switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK
      by PCR.
    

Detailed description: 
      Our standard of care has been changed from Thymoglobulin to Simulect and now patients were
      enrolled in this observational trial to gather data on their outcomes related to BK viremia
      and rejection rates. Two groups of patients were compared.

      Retrospective (historical or control) group of subjects: patients who had received a kidney
      transplant and were inducted with Thymoglobulin prior to study initiation.

      Prospective group of subjects: patients who is scheduled to receive kidney transplant and
      will be inducted with Simulect (Basiliximab).

      Inductions in both groups was/is Standard of Care at a time of treatment.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        de novo renal or renal/pancrease transplant patients
      
Keywords: BK Polyomavirus; Transplantation, Kidney; Transplantation, Pancreas
Remote Effects of Lower Limb Stretching
Condition: Fascia; Randomized Controlled Trial; Stretching; Myofascial
Study type: Interventional

Summary: 
      Recent research suggests that the skeletal muscles and the fibrous connective tissue form a
      body-wide network of myofascial chains. A systematic analysis of dissection studies suggests
      that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As
      fascia can modify its stiffness, strain transmission along these meridians is supposable
      (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to
      the proper functioning of the movement system. However, despite solid evidence from in vitro
      studies, scarce data is available concerning the in vivo behavior of the meridians. The
      present study is conducted to resolve this research deficit and to elucidate whether
      stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20)
      participate in the randomized controlled trial. One group performs three 30 s bouts of static
      stretching for the gastrocnemius and the hamstrings respectively. A control group remains
      inactive for the same time. Participants of the third group perform 6x30 s bouts of static
      stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post
      intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM)
      in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement
      analysis system.
    


Intervention name(s): Static Stretching lower limb; Static stretching Cervical
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      CSL112 in healthy volunteers after multiple infusions.
    


Intervention name(s): CSL112; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): reconstituted high density lipoprotein; Normal saline (0.9%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Childhood Reactive Thrombocytosis
Condition: Reactive Thromobocytosis in Children
MeSH terms: Thrombocytosis
Study type: Observational

Summary: 
      Reactive thrombocytosis (RT) in pediatric patients is common, but usually without symptoms.
      The incidence of RT is different depending on age. Mostly, we reasoned that RT is a
      phenomenon, nevertheless the diagnostic value of RT is little known. Therefore, the aim of
      this study was to determine the association of RT and clinical or laboratory characteristics
      in pediatric diseases.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The investigators will enroll all pediatric hospitalized patients with platelet counts more
        than (500x109/l) at complete blood counts examination.The association of reactive
        thrombocytosis and clinical manifestation will be analyzed.