bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Lenalidomide for Treatment of Autistic Spectrum Disorders
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory
      cytokines including TNF-alpha and may actually alter the clinical course of autism for some
      children.
    

Detailed description: 
      Autism currently affects 1:142 births and has no definite cause. Recent research has shown
      possible identifying markers in neuroglial inflammation with elevated cytokines IL-1, Il-6,
      and MCP-1 and elevated ratios of CSF/serum levels of TNF-alpha in patients with regressive
      autism.

      Lenalidomide (Revlimid®) is an analogue of thalidomide. Based on the improved clinical
      efficacy predicted for Revlimid® in its effects on TNF-alpha and other immunomodulatory
      cytokines, this oral compound may prove efficacious with less toxicity compared with
      thalidomide.

      The study will evaluate the efficacy of lenalidomide by measurement of changes in EEG,
      clinical global impression, Childhood Autism Rating Scale, and serum and CSF (if available)
      TNF-alpha at the end of the study compared with the same measurements at baseline.
    

Intervention name(s): lenalidomide
Intervention type(s): Drug
Intervention description(s): 2.5 mgs per day orally for 12 weeks
Other intervention name(s): Revlimid
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autistic spectrum disorder; lenalidomide
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is looking at whether Metformin, an agent that is commonly used to treat diabetes,
      can decrease or affect the ability of breast cancer cells to grow and whether Metformin will
      work with other therapies to keep cancer from recurring. Health Canada has not approved the
      sale or use of Metformin to treat breast cancer, although they have approved its use in this
      clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its
      use in breast cancer is considered investigational.
    

Detailed description: 
      This is a multicenter study. Patients are stratified according to hormone-receptor status
      (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body
      mass index (≤ 30 vs > 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy
      (any vs none). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks
           1-4). Treatment continues for up to 5 years in the absence of disease progression or
           unacceptable toxicity.

        -  Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment
           continues for up to 5 years in the absence of disease progression or unacceptable
           toxicity.

      Blood and tumor samples are collected periodically for correlative studies.

      Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline
      and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients).

      After completion of study treatment, patients are followed annually.
    

Intervention name(s): metformin hydrochloride; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIC breast cancer; male breast cancer; HER2-negative breast cancer; estrogen receptor-positive breast cancer; HER2-positive breast cancer; progesterone receptor-positive breast cancer
Intramuscular Hydroxyprogesterone Caproate and Placenta Previa
Condition: Preterm Labor
MeSH terms: Obstetric Labor, Premature; Placenta Previa
Study type: Interventional
Phase: Phase 2

Summary: 
      Antepartum hemorrhage is defined as bleeding from or within the female genital tract,
      occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage
      occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity
      and mortality worldwide.

      Placenta previa is a placenta inserted wholly or in part into the lower segment of the
      uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of
      the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree
      if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal
      os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal
      mortality of 8.1% in the developed world and much more in developing countries.

      Many studies in literature proved the positive correlation between the Placenta previa and
      preterm uterine contractility and also reported that large proportion of women who have
      Placenta previa associated with vaginal bleeding will have subclinical uterine contractions
      before the onset of evident vaginal bleeding.

      There are many tocolytic agents may have a role in conservative management of Placenta previa
      such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation
      of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal
      morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized
      placebo-controlled trial found a significant reduction in recurrent preterm birth before 37
      weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus
      54.9%).
    


Intervention name(s): 17α hydroxy progesterone caproate
Intervention type(s): Drug
Intervention description(s): where patients will have a 17α hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks
Intervention MeSH terms: Progesterone; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers
Condition: Focus of Study: Pharmacokinetics Analysis, in Vivo Dissolution Studies
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an
      orally administered solid dosage form. The aim of this study was to evaluate the
      pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese
      healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters,
      investigators trend to propose a method to estimate in vivo dissolution time and dissolution
      kinetics of solid dosage form.
    


Intervention name(s): paracetamol oral solution; paracetamol tablet
Intervention type(s): Drug; Drug
Intervention description(s): dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose; dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to determine whether the addition of trospium chloride to xanomeline
      tartrate will ameliorate the peripheral cholinergic side effects that have been previously
      experienced with xanomeline tartrate when administered alone.
    

Detailed description: 
      In this inpatient study, volunteers will received either xanomeline alone, or xanomeline plus
      trospium for 7 days. Subjects will report cholinergic side effects daily via visual analog
      scales, for each of nausea, vomiting, diarrhea, sweating and excessive salivation. Clinician
      administered scales will also be administered daily for assessment of the same cholinergic
      side effects.
    

Intervention name(s): xanomeline tartrate; Trospium chloride
Intervention type(s): Drug; Drug
Intervention description(s): xanomeline tartrate, 75 mg capsule, TID; trospium chloride, over encapsulated 20 mg tablet, BID
Other intervention name(s): LY246708; Sanctura
Intervention MeSH terms: Xanomeline; Trospium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Age-Related Changes in Myosin Heavy Chain Composition in Human Orbicularis Oculi Muscle
Condition: Aging
Study type: Interventional
Phase: Phase 1

Summary: 
      Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible
      for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of
      great interest in plastic surgery. We believe that understanding the age-related
      histomorphometric changes in orbicularis oculi muscle is important for improving the current
      rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this
      topic has never been performed before, simply because it is difficult and dangerous to
      perform needle biopsy on orbicularis oculi muscle.
    

Detailed description: 
      Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking
      advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral
      orbicularis oculi muscle can be easily obtained from patients of various ages. This study is
      designed to objectively evaluate the age-related changes in human orbicularis oculi muscle by
      analyzing the composition of isoforms of myosin heavy chain (MHC), which is the predominant
      protein in skeletal muscle. MHC isoforms exist in different types of muscle fibers, and
      determines the maximum contraction speed of the muscle fiber. Therefore, The composition of
      MHC isoforms represents the composition of different types of muscle fiber.

      These muscle specimens are stored with liquid nitrogen right after surgery. In the lab, the
      specimens are sectioned to 40μm in thickness, and soaked in special buffer solution. After
      electrophoresis and staining, bands of different types of MHC can be visualized. The gel is
      scanned and processed with an image analysis system. The density of each band can be
      determined, and the ratio of the different types of MHC can be calculated.

      By dividing the subjects who had their orbicularis oculi muscle sampled during upper
      blepharoplasty operation into age groups of 20, 30, 40, 50, 60 and 70 years, these MHC
      subtypes composition ratios can be compared among the different groups. Therefore, the
      age-related changes of the composition of different muscle types can be concluded.
    

Intervention name(s): obtain surgical specimen for analysis
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: Aging; Orbicularis oculi; Blepharoplasty; Myosin heavy chain (MHC)
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis
Condition: Anesthesia, Endotracheal
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effects of McGrath MAC
      videolaryngoscopy on the intubation time for orotracheal intubation in children with
      torticollis.

      The secondary purpose of this study is to investigate the effects of McGrath MAC
      videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with
      torticollis.
    


Intervention name(s): McGrath MAC videolaryngoscopy; Macintosh Laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction; Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate,
      sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum
      healing. This Proof-of-Principle study will investigate the efficacy of an experimental
      dentifrice compared to a regular fluoride dentifrice, and also whether this provides any
      additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium
      bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.
    

Detailed description: 
      This study will be a single-center, examiner-blind, randomized, stratified, three-treatment,
      parallel group study in healthy adult volunteers with mild to moderate gingivitis. There will
      be six visits to the study site: Screening, Baseline, Day 3 and Weeks 1, 2 and 6. Gingivitis
      will be assessed using a Modified Gingival Index (MGI) and a Bleeding Index (BI). Plaque will
      be assessed by the Turesky modification of the Quigley Hein (TPI). All evaluable teeth (in
      relation to the inclusion/ exclusion general dentition criteria) will be assessed.

      The dosage regimen of twice daily treatment (morning and evening) for the washout dentifrice
      and study products will be the same for all participants and is based on widely recommended
      oral hygiene practice/typical consumer habit. Study participants will be instructed to brush
      for at least 1 timed minute with their assigned study dentifrice on each brushing occasion.
      After 6 weeks (Day 42+/-3 days) twice daily treatment, each participant should complete
      between approximately 84-90 treatment applications. During the washout period for this study
      (minimum 14 days/ maximum 28 days), eligible participants will use a marketed, regular
      fluoride toothpaste and toothbrush (as provided).
    

Intervention name(s): Experimental Dentrifrice; Positive control dentifrice; Negative control dentifrice
Intervention type(s): Other; Other; Other
Intervention description(s): Toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride; Dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride; Dentifrice containing 1100ppm fluoride as sodium fluoride (Crest Cavity Protection)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)
Condition: Hepatitis C, Chronic; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Insulin Resistance
Study type: Observational

Summary: 
      Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard
      treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice
      in Russia. The objective of this study is to examine the influence of insulin resistance on
      the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine
      the prevalence of insulin resistance in different populations of CHC patients.
    

Detailed description: 
      consecutive patient sampling
    

Intervention name(s): Pegylated Interferon; Ribavirin
Intervention type(s): Biological; Drug
Intervention description(s): Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
The treatment course duration complied with the labeled dosage regimen. Each dose of pegylated interferon was administered as a subcutaneous
injection calculated as 1.5 mcg/kg once a week. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.
The Sponsor did not provide formal drug supply.; Routine treatment with a combination of any pegylated interferon and ribavirin was used according to the label/local practice in Russia.
The treatment course duration complied with the labeled dosage regimen. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the
morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
The Sponsor did not provide formal drug supply.
Other intervention name(s): PegIntron; (SCH 54031); Rebetol; (SCH 18908)
Intervention MeSH terms: Interferons; Ribavirin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include naïve patients with chronic hepatitis C (CHC) of any genotype who
        will be treated with a standard treatment regimen (pegylated interferon and ribavirin)
        according to routine clinical practice in Russia.
The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of EFEX-OA-02 is to explore how running, cycling, exercise simulation and resting
      acutely influence collagen and proteoglycan homeostasis in OA, as reflected by changes in
      collagen and proteoglycan levels in urine and serum.
    


Intervention name(s): Cycling then running; Running then cycling; Inotropy; Resting
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Ergometer cycling Treadmill running; Treadmill running Ergometer cycling; Adrenaline induced inotropy; Subjects must be minimally physically active
Other intervention name(s): Exercise; Exercise; Exercise simulation; Non-Ex
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study period will be 4 weeks. In each week, the subjects will undergo a different physical activity intervention. The order of the interventions will be randomized. The interventions will be separated by a minimum of 4 days. Inteventions: Cycling, Running, exercise-simulation with inotropy and resting.
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity
Condition: Diet Habit; Microbial Colonization; Activity, Motor
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      Both the endocannabinoid system and the microbiome are highly conditioned by nutrition and
      physical activity, and have an interdependent, bidirectional relationship. We suggest
      studying the interleaving between the endocannabinoidome-microbiome axis and host metabolism
      under the combined effect of a diet and physical activity. More specificly, we will study the
      link between the impact of the diet on the intestinal microbiome and the endocannabinoid
      reaction after intense exercise.
    

Detailed description: 
      Aims of the study are to compare the impacts of two short 7-day contrasted nutritional
      interventions (the Mediterranean diet (MED) and the Canadian diet (CAN)) on blood metabolites
      (endocannabinoids) after a maximal aerobic test. A 3 weeks washout between the two diets is
      planned. Gut microbiome at each test will also be evaluated.
    

Intervention name(s): 3 maximal aerobic tests
Intervention type(s): Other
Intervention description(s): Maximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Microbiome; Endocannabinoids
Second Line Chemotherapy for Advanced Pancreatic Cancer
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      No validated second-line chemotherapy for the treatment of locally advanced/metastatic
      pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or
      Oxaliplatin)-based regimen.

      Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was
      reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI)
      which could be useful even as second-line chemotherapy.

      An exploratory study in this setting seem warranted.
    


Intervention name(s): FOLFIRI
Intervention type(s): Drug
Intervention description(s): Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FOLFIRI; Metastases; pancreatic adenocarcinoma; locally advanced or metastatic pancreatic adenocarcinoma
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects
      with overactive bladder compared to tolterodine wmg, bid
    


Intervention name(s): solifenacin succinate; tolterodine
Intervention type(s): Drug; Drug
Intervention description(s): Oral; oral
Other intervention name(s): Vesicare; YM905
Intervention MeSH terms: Solifenacin Succinate; Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: solifenacin; Overactive bladder; Urinary incontinence; Treatment outcomes; VESIcare