bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the immune memory through the administration of an
      additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody
      persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H.
      influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate
      vaccine GSK1024850A in previous primary and booster studies. For subjects that did not
      receive the investigational vaccine during the primary and booster study, the objective is to
      evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK
      Biologicals' pneumococcal conjugate vaccine GSK1024850A.

      This protocol posting deals with objectives & outcome measures of the extension phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT00370318). The objectives & outcome measures of the booster phase are presented
      in a separate protocol posting (NCT00496015).
    

Detailed description: 
      This protocol posting has been updated according to Protocol Amendment 1, July 2009
    

Intervention name(s): Pneumococcal vaccine GSK1024850A
Intervention type(s): Biological
Intervention description(s): 1 or 2 intramuscular injections
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Catch-up vaccination; Pneumococcal vaccine; Immune memory; Nasopharyngeal carriage; Immunogenicity; Pneumococcal disease; Safety
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Young Adults
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      This study will evaluate the adaptations in skeletal muscle that occur in response to 10
      weeks of weight training with or without peanut protein supplementation in untrained men and
      women ages 18-30
    

Detailed description: 
      This is a two-phase study using both novel and conventional methods to assess how PP
      supplementation affects muscle tissue in young adults who engage in resistance training.
      These two phases will be conducted as part of a 10-week randomized controlled trial in which
      men and women aged 18-30 years (n=40), will be stratified by gender and randomized to a
      resistance training intervention (whole body, two days per week) with PP powder (72g daily;
      n=10 males, n=10 females) provided during the intervention (immediate group, IG) or after the
      intervention (wait-list control, WLC, n=10 males, n=10 females). The aims of this study are
      to determine the acute (deuterium oxide tracer) and chronic (peripheral quantitative computed
      tomography) effects of PP during resistance training on skeletal muscle myofibrillar protein
      synthesis rates, changes in skeletal muscle size and quality, changes in whole and
      appendicular body composition (dual energy x-ray absorptiometry), changes in inflammatory
      markers and the fecal microbiome.
    

Intervention name(s): Peanut protein powder; Full body resistance training
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water; Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group will receive the supplement during the study period and the wait-listed control group will receive the supplement after the study period. Both groups will participate in resistance training during the 10 week period
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: resistance training; muscle hypertrophy; muscle quality
The Detection of CTCs in Patients With Pancreatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment.
Condition: Neoplastic Cells, Circulating
MeSH terms: Neoplastic Cells, Circulating
Study type: Observational [Patient Registry]

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      pancreatic cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers.In view of these facts, We wanted
      to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of
      pancreatic cancer in normal peripheral blood after cryosurgery with or without dendritic
      cell(DC)-cytokine-induced killers(CIK) treatment, and we also compared the specificity with
      reverse transcriptase polymerase chain reaction (RT-PCR) method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with pancreatic cancer and healthy volunteers. The blood of the healthy volunteers will be
      used to evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage pancreatic cancer come to Fuda Hospital for treatment.
      
Keywords: Pancreatic Neoplasms; Circulating Tumor Cells
Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
Condition: Odontalgia
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 4

Summary: 
      This project examines experimental pain and chronic pain in the mouth, specifically the
      condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16
      healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain
      is evaluated by the participants. In three sessions, 3 different medications are tested for
      effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline).
      The aim is to know more about pain mechanisms in AO in order to develop an effective
      treatment.
    


Intervention name(s): fentanyl; S-ketamine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fentanyl; Ketamine; Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Atypical odontalgia; capsaicin; pain; neuropathic pain
Maxillary Sinus Lift With and Without Self-hardening Biphasic Calcium Phosphate.
Condition: Maxillary Sinus Augmentation
Study type: Interventional

Summary: 
      This study was carried out to compare the outcome of sinus lift without grafting material,
      versus the use of moldable, self hardening calcium phosphate biomaterials with simultaneous
      implant placement.
    

Detailed description: 
      This study was designed as a randomized controlled clinical trial, the study population
      consisted of 20 patients with missing maxillary posterior teeth and residual bone height
      5-7mm. The sample was selected conveniently according to a list of inclusion and exclusion
      criteria, the participants were allocated randomly into two equal groups. All patients had
      sinus lift using piezosurgery device with simultaneous implant placement. In group I, blood
      clot was the only filling material. In group II, moldable, self-hardening calcium phosphate
      was the filling material. Clinical and radiographic evaluations were done through 6 months
      postoperatively.
    

Intervention name(s): Moldable self-hardening biphasic calcium phosphate graft; No graft material placed - Blood Clot only
Intervention type(s): Other; Procedure
Intervention description(s): Incision was performed in the canine area then a full thickness mucoperiosteal flap was elevated and exposure of the lateral aspect of the maxillary sinus. Osteotomy of the buccal window was performed using the piezosurgery device followed by meticulous dissection of the sinus membrane. Drilling the site were implants were to be placed, guided by the preformed surgical stent. Implants of appropriate size were torqued to engage the apical aspect of the implant recipient site. The sinus was augmented with moldable self-hardening biphasic calcium phosphate. Repositioning and suturing of the flap using 3-0 black silk suture material.; A pyramidal full thickness mucoperiosteal flap was performed distal to the canine area with a crestal incision located palatally in the edentulous area and vertical extension of the incision to the buccal vestibule using Bard Parker blade number 15. The flap was reflected exposing the alveolar bone. Lateral window was performed and the sinus membrane was elevated using piezo surgery. Drilling at the sites where implants were to be placed was done using Neobiotech implant drilling Kit. Implants. Implants were placed in a self-tapping fashion using a torque wrench. Flaps were replaced back and sutured using 3-0 black silk suture material.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was designed as a randomized controlled clinical trial and the participants were allocated randomly into two equal groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maxillary sinus lift; Piezosurgery; Grafting materials
Tele-assessment in Individuals With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      In most countries, after the measures taken to reduce the effects of the epidemic and
      quarantine practices, a remote screening tool has emerged in order to screen the needs
      developing after COVID-19 and to make the necessary rehabilitation applications in time.
      Sivan et al. A comprehensive multi-system phone scan of the COVID-19 Yorkshire Rehabilitation
      Screening Tool (C19-YRS) has been developed by a multidisciplinary rehabilitation team.

      This study, which will be carried out using the C19-YRS tool and the 30-second sit-and-go
      test that evaluates functional capacity and mobility conditions, is expected to contribute to
      the clinical and literature since most of the studies on COVID-19 focused only on the acute
      and subacute periods. In addition, considering the pandemic conditions all over the world, it
      will be possible to benefit from the advantages of the tele-assessment application and by
      reaching more people, possible clinical problems/needs and whether there is a change
      functional capacities in individuals after COVID-19 will be identified.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who have had COVID-19 and whose treatment was completed and the PCR test was
        negative for 2 times or who passed the positive PCR test for 28 days
      
Keywords: COVID-19; tele-assessment; C19-YRS; rehabilitation needs; functional capacity
A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects
Condition: Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ALN-TTRSC02 in healthy subjects.
    


Intervention name(s): ALN-TTRSC02; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Ascending doses of ALN-TTRSC02 by subcutaneous (SC) injection; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TTR-mediated Amyloidosis; Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Familial Amyloid Polyneuropathies; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related; Familial Amyloidosis; RNAi therapeutic
The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability for the ProLung Test and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Assess the repeatability of the ProLung Test
    

Detailed description: 
      This repeatability study of the ProLung Test enrolled sixty subjects, 30 male and 30 female,
      half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or
      less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by
      the same operator on the same device. Fifty-nine subjects produced evaluable data. Four
      models (algorithms) were tested.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to investigate the effect of barberry juice (BJ) as a natural
      antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a
      randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from "Diabetes
      Association of Iran-Babul ". Patients were randomly allocated to either the BJ group (n=23)
      who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no
      intervention. At the baseline and the end of 8-week intervention, blood pressure and
      biochemical markers were conducted.
    


Intervention name(s): barberry juice
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
APA on Sleep Quality in Women With PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep
      problems. The aim of this study was to explore the effect of auricular point acupressure
      (APA) pressure on sleep quality in women with PCOS.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age
      women. In recent years, women with PCOS appear to have an increased frequency of sleep
      problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was
      to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women
      with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety
      level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So
      as to provide a sleep management strategy in PCOS women for future clinical practice
      guidelines.
    

Intervention name(s): Auricular point acupressure (APA)
Intervention type(s): Other
Intervention description(s): Auricular point acupressure (APA) is a method derived from Traditional Chinese Medicine. PCOS women in the APA group began to apply pressure on the first day of enrollment. Patients were instructed to press each acupuncture point 3 times a day for 30 times. The PCOS woman is then trained to go to the outpatient clinic every 5-7 days to change the auricular acupressure sticker. The intervention period was 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Depakote ER Therapy for Mania Comorbid With Substance Abuse
Condition: Bipolar Disorder; Mania; Substance Abuse; Substance Dependence
MeSH terms: Mania; Substance-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in
      the treatment of patients with bipolar disorder in the manic phase, who also have comorbid
      substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young
      Mania Rating Scale and the Substance Abuse Time Line Follow Back.
    

Detailed description: 
      This study will be performed in male and female subjects with a diagnosis of bipolar disorder
      in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This
      population is selected so the efficacy of Depakote ER in this population can be tested.
    

Intervention name(s): Divalproex ER
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Mania; Substance Abuse; Substance Dependence; Comorbid
This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to assess the effects on coronary artery plaque using aggressive
      lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the
      effect of these treatments on brachial artery vasoactivity.
    


Intervention name(s): Atorvastatin; Pravastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Microcirculation Assessment in Diabetes and Metabolic Syndrome
Condition: Coronary Microvascular Dysfunction; Metabolic Syndrome; Diabetes
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes
      and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear.
      The aim of this study is to invasively assess coronary microcirculation and to investigate
      the relationship of insulin resistance with coronary microvascular dysfunction.

      A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries
      without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will
      be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a
      5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR)
      will be calculated as the distal coronary pressure at maximal hyperemia divided by the
      inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal
      hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA)
      index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood
      examinations before the procedure.
    


Intervention name(s): Coronary microcirculation assessment
Intervention type(s): Other
Intervention description(s): Patients will arrive to the cardiac catheterization laboratory in a fasting state without discontinuation of their cardiac medications. After conventional diagnostic coronary angiography, 3000-5000 I.U. i.v. heparin will be administered, and a 6F coronary guiding catheter will be placed in the ostium of the coronary artery of interest. A 0.014" coronary pressure wire (Radi Medical Systems, Wilmington, Mass) will be calibrated, equalized to the guiding catheter pressure with the sensor positioned in the coronary ostium, and then advanced to the distal coronary artery (down to at least two thirds of the epicardial vessel length). Coronary flow reserve (CFR), fractional flow reserve (FFR) and the index of microvascular resistance (IMR) will be measured after an intravenous infusion of adenosine [140 ug/kg/min] to induce steady state maximal hyperemia.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Positive Effects of Daily Consumption of Bread Enriched With Hydroxytyrosol on the Results of a 12-week Dietary Intervention on Subjects With Type 2 Diabetes Mellitus and Overweight/ Obesity
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      Hydroxytyrosol is a phenolic compound drawn from the olive tree and its leaves as a
      by-product obtained from the manufacturing of olive oil and has antioxidant and antidiabetic
      effects. The use of HT extract in food products is a good strategy to improve their
      nutritional quality. However, this extract has a strong odour and flavour, so it is important
      to be encapsulated for the odour and flavour to be covered up. The purpose of the study is to
      investigate the effects of regular consumption of bread enriched with HT on biochemical
      parameters (blood glucose and cholesterol levels).
    

Detailed description: 
      Subjects with type 2 diabetes mellitus and overweight/ obesity will participate in the
      present study. They will follow a 12-week energy-restricted dietary intervention supplemented
      with a certain amount of bread enriched with hydroxytyrosol. The effects of the dietary
      intervention on biochemical parameters (blood glucose and cholesterol levels) and body weight
      reduction will be examined.
    

Intervention name(s): Wheat bread enriched with hydroxytyrosol; Wheat bread
Intervention type(s): Other; Other
Intervention description(s): Wheat bread enriched with hydroxytyrosol; Wheat bread
Intervention MeSH terms: 3,4-dihydroxyphenylethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment