bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine how reducing the level of nicotine in cigarettes
      may affect adolescent smoking behavior. In this study, the researchers will randomize
      adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine
      content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline
      period. Participants will be instructed to smoke only those cigarettes. The researchers will
      conduct daily assessments of total cigarette use (both study cigarette and non-compliant use
      of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon
      monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes
      and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and
      toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect
      real-world smoking behavior in adolescents, and illuminate the potential mechanisms through
      which these products may effect such changes. Such knowledge will contribute to the science
      base that may inform future policy decisions.
    


Intervention name(s): Very low nicotine content cigarettes; Standard nicotine content cigarettes
Intervention type(s): Other; Other
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Validation Study of Linear Quantification of CD3+ Cells in Localized Colorectal Carcinomas
Condition: Metastatic Colorectal Cancer
MeSH terms: Carcinoma; Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to confirm that linear quantification of CD3+ cells is a
      prognostic biomarker in localized colorectal carcinomas.
    

Detailed description: 
      Adult patients of both gender who have underwent surgical resection of stage III colorectal
      carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the
      PETACC8 trial.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patient of both gender who have underwent surgical resection of stage III colorectal
        carcinoma
      
Biospecimen description: 
      Tissues: colorectal carcinoma and adjacent non-tumor tissues are collected in formalin fixed
      paraffin embedded blocks.
    
Keywords: Colon and rectum carcinoma; Immune response; Biomarker; Prognosis
Evaluation of Levator Injuries Using Transvaginal Endosonography
Condition: Childbirth Related Levator Injuries
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Prospective studies to date have identified that the levator ani muscle injuries occur in
      14-19% of women after vaginal delivery.

      In none of studies a vaginal examination was performed at the time of delivery. It has
      previously been shown that sonographic injuries of the anal sphincter that were believed to
      be occult were in fact clinically apparent but not recognised at the time of delivery. It is
      therefore important to correlate clinical findings to ultrasound images.

      3D endovaginal endosonography has not previously been used to identify levator injuries. This
      should potentially provide a better view of the pelvic floor muscles.

      The relationship between levator injury and symptoms of pelvic floor dysfunction has not been
      previously established using validated questionnaires. In this study, we include validated
      questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As
      symptoms may become apparent only in the long term it is prudent that the women are followed
      up in the long term.

      The principle objective is to establish the incidence of levator muscle defects during
      pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and
      damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic
      organ prolapse.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous
Hyaluronic Acid Application Following Frenectomy
Condition: Frenulum; Hypertrophy, Lip
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      This randomized clinical study aimed to compare the outcomes of the laser-assisted frenectomy
      with and without topical hyaluronic acid application to evaluate the effect of HA on
      secondary wound healing after frenectomy surgery.

      The study included a total of sytemically healthy 40 patients , with high labial frenulum
      attachment requiring frenectomy. Following laser-assisted frenectomy operation HA gel was
      applied to the wound surface in the test group, and no application was made to the control
      group The HA application was made topically to completely cover the surgical area on days 3,
      7, and 14 postoperatively. Photographs of the operation area were taken on days 3, 7, and 14.
      The changes in the area measurements between the digital images according to the healing
      periods were calculated on a computer. according to Visual Analogue Scale (VAS) was used to
      evaluate Patient comfort and pain levels.
    

Detailed description: 
      the aim of this study was to clinically evaluate the effect on secondary wound healing of the
      topical application of hyaluronic acid to the surgical field after frenectomy operation
      performed with laser, through evaluation of the amount of reduction of the wound site and
      postoperative pain levels.The study included a total of 40 patients who had maxillary high
      labial frenulum attachment and were planned to undergo frenectomy and met the study inclusion
      criteria. All the patients were informed about oral hygiene control and attention was paid
      that optimal oral hygiene was maintained throughout the study. Phase I periodontal treatment
      was applied to patients where necessary. The area measurements of the wound site formed after
      frenectomy was taken immediately after the frenectomy and on days 3, 7, and 21
      postoperatively. HA gel was applied topically after the frenectomy operation to the test
      group and not to the control group. All the surgical procedures were performed by the same
      surgeon.
    

Intervention name(s): Hyaluronic acid
Intervention type(s): Biological
Intervention description(s): Topical application of hyaluronic acid following Laser assisted frenectomy
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the current study is to determine whether ibuprofen, given as immediate or delayed
      prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune
      response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals'
      10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3,
      4 and 5 months of age.

      In addition, this study will further evaluate the impact of prophylactic administration of
      paracetamol following primary vaccination with immediate or delayed administration or when
      given in an immediate manner at the time of the booster dose.
    


Intervention name(s): GSK1024850A (SynflorixTM); Infanrix hexa; Infanrix-IPV/Hib; Ibuprofen; Paracetamol
Intervention type(s): Biological; Biological; Biological; Drug; Drug
Intervention description(s): Intramuscular injection, 4 doses; Intramuscular injection, 3 doses; Intramuscular injection, 1 dose; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight; Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other intervention name(s): Nurofen for Children; Panadol Baby
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Immunogenicity; Safety; Fever; Primary vaccination; Booster vaccination; Pneumococcal disease; Prophylactic antipyretic
Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture
Condition: Prosthesis Durability
MeSH terms: Prosthesis Failure
Study type: Interventional

Summary: 
      This clinical study will be conducted to evaluate and compare non-modified printable acrylic
      resin base material and modified printable acrylic resin base material with zirconia oxide
      nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness;
      microbiological assessment of denture base microbiological analysis peri-implant soft tissue
      health around used implants
    


Intervention name(s): implant supported overdenture
Intervention type(s): Procedure
Intervention description(s): mandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.
Condition: Prophylaxis of A/H3N2v Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in
      children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly
      65 years and older.
    


Intervention name(s): Swine Influenza
Intervention type(s): Biological
Intervention description(s): Comparison of different dosages of vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza
A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy of the study drug known as
      duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.
    


Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY248686
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Healthy Eating & Active Living for Diabetes in Primary Care Networks
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators aim to establish the effectiveness of a prescribed, community-based
      lifestyle modification program for those with recently diagnosed diabetes. The investigators
      hypothesize that those who enter a 6 month program will report greater levels of physical
      activity compared to a group who do not enter the program but who continue to receive usual
      care.
    


Intervention name(s): HEALD; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A six month, two phase pedometer-based walking program. For weeks one and two of phase I, participants will attend a group-based 60 minute education/supervised walking session. They will be asked to set a daily step goal and to attempt to achieve this on a daily basis over three months. Their steps will be recorded in a step log. For weeks one and two of phase II, participants will learn how to increase the speed of a portion of their daily steps and will learn the concept of low glycemic index and how to set dietary goals related to this concept. They will attend two sixty minute group-based education/supervised walking sessions.; Control
Other intervention name(s): Pedometer-based lifestyle intervention; Control, Usual care, off group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
Condition: End-Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic
      changes or both. Human immunodeficiency virus-infection may exacerbate the state of
      malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on
      hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no
      peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition.
      The nutritional state will be determined in magnet resonance tomography at the start and at
      the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma
      albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal
      per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their
      counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV
      patients. This pilot study may lead to larger randomized clinical trials and, may affect
      dietary recommendations.
    

Detailed description: 
      In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes,
      malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body
      weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In
      addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or
      not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is
      unclear.

      Hypothesis to be tested:

      Daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF
      alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in
      mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in
      chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental
      nutrition.
    

Intervention name(s): peroral high-caloric supplemental nutrition; peroral supplemental nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): HIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet; Chronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet
Other intervention name(s): Renilon 7.5 by Pfrimmer Nutricia; Renilon 7.5 by Pfrimmer-Nutricia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: end-stage renal disease; chronic kidney disease
An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Autism Spectrum Disorder; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study is a feasibility study of Internet-delivered CBT for OCD in children and
      adolescents (7-17 years) with comorbid Autism Spectrum Disorder.
    

Detailed description: 
      The main objectives of this study is to evaluate the feasibility, acceptability and
      preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive
      Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum
      Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18).
      The treatment is delivered over 16 weeks. Study participants will be followed up at 3
      (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease
      OCD-symptoms.
    

Intervention name(s): Internet CBT
Intervention type(s): Behavioral
Intervention description(s): The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.
Other intervention name(s): ICBT; Internet-delivered Cognitive Behavior Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD; ASD; Obsessive Compulsive Disorder; Autism Spectrum Disorder; ICBT; eHealth; Internet; CBT; Pediatric; Adolescents; Children; Internet-delivered
Study of Repetitive Transcranial Magnetic Stimulation in the Treatment of Cognitive Impairment in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      1. Exploration of repetitive transcranial magnetic stimulation（rTMS）on working memory and
           cognitive impairment symptoms of schizophrenia treatment and mechanism.

        2. Analysis of high-frequency repetitive transcranial magnetic stimulation stimulation to
           the improvement of negative symptoms and psychotic symptoms.
    

Detailed description: 
      The study was a randomized double-blind sham-controlled trial for 4 weeks. Patients with
      schizophrenia were treated with 20-Hz rTMS for 4 weeks to the left dorsolateral prefrontal
      cortex (added to the ongoing treatment). Negative symptoms were assessed with the Scale for
      the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale
      (PANSS).The auditory steady state responses (ASSR) were obtained for the assessment of gamma
      oscillation.And cognitive symptoms were assessed by MATRICS cognitive test battery (MCCB)
      Chinese version and n-back task.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
Condition: Volume Loss in the Infraorbital Hollow Area
Study type: Interventional

Summary: 
      -  Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the
           correction of volume loss in the infraorbital hollow (IOH) area by demonstrating
           superiority to untreated control.

        -  Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
    


Intervention name(s): Belotero Balance (+) Lidocaine, needle; Belotero Balance (+) Lidocaine, cannula; Untreated-control / delayed-treatment, needle; Untreated-control / delayed-treatment, cannulas
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles; Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas; Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles); Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)
Intervention MeSH terms: Lidocaine; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Women's Health Trial: Feasibility Study in Minority Populations
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Postmenopause
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the feasibility of recruiting women of different socioeconomic status and
      minority groups and to determine whether these women could achieve and maintain a modified
      fat-eating pattern. The full-scale trial sought to determine whether a low-fat diet could
      decrease the incidence of cancer and coronary heart disease in postmenopausal women. The
      National Heart, Lung, and Blood Institute contributed funds over a three-year period to
      measure lipids, lipoproteins, and other cardiovascular disease risk factors.
    

Detailed description: 
      BACKGROUND:

      The Request for Proposal for the Women's Health Trial: Feasibility Study in Minority
      Populations was developed and released by the National Cancer Institute with assistance from
      the National Heart, Lung, and Blood Institute.

      DESIGN NARRATIVE:

      Randomized. Recruitment began in August 1992 and ended in February 1994. Forty percent of the
      subjects were randomized to a control group and 60 percent to the dietary intervention group.
      Dietary counseling aimed to reduce total fat to 20 percent of calories, reduce saturated fat
      and dietary cholesterol intakes, and to increase the intake of fruits, vegetables, and grain
      products. Recruitment and randomization were conducted over an 18-month period at three
      clinical centers. Other objectives of the trial included: development and evaluation of
      strategies for recruiting and retaining women of different racial and SES groups into a
      dietary intervention study; identification of factors affecting compliance; assessment of the
      effects of a modified fat eating pattern on cardiovascular disease risk factors, including
      fasting blood lipids and lipoproteins, glucose and insulin, body weight and blood pressure;
      identification and assessment of potential biochemical and/or biological markers for dietary
      adherence.

      Close-out visits began in May 1994 and ended in September 1994. These visits included six,
      twelve, and eighteen-month follow-up. NCI extended the coordinating center contract through
      January 1996 to support data analysis and publication of research results.
    

Intervention name(s): diet, fat-restricted
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Prevention