bioihbjkbjnl/mcl2 huggingface dataset:
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On
      Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With
      Obesity
    

Detailed description: 
      This study is designed to look at the effect of two doses of PF 06882961 (120 milligram (mg)
      twice a day (BID) and 200 mg BID) on the levels of one dose of rosuvastatin 10 mg and one
      dose of midazolam 2 mg, in otherwise healthy, adult participants with obesity. Total duration
      of study from screening to the telephone visit will be approximately 17 weeks, of which up to
      63 days will be inpatient. All subjects take (i) Rosuvastatin alone, Midazolam alone, PF
      06882961 alone (120 mg BID), PF 06882961 (120 mg BID) + Rosuvastatin, PF 06882961 (120 mg
      BID) + Midazolam, PF 06882961 (200 mg BID) alone, PF 06882961 (200 mg BID) + Rosuvastatin, PF
      06882961 (200 mg BID)+ Midazolam in the study.
    

Intervention name(s): PF-06882961; Rosuvastatin; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 120 mg and 200 mg BID; 10 mg single dose; 2mg single dose
Intervention MeSH terms: Midazolam; Rosuvastatin Calcium
Intervention model: Crossover Assignment
Intervention model description: Crossover
Masking: None (Open Label)
Primary purpose: Other
Keywords: obesity
Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants
Condition: Stress
Study type: Interventional

Summary: 
      Randomized crossover clinical trial in which is intended to assess the effect of facilitated
      tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale
      stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with
      normal practice, without facilitated tucking device.
    

Detailed description: 
      Population(n): 20 newborn When a patient is a possible candidate, consent will be asked their
      parents. After obtaining informed consent signed by parents, it will be assigned a random
      group (G1, G2). In the G1, the first weight without facilitated tucking device and the next
      day with facilitated tucking device will be held. G2 will be done in reverse.

      Handling pre phase (T0): at least 20 minutes before vitals heart rate and respiratory rate
      are taken in five times.

      handling phase (T1): 1. the facilitated tucking device is placed. 2. will wait five minutes
      and weight will be held in the incubator;at the time of leaving it in the incubator the same
      constants are taken.

      post handling phase (T2): the same constants are taken one hour after such manipulation.
    

Intervention name(s): Facilitated tucking device
Intervention type(s): Procedure
Intervention description(s): 20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: newborn; facilitated tucking; position; weight; stress
Feasibility of Action Observation Training [AOT] in Infants After Unilateral Brain Lesion
Condition: Perinatal Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The study examines whether infants with a perinatal unilateral brain lesion can perform an
      "Action Observation Training" [AOT] at the age of 9-12 months . AOT is the targeted and
      concentrated observation of movements and actions to learn new motor skills. In adults with
      hemiplegia after a stroke and in older children with hemiplegia, AOT can lead to an
      improvement in the functions of the affected hand/arm. Infants with early unilateral brain
      damage are at increased risk of developing a hemiplegia and thus impaired upper limb
      function. There is little known about treatment options to promote arm and hand skills in
      early childhood and their effectiveness. In particular, there is a lack of knowledge whether
      AOT could also be used in infants. It is known that even in infants at an early age brain
      activity can be measured while they are observing movements and infants learn a lot about
      observing and imitating.

      Knowledge about the measurement of manual skills is also reduced. So far, tests have been
      used to observe and evaluate how infants use their hands when playing (e.g. Mini-Assisting
      Hand Assessment). The aim of this study is to investigate whether measurements with motion
      sensors can also be used in infants.

      In the pre-post study, about 5 to 10 toddlers will be examined. During four weeks, the
      parents should give the child 20 minutes of AOT per day at home. A therapy diary will be
      completed for this purpose. During six weeks, the parents will use movement sensors on two
      days a week for the upper limb of the infants. Finally, three questionnaires about the AOT
      and the motion sensors will be completed by the parents.
    


Intervention name(s): Action Observation Training [AOT]
Intervention type(s): Other
Intervention description(s): Parents are instructed to show their child repetitive arm, hand and finger movements in a playful and age-appropriate way for about 20 minutes a day, divided into several short sequences. AOT is to be carried out for four weeks at home by the parents and, if necessary, other caregivers. The parents receive instructions which contain background information on the possible importance of AOT for improving the functions of the upper limb, information about positions, promoting motivation, attention and interest as well as tips for promoting movement observation in everyday life.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 4

Summary: 
      This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with
      vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung
      cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with
      neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate
      and the rate of resection, At the same time, the study before and after the anti angiogenesis
      therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of
      Endothelial progenitor cells（EPC）, micro vascular density（MVD） and vascular endothelial
      growth factor(VEGF) expression level, to understanding the correlation between the clinical
      efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these
      markers. In order to find the reference basis for the prediction of the effect of curative
      effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer
      before and after treatment with CT perfusion imaging are studied.
    


Intervention name(s): Endostatin; Vinorelbine; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Endostatin,7.5mg/m^2,intravenous, d1-14;; vinorelbine,25mg/m^2,intravenous, d1, d8;; Cisplatin，75mg/m^2 intravenous,divide into d1-3
Other intervention name(s): Endostar
Intervention MeSH terms: Vinorelbine; Endostatins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer Anti angiogenesis therapy survival
The Effect of New Dentifrices Containing Centella Asiatica and Bamboo Salt on Reducing Plaque and Gingivitis
Condition: Labor Trial Refused
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the effect of dentifrice formulations containing Centella
      asiatica and bamboo salt on gingivitis and dental plaque. Participants uses dentifrice which
      contains Centella asiatica and bamboo salt and the same participants will also use placebo
      for tooth brushing by cross-over design.
    

Detailed description: 
      With growing interest in plant-based products among researchers, many toothpastes with
      various herbal extracts have been introduced over the past few decades,Centella asiatica
      (CA), a small herb broadly cultivated in China, Southeast Asia, India and Oceanic countries,
      has long been used for therapeutic purposes since ancient times.CA has been reported to be
      useful in the treatment of skin diseases wound repair and healing of burn. In dentistry, few
      studies have explored the efficacy of CA. In one study, CA was demonstrated to be an
      effective supportive agent following periodontal treatment, resulting in reduced plaque and
      gingivitis. In spite of such wound healing properties of CA, its usage in dental field has
      been limited.

      Bamboo salt (BS) is a Korean folk remedy consisting of sea salt roasted in bamboo which has
      long been used for therapeutic purposes in Korea. Toothpastes containing BS has been sold in
      Korea for some decades. Some in vitro studies and animal studies using rats demonstrated
      anti-inflammatory effects of BS. Nevertheless, no human study has yet evaluated the effect of
      BS on periodontal health.

      Therefore, the new dentifrice containing CA and BS was developed.
    

Intervention name(s): Centella asiatica and bamboo salt; Centella asiatica
Intervention type(s): Other; Other
Intervention description(s): Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.; Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Centella asiatica; bamboo salt; dentifrice
Expression of CVD and HA Between Obesity and Non-obesity Polycystic Ovary Syndrome (PCOS) Women in Taiwan
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in reproductive
      women. It is estimated that 5 to 10% of women of reproductive age have PCOS. One of the major
      diagnostic criteria of PCOS was chronic anovulation which lead to irregular menstruation,
      amenorrhea, and infertility; the other diagnostic criteria was hyperandrogenism which lead to
      hirsutism, acne and alopecia. Furthermore, PCOS is thought as a metabolic disorder, the
      long-term consequence of PCOS were diabetes mellitus and cardiovascular disease, which are
      potentially dangerous in women health. Early diagnosis and prevention is very important to
      the PCOS patients.

      Obesity is the most potential risk of threat to health of populations. There is a major
      impact of obesity on the PCOS related disorders. Insulin resistance and distribution of
      adipose tissue were thought to be the important risk factors of cardiovascular and metabolic
      syndrome. To treat PCOS patients properly,Wan-Fang hospital had established a specific
      medical team. We recently published in "Fertility and Sterility" about the clinical
      presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence (30%)
      in Taiwanese PCOS women than that previous reported (65-80%) in theWestern women. It is
      important to know that some clinical presentation of PCOS might have ethic variance. Insulin
      resistance was reported as another candidate that might have ethic variance.We had reported
      about 40% women in PCOS women were obese, it is similar with previous literature reported.
      Obesity is a major factor that could be controlled during the treatment of PCOS.Weight
      reduction is one of our methods in PCOS treatment. The progressive results for obese PCOS
      women would be facing the risks of diabetes and metabolic syndrome.We thought like to
      evaluate the benefit of weight reduction program to the prognosis of obese women with PCOS.

      Furthermore, it is known that Endothelial progenitor cells (EPC) be an early marker of
      cardiovascular disease, we would like to know the role of EPC to predict metabolic syndrome
      in women with PCOS. Wan-Fang hospital has a professional team in PCOS treatment and research
      which including gynecological endocrinologist, cardiologist, medical endocrinologist,
      specialist in weight reduction. This team had been working well for more that 4 years.

      We hope we can make a contribution to the study and treatment of PCOS in Taiwan.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Polycystic Ovarian Syndrome(PCOS) women in wanfang hospital.
      
Keywords: Obesity,; PCOS,; HA,; CVD
A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor
Condition: Tinea Versicolor
MeSH terms: Tinea; Tinea Versicolor
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the
      Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs.
      Aqueous Gel in Adults with Tinea Versicolor (DBI-202).
    


Intervention name(s): DBI-002 probiotic gel; Aqueous gel
Intervention type(s): Biological; Biological
Intervention description(s): Topical application on skin affected with tinea versicolor; Topical application on skin affected with tinea versicolor
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
Condition: General Anesthesia; Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Observational

Summary: 
      Surgery performed during general anesthesia induces a stress effect on the body. Our plan is
      to identify population at risk of hyperglycemia during perioperative period.
    

Detailed description: 
      This is a prospective study to define the relationship between time profile of glucose
      control before, during and after surgery with patient variables, surgical variables and
      anesthetic variables. Serum glucose levels will be measured preoperatively and then at 30
      minute intervals during surgery. Pain score, pain medication and glucose levels will be
      measured in the post anesthesia recovery room. Subjects will be contacted 2 weeks following
      the date of surgery to determine the incidence of postoperative complications.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        non-diabetic adults undergoing surgery
      
Keywords: non diabetic; catabolic energy state
Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
Condition: Attention Deficit Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a placebo controlled study evaluating the efficacy and safety of medication in adults
      with Attention-Deficit Hyperactivity Disorder (ADHD).
    


Intervention name(s): Extended-release bupropion hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADD; ADHD; attention deficit; hyperactivity
Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology
Condition: Cancer Stem Cells; Postoperative Recurrence and Metastasis; Hepatocellular Carcinoma
MeSH terms: Recurrence
Study type: Observational

Summary: 
      The aim of this study is to establish a platform of detecting and sorting circulating tumor
      stem cells from peripheral blood in HCC patients; to investigate the relationship between
      circulating tumor stem cells and their effects on postoperative recurrence and metastasis, in
      order to provide a new therapeutic target for hepatocellular carcinoma treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        250 healthy volunteers, 250 patients with hepatitis cirrhosis, 500 patients with HCC;
      
Keywords: cancer stem cells
Hepatitis C Antiviral Resistance in African-Americans
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test the hypothesis that African-Americans respond less well to
      combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have
      chronic hepatitis C genotype 1 and who were not previously treated with either interferon or
      ribavirin. Reasons for differences in response, regardless of race, will be studied.
    


Intervention name(s): peginterferon alfa-2a; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Interferon; Ribavirin; Efficacy; Viral load; Genetics; Cytokines; Immunology
TIPS Combined With Variceal Embolization for the Prevention of Variceal Rebleeding in Patients With Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether TIPS combined with variceal embolization
      are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.
    

Detailed description: 
      Variceal bleeding is one of the leading causes of death in patients with cirrhosis. Patients
      with cirrhosis surviving a variceal bleeding are at high risk of rebleeding (over 60% at 1
      year), and mortality from each rebleeding episode is about 20%.

      Placement of TIPS is a well-established technique that is highly effective in preventing
      recurrent variceal bleeding, especially if the TIPS is created with an expanded
      polytetrafluoroethylene (ePTFE)-covered stent, which has a significantly lower risk of shunt
      dysfunction than does TIPS created with bare stents. But the risk of hepatic encephalopathy
      greatly increases and the risk of recurrent variceal bleeding after TIPS placement remains an
      issue. Besides an insufficient decrease in portosystemic pressure gradient after TIPS
      creation alone, fragile variceal vessels also are considered a risk factor for recurrent
      bleeding.

      Accordingly, TIPS combined with variceal embolization has been advocated to achieve the best
      result possible in preventing recurrent variceal bleeding. However, in recent American
      Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus,
      no treatment strategies were clearly recommended maybe because the exact efficacy of this
      strategy remains unclear and high-quality randomized controlled trials still lacks.

      So the investigators hypothesized that embolization of these collateral vessels may increase
      the blood flow within the shunt and into the liver, which can theoretically decrease the
      incidence of shunt dysfunction and encephalopathy, even can prolong the patients' survival.
    

Intervention name(s): TIPS; Variceal Embolization
Intervention type(s): Procedure; Procedure
Intervention description(s): TIPS will be performed with a standard technique. TIPS revision will be planned if any evidence of shunt dysfunction is observed.; Embolization of gastroesophageal collaterals will be conducted via the same jugular vein before TIPS implantation. The major procedures includ (a) angiography of gastroesophageal collaterals after successful intrahepatic puncture of a branch of the portal vein and (b) embolization of gastroesophageal collaterals with coils of varying diameters, which result in the gastroesophageal collaterals disappearing at postembolization angiography.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TIPS; Embolization; Variceal rebleeding
SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
Condition: Generalized Anxiety Disorder (GAD); Anxiety, Separation; Phobia, Social
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years
      with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and
      ECGs.
    


Intervention name(s): SPD503 (extended-release Guanfacine hydrochloride); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance).; Once-daily oral dosing in the evening for 12 weeks.
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment